Alyglo™ (Immune Globulin Intravenous (Human)-stwk) Asceniv™ (Immune Globulin Intravenous (Human) - slra); Bivigam®; Flebogamma® DIF; Gammagard®Liquid; Gammagard® Liquid ERC; Gammagard® S/D; Gammaked™; Gammaplex^®; Gamunex®-C; Octagam®; Panzyga® (Immune Globulin Intravenous (Human) - ifas); Privigen®; Qivigy®(Immune Globulin Intravenous (Human) - kthm); Yimmugo®(Immune Globulin Intravenous (Human) - dira)

IMPORTANT REMINDER

We develop Medical Policies to provide guidance to Members and Providers. This Medical Policy relates only to the services or supplies described in it. The existence of a Medical Policy is not an authorization, certification, explanation of benefits or a contract for the service (or supply) that is referenced in the Medical Policy. For a determination of the benefits that a Member is entitled to receive under his or her health plan, the Member's health plan must be reviewed. If there is a conflict between the Medical Policy and a health plan or government program (e.g., TennCare), the express terms of the health plan or government program will govern.

POLICY

IMPORTANT REMINDER

We develop Medical Policies to provide guidance to Members and Providers. This Medical Policy relates only to the services or supplies described in it. The existence of a Medical Policy is not an authorization, certification, explanation of benefits or a contract for the service (or supply) that is referenced in the Medical Policy. For a determination of the benefits that a Member is entitled to receive under his or her health plan, the Member's health plan must be reviewed. If there is a conflict between the medical policy and a health plan or government program (e.g., TennCare), the express terms of the health plan or government program will govern.

POLICY

INDICATIONS

The indications below including FDA-approved indications and compendial uses are considered a covered benefit provided that all the approval criteria are met and the member has no exclusions to the prescribed therapy.

FDA-Approved Indications

Primary immunodeficiency
Idiopathic thrombocytopenic purpura (ITP)
Chronic inflammatory demyelinating polyneuropathy (CIDP)
Multifocal motor neuropathy
Kawasaki syndrome
B-cell chronic lymphocytic leukemia (CLL)
Dermatomyositis

Compendial Uses

Prophylaxis of bacterial infections in pediatric human immunodeficiency virus (HIV) infection
Bone marrow transplant (BMT)/hematopoietic stem cell transplant (HSCT)
Polymyositis
Myasthenia gravis
Guillain-Barré syndrome
Lambert-Eaton myasthenic syndrome
Fetal/neonatal alloimmune thrombocytopenia
Parvovirus B19-induced pure red cell aplasia
Stiff-person syndrome
Management of immune checkpoint inhibitor-related toxicites
Acquired red cell aplasia
Acute disseminated encephalomyelitis
Autoimmune mucocutaneous blistering diseases
Autoimmune hemolytic anemia
Autoimmune neutropenia
Birdshot retinochoroidopathy
BK virus associated nephropathy
Churg-Strauss Syndrome
Enteroviral meningoencephalitis
Hematophagocytic lymphohistiocytosis (HLH) or macrophage activation syndrome (MAS)
Hemolytic disease of newborn
HIV-associated thrombocytopenia
Hyperimmunoglobulinemia E Syndrome
Hypogammaglobulinemia from chimeric antigen receptor T (CAR-T) therapy
Multiple myeloma
Neonatal hemochromatosis, prophylaxis
Opsoclonus-myoclonus
Paraneoplastic ospoclonus-myoclonus ataxia associated with neuroblastoma
Pediatric Acute-onset Neuropsychiatric Syndrome (PANS)/Pediatric Autoimmune Neuropsychiatric Disorder Associated with Streptococcal Infections (PANDAS)
Post-transfusion purpura
Rasmussen encephalitis
Renal transplantation from a live donor with ABO incompatibility or positive cross match
Retinocochleocerebral vasculopathy, Central nervous system-predominant
Secondary immunosuppression associated with major surgery, hematological malignancy, major burns, and collagen-vascular diseases
Solid organ transplantation, for allosensitized members
Toxic epidermal necrolysis and Stevens-Johnson syndrome
Toxic shock syndrome
Systemic lupus erythematosus (SLE)
Toxic necrotizing fasciitis due to group A streptococcus
Measles (Rubeola) prophylaxis
Tetanus treatment and prophylaxis
Varicella prophylaxis

All other indications are considered experimental/investigational and not medically necessary.

DOCUMENTATION

The following information is necessary to initiate the prior authorization review:

Primary immunodeficiency

Diagnostic test results

Copy of laboratory report with serum immunoglobulin levels: IgG, IgA, IgM, and IgG subclasses
Vaccine response to pneumococcal polysaccharide vaccine (post-vaccination Streptococcus pneumoniae antibody titers)
Pertinent genetic or molecular testing in members with a known genetic disorder
Copy of laboratory report with lymphocyte subset enumeration by flow cytometry

IgG trough level for those continuing with IG therapy

Myasthenia gravis

Clinical records describing standard treatments tried and failed

Secondary hypogammaglobulinemia (e.g., CLL, BMT/HSCT recipients)

Copy of laboratory report with pre-treatment serum IgG level

Chronic inflammatory demyelinating polyneuropathy (CIDP) and multifocal motor neuropathy (MMN)

Pre-treatment electrodiagnostic studies (electromyography [EMG] or nerve conduction studies [NCS])

Dermatomyositis and polymyositis

Clinical records describing standard treatments tried and failed

Lambert-Eaton Myasthenic Syndrome (LEMS)

Neurophysiology studies (e.g., electromyography)
A positive anti- P/Q type voltage-gated calcium channel antibody test

Idiopathic thrombocytopenic purpura

Laboratory report with pre-treatment/current platelet count
Chronic/persistent ITP: copy of medical records supporting trial and failure with corticosteroid or anti-D therapy (unless contraindicated)

Parvovirus B19-indicated Pure Red Cell Aplasia (PRCA)

Copy of test result confirming presence of parvovirus B19

Pediatric Acute-onset Neuropsychiatric Syndrome (PANS)/Pediatric Autoimmune Neuropsychiatric Disorder Associated with Streptococcal Infections (PANDAS)

Medical records confirming the diagnosis and previous treatment with systemic corticosteroids for those initiating the IG therapy
Medical records documenting that other causes of symptoms have been ruled out
Medical records documenting objective assessment of baseline symptoms
Medical records documenting a clinical response for those continuing with IG therapy

Stiff-person syndrome

Anti-glutamic acid decarboxylase (GAD) antibody testing results
Clinical records describing standard treatments tried and failed

Toxic shock syndrome or toxic necrotizing fasciitis due to group A streptococcus

Documented presence of fasciitis (toxic necrotizing fasciitis due to group A streptococcus only)
Microbiological data (culture or Gram stain)

COVERAGE CRITERIA

Primary Immunodeficiency

Initial authorization of 6 months may be granted for members with any of the following diagnoses:

Severe combined immunodeficiency (SCID) or congenital agammaglobulinemia (e.g., X-linked or autosomal recessive agammaglobulinemia):

Diagnosis confirmed by genetic or molecular testing, or
Pretreatment IgG level < 200 mg/dL, or
Absence or very low number of T cells (CD3 T cells < 300/microliter) or the presence of maternal T cells in the circulation (SCID only)

Wiskott-Aldrich syndrome, DiGeorge syndrome, or ataxia-telangiectasia (or other non-SCID combined immunodeficiency):

Diagnosis confirmed by genetic or molecular testing (if applicable), and
History of recurrent bacterial infections (e.g., pneumonia, otitis media, sinusitis, sepsis, gastrointestinal), and
Impaired antibody response to pneumococcal polysaccharide vaccine (see Appendix A)

Common variable immunodeficiency (CVID):

Age 2 years or older, and
Other causes of immune deficiency have been excluded (e.g., drug induced, genetic disorders, infectious diseases such as HIV, malignancy), and
Pretreatment IgG level < 500 mg/dL or ≥ 2 SD below the mean for age, and
History of recurrent bacterial infections, and
Impaired antibody response to pneumococcal polysaccharide vaccine (see Appendix A)

Hypogammaglobulinemia (unspecified), IgG subclass deficiency, selective IgA deficiency, selective IgM deficiency, or specific antibody deficiency:

History of recurrent bacterial infections, and
Impaired antibody response to pneumococcal polysaccharide vaccine (see Appendix A), and
Any of the following pre-treatment laboratory findings:

Hypogammaglobulinemia: IgG < 500 mg/dL or ≥ 2 SD below the mean for age
Selective IgA deficiency: IgA level < 7 mg/dL with normal IgG and IgM levels
Selective IgM deficiency: IgM level < 30 mg/dL with normal IgG and IgA levels
IgG subclass deficiency: IgG1, IgG2, or IgG3 ≥ 2 SD below mean for age assessed on at least 2 occasions; normal IgG (total) and IgM levels, normal/low IgA levels
Specific antibody deficiency: normal IgG, IgA and IgM levels
Other predominant antibody deficiency disorders must meet all of the following:

History of recurrent bacterial infections, and
Impaired antibody response to pneumococcal polysaccharide vaccine (see Appendix A), and
A pre-treatment laboratory finding of hypogammaglobulinemia: IgG < 500 mg/dL or ≥ 2 SD below the mean for age

Other combined immunodeficiency must meet all of the following:

Diagnosis confirmed by genetic or molecular testing (if applicable), and
History of recurrent bacterial infections (e.g., pneumonia, otitis media, sinusitis, sepsis, gastrointestinal), and
Impaired antibody response to pneumococcal polysaccharide vaccine (see Appendix A)

Re-authorization of 12 months may be granted when the following criteria are met:

A reduction in the frequency of bacterial infections has been demonstrated since initiation of IG therapy, AND
IgG trough levels are monitored at least yearly and maintained at or above the lower range of normal for age (when applicable for indication), OR
The prescriber will re-evaluate the dose of IG and consider a dose adjustment (when appropriate).

Myasthenia Gravis

Authorization of 1 month may be granted to members who are prescribed IG for worsening weakness, acute exacerbation, or in preparation for surgery.

Worsening weakness includes an increase in any of the following symptoms: diplopia, ptosis, blurred vision, difficulty speaking (dysarthria), difficulty swallowing (dysphagia), difficulty chewing, impaired respiratory status, fatigue, and limb weakness. Acute exacerbations include more severe swallowing difficulties and/or respiratory failure
Pre-operative management (e.g., prior to thymectomy)

Authorization of 6 months may be granted to members with refractory myasthenia gravis who have tried and failed 2 or more standard therapies (e.g., corticosteroids, azathioprine, cyclosporine, mycophenolate mofetil, rituximab).

Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)

Initial authorization of 3 months may be granted when the following criteria are met:

Disease course is progressive or relapsing/remitting for 2 months or longer
Moderate to severe functional disability
The diagnosis was confirmed by electrodiagnostic studies

Re-authorization of 6 months may be granted when the following criteria are met:

Significant improvement in disability and maintenance of improvement since initiation of IG therapy
IG is being used at the lowest effective dose and frequency

Dermatomyositis or Polymyositis

Initial authorization of 3 months may be granted when the following criteria are met:

Member has at least 4 of the following:

Proximal muscle weakness (upper or lower extremity and trunk)
Elevated serum creatine kinase (CK) or aldolase level
Muscle pain on grasping or spontaneous pain
Myogenic changes on EMG (short-duration, polyphasic motor unit potentials with spontaneous fibrillation potentials)
Positive for anti-synthetase antibodies (e.g., anti-Jo-1, also called histadyl tRNA synthetase)
Non-destructive arthritis or arthralgias
Systemic inflammatory signs (fever: more than 37°C at axilla, elevated serum CRP level or accelerated ESR of more than 20 mm/h by the Westergren method)
Pathological findings compatible with inflammatory myositis (inflammatory infiltration of skeletal evidence of active regeneration may be seen), and

Standard first-line treatments (corticosteroids) and second-line treatments (immunosuppressants) have been tried but were unsuccessful or not tolerated, or
Member is unable to receive standard first-line and second-line therapy because of a contraindication or other clinical reason.

Re-authorization of 6 months may be granted when the following criterion is met:

Significant improvement in disability and maintenance of improvement since initiation of IG therapy

Idiopathic Thrombocytopenic Purpura ITP/(Immune Thrombocytopenia)

Newly diagnosed ITP (diagnosed within the past 3 months) or initial therapy: authorization of 1 month may be granted when the following criteria are met:

Children (< 18 years of age)

Significant bleeding symptoms (mucosal bleeding or other moderate/severe bleeding) or
High risk for bleeding (see Appendix B), or
Rapid increase in platelets is required (e.g., surgery or procedure)

Adults (≥ 18 years of age)

Platelet count < 30,000/mcL, or
Platelet count < 50,000/mcL and significant bleeding symptoms, high risk for bleeding or rapid increase in platelets is required, and
Corticosteroid therapy is contraindicated and IG will be used alone or IG will be used in combination with corticosteroid therapy
Chronic/persistent ITP (≥ 3 months from diagnosis) or ITP unresponsive to first-line therapy: authorization of 6 months may be granted when the following criteria are met:

Platelet count < 30,000/mcL, or
Platelet count < 50,000/mcL and significant bleeding symptoms, high risk for bleeding or rapid increase in platelets is required, and
Relapse after previous response to IG or inadequate response/intolerance/contraindication to corticosteroid or anti-D therapy

Adults with refractory ITP after splenectomy: authorization of 6 months may be granted when either of the following criteria is met:

Platelet count < 30,000/mcL, or
Significant bleeding symptoms

ITP in pregnant women: authorization through delivery may be granted to pregnant women with ITP.

The member’s risk factor(s) for bleeding (see Appendix B) or reason requiring a rapid increase in platelets must be provided.

B-cell Chronic Lymphocytic Leukemia (CLL)

Initial authorization of 6 months may be granted when all of the following criteria are met:

IG is prescribed for prophylaxis of bacterial infections.
Member has a history of recurrent sinopulmonary infections requiring intravenous antibiotics or hospitalization.
Member has a pretreatment serum IgG level <500 mg/dL.

Re-authorization of 6 months may be granted when a reduction in the frequency of bacterial infections has been demonstrated since initiation of IG therapy.

Prophylaxis of Bacterial Infections in HIV-Infected Pediatric Patients

Initial authorization of up to 6 months may be granted to pediatric members with HIV infection when any of the following criteria are met:

IG is prescribed for primary prophylaxis of bacterial infections and pretreatment serum IgG < 400 mg/dL, or
IG is prescribed for secondary prophylaxis of bacterial infections for members with a history of recurrent bacterial infections (> 2 serious bacterial infections in a 1-year period), or
Member has failed to form antibodies to common antigens, such as measles, pneumococcal, and/or Haemophilus influenzae type b vaccine, or
Member lives in an area where measles is highly prevalent and who have not developed an antibody response after two doses of measles, mumps, and rubella virus vaccine live, or
Member has been exposed to measles and request is for a single dose, or
Member has chronic bronchiectasis that is suboptimally responsive to antimicrobial and pulmonary therapy

Re-authorization of 6 months may be granted when a reduction in the frequency of bacterial infections has been demonstrated since initiation of IG therapy.

Bone Marrow Transplant/Hemopoietic Stem Cell Transplant (BMT/HSCT)

Initial authorization of 6 months may be granted to members who are BMT/HSCT recipients when the following criteria are met:

Therapy will be used to prevent the risk of acute graft-versus-host disease, associated interstitial pneumonia (infectious or idiopathic), septicemia, and other infections (e.g., cytomegalovirus infections [CMV], recurrent bacterial infection).
Either of the following:

IG is requested within the first 100 days post-transplant.
Member has a pretreatment serum IgG < 400 mg/dL.
Re-authorization of 6 months may be granted when a reduction in the frequency of bacterial infections has been demonstrated since initiation of IG therapy.

Multifocal Motor Neuropathy (MMN)

Initial authorization of 3 months may be granted when the following criteria are met:

Member experienced progressive, multifocal, asymmetrical weakness without objective sensory loss in 2 or more nerves for at least 1 month
The diagnosis was confirmed by electrodiagnostic studies

Re-authorization of 6 months may be granted when significant improvement in disability and maintenance of improvement have occurred since initiation of IG therapy

Guillain-Barre Syndrome (GBS)

Authorization of 1 month total may be granted for GBS when the following criteria are met:

Member has severe disease with significant weakness (e.g., inability to stand or walk without aid, respiratory weakness)
Onset of neurologic symptoms occurred less than 4 weeks from the anticipated start of therapy

Lambert-Eaton Myasthenic Syndrome (LEMS)

Initial authorization of 6 months may be granted for LEMS when the following criteria are met:

Diagnosis has been confirmed by either of the following:

Neurophysiology studies (e.g., electromyography)
A positive anti- P/Q type voltage-gated calcium channel antibody test

Anticholinesterases (e.g., pyridostigmine) and amifampridine (e.g., 3,4-diaminopyridine phosphate, Firdapse) have been tried but were unsuccessful or not tolerated
Weakness is severe or there is difficulty with venous access for plasmapheresis

Re-authorization of 6 months may be granted when member is responding to therapy (i.e., there is stability or improvement in symptoms relative to the natural course of LEMS).

Kawasaki Syndrome

Authorization of 1 month may be granted for pediatric members with Kawasaki syndrome.

Fetal/Neonatal Alloimmune Thrombocytopenia (F/NAIT)

Authorization of 6 months may be granted for treatment of F/NAIT.

Parvovirus B19-induced Pure Red Cell Aplasia (PRCA)

Authorization of 6 months may be granted for severe, refractory anemia associated with bone marrow suppression, with parvovirus B19 viremia.

Stiff-person Syndrome

Authorization of 6 months may be granted for stiff-person syndrome when the following criteria are met:

Diagnosis has been confirmed by anti-glutamic acid decarboxylase (GAD) antibody testing
Member had an inadequate response to first-line treatment (benzodiazepines and/or baclofen)

Management of Immune Checkpoint Inhibitor-Related Toxicities

Authorization of 1 month may be granted for management of immune checkpoint-inhibitor toxicities when all of the following criteria are met:

Member has experienced a moderate or severe adverse event to a PD-1 or PD-L1 inhibitor (e.g., pembrolizumab, nivolumab, atezolizumab, avelumab, durvalumab)
The offending medication has been held or discontinued
Member experienced one or more of the following adverse events: myocarditis, bullous dermatitis, Stevens-Johnson syndrome, toxic epidermal necrolysis, pneumonitis, myasthenia gravis, peripheral neuropathy, encephalitis, transverse myelitis, severe inflammatory arthritis, Guillain-Barre syndrome, or steroid-refractory myalgias or myositis

Acquired Red Cell Aplasia

Authorization of 6 months may be granted for acquired red cell aplasia.

Acute Disseminated Encephalomyelitis

Authorization of 1 month may be granted for acute disseminated encephalomyelitis in members who have had an insufficient response or a contraindication to intravenous corticosteroid treatment.

Autoimmune Mucocutaneous Blistering Disease

Authorization of 6 months may be granted for autoimmune mucocutaneous blistering disease (includes pemphigus vulgaris, pemphigus foliaceus, bullous pemphigoid, mucous membrane pemphigoid, and epidermolysis bullosa acquisita) when the following criteria are met:

Diagnosis has been proven by biopsy and confirmed by pathology report, and
Condition is rapidly progressing, extensive or debilitating, and
Member has failed or experienced significant complications (e.g., diabetes, steroid-induced osteoporosis) from standard treatment (corticosteroids, immunosuppressive agents).

Autoimmune Hemolytic Anemia

Authorization of 6 months may be granted for warm-type autoimmune hemolytic anemia in members who do not respond or have a contraindication to corticosteroids or splenectomy.

Autoimmune Neutropenia

Authorization of 6 months may be granted for autoimmune neutropenia where treatment with G-CSF (granulocyte colony stimulating factor) is not appropriate.

Birdshot Retinochoroidopathy

Authorization of 6 months may be granted for birdshot (vitiliginous) retinochoroidopathy that is not responsive to immunosuppressives (e.g., corticosteroids, cyclosporine).

BK Virus Associated Nephropathy

Authorization of 6 months may be granted for BK virus associated nephropathy.

Churg-Strauss Syndrome

Authorization of 6 months may be granted for severe, active Churg-Strauss syndrome as adjunctive therapy for members who have experienced failure, intolerance, or are contraindicated to other interventions.

Enteroviral Meningoencephalitis

Authorization of 6 months may be granted for severe cases of enteroviral meningoencephalitis.

Hematophagocytic Lymphohistiocytosis (HLH) or Macrophage Activation Syndrome (MAS)

Authorization of 6 months may be granted for treatment of hypogammaglobulinemia in HLH or MAS when total IgG is less than 400 mg/dL or two standard deviations below the mean for age.

Hemolytic Disease of Newborn

Authorization of 6 months may be granted for isoimmune hemolytic disease in neonates.

HIV-associated Thrombocytopenia

Authorization of 6 months may be granted for HIV-associated thrombocytopenia when the following criteria are met:

Pediatric members with IgG < 400 mg/dL and one of the following:

2 or more bacterial infections in a 1-year period despite antibiotic chemoprophylaxis with TMP-SMZ or another active agent, or
Received 2 doses of measles vaccine and lives in a region with a high prevalence or measles, or
HIV-associated thrombocytopenia despite anti-retroviral therapy, or
Chronic bronchiectasis that is suboptimally responsive to antimicrobial and pulmonary therapy, or
T4 cell count ≥ 200/mm³

Adult members with significant bleeding, platelet count < 20,000/mcL, and failure of RhIG in Rh-positive patients

Hyperimmunoglobulinemia E Syndrome

Authorization of 6 months may be granted to treat severe eczema in hyperimmunoglobulinemia E syndrome.

Hypogammaglobulinemia from CAR-T therapy

Authorization of 6 months may be granted for members with IgG < 400 mg/dL receiving treatment with CAR-T therapy (including but not limited to idecabtagene vicleucel [Abecma], tisagenlecleucel [Kymriah], or axicabtagene ciloleucel [Yescarta]).

Multiple Myeloma

Authorization of 6 months may be granted for multiple myeloma in members who have recurrent, serious infections despite the use of prophylactic antibiotics.

Neonatal Hemochromatosis

Authorization of 6 months may be granted for prophylaxis in members who are pregnant with a history of pregnancy ending in documented neonatal hemochromatosis.

Opsoclonus-myoclonus

Authorization of 6 months may be granted for treatment of either of the following:

Paraneoplastic opsoclonus-myoclonus-ataxia associated with neuroblastoma
Refractory opsoclonus-myoclonus, as last-resort treatment

Pediatric Acute-onset Neuropsychiatric Syndrome (PANS)/Pediatric Autoimmune Neuropsychiatric Disorder Associated with Streptococcal Infections (PANDAS) (See Appendix C)

Initial Authorization of 6 months may be granted when the following criteria are met:

Child meets PANS Research Consortium Diagnostic Criteria for PANS/PANDAS:

Documentation of abrupt, dramatic onset (within less than one month) of obsessive-compulsive disorder or severely restricted food intake; and
Documentation of concurrent presence of additional neuropsychiatric symptoms, with similarly severe and acute onset, from at least two of the following seven categories:

Anxiety
Emotional lability and/or depression
Irritability, aggression, and/or severely oppositional behaviors
Behavioral (developmental) regression
Deterioration in school performance (related to attention deficit/hyperactivity disorder (ADHD)-like symptoms, memory deficits, cognitive changes)
Sensory or motor abnormalities
Somatic signs and symptoms, including sleep disturbances, enuresis, or urinary frequency; and

Onset of symptoms occurs between 3 years of age and puberty; and
Documentation that other causes of symptoms have been ruled out.

Child has tried and failed treatment with systemic corticosteroids.
Documented objective assessment of baseline symptoms has been submitted (e.g., Children's Yale-Brown Obsessive-Compulsive Scale [CY-BOCS], Clinical Global Impression of Severity [CGIS], Parent-Rated Pediatric Acute Neuropsychiatric Symptom Scale [PANS Scale]).

Re-authorization of 6 months maybe granted when documentation of objective clinical response to therapy has been submitted (e.g., Children's Yale-Brown Obsessive-Compulsive Scale [CY-BOCS], Clinical Global Impression of Severity [CGIS], Parent-Rated Pediatric Acute Neuropsychiatric Symptom Scale [PANS Scale]).

Post-transfusion Purpura

Authorization of 1 month may be granted for post-transfusion purpura.

Rasmussen Encephalitis

Authorization of 6 months may be granted for Rasmussen encephalitis in members whose symptoms do not improve with anti-epileptic drugs and corticosteroids.

Renal Transplantation

Authorization of 6 months may be granted for a member undergoing renal transplantation from a live donor with ABO incompatibility or positive cross match.

Retinocochleocerebral vasculopathy, Central nervous system-predominant

Authorization of 6 months may be granted for treatment of central nervous system (CNS)-predominant Retinocochleocerebral vasculopathy (Susac syndrome (SuS)) when used as an adjunctive therapy to corticosteroid and other treatment options.

Secondary Immunosuppression Associated with Major Surgery, Hematological Malignancy, Major Burns, and Collagen-Vascular Diseases

Authorization of 6 months may be granted to prevent or modify recurrent bacterial or viral infections in members with secondary immunosuppression (IgG < 400 mg/dL) associated with major surgery, hematological malignancy, extensive burns, or collagen-vascular disease.

Solid Organ Transplantation

Authorization of 6 months may be granted for solid organ transplantation for allosensitized members.

Toxic Epidermal Necrolysis and Stevens-Johnson Syndrome

Authorization of 1 month may be granted for severe cases of toxic epidermal necrolysis or Stevens-Johnson syndrome.

Toxic Shock Syndrome

Authorization of 1 month may be granted for staphylococcal or streptococcal toxic shock syndrome when the infection is refractory to several hours of aggressive therapy, an undrainable focus is present, or the member has persistent oliguria with pulmonary edema.

Systemic Lupus Erythematosus

Authorization of 6 months may be granted for severe, active SLE in members who have experienced inadequate response, intolerance or have a contraindication to first and second line therapies (e.g., hydroxychloroquine, glucocorticoids, anifrolumab, rituximab).

Measles (Rubeola) Prophylaxis

Authorization of 1 month may be granted for postexposure prophylaxis to prevent or modify symptoms of measles (rubeola) in susceptible members exposed to the disease less than 6 days previously.

Tetanus Treatment and Prophylaxis

Authorization of 1 month may be granted for treatment or postexposure prophylaxis of tetanus as an alternative when tetanus immune globulin (TIG) is unavailable.

Varicella Prophylaxis

Authorization of 1 month may be granted for postexposure prophylaxis of varicella in susceptible individuals when varicella-zoster immune globulin (VZIG) is unavailable.

Toxic Necrotizing Fasciitis Due to Group A Streptococcus

Authorization of 1 month may be granted for members with fasciitis due to invasive streptococcal infection.

CONTINUATION OF THERAPY

Authorization may be granted for continuation of therapy when either the following criteria is met:

For conditions with reauthorization criteria listed under the coverage criteria section: Members who are currently receiving IG therapy must meet the applicable reauthorization criteria for the member’s condition.
For all other conditions, all members (including new members) must meet the requirements in the coverage criteria.

APPENDIX

Appendix A: Impaired Antibody Response to Pneumococcal Polysaccharide Vaccine

Age 2 years and older: impaired antibody response demonstrated to vaccination with a pneumococcal polysaccharide vaccine
Not established for children less than 2 years of age
Excludes the therapy initiated in the hospital setting

Appendix B: Examples of Risk Factors for Bleeding (not all inclusive)

Undergoing a medical or dental procedure where blood loss is anticipated
Comorbidity (e.g., peptic ulcer disease, hypertension)
Mandated anticoagulation therapy
Profession or lifestyle predisposes patient to trauma (e.g., construction worker, fireman, professional athlete)

Appendix C

Members suspected of having PANS/PANDAS should be evaluated with the following tests, as indicated:

Complete blood cell counts with manual differential
Erythrocyte sedimentation rate (ESR) and C-reactive protein (CRP)

If there are elevated inflammatory markers, fatigue, rashes, or joint pain, antinuclear antibody (ANA) or fluorescent antinuclear antibody (FANA) should be obtained (if ANA is elevated, the member should be evaluated for lupus)

Comprehensive metabolic panel

If liver function tests are abnormal or Kayser–Fleisher rings are present, the member should be evaluated for Wilson’s disease with ceruloplasmin and 24 urine copper tests.

Throat culture, anti-streptolysin O (ASO) and anti-DNAse B
Urinalysis (to assess hydration) and to rule out inflammation for children with urinary complaints

If urinalysis reveals pyuria, clean-catch urine culture

Antiphospholipid antibody work up if the member has chorea, petechiae, migraines, stroke, thrombosis, thrombocytopenia, or levido rash. Workup should include:

anticardiolipin antibody,
dilute Russell’s viper venom time (dRVVT),
b 2-glycoprotein I antibodies.

Members should be evaluated for other causes of symptoms, including:

Autism/Autistic Spectrum Disorder
Developmental Delay/Mental Retardation
Cerebral palsy
Genetic conditions and syndromes (such as Down Syndrome, Fragile X, Rett Syndrome, etc.)
Cerebral malformation syndromes
Inborn errors of metabolism
CNS infections
Toxic cerebral insults (such as kernicterus, chemo-radiation, etc.)
Obsessive compulsive disorder
Anorexia nervosa
Avoidant/restrictive food intake disorder (ARFID)
Tourette syndrome
Transient tic disorder
Bipolar disorder
Sydenham chorea
Autoimmune encephalitis
Systemic autoimmune disease
Wilson’s disease

MEDICATION QUANTITY LIMITS

Drug Name	Diagnosis	Maximum Dosing Regimen
Alyglo Immune Globulin Intravenous (Human) - stwk	Acquired Red Cell Aplasia	Route of Administration: Intravenous 2g/kg per treatment, divided over 2 to 5 consecutive days
Alyglo Immune Globulin Intravenous (Human) - stwk	Acute Disseminated Encephalomyelitis	Route of Administration: Intravenous 2g/kg per treatment, divided over 2 to 5 consecutive days
Alyglo Immune Globulin Intravenous (Human) - stwk	Autoimmune Hemolytic Anemia	Route of Administration: Intravenous 2g/kg per treatment, divided over 2 to 5 consecutive days
Alyglo Immune Globulin Intravenous (Human) - stwk	Autoimmune Mucocutaneous Blistering Diseases	Route of Administration: Intravenous 2g/kg divided over 2 to 5 consecutive days every 4 weeks
Alyglo Immune Globulin Intravenous (Human) - stwk	Autoimmune Neutropenia	Route of Administration: Intravenous 1g/kg per day
Alyglo Immune Globulin Intravenous (Human) - stwk	B-Cell Chronic Lymphocytic Leukemia (CLL)	Route of Administration: Intravenous 400mg/kg every 3 weeks
Alyglo Immune Globulin Intravenous (Human) - stwk	Birdshot Retinochoroidopathy	Route of Administration: Intravenous 2g/kg divided over 2 to 5 consecutive days every 4 weeks
Alyglo Immune Globulin Intravenous (Human) - stwk	BK Virus Associated Nephropathy	Route of Administration: Intravenous 2g/kg per dose
Alyglo Immune Globulin Intravenous (Human) - stwk	Bone Marrow Transplant (BMT)/ Hematopoietic Stem Cell Transplant (HSCT)	Route of Administration: Intravenous 800mg/kg every week
Alyglo Immune Globulin Intravenous (Human) - stwk	Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)	Route of Administration: Intravenous Initial: 2g/kg divided over 2 to 5 consecutive days Maintenance: 1g/kg divided over 1 to 2 consecutive days every 3 weeks
Alyglo Immune Globulin Intravenous (Human) - stwk	Churg-Strauss Syndrome	Route of Administration: Intravenous 2g/kg divided over 2 to 5 days every 3 weeks
Alyglo Immune Globulin Intravenous (Human) - stwk	Dermatomyositis	Route of Administration: Intravenous 2g/kg divided over 1 to 5 consecutive days every 4 weeks
Alyglo Immune Globulin Intravenous (Human) - stwk	Enteroviral Meningoencephalitis	Route of Administration: Intravenous 2g/kg per dose
Alyglo Immune Globulin Intravenous (Human) - stwk	Fetal/Neonatal Alloimmune Thrombocytopenia	Route of Administration: Intravenous 2g/kg per week (maternal administration) 1g/kg once (neonatal administration). Repeat if needed.
Alyglo Immune Globulin Intravenous (Human) - stwk	Guillain-Barré Syndrome	Route of Administration: Intravenous 2g/kg divided over 1 to 5 consecutive days
Alyglo Immune Globulin Intravenous (Human) - stwk	Hematophagocytic Lymphohistiocytosis (HLH) or Macrophage Activation Syndrome (MAS)	Route of Administration: Intravenous 2g/kg per dose
Alyglo Immune Globulin Intravenous (Human) - stwk	Hemolytic Disease of Newborn	Route of Administration: Intravenous 1g/kg as a single dose; repeat in 12 hours if needed
Alyglo Immune Globulin Intravenous (Human) - stwk	HIV-Associated Thrombocytopenia	Route of Administration: Intravenous 1g/kg daily for 2 days. Repeat if needed
Alyglo Immune Globulin Intravenous (Human) - stwk	Hyperimmunoglobulinemia E Syndrome	Route of Administration: Intravenous 2mg/kg divided over 2-5 days
Alyglo Immune Globulin Intravenous (Human) - stwk	Hypogammaglobulinemia from CAR-T Therapy	Route of Administration: Intravenous 500mg/kg every 4 weeks
Alyglo Immune Globulin Intravenous (Human) - stwk	Idiopathic Thrombocytopenic Purpura (ITP)	Route of Administration: Intravenous 1g/kg once daily for 2 days 400mg/kg every day for 5 days
Alyglo Immune Globulin Intravenous (Human) - stwk	Kawasaki Syndrome	Route of Administration: Intravenous <18 year(s) 2g/kg as a single dose; repeat if needed
Alyglo Immune Globulin Intravenous (Human) - stwk	Lambert-Eaton Myasthenic Syndrome	Route of Administration: Intravenous 2g/kg divided over 2 to 5 days, may repeat every 4 to 12 weeks
Alyglo Immune Globulin Intravenous (Human) - stwk	Management of Immune Checkpoint Inhibitor-Related Toxicities	Route of Administration: Intravenous 2g/kg per treatment, divided over 2 to 5 consecutive days
Alyglo Immune Globulin Intravenous (Human) - stwk	Measles (Rubeola) Prophylaxis	Route of Administration: Intravenous 400mg/kg once as soon as possible and within 6 days after exposure
Alyglo Immune Globulin Intravenous (Human) - stwk	Multifocal Motor Neuropathy	Route of Administration: Intravenous 2g/kg divided over 2 to 5 consecutive days, followed by 1-2 g/kg every 2-6 weeks (max 1 g/kg/day)
Alyglo Immune Globulin Intravenous (Human) - stwk	Multiple Myeloma	Route of Administration: Intravenous 800mg/kg every 3 weeks
Alyglo Immune Globulin Intravenous (Human) - stwk	Myasthenia Gravis	Route of Administration: Intravenous 2g/kg divided over 1 to 5 consecutive days per treatment course for worsening weakness, acute exacerbation, or in preparation for surgery 1g/kg every 2-6 weeks for maintenance of refractory disease
Alyglo Immune Globulin Intravenous (Human) - stwk	Neonatal Hemochromatosis, Prophylaxis	Route of Administration: Intravenous 1g/kg every week beginning on the 18th week of gestation until delivery
Alyglo Immune Globulin Intravenous (Human) - stwk	Opsoclonus-Myoclonus or Paraneoplastic Opsoclonus-Myoclonus-Ataxia Associated with Neuroblastoma	Route of Administration: Intravenous 2g/kg divided over 2 to 5 consecutive days every 4 weeks
Alyglo Immune Globulin Intravenous (Human) - stwk	Parvovirus B19-Induced Pure Red Cell Aplasia	Route of Administration: Intravenous 2g/kg divided over 2 to 5 consecutive days; For HIV patients with CD4 count <100 cells/mm3, maintenance dose of 400 mg/kg every 4 weeks
Alyglo Immune Globulin Intravenous (Human) - stwk	Pediatric Acute-onset Neuropsychiatric Syndrome (PANS)/Pediatric Autoimmune Neuropsychiatric Disorder Associated with Streptococcal Infections (PANDAS)	Route of Administration: Intravenous 800mg/kg every 3 weeks
Alyglo Immune Globulin Intravenous (Human) - stwk	Polymyositis	Route of Administration: Intravenous 2g/kg divided over 1 to 5 consecutive days every 4 weeks
Alyglo Immune Globulin Intravenous (Human) - stwk	Post-Transfusion Purpura	Route of Administration: Intravenous 2g/kg divided over 2 to 5 consecutive days
Alyglo Immune Globulin Intravenous (Human) - stwk	Primary Immunodeficiency	Route of Administration: Intravenous 800mg/kg every 3 weeks
Alyglo Immune Globulin Intravenous (Human) - stwk	Prophylaxis of Bacterial Infections in Pediatric HIV Infection	Route of Administration: Intravenous <18 year(s) 400mg/kg every 2 weeks
Alyglo Immune Globulin Intravenous (Human) - stwk	Rasmussen Encephalitis	Route of Administration: Intravenous 400mg/kg daily for 5 days every 4 weeks
Alyglo Immune Globulin Intravenous (Human) - stwk	Renal Transplantation from a Live Donor with ABO Incompatibility or Positive Cross Match	Route of Administration: Intravenous 2g/kg per dose
Alyglo Immune Globulin Intravenous (Human) - stwk	Retinocochleocerebral Vasculopathy, Central Nervous System-Predominant	Route of Administration: Intravenous Initial dosage: 2g/kg 2 g/kg IV over 2 days, followed by 1 g/kg every 2 weeks until stable; then, 1.5 g/kg every 3 weeks until further stable. Maintenance dosage: 2 g/kg every 4 weeks for 6 months; then, 1 g/kg every 4 weeks for at least 6 months
Alyglo Immune Globulin Intravenous (Human) - stwk	Secondary Immunosuppression Associated with Major Surgery, Hematological Malignancy, Major Burns, and Collagen-Vascular Diseases	Route of Administration: Intravenous 800mg/kg every 3 weeks
Alyglo Immune Globulin Intravenous (Human) - stwk	Solid Organ Transplantation, for Allosensitized Members	Route of Administration: Intravenous 3g/kg divided over 2-5 days (max 1 g/kg/day) every 2-4 weeks
Alyglo Immune Globulin Intravenous (Human) - stwk	Stevens-Johnson Syndrome or Toxic Epidermal Necrolysis	Route of Administration: Intravenous 3g/kg divided over 1 to 5 consecutive days. Repeat if needed.
Alyglo Immune Globulin Intravenous (Human) - stwk	Stiff-Person Syndrome	Route of Administration: Intravenous 2g/kg divided over 2 to 5 consecutive days every month
Alyglo Immune Globulin Intravenous (Human) - stwk	Systemic Lupus Erythematosus (SLE)	Route of Administration: Intravenous 2g/kg divided over 2 to 5 consecutive days every 4 weeks
Alyglo Immune Globulin Intravenous (Human) - stwk	Tetanus Treatment and Prophylaxis	Route of Administration: Intravenous 400mg/kg once if tetanus immune globulin is not available
Alyglo Immune Globulin Intravenous (Human) - stwk	Toxic Necrotizing Fasciitis due to Group A Streptococcus	Route of Administration: Intravenous 2g/kg divided over 1 to 5 consecutive days
Alyglo Immune Globulin Intravenous (Human) - stwk	Toxic Shock Syndrome	Route of Administration: Intravenous 2g/kg divided over 1 to 5 consecutive days
Alyglo Immune Globulin Intravenous (Human) - stwk	Varicella Prophylaxis	Route of Administration: Intravenous 400mg/kg once as soon as possible and within 10 days after exposure
Asceniv Immune Globulin Intravenous (Human) - slra	Acquired Red Cell Aplasia	Route of Administration: Intravenous 2g/kg per treatment, divided over 2 to 5 consecutive days
Asceniv Immune Globulin Intravenous (Human) - slra	Acute Disseminated Encephalomyelitis	Route of Administration: Intravenous 2g/kg per treatment, divided over 2 to 5 consecutive days
Asceniv Immune Globulin Intravenous (Human) - slra	Autoimmune Hemolytic Anemia	Route of Administration: Intravenous 2g/kg per treatment, divided over 2 to 5 consecutive days
Asceniv Immune Globulin Intravenous (Human) - slra	Autoimmune Mucocutaneous Blistering Diseases	Route of Administration: Intravenous 2g/kg divided over 2 to 5 consecutive days every 4 weeks
Asceniv Immune Globulin Intravenous (Human) - slra	Autoimmune Neutropenia	Route of Administration: Intravenous 1g/kg per day
Asceniv Immune Globulin Intravenous (Human) - slra	B-Cell Chronic Lymphocytic Leukemia (CLL)	Route of Administration: Intravenous 400mg/kg every 3 weeks
Asceniv Immune Globulin Intravenous (Human) - slra	Birdshot Retinochoroidopathy	Route of Administration: Intravenous 2g/kg divided over 2 to 5 consecutive days every 4 weeks
Asceniv Immune Globulin Intravenous (Human) - slra	BK Virus Associated Nephropathy	Route of Administration: Intravenous 2g/kg per dose
Asceniv Immune Globulin Intravenous (Human) - slra	Bone Marrow Transplant (BMT)/ Hematopoietic Stem Cell Transplant (HSCT)	Route of Administration: Intravenous 800mg/kg every week
Asceniv Immune Globulin Intravenous (Human) - slra	Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)	Route of Administration: Intravenous Initial: 2g/kg divided over 2 to 5 consecutive days Maintenance: 1g/kg divided over 1 to 2 consecutive days every 3 weeks
Asceniv Immune Globulin Intravenous (Human) - slra	Churg-Strauss Syndrome	Route of Administration: Intravenous 2g/kg divided over 2 to 5 days every 3 weeks
Asceniv Immune Globulin Intravenous (Human) - slra	Dermatomyositis	Route of Administration: Intravenous 2g/kg divided over 1 to 5 consecutive days every 4 weeks
Asceniv Immune Globulin Intravenous (Human) - slra	Enteroviral Meningoencephalitis	Route of Administration: Intravenous 2g/kg per dose
Asceniv Immune Globulin Intravenous (Human) - slra	Fetal/Neonatal Alloimmune Thrombocytopenia	Route of Administration: Intravenous 2g/kg per week (maternal administration) 1g/kg once (neonatal administration). Repeat if needed.
Asceniv Immune Globulin Intravenous (Human) - slra	Guillain-Barré Syndrome	Route of Administration: Intravenous 2g/kg divided over 1 to 5 consecutive days
Asceniv Immune Globulin Intravenous (Human) - slra	Hematophagocytic Lymphohistiocytosis (HLH) or Macrophage Activation Syndrome (MAS)	Route of Administration: Intravenous 2g/kg per dose
Asceniv Immune Globulin Intravenous (Human) - slra	Hemolytic Disease of Newborn	Route of Administration: Intravenous 1g/kg as a single dose; repeat in 12 hours if needed
Asceniv Immune Globulin Intravenous (Human) - slra	HIV-Associated Thrombocytopenia	Route of Administration: Intravenous 1g/kg daily for 2 days. Repeat if needed
Asceniv Immune Globulin Intravenous (Human) - slra	Hyperimmunoglobulinemia E Syndrome	Route of Administration: Intravenous 2mg/kg divided over 2-5 days
Asceniv Immune Globulin Intravenous (Human) - slra	Hypogammaglobulinemia from CAR-T Therapy	Route of Administration: Intravenous 500mg/kg every 4 weeks
Asceniv Immune Globulin Intravenous (Human) - slra	Idiopathic Thrombocytopenic Purpura (ITP)	Route of Administration: Intravenous 1g/kg once daily for 2 days 400mg/kg every day for 5 days
Asceniv Immune Globulin Intravenous (Human) - slra	Kawasaki Syndrome	Route of Administration: Intravenous <18 year(s) 2g/kg as a single dose; repeat if needed
Asceniv Immune Globulin Intravenous (Human) - slra	Lambert-Eaton Myasthenic Syndrome	Route of Administration: Intravenous 2g/kg divided over 2 to 5 days, may repeat every 4 to 12 weeks
Asceniv Immune Globulin Intravenous (Human) - slra	Management of Immune Checkpoint Inhibitor-Related Toxicities	Route of Administration: Intravenous 2g/kg per treatment, divided over 2 to 5 consecutive days
Asceniv Immune Globulin Intravenous (Human) - slra	Measles (Rubeola) Prophylaxis	Route of Administration: Intravenous 400mg/kg once as soon as possible and within 6 days after exposure
Asceniv Immune Globulin Intravenous (Human) - slra	Multifocal Motor Neuropathy	Route of Administration: Intravenous 2g/kg divided over 2 to 5 consecutive days, followed by 1-2 g/kg every 2-6 weeks (max 1 g/kg/day)
Asceniv Immune Globulin Intravenous (Human) - slra	Multiple Myeloma	Route of Administration: Intravenous 800mg/kg every 3 weeks
Asceniv Immune Globulin Intravenous (Human) - slra	Myasthenia Gravis	Route of Administration: Intravenous 2g/kg divided over 1 to 5 consecutive days per treatment course for worsening weakness, acute exacerbation, or in preparation for surgery 1g/kg every 2-6 weeks for maintenance of refractory disease
Asceniv Immune Globulin Intravenous (Human) - slra	Neonatal Hemochromatosis, Prophylaxis	Route of Administration: Intravenous 1g/kg every week beginning on the 18th week of gestation until delivery
Asceniv Immune Globulin Intravenous (Human) - slra	Opsoclonus-Myoclonus or Paraneoplastic Opsoclonus-Myoclonus-Ataxia Associated with Neuroblastoma	Route of Administration: Intravenous 2g/kg divided over 2 to 5 consecutive days every 4 weeks
Asceniv Immune Globulin Intravenous (Human) - slra	Parvovirus B19-Induced Pure Red Cell Aplasia	Route of Administration: Intravenous 2g/kg divided over 2 to 5 consecutive days; For HIV patients with CD4 count <100 cells/mm3, maintenance dose of 400 mg/kg every 4 weeks
Asceniv Immune Globulin Intravenous (Human) - slra	Pediatric Acute-onset Neuropsychiatric Syndrome (PANS)/Pediatric Autoimmune Neuropsychiatric Disorder Associated with Streptococcal Infections (PANDAS)	Route of Administration: Intravenous 800mg/kg every 3 weeks
Asceniv Immune Globulin Intravenous (Human) - slra	Polymyositis	Route of Administration: Intravenous 2g/kg divided over 1 to 5 consecutive days every 4 weeks
Asceniv Immune Globulin Intravenous (Human) - slra	Post-Transfusion Purpura	Route of Administration: Intravenous 2g/kg divided over 2 to 5 consecutive days
Asceniv Immune Globulin Intravenous (Human) - slra	Primary Immunodeficiency	Route of Administration: Intravenous 800mg/kg every 3 weeks
Asceniv Immune Globulin Intravenous (Human) - slra	Prophylaxis of Bacterial Infections in Pediatric HIV Infection	Route of Administration: Intravenous <18 year(s) 400mg/kg every 2 weeks
Asceniv Immune Globulin Intravenous (Human) - slra	Rasmussen Encephalitis	Route of Administration: Intravenous 400mg/kg daily for 5 days every 4 weeks
Asceniv Immune Globulin Intravenous (Human) - slra	Renal Transplantation from a Live Donor with ABO Incompatibility or Positive Cross Match	Route of Administration: Intravenous 2g/kg per dose
Asceniv Immune Globulin Intravenous (Human) - slra	Retinocochleocerebral Vasculopathy, Central Nervous System-Predominant	Route of Administration: Intravenous Initial dosage: 2g/kg 2 g/kg IV over 2 days, followed by 1 g/kg every 2 weeks until stable; then, 1.5 g/kg every 3 weeks until further stable. Maintenance dosage: 2 g/kg every 4 weeks for 6 months; then, 1 g/kg every 4 weeks for at least 6 months
Asceniv Immune Globulin Intravenous (Human) - slra	Secondary Immunosuppression Associated with Major Surgery, Hematological Malignancy, Major Burns, and Collagen-Vascular Diseases	Route of Administration: Intravenous 800mg/kg every 3 weeks
Asceniv Immune Globulin Intravenous (Human) - slra	Solid Organ Transplantation, for Allosensitized Members	Route of Administration: Intravenous 3g/kg divided over 2-5 days (max 1 g/kg/day) every 2-4 weeks
Asceniv Immune Globulin Intravenous (Human) - slra	Stevens-Johnson Syndrome or Toxic Epidermal Necrolysis	Route of Administration: Intravenous 3g/kg divided over 1 to 5 consecutive days. Repeat if needed.
Asceniv Immune Globulin Intravenous (Human) - slra	Stiff-Person Syndrome	Route of Administration: Intravenous 2g/kg divided over 2 to 5 consecutive days every month
Asceniv Immune Globulin Intravenous (Human) - slra	Systemic Lupus Erythematosus (SLE)	Route of Administration: Intravenous 2g/kg divided over 2 to 5 consecutive days every 4 weeks
Asceniv Immune Globulin Intravenous (Human) - slra	Tetanus Treatment and Prophylaxis	Route of Administration: Intravenous 400mg/kg once if tetanus immune globulin is not available
Asceniv Immune Globulin Intravenous (Human) - slra	Toxic Necrotizing Fasciitis due to Group A Streptococcus	Route of Administration: Intravenous 2g/kg divided over 1 to 5 consecutive days
Asceniv Immune Globulin Intravenous (Human) - slra	Toxic Shock Syndrome	Route of Administration: Intravenous 2g/kg divided over 1 to 5 consecutive days
Asceniv Immune Globulin Intravenous (Human) - slra	Varicella Prophylaxis	Route of Administration: Intravenous 400mg/kg once as soon as possible and within 10 days after exposure
Bivigam Immune Globulin Intravenous (Human)	Acquired Red Cell Aplasia	Route of Administration: Intravenous 2g/kg per treatment, divided over 2 to 5 consecutive days
Bivigam Immune Globulin Intravenous (Human)	Acute Disseminated Encephalomyelitis	Route of Administration: Intravenous 2g/kg per treatment, divided over 2 to 5 consecutive days
Bivigam Immune Globulin Intravenous (Human)	Autoimmune Hemolytic Anemia	Route of Administration: Intravenous 2g/kg per treatment, divided over 2 to 5 consecutive days
Bivigam Immune Globulin Intravenous (Human)	Autoimmune Mucocutaneous Blistering Diseases	Route of Administration: Intravenous 2g/kg divided over 2 to 5 consecutive days every 4 weeks
Bivigam Immune Globulin Intravenous (Human)	Autoimmune Neutropenia	Route of Administration: Intravenous 1g/kg per day
Bivigam Immune Globulin Intravenous (Human)	B-Cell Chronic Lymphocytic Leukemia (CLL)	Route of Administration: Intravenous 400mg/kg every 3 weeks
Bivigam Immune Globulin Intravenous (Human)	Birdshot Retinochoroidopathy	Route of Administration: Intravenous 2g/kg divided over 2 to 5 consecutive days every 4 weeks
Bivigam Immune Globulin Intravenous (Human)	BK Virus Associated Nephropathy	Route of Administration: Intravenous 2g/kg per dose
Bivigam Immune Globulin Intravenous (Human)	Bone Marrow Transplant (BMT)/ Hematopoietic Stem Cell Transplant (HSCT)	Route of Administration: Intravenous 800mg/kg every week
Bivigam Immune Globulin Intravenous (Human)	Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)	Route of Administration: Intravenous Initial: 2g/kg divided over 2 to 5 consecutive days Maintenance: 1g/kg divided over 1 to 2 consecutive days every 3 weeks
Bivigam Immune Globulin Intravenous (Human)	Churg-Strauss Syndrome	Route of Administration: Intravenous 2g/kg divided over 2 to 5 days every 3 weeks
Bivigam Immune Globulin Intravenous (Human)	Dermatomyositis	Route of Administration: Intravenous 2g/kg divided over 1 to 5 consecutive days every 4 weeks
Bivigam Immune Globulin Intravenous (Human)	Enteroviral Meningoencephalitis	Route of Administration: Intravenous 2g/kg per dose
Bivigam Immune Globulin Intravenous (Human)	Fetal/Neonatal Alloimmune Thrombocytopenia	Route of Administration: Intravenous 2g/kg per week (maternal administration) 1g/kg once (neonatal administration). Repeat if needed.
Bivigam Immune Globulin Intravenous (Human)	Guillain-Barré Syndrome	Route of Administration: Intravenous 2g/kg divided over 1 to 5 consecutive days
Bivigam Immune Globulin Intravenous (Human)	Hematophagocytic Lymphohistiocytosis (HLH) or Macrophage Activation Syndrome (MAS)	Route of Administration: Intravenous 2g/kg per dose
Bivigam Immune Globulin Intravenous (Human)	Hemolytic Disease of Newborn	Route of Administration: Intravenous 1g/kg as a single dose; repeat in 12 hours if needed
Bivigam Immune Globulin Intravenous (Human)	HIV-Associated Thrombocytopenia	Route of Administration: Intravenous 1g/kg daily for 2 days. Repeat if needed
Bivigam Immune Globulin Intravenous (Human)	Hyperimmunoglobulinemia E Syndrome	Route of Administration: Intravenous 2mg/kg divided over 2-5 days
Bivigam Immune Globulin Intravenous (Human)	Hypogammaglobulinemia from CAR-T Therapy	Route of Administration: Intravenous 500mg/kg every 4 weeks
Bivigam Immune Globulin Intravenous (Human)	Idiopathic Thrombocytopenic Purpura (ITP)	Route of Administration: Intravenous 1g/kg once daily for 2 days 400mg/kg every day for 5 days
Bivigam Immune Globulin Intravenous (Human)	Kawasaki Syndrome	Route of Administration: Intravenous <18year(s) 2g/kg as a single dose; repeat if needed
Bivigam Immune Globulin Intravenous (Human)	Lambert-Eaton Myasthenic Syndrome	Route of Administration: Intravenous 2g/kg divided over 2 to 5 days, may repeat every 4 to 12 weeks
Bivigam Immune Globulin Intravenous (Human)	Management of Immune Checkpoint Inhibitor-Related Toxicities	Route of Administration: Intravenous 2g/kg per treatment, divided over 2 to 5 consecutive days
Bivigam Immune Globulin Intravenous (Human)	Measles (Rubeola) Prophylaxis	Route of Administration: Intravenous 400mg/kg once as soon as possible and within 6 days after exposure
Bivigam Immune Globulin Intravenous (Human)	Multifocal Motor Neuropathy	Route of Administration: Intravenous 2g/kg divided over 2 to 5 consecutive days, followed by 1-2 g/kg every 2-6 weeks (max 1 g/kg/day)
Bivigam Immune Globulin Intravenous (Human)	Multiple Myeloma	Route of Administration: Intravenous 800mg/kg every 3 weeks
Bivigam Immune Globulin Intravenous (Human)	Myasthenia Gravis	Route of Administration: Intravenous 2g/kg divided over 1 to 5 consecutive days per treatment course for worsening weakness, acute exacerbation, or in preparation for surgery 1g/kg every 2-6 weeks for maintenance of refractory disease
Bivigam Immune Globulin Intravenous (Human)	Neonatal Hemochromatosis, Prophylaxis	Route of Administration: Intravenous 1g/kg every week beginning on the 18th week of gestation until delivery
Bivigam Immune Globulin Intravenous (Human)	Opsoclonus-Myoclonus or Paraneoplastic Opsoclonus-Myoclonus-Ataxia Associated with Neuroblastoma	Route of Administration: Intravenous 2g/kg divided over 2 to 5 consecutive days every 4 weeks
Bivigam Immune Globulin Intravenous (Human)	Parvovirus B19-Induced Pure Red Cell Aplasia	Route of Administration: Intravenous 2g/kg divided over 2 to 5 consecutive days; For HIV patients with CD4 count <100 cells/mm3, maintenance dose of 400 mg/kg every 4 weeks
Bivigam Immune Globulin Intravenous (Human)	Pediatric Acute-onset Neuropsychiatric Syndrome (PANS)/Pediatric Autoimmune Neuropsychiatric Disorder Associated with Streptococcal Infections (PANDAS)	Route of Administration: Intravenous 800mg/kg every 3 weeks
Bivigam Immune Globulin Intravenous (Human)	Polymyositis	Route of Administration: Intravenous 2g/kg divided over 1 to 5 consecutive days every 4 weeks
Bivigam Immune Globulin Intravenous (Human)	Post-Transfusion Purpura	Route of Administration: Intravenous 2g/kg divided over 2 to 5 consecutive days
Bivigam Immune Globulin Intravenous (Human)	Primary Immunodeficiency	Route of Administration: Intravenous 800mg/kg every 3 weeks
Bivigam Immune Globulin Intravenous (Human)	Prophylaxis of Bacterial Infections in Pediatric HIV Infection	Route of Administration: Intravenous <18year(s) 400mg/kg every 2 weeks
Bivigam Immune Globulin Intravenous (Human)	Rasmussen Encephalitis	Route of Administration: Intravenous 400mg/kg daily for 5 days every 4 weeks
Bivigam Immune Globulin Intravenous (Human)	Renal Transplantation from a Live Donor with ABO Incompatibility or Positive Cross Match	Route of Administration: Intravenous 2g/kg per dose
Bivigam Immune Globulin Intravenous (Human)	Retinocochleocerebral Vasculopathy, Central Nervous System-Predominant	Route of Administration: Intravenous Initial dosage: 2g/kg 2 g/kg IV over 2 days, followed by 1 g/kg every 2 weeks until stable; then, 1.5 g/kg every 3 weeks until further stable. Maintenance dosage: 2 g/kg every 4 weeks for 6 months; then, 1 g/kg every 4 weeks for at least 6 months
Bivigam Immune Globulin Intravenous (Human)	Secondary Immunosuppression Associated with Major Surgery, Hematological Malignancy, Major Burns, and Collagen-Vascular Diseases	Route of Administration: Intravenous 800mg/kg every 3 weeks
Bivigam Immune Globulin Intravenous (Human)	Solid Organ Transplantation, for Allosensitized Members	Route of Administration: Intravenous 3g/kg divided over 2-5 days (max 1 g/kg/day) every 2-4 weeks
Bivigam Immune Globulin Intravenous (Human)	Stevens-Johnson Syndrome or Toxic Epidermal Necrolysis	Route of Administration: Intravenous 3g/kg divided over 1 to 5 consecutive days. Repeat if needed.
Bivigam Immune Globulin Intravenous (Human)	Stiff-Person Syndrome	Route of Administration: Intravenous 2g/kg divided over 2 to 5 consecutive days every month
Bivigam Immune Globulin Intravenous (Human)	Systemic Lupus Erythematosus (SLE)	Route of Administration: Intravenous 2g/kg divided over 2 to 5 consecutive days every 4 weeks
Bivigam Immune Globulin Intravenous (Human)	Tetanus Treatment and Prophylaxis	Route of Administration: Intravenous 400mg/kg once if tetanus immune globulin is not available
Bivigam Immune Globulin Intravenous (Human)	Toxic Necrotizing Fasciitis due to Group A Streptococcus	Route of Administration: Intravenous 2g/kg divided over 1 to 5 consecutive days
Bivigam Immune Globulin Intravenous (Human)	Toxic Shock Syndrome	Route of Administration: Intravenous 2g/kg divided over 1 to 5 consecutive days
Bivigam Immune Globulin Intravenous (Human)	Varicella Prophylaxis	Route of Administration: Intravenous 400mg/kg once as soon as possible and within 10 days after exposure
Flebogamma DIF Immune Globulin Intravenous (Human)	Acquired Red Cell Aplasia	Route of Administration: Intravenous 2g/kg per treatment, divided over 2 to 5 consecutive days
Flebogamma DIF Immune Globulin Intravenous (Human)	Acute Disseminated Encephalomyelitis	Route of Administration: Intravenous 2g/kg per treatment, divided over 2 to 5 consecutive days
Flebogamma DIF Immune Globulin Intravenous (Human)	Autoimmune Hemolytic Anemia	Route of Administration: Intravenous 2g/kg per treatment, divided over 2 to 5 consecutive days
Flebogamma DIF Immune Globulin Intravenous (Human)	Autoimmune Mucocutaneous Blistering Diseases	Route of Administration: Intravenous 2g/kg divided over 2 to 5 consecutive days every 4 weeks
Flebogamma DIF Immune Globulin Intravenous (Human)	Autoimmune Neutropenia	Route of Administration: Intravenous 1g/kg per day
Flebogamma DIF Immune Globulin Intravenous (Human)	B-Cell Chronic Lymphocytic Leukemia (CLL)	Route of Administration: Intravenous 400mg/kg every 3 weeks
Flebogamma DIF Immune Globulin Intravenous (Human)	Birdshot Retinochoroidopathy	Route of Administration: Intravenous 2g/kg divided over 2 to 5 consecutive days every 4 weeks
Flebogamma DIF Immune Globulin Intravenous (Human)	BK Virus Associated Nephropathy	Route of Administration: Intravenous 2g/kg per dose
Flebogamma DIF Immune Globulin Intravenous (Human)	Bone Marrow Transplant (BMT)/ Hematopoietic Stem Cell Transplant (HSCT)	Route of Administration: Intravenous 800mg/kg every week
Flebogamma DIF Immune Globulin Intravenous (Human)	Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)	Route of Administration: Intravenous Initial: 2g/kg divided over 2 to 5 consecutive days Maintenance: 1g/kg divided over 1 to 2 consecutive days every 3 weeks
Flebogamma DIF Immune Globulin Intravenous (Human)	Churg-Strauss Syndrome	Route of Administration: Intravenous 2g/kg divided over 2 to 5 days every 3 weeks
Flebogamma DIF Immune Globulin Intravenous (Human)	Dermatomyositis	Route of Administration: Intravenous 2g/kg divided over 1 to 5 consecutive days every 4 weeks
Flebogamma DIF Immune Globulin Intravenous (Human)	Enteroviral Meningoencephalitis	Route of Administration: Intravenous 2g/kg per dose
Flebogamma DIF Immune Globulin Intravenous (Human)	Fetal/Neonatal Alloimmune Thrombocytopenia	Route of Administration: Intravenous 2g/kg per week (maternal administration) 1g/kg once (neonatal administration). Repeat if needed.
Flebogamma DIF Immune Globulin Intravenous (Human)	Guillain-Barré Syndrome	Route of Administration: Intravenous 2g/kg divided over 1 to 5 consecutive days
Flebogamma DIF Immune Globulin Intravenous (Human)	Hematophagocytic Lymphohistiocytosis (HLH) or Macrophage Activation Syndrome (MAS)	Route of Administration: Intravenous 2g/kg per dose
Flebogamma DIF Immune Globulin Intravenous (Human)	Hemolytic Disease of Newborn	Route of Administration: Intravenous 1g/kg as a single dose; repeat in 12 hours if needed
Flebogamma DIF Immune Globulin Intravenous (Human)	HIV-Associated Thrombocytopenia	Route of Administration: Intravenous 1g/kg daily for 2 days. Repeat if needed
Flebogamma DIF Immune Globulin Intravenous (Human)	Hyperimmunoglobulinemia E Syndrome	Route of Administration: Intravenous 2mg/kg divided over 2-5 days
Flebogamma DIF Immune Globulin Intravenous (Human)	Hypogammaglobulinemia from CAR-T Therapy	Route of Administration: Intravenous 500mg/kg every 4 weeks
Flebogamma DIF Immune Globulin Intravenous (Human)	Idiopathic Thrombocytopenic Purpura (ITP)	Route of Administration: Intravenous 1g/kg once daily for 2 days 400mg/kg every day for 5 days
Flebogamma DIF Immune Globulin Intravenous (Human)	Kawasaki Syndrome	Route of Administration: Intravenous <18year(s) 2g/kg as a single dose; repeat if needed
Flebogamma DIF Immune Globulin Intravenous (Human)	Lambert-Eaton Myasthenic Syndrome	Route of Administration: Intravenous 2g/kg divided over 2 to 5 days, may repeat every 4 to 12 weeks
Flebogamma DIF Immune Globulin Intravenous (Human)	Management of Immune Checkpoint Inhibitor-Related Toxicities	Route of Administration: Intravenous 2g/kg per treatment, divided over 2 to 5 consecutive days
Flebogamma DIF Immune Globulin Intravenous (Human)	Measles (Rubeola) Prophylaxis	Route of Administration: Intravenous 400mg/kg once as soon as possible and within 6 days after exposure
Flebogamma DIF Immune Globulin Intravenous (Human)	Multifocal Motor Neuropathy	Route of Administration: Intravenous 2g/kg divided over 2 to 5 consecutive days, followed by 1-2 g/kg every 2-6 weeks (max 1 g/kg/day)
Flebogamma DIF Immune Globulin Intravenous (Human)	Multiple Myeloma	Route of Administration: Intravenous 800mg/kg every 3 weeks
Flebogamma DIF Immune Globulin Intravenous (Human)	Myasthenia Gravis	Route of Administration: Intravenous 2g/kg divided over 1 to 5 consecutive days per treatment course for worsening weakness, acute exacerbation, or in preparation for surgery 1g/kg every 2-6 weeks for maintenance of refractory disease
Flebogamma DIF Immune Globulin Intravenous (Human)	Neonatal Hemochromatosis, Prophylaxis	Route of Administration: Intravenous 1g/kg every week beginning on the 18th week of gestation until delivery
Flebogamma DIF Immune Globulin Intravenous (Human)	Opsoclonus-Myoclonus or Paraneoplastic Opsoclonus-Myoclonus-Ataxia Associated with Neuroblastoma	Route of Administration: Intravenous 2g/kg divided over 2 to 5 consecutive days every 4 weeks
Flebogamma DIF Immune Globulin Intravenous (Human)	Parvovirus B19-Induced Pure Red Cell Aplasia	Route of Administration: Intravenous 2g/kg divided over 2 to 5 consecutive days; For HIV patients with CD4 count <100 cells/mm3, maintenance dose of 400 mg/kg every 4 weeks
Flebogamma DIF Immune Globulin Intravenous (Human)	Pediatric Acute-onset Neuropsychiatric Syndrome (PANS)/Pediatric Autoimmune Neuropsychiatric Disorder Associated with Streptococcal Infections (PANDAS)	Route of Administration: Intravenous 800mg/kg every 3 weeks
Flebogamma DIF Immune Globulin Intravenous (Human)	Polymyositis	Route of Administration: Intravenous 2g/kg divided over 1 to 5 consecutive days every 4 weeks
Flebogamma DIF Immune Globulin Intravenous (Human)	Post-Transfusion Purpura	Route of Administration: Intravenous 2g/kg divided over 2 to 5 consecutive days
Flebogamma DIF Immune Globulin Intravenous (Human)	Primary Immunodeficiency	Route of Administration: Intravenous 800mg/kg every 3 weeks
Flebogamma DIF Immune Globulin Intravenous (Human)	Prophylaxis of Bacterial Infections in Pediatric HIV Infection	Route of Administration: Intravenous <18year(s) 400mg/kg every 2 weeks
Flebogamma DIF Immune Globulin Intravenous (Human)	Rasmussen Encephalitis	Route of Administration: Intravenous 400mg/kg daily for 5 days every 4 weeks
Flebogamma DIF Immune Globulin Intravenous (Human)	Renal Transplantation from a Live Donor with ABO Incompatibility or Positive Cross Match	Route of Administration: Intravenous 2g/kg per dose
Flebogamma DIF Immune Globulin Intravenous (Human)	Retinocochleocerebral Vasculopathy, Central Nervous System-Predominant	Route of Administration: Intravenous Initial dosage: 2g/kg 2 g/kg IV over 2 days, followed by 1 g/kg every 2 weeks until stable; then, 1.5 g/kg every 3 weeks until further stable. Maintenance dosage: 2 g/kg every 4 weeks for 6 months; then, 1 g/kg every 4 weeks for at least 6 months
Flebogamma DIF Immune Globulin Intravenous (Human)	Secondary Immunosuppression Associated with Major Surgery, Hematological Malignancy, Major Burns, and Collagen-Vascular Diseases	Route of Administration: Intravenous 800mg/kg every 3 weeks
Flebogamma DIF Immune Globulin Intravenous (Human)	Solid Organ Transplantation, for Allosensitized Members	Route of Administration: Intravenous 3g/kg divided over 2-5 days (max 1 g/kg/day) every 2-4 weeks
Flebogamma DIF Immune Globulin Intravenous (Human)	Stevens-Johnson Syndrome or Toxic Epidermal Necrolysis	Route of Administration: Intravenous 3g/kg divided over 1 to 5 consecutive days. Repeat if needed.
Flebogamma DIF Immune Globulin Intravenous (Human)	Stiff-Person Syndrome	Route of Administration: Intravenous 2g/kg divided over 2 to 5 consecutive days every month
Flebogamma DIF Immune Globulin Intravenous (Human)	Systemic Lupus Erythematosus (SLE)	Route of Administration: Intravenous 2g/kg divided over 2 to 5 consecutive days every 4 weeks
Flebogamma DIF Immune Globulin Intravenous (Human)	Tetanus Treatment and Prophylaxis	Route of Administration: Intravenous 400mg/kg once if tetanus immune globulin is not available
Flebogamma DIF Immune Globulin Intravenous (Human)	Toxic Necrotizing Fasciitis due to Group A Streptococcus	Route of Administration: Intravenous 2g/kg divided over 1 to 5 consecutive days
Flebogamma DIF Immune Globulin Intravenous (Human)	Toxic Shock Syndrome	Route of Administration: Intravenous 2g/kg divided over 1 to 5 consecutive days
Flebogamma DIF Immune Globulin Intravenous (Human)	Varicella Prophylaxis	Route of Administration: Intravenous 400mg/kg once as soon as possible and within 10 days after exposure
Gammagard Liquid Immune Globulin Intravenous (Human)	Acquired Red Cell Aplasia	Route of Administration: Intravenous 2g/kg per treatment, divided over 2 to 5 consecutive days
Gammagard Liquid Immune Globulin Intravenous (Human)	Acute Disseminated Encephalomyelitis	Route of Administration: Intravenous 2g/kg per treatment, divided over 2 to 5 consecutive days
Gammagard Liquid Immune Globulin Intravenous (Human)	Autoimmune Hemolytic Anemia	Route of Administration: Intravenous 2g/kg per treatment, divided over 2 to 5 consecutive days
Gammagard Liquid Immune Globulin Intravenous (Human)	Autoimmune Mucocutaneous Blistering Diseases	Route of Administration: Intravenous 2g/kg divided over 2 to 5 consecutive days every 4 weeks
Gammagard Liquid Immune Globulin Intravenous (Human)	Autoimmune Neutropenia	Route of Administration: Intravenous 1g/kg per day
Gammagard Liquid Immune Globulin Intravenous (Human)	B-Cell Chronic Lymphocytic Leukemia (CLL)	Route of Administration: Intravenous 400mg/kg every 3 weeks
Gammagard Liquid Immune Globulin Intravenous (Human)	Birdshot Retinochoroidopathy	Route of Administration: Intravenous 2g/kg divided over 2 to 5 consecutive days every 4 weeks
Gammagard Liquid Immune Globulin Intravenous (Human)	BK Virus Associated Nephropathy	Route of Administration: Intravenous 2g/kg per dose
Gammagard Liquid Immune Globulin Intravenous (Human)	Bone Marrow Transplant (BMT)/ Hematopoietic Stem Cell Transplant (HSCT)	Route of Administration: Intravenous 800mg/kg every week
Gammagard Liquid Immune Globulin Intravenous (Human)	Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)	Route of Administration: Intravenous Initial: 2g/kg divided over 2 to 5 consecutive days Maintenance: 1g/kg divided over 1 to 4 consecutive days every 3 weeks
Gammagard Liquid Immune Globulin Intravenous (Human)	Churg-Strauss Syndrome	Route of Administration: Intravenous 2g/kg divided over 2 to 5 days every 3 weeks
Gammagard Liquid Immune Globulin Intravenous (Human)	Dermatomyositis	Route of Administration: Intravenous 2g/kg divided over 1 to 5 consecutive days every 4 weeks
Gammagard Liquid Immune Globulin Intravenous (Human)	Enteroviral Meningoencephalitis	Route of Administration: Intravenous 2g/kg per dose
Gammagard Liquid Immune Globulin Intravenous (Human)	Fetal/Neonatal Alloimmune Thrombocytopenia	Route of Administration: Intravenous 2g/kg per week (maternal administration) 1g/kg once (neonatal administration). Repeat if needed.
Gammagard Liquid Immune Globulin Intravenous (Human)	Guillain-Barré Syndrome	Route of Administration: Intravenous 2g/kg divided over 1 to 5 consecutive days
Gammagard Liquid Immune Globulin Intravenous (Human)	Hematophagocytic Lymphohistiocytosis (HLH) or Macrophage Activation Syndrome (MAS)	Route of Administration: Intravenous 2g/kg per dose
Gammagard Liquid Immune Globulin Intravenous (Human)	Hemolytic Disease of Newborn	Route of Administration: Intravenous 1g/kg as a single dose; repeat in 12 hours if needed
Gammagard Liquid Immune Globulin Intravenous (Human)	HIV-Associated Thrombocytopenia	Route of Administration: Intravenous 1g/kg daily for 2 days. Repeat if needed
Gammagard Liquid Immune Globulin Intravenous (Human)	Hyperimmunoglobulinemia E Syndrome	Route of Administration: Intravenous 2mg/kg divided over 2-5 days
Gammagard Liquid Immune Globulin Intravenous (Human)	Hypogammaglobulinemia from CAR-T Therapy	Route of Administration: Intravenous 500mg/kg every 4 weeks
Gammagard Liquid Immune Globulin Intravenous (Human)	Idiopathic Thrombocytopenic Purpura (ITP)	Route of Administration: Intravenous 1g/kg once daily for 2 days 400mg/kg every day for 5 days
Gammagard Liquid Immune Globulin Intravenous (Human)	Kawasaki Syndrome	Route of Administration: Intravenous <18year(s) 2g/kg as a single dose; repeat if needed
Gammagard Liquid Immune Globulin Intravenous (Human)	Lambert-Eaton Myasthenic Syndrome	Route of Administration: Intravenous 2g/kg divided over 2 to 5 days, may repeat every 4 to 12 weeks
Gammagard Liquid Immune Globulin Intravenous (Human)	Management of Immune Checkpoint Inhibitor-Related Toxicities	Route of Administration: Intravenous 2g/kg per treatment, divided over 2 to 5 consecutive days
Gammagard Liquid Immune Globulin Intravenous (Human)	Measles (Rubeola) Prophylaxis	Route of Administration: Intravenous 400mg/kg once as soon as possible and within 6 days after exposure
Gammagard Liquid Immune Globulin Intravenous (Human)	Multifocal Motor Neuropathy	Route of Administration: Intravenous 2.4g/kg once per month
Gammagard Liquid Immune Globulin Intravenous (Human)	Multiple Myeloma	Route of Administration: Intravenous 800mg/kg every 3 weeks
Gammagard Liquid Immune Globulin Intravenous (Human)	Myasthenia Gravis	Route of Administration: Intravenous 2g/kg divided over 1 to 5 consecutive days per treatment course for worsening weakness, acute exacerbation, or in preparation for surgery 1g/kg every 2-6 weeks for maintenance of refractory disease
Gammagard Liquid Immune Globulin Intravenous (Human)	Neonatal Hemochromatosis, Prophylaxis	Route of Administration: Intravenous 1g/kg every week beginning on the 18th week of gestation until delivery
Gammagard Liquid Immune Globulin Intravenous (Human)	Opsoclonus-Myoclonus or Paraneoplastic Opsoclonus-Myoclonus-Ataxia Associated with Neuroblastoma	Route of Administration: Intravenous 2g/kg divided over 2 to 5 consecutive days every 4 weeks
Gammagard Liquid Immune Globulin Intravenous (Human)	Parvovirus B19-Induced Pure Red Cell Aplasia	Route of Administration: Intravenous 2g/kg divided over 2 to 5 consecutive days; For HIV patients with CD4 count <100 cells/mm3, maintenance dose of 400 mg/kg every 4 weeks
Gammagard Liquid Immune Globulin Intravenous (Human)	Pediatric Acute-onset Neuropsychiatric Syndrome (PANS)/Pediatric Autoimmune Neuropsychiatric Disorder Associated with Streptococcal Infections (PANDAS)	Route of Administration: Intravenous 800mg/kg every 3 weeks
Gammagard Liquid Immune Globulin Intravenous (Human)	Polymyositis	Route of Administration: Intravenous 2g/kg divided over 1 to 5 consecutive days every 4 weeks
Gammagard Liquid Immune Globulin Intravenous (Human)	Post-Transfusion Purpura	Route of Administration: Intravenous 2g/kg divided over 2 to 5 consecutive days
Gammagard Liquid Immune Globulin Intravenous (Human)	Primary Immunodeficiency	Route of Administration: Intravenous, Subcutaneous 800mg/kg every 3 weeks
Gammagard Liquid Immune Globulin Intravenous (Human)	Prophylaxis of Bacterial Infections in Pediatric HIV Infection	Route of Administration: Intravenous <18year(s) 400mg/kg every 2 weeks
Gammagard Liquid Immune Globulin Intravenous (Human)	Rasmussen Encephalitis	Route of Administration: Intravenous 400mg/kg daily for 5 days every 4 weeks
Gammagard Liquid Immune Globulin Intravenous (Human)	Renal Transplantation from a Live Donor with ABO Incompatibility or Positive Cross Match	Route of Administration: Intravenous 2g/kg per dose
Gammagard Liquid Immune Globulin Intravenous (Human)	Retinocochleocerebral Vasculopathy, Central Nervous System-Predominant	Route of Administration: Intravenous Initial dosage: 2g/kg 2 g/kg IV over 2 days, followed by 1 g/kg every 2 weeks until stable; then, 1.5 g/kg every 3 weeks until further stable. Maintenance dosage: 2 g/kg every 4 weeks for 6 months; then, 1 g/kg every 4 weeks for at least 6 months
Gammagard Liquid Immune Globulin Intravenous (Human)	Secondary Immunosuppression Associated with Major Surgery, Hematological Malignancy, Major Burns, and Collagen-Vascular Diseases	Route of Administration: Intravenous 800mg/kg every 3 weeks
Gammagard Liquid Immune Globulin Intravenous (Human)	Solid Organ Transplantation, for Allosensitized Members	Route of Administration: Intravenous 3g/kg divided over 2-5 days (max 1 g/kg/day) every 2-4 weeks
Gammagard Liquid Immune Globulin Intravenous (Human)	Stevens-Johnson Syndrome or Toxic Epidermal Necrolysis	Route of Administration: Intravenous 3g/kg divided over 1 to 5 consecutive days. Repeat if needed.
Gammagard Liquid Immune Globulin Intravenous (Human)	Stiff-Person Syndrome	Route of Administration: Intravenous 2g/kg divided over 2 to 5 consecutive days every month
Gammagard Liquid Immune Globulin Intravenous (Human)	Systemic Lupus Erythematosus (SLE)	Route of Administration: Intravenous 2g/kg divided over 2 to 5 consecutive days every 4 weeks
Gammagard Liquid Immune Globulin Intravenous (Human)	Tetanus Treatment and Prophylaxis	Route of Administration: Intravenous 400mg/kg once if tetanus immune globulin is not available
Gammagard Liquid Immune Globulin Intravenous (Human)	Toxic Necrotizing Fasciitis due to Group A Streptococcus	Route of Administration: Intravenous 2g/kg divided over 1 to 5 consecutive days
Gammagard Liquid Immune Globulin Intravenous (Human)	Toxic Shock Syndrome	Route of Administration: Intravenous 2g/kg divided over 1 to 5 consecutive days
Gammagard Liquid Immune Globulin Intravenous (Human)	Varicella Prophylaxis	Route of Administration: Intravenous 400mg/kg once as soon as possible and within 10 days after exposure
Gammagard Liquid ERC Immune Globulin Infusion (Human)	Acquired Red Cell Aplasia	Route of Administration: Intravenous 2g/kg per treatment, divided over 2 to 5 consecutive days
Gammagard Liquid ERC Immune Globulin Infusion (Human)	Acute Disseminated Encephalomyelitis	Route of Administration: Intravenous 2g/kg per treatment, divided over 2 to 5 consecutive days
Gammagard Liquid ERC Immune Globulin Infusion (Human)	Autoimmune Hemolytic Anemia	Route of Administration: Intravenous 2g/kg per treatment, divided over 2 to 5 consecutive days
Gammagard Liquid ERC Immune Globulin Infusion (Human)	Autoimmune Mucocutaneous Blistering Diseases	Route of Administration: Intravenous 2g/kg divided over 2 to 5 consecutive days every 4 weeks
Gammagard Liquid ERC Immune Globulin Infusion (Human)	Autoimmune Neutropenia	Route of Administration: Intravenous 1g/kg per day
Gammagard Liquid ERC Immune Globulin Infusion (Human)	B-Cell Chronic Lymphocytic Leukemia (CLL)	Route of Administration: Intravenous 400mg/kg every 3 weeks
Gammagard Liquid ERC Immune Globulin Infusion (Human)	Birdshot Retinochoroidopathy	Route of Administration: Intravenous 2g/kg divided over 2 to 5 consecutive days every 4 weeks
Gammagard Liquid ERC Immune Globulin Infusion (Human)	BK Virus Associated Nephropathy	Route of Administration: Intravenous 2g/kg per dose
Gammagard Liquid ERC Immune Globulin Infusion (Human)	Bone Marrow Transplant (BMT)/ Hematopoietic Stem Cell Transplant (HSCT)	Route of Administration: Intravenous 800mg/kg every week
Gammagard Liquid ERC Immune Globulin Infusion (Human)	Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)	Route of Administration: Intravenous Initial: 2g/kg divided over 2 to 5 consecutive days Maintenance: 1g/kg divided over 1 to 2 consecutive days every 3 weeks
Gammagard Liquid ERC Immune Globulin Infusion (Human)	Churg-Strauss Syndrome	Route of Administration: Intravenous 2g/kg divided over 2 to 5 days every 3 weeks
Gammagard Liquid ERC Immune Globulin Infusion (Human)	Dermatomyositis	Route of Administration: Intravenous 2g/kg divided over 1 to 5 consecutive days every 4 weeks
Gammagard Liquid ERC Immune Globulin Infusion (Human)	Enteroviral Meningoencephalitis	Route of Administration: Intravenous 2g/kg per dose
Gammagard Liquid ERC Immune Globulin Infusion (Human)	Fetal/Neonatal Alloimmune Thrombocytopenia	Route of Administration: Intravenous 2g/kg per week (maternal administration) 1g/kg once (neonatal administration). Repeat if needed.
Gammagard Liquid ERC Immune Globulin Infusion (Human)	Guillain-Barré Syndrome	Route of Administration: Intravenous 2g/kg divided over 1 to 5 consecutive days
Gammagard Liquid ERC Immune Globulin Infusion (Human)	Hematophagocytic Lymphohistiocytosis (HLH) or Macrophage Activation Syndrome (MAS)	Route of Administration: Intravenous 2g/kg per dose
Gammagard Liquid ERC Immune Globulin Infusion (Human)	Hemolytic Disease of Newborn	Route of Administration: Intravenous 1g/kg as a single dose; repeat in 12 hours if needed
Gammagard Liquid ERC Immune Globulin Infusion (Human)	HIV-Associated Thrombocytopenia	Route of Administration: Intravenous 1g/kg daily for 2 days. Repeat if needed
Gammagard Liquid ERC Immune Globulin Infusion (Human)	Hyperimmunoglobulinemia E Syndrome	Route of Administration: Intravenous 2mg/kg divided over 2-5 days
Gammagard Liquid ERC Immune Globulin Infusion (Human)	Hypogammaglobulinemia from CAR-T Therapy	Route of Administration: Intravenous 500mg/kg every 4 weeks
Gammagard Liquid ERC Immune Globulin Infusion (Human)	Idiopathic Thrombocytopenic Purpura (ITP)	Route of Administration: Intravenous 1g/kg once daily for 2 days 400mg/kg every day for 5 days
Gammagard Liquid ERC Immune Globulin Infusion (Human)	Kawasaki Syndrome	Route of Administration: Intravenous <18 year(s) 2g/kg as a single dose; repeat if needed
Gammagard Liquid ERC Immune Globulin Infusion (Human)	Lambert-Eaton Myasthenic Syndrome	Route of Administration: Intravenous 2g/kg divided over 2 to 5 days, may repeat every 4 to 12 weeks
Gammagard Liquid ERC Immune Globulin Infusion (Human)	Management of Immune Checkpoint Inhibitor-Related Toxicities	Route of Administration: Intravenous 2g/kg per treatment, divided over 2 to 5 consecutive days
Gammagard Liquid ERC Immune Globulin Infusion (Human)	Measles (Rubeola) Prophylaxis	Route of Administration: Intravenous 400mg/kg once as soon as possible and within 6 days after exposure
Gammagard Liquid ERC Immune Globulin Infusion (Human)	Multifocal Motor Neuropathy	Route of Administration: Intravenous 2g/kg divided over 2 to 5 consecutive days, followed by 1-2 g/kg every 2-6 weeks (max 1 g/kg/day)
Gammagard Liquid ERC Immune Globulin Infusion (Human)	Multiple Myeloma	Route of Administration: Intravenous 800mg/kg every 3 weeks
Gammagard Liquid ERC Immune Globulin Infusion (Human)	Myasthenia Gravis	Route of Administration: Intravenous 2g/kg divided over 1 to 5 consecutive days per treatment course for worsening weakness, acute exacerbation, or in preparation for surgery 1g/kg every 2-6 weeks for maintenance of refractory disease
Gammagard Liquid ERC Immune Globulin Infusion (Human)	Neonatal Hemochromatosis, Prophylaxis	Route of Administration: Intravenous 1g/kg every week beginning on the 18th week of gestation until delivery
Gammagard Liquid ERC Immune Globulin Infusion (Human)	Opsoclonus-Myoclonus or Paraneoplastic Opsoclonus-Myoclonus-Ataxia Associated with Neuroblastoma	Route of Administration: Intravenous 2g/kg divided over 2 to 5 consecutive days every 4 weeks
Gammagard Liquid ERC Immune Globulin Infusion (Human)	Parvovirus B19-Induced Pure Red Cell Aplasia	Route of Administration: Intravenous 2g/kg divided over 2 to 5 consecutive days; For HIV patients with CD4 count <100 cells/mm3, maintenance dose of 400 mg/kg every 4 weeks
Gammagard Liquid ERC Immune Globulin Infusion (Human)	Pediatric Acute-onset Neuropsychiatric Syndrome (PANS)/Pediatric Autoimmune Neuropsychiatric Disorder Associated with Streptococcal Infections (PANDAS)	Route of Administration: Intravenous 800mg/kg every 3 weeks
Gammagard Liquid ERC Immune Globulin Infusion (Human)	Polymyositis	Route of Administration: Intravenous 2g/kg divided over 1 to 5 consecutive days every 4 weeks
Gammagard Liquid ERC Immune Globulin Infusion (Human)	Post-Transfusion Purpura	Route of Administration: Intravenous 2g/kg divided over 2 to 5 consecutive days
Gammagard Liquid ERC Immune Globulin Infusion (Human)	Primary Immunodeficiency	Route of Administration: Intravenous, Subcutaneous 800mg/kg every 3 weeks
Gammagard Liquid ERC Immune Globulin Infusion (Human)	Prophylaxis of Bacterial Infections in Pediatric HIV Infection	Route of Administration: Intravenous <18 year(s) 400mg/kg every 2 weeks
Gammagard Liquid ERC Immune Globulin Infusion (Human)	Rasmussen Encephalitis	Route of Administration: Intravenous 400mg/kg daily for 5 days every 4 weeks
Gammagard Liquid ERC Immune Globulin Infusion (Human)	Renal Transplantation from a Live Donor with ABO Incompatibility or Positive Cross Match	Route of Administration: Intravenous 2g/kg per dose
Gammagard Liquid ERC Immune Globulin Infusion (Human)	Retinocochleocerebral Vasculopathy, Central Nervous System-Predominant	Route of Administration: Intravenous Initial dosage: 2g/kg 2 g/kg IV over 2 days, followed by 1 g/kg every 2 weeks until stable; then, 1.5 g/kg every 3 weeks until further stable. Maintenance dosage: 2 g/kg every 4 weeks for 6 months; then, 1 g/kg every 4 weeks for at least 6 months
Gammagard Liquid ERC Immune Globulin Infusion (Human)	Secondary Immunosuppression Associated with Major Surgery, Hematological Malignancy, Major Burns, and Collagen-Vascular Diseases	Route of Administration: Intravenous 800mg/kg every 3 weeks
Gammagard Liquid ERC Immune Globulin Infusion (Human)	Solid Organ Transplantation, for Allosensitized Members	Route of Administration: Intravenous 3g/kg divided over 2-5 days (max 1 g/kg/day) every 2-4 weeks
Gammagard Liquid ERC Immune Globulin Infusion (Human)	Stevens-Johnson Syndrome or Toxic Epidermal Necrolysis	Route of Administration: Intravenous 3g/kg divided over 1 to 5 consecutive days. Repeat if needed.
Gammagard Liquid ERC Immune Globulin Infusion (Human)	Stiff-Person Syndrome	Route of Administration: Intravenous 2g/kg divided over 2 to 5 consecutive days every month
Gammagard Liquid ERC Immune Globulin Infusion (Human)	Systemic Lupus Erythematosus (SLE)	Route of Administration: Intravenous 2g/kg divided over 2 to 5 consecutive days every 4 weeks
Gammagard Liquid ERC Immune Globulin Infusion (Human)	Tetanus Treatment and Prophylaxis	Route of Administration: Intravenous 400mg/kg once if tetanus immune globulin is not available
Gammagard Liquid ERC Immune Globulin Infusion (Human)	Toxic Necrotizing Fasciitis due to Group A Streptococcus	Route of Administration: Intravenous 2g/kg divided over 1 to 5 consecutive days
Gammagard Liquid ERC Immune Globulin Infusion (Human)	Toxic Shock Syndrome	Route of Administration: Intravenous 2g/kg divided over 1 to 5 consecutive days
Gammagard Liquid ERC Immune Globulin Infusion (Human)	Varicella Prophylaxis	Route of Administration: Intravenous 400mg/kg once as soon as possible and within 10 days after exposure
Gammagard S/D Immune Globulin Intravenous (Human)	Acquired Red Cell Aplasia	Route of Administration: Intravenous 2g/kg per treatment, divided over 2 to 5 consecutive days
Gammagard S/D Immune Globulin Intravenous (Human)	Acute Disseminated Encephalomyelitis	Route of Administration: Intravenous 2g/kg per treatment, divided over 2 to 5 consecutive days
Gammagard S/D Immune Globulin Intravenous (Human)	Autoimmune Hemolytic Anemia	Route of Administration: Intravenous 2g/kg per treatment, divided over 2 to 5 consecutive days
Gammagard S/D Immune Globulin Intravenous (Human)	Autoimmune Mucocutaneous Blistering Diseases	Route of Administration: Intravenous 2g/kg divided over 2 to 5 consecutive days every 4 weeks
Gammagard S/D Immune Globulin Intravenous (Human)	Autoimmune Neutropenia	Route of Administration: Intravenous 1g/kg per day
Gammagard S/D Immune Globulin Intravenous (Human)	B-Cell Chronic Lymphocytic Leukemia (CLL)	Route of Administration: Intravenous 400mg/kg every 3 weeks
Gammagard S/D Immune Globulin Intravenous (Human)	Birdshot Retinochoroidopathy	Route of Administration: Intravenous 2g/kg divided over 2 to 5 consecutive days every 4 weeks
Gammagard S/D Immune Globulin Intravenous (Human)	BK Virus Associated Nephropathy	Route of Administration: Intravenous 2g/kg per dose
Gammagard S/D Immune Globulin Intravenous (Human)	Bone Marrow Transplant (BMT)/ Hematopoietic Stem Cell Transplant (HSCT)	Route of Administration: Intravenous 800mg/kg every week
Gammagard S/D Immune Globulin Intravenous (Human)	Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)	Route of Administration: Intravenous Initial: 2g/kg divided over 2 to 5 consecutive days Maintenance: 1g/kg divided over 1 to 2 consecutive days every 3 weeks
Gammagard S/D Immune Globulin Intravenous (Human)	Churg-Strauss Syndrome	Route of Administration: Intravenous 2g/kg divided over 2 to 5 days every 3 weeks
Gammagard S/D Immune Globulin Intravenous (Human)	Dermatomyositis	Route of Administration: Intravenous 2g/kg divided over 1 to 5 consecutive days every 4 weeks
Gammagard S/D Immune Globulin Intravenous (Human)	Enteroviral Meningoencephalitis	Route of Administration: Intravenous 2g/kg per dose
Gammagard S/D Immune Globulin Intravenous (Human)	Fetal/Neonatal Alloimmune Thrombocytopenia	Route of Administration: Intravenous 2g/kg per week (maternal administration) 1g/kg once (neonatal administration). Repeat if needed.
Gammagard S/D Immune Globulin Intravenous (Human)	Guillain-Barré Syndrome	Route of Administration: Intravenous 2g/kg divided over 1 to 5 consecutive days
Gammagard S/D Immune Globulin Intravenous (Human)	Hematophagocytic Lymphohistiocytosis (HLH) or Macrophage Activation Syndrome (MAS)	Route of Administration: Intravenous 2g/kg per dose
Gammagard S/D Immune Globulin Intravenous (Human)	Hemolytic Disease of Newborn	Route of Administration: Intravenous 1g/kg as a single dose; repeat in 12 hours if needed
Gammagard S/D Immune Globulin Intravenous (Human)	HIV-Associated Thrombocytopenia	Route of Administration: Intravenous 1g/kg daily for 2 days. Repeat if needed
Gammagard S/D Immune Globulin Intravenous (Human)	Hyperimmunoglobulinemia E Syndrome	Route of Administration: Intravenous 2mg/kg divided over 2-5 days
Gammagard S/D Immune Globulin Intravenous (Human)	Hypogammaglobulinemia from CAR-T Therapy	Route of Administration: Intravenous 500mg/kg every 4 weeks
Gammagard S/D Immune Globulin Intravenous (Human)	Idiopathic Thrombocytopenic Purpura (ITP)	Route of Administration: Intravenous 1g/kg once; may repeat on alternating days for a maximum of 3 doses 400mg/kg every day for 5 days
Gammagard S/D Immune Globulin Intravenous (Human)	Kawasaki Syndrome	Route of Administration: Intravenous <18year(s) 400mg/kg every day for 4 days 1g/kg as a single dose
Gammagard S/D Immune Globulin Intravenous (Human)	Lambert-Eaton Myasthenic Syndrome	Route of Administration: Intravenous 2g/kg divided over 2 to 5 days, may repeat every 4 to 12 weeks
Gammagard S/D Immune Globulin Intravenous (Human)	Management of Immune Checkpoint Inhibitor-Related Toxicities	Route of Administration: Intravenous 2g/kg per treatment, divided over 2 to 5 consecutive days
Gammagard S/D Immune Globulin Intravenous (Human)	Measles (Rubeola) Prophylaxis	Route of Administration: Intravenous 400mg/kg once as soon as possible and within 6 days after exposure
Gammagard S/D Immune Globulin Intravenous (Human)	Multifocal Motor Neuropathy	Route of Administration: Intravenous 2g/kg divided over 2 to 5 consecutive days, followed by 1-2 g/kg every 2-6 weeks (max 1 g/kg/day)
Gammagard S/D Immune Globulin Intravenous (Human)	Multiple Myeloma	Route of Administration: Intravenous 800mg/kg every 3 weeks
Gammagard S/D Immune Globulin Intravenous (Human)	Myasthenia Gravis	Route of Administration: Intravenous 2g/kg divided over 1 to 5 consecutive days per treatment course for worsening weakness, acute exacerbation, or in preparation for surgery 1g/kg every 2-6 weeks for maintenance of refractory disease
Gammagard S/D Immune Globulin Intravenous (Human)	Neonatal Hemochromatosis, Prophylaxis	Route of Administration: Intravenous 1g/kg every week beginning on the 18th week of gestation until delivery
Gammagard S/D Immune Globulin Intravenous (Human)	Opsoclonus-Myoclonus or Paraneoplastic Opsoclonus-Myoclonus-Ataxia Associated with Neuroblastoma	Route of Administration: Intravenous 2g/kg divided over 2 to 5 consecutive days every 4 weeks
Gammagard S/D Immune Globulin Intravenous (Human)	Parvovirus B19-Induced Pure Red Cell Aplasia	Route of Administration: Intravenous 2g/kg divided over 2 to 5 consecutive days; For HIV patients with CD4 count <100 cells/mm3, maintenance dose of 400 mg/kg every 4 weeks
Gammagard S/D Immune Globulin Intravenous (Human)	Pediatric Acute-onset Neuropsychiatric Syndrome (PANS)/Pediatric Autoimmune Neuropsychiatric Disorder Associated with Streptococcal Infections (PANDAS)	Route of Administration: Intravenous 800mg/kg every 3 weeks
Gammagard S/D Immune Globulin Intravenous (Human)	Polymyositis	Route of Administration: Intravenous 2g/kg divided over 1 to 5 consecutive days every 4 weeks
Gammagard S/D Immune Globulin Intravenous (Human)	Post-Transfusion Purpura	Route of Administration: Intravenous 2g/kg divided over 2 to 5 consecutive days
Gammagard S/D Immune Globulin Intravenous (Human)	Primary Immunodeficiency	Route of Administration: Intravenous 800mg/kg every 3 weeks
Gammagard S/D Immune Globulin Intravenous (Human)	Prophylaxis of Bacterial Infections in Pediatric HIV Infection	Route of Administration: Intravenous <18year(s) 400mg/kg every 2 weeks
Gammagard S/D Immune Globulin Intravenous (Human)	Rasmussen Encephalitis	Route of Administration: Intravenous 400mg/kg daily for 5 days every 4 weeks
Gammagard S/D Immune Globulin Intravenous (Human)	Renal Transplantation from a Live Donor with ABO Incompatibility or Positive Cross Match	Route of Administration: Intravenous 2g/kg per dose
Gammagard S/D Immune Globulin Intravenous (Human)	Retinocochleocerebral Vasculopathy, Central Nervous System-Predominant	Route of Administration: Intravenous Initial dosage: 2g/kg 2 g/kg IV over 2 days, followed by 1 g/kg every 2 weeks until stable; then, 1.5 g/kg every 3 weeks until further stable. Maintenance dosage: 2 g/kg every 4 weeks for 6 months; then, 1 g/kg every 4 weeks for at least 6 months
Gammagard S/D Immune Globulin Intravenous (Human)	Secondary Immunosuppression Associated with Major Surgery, Hematological Malignancy, Major Burns, and Collagen-Vascular Diseases	Route of Administration: Intravenous 800mg/kg every 3 weeks
Gammagard S/D Immune Globulin Intravenous (Human)	Solid Organ Transplantation, for Allosensitized Members	Route of Administration: Intravenous 3g/kg divided over 2-5 days (max 1 g/kg/day) every 2-4 weeks
Gammagard S/D Immune Globulin Intravenous (Human)	Stevens-Johnson Syndrome or Toxic Epidermal Necrolysis	Route of Administration: Intravenous 3g/kg divided over 1 to 5 consecutive days. Repeat if needed.
Gammagard S/D Immune Globulin Intravenous (Human)	Stiff-Person Syndrome	Route of Administration: Intravenous 2g/kg divided over 2 to 5 consecutive days every month
Gammagard S/D Immune Globulin Intravenous (Human)	Systemic Lupus Erythematosus (SLE)	Route of Administration: Intravenous 2g/kg divided over 2 to 5 consecutive days every 4 weeks
Gammagard S/D Immune Globulin Intravenous (Human)	Tetanus Treatment and Prophylaxis	Route of Administration: Intravenous 400mg/kg once if tetanus immune globulin is not available
Gammagard S/D Immune Globulin Intravenous (Human)	Toxic Necrotizing Fasciitis due to Group A Streptococcus	Route of Administration: Intravenous 2g/kg divided over 1 to 5 consecutive days
Gammagard S/D Immune Globulin Intravenous (Human)	Toxic Shock Syndrome	Route of Administration: Intravenous 2g/kg divided over 1 to 5 consecutive days
Gammagard S/D Immune Globulin Intravenous (Human)	Varicella Prophylaxis	Route of Administration: Intravenous 400mg/kg once as soon as possible and within 10 days after exposure
Gammaked Immune Globulin Intravenous (Human)	Acquired Red Cell Aplasia	Route of Administration: Intravenous 2g/kg per treatment, divided over 2 to 5 consecutive days
Gammaked Immune Globulin Intravenous (Human)	Acute Disseminated Encephalomyelitis	Route of Administration: Intravenous 2g/kg per treatment, divided over 2 to 5 consecutive days
Gammaked Immune Globulin Intravenous (Human)	Autoimmune Hemolytic Anemia	Route of Administration: Intravenous 2g/kg per treatment, divided over 2 to 5 consecutive days
Gammaked Immune Globulin Intravenous (Human)	Autoimmune Mucocutaneous Blistering Diseases	Route of Administration: Intravenous 2g/kg divided over 2 to 5 consecutive days every 4 weeks
Gammaked Immune Globulin Intravenous (Human)	Autoimmune Neutropenia	Route of Administration: Intravenous 1g/kg per day
Gammaked Immune Globulin Intravenous (Human)	B-Cell Chronic Lymphocytic Leukemia (CLL)	Route of Administration: Intravenous 400mg/kg every 3 weeks
Gammaked Immune Globulin Intravenous (Human)	Birdshot Retinochoroidopathy	Route of Administration: Intravenous 2g/kg divided over 2 to 5 consecutive days every 4 weeks
Gammaked Immune Globulin Intravenous (Human)	BK Virus Associated Nephropathy	Route of Administration: Intravenous 2g/kg per dose
Gammaked Immune Globulin Intravenous (Human)	Bone Marrow Transplant (BMT)/ Hematopoietic Stem Cell Transplant (HSCT)	Route of Administration: Intravenous 800mg/kg every week
Gammaked Immune Globulin Intravenous (Human)	Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)	Route of Administration: Intravenous Initial: 2g/kg divided over 2 to 5 consecutive days Maintenance: 1g/kg divided over 1 to 2 consecutive days every 3 weeks
Gammaked Immune Globulin Intravenous (Human)	Churg-Strauss Syndrome	Route of Administration: Intravenous 2g/kg divided over 2 to 5 days every 3 weeks
Gammaked Immune Globulin Intravenous (Human)	Dermatomyositis	Route of Administration: Intravenous 2g/kg divided over 1 to 5 consecutive days every 4 weeks
Gammaked Immune Globulin Intravenous (Human)	Enteroviral Meningoencephalitis	Route of Administration: Intravenous 2g/kg per dose
Gammaked Immune Globulin Intravenous (Human)	Fetal/Neonatal Alloimmune Thrombocytopenia	Route of Administration: Intravenous 2g/kg per week (maternal administration) 1g/kg once (neonatal administration). Repeat if needed.
Gammaked Immune Globulin Intravenous (Human)	Guillain-Barré Syndrome	Route of Administration: Intravenous 2g/kg divided over 1 to 5 consecutive days
Gammaked Immune Globulin Intravenous (Human)	Hematophagocytic Lymphohistiocytosis (HLH) or Macrophage Activation Syndrome (MAS)	Route of Administration: Intravenous 2g/kg per dose
Gammaked Immune Globulin Intravenous (Human)	Hemolytic Disease of Newborn	Route of Administration: Intravenous 1g/kg as a single dose; repeat in 12 hours if needed
Gammaked Immune Globulin Intravenous (Human)	HIV-Associated Thrombocytopenia	Route of Administration: Intravenous 1g/kg daily for 2 days. Repeat if needed
Gammaked Immune Globulin Intravenous (Human)	Hyperimmunoglobulinemia E Syndrome	Route of Administration: Intravenous 2mg/kg divided over 2-5 days
Gammaked Immune Globulin Intravenous (Human)	Hypogammaglobulinemia from CAR-T Therapy	Route of Administration: Intravenous 500mg/kg every 4 weeks
Gammaked Immune Globulin Intravenous (Human)	Idiopathic Thrombocytopenic Purpura (ITP)	Route of Administration: Intravenous 1g/kg once daily for 2 days 400mg/kg every day for 5 days
Gammaked Immune Globulin Intravenous (Human)	Kawasaki Syndrome	Route of Administration: Intravenous <18year(s) 2g/kg as a single dose; repeat if needed
Gammaked Immune Globulin Intravenous (Human)	Lambert-Eaton Myasthenic Syndrome	Route of Administration: Intravenous 2g/kg divided over 2 to 5 days, may repeat every 4 to 12 weeks
Gammaked Immune Globulin Intravenous (Human)	Management of Immune Checkpoint Inhibitor-Related Toxicities	Route of Administration: Intravenous 2g/kg per treatment, divided over 2 to 5 consecutive days
Gammaked Immune Globulin Intravenous (Human)	Measles (Rubeola) Prophylaxis	Route of Administration: Intravenous 400mg/kg once as soon as possible and within 6 days after exposure
Gammaked Immune Globulin Intravenous (Human)	Multifocal Motor Neuropathy	Route of Administration: Intravenous 2g/kg divided over 2 to 5 consecutive days, followed by 1-2 g/kg every 2-6 weeks (max 1 g/kg/day)
Gammaked Immune Globulin Intravenous (Human)	Multiple Myeloma	Route of Administration: Intravenous 800mg/kg every 3 weeks
Gammaked Immune Globulin Intravenous (Human)	Myasthenia Gravis	Route of Administration: Intravenous 2g/kg divided over 1 to 5 consecutive days per treatment course for worsening weakness, acute exacerbation, or in preparation for surgery 1g/kg every 2-6 weeks for maintenance of refractory disease
Gammaked Immune Globulin Intravenous (Human)	Neonatal Hemochromatosis, Prophylaxis	Route of Administration: Intravenous 1g/kg every week beginning on the 18th week of gestation until delivery
Gammaked Immune Globulin Intravenous (Human)	Opsoclonus-Myoclonus or Paraneoplastic Opsoclonus-Myoclonus-Ataxia Associated with Neuroblastoma	Route of Administration: Intravenous 2g/kg divided over 2 to 5 consecutive days every 4 weeks
Gammaked Immune Globulin Intravenous (Human)	Parvovirus B19-Induced Pure Red Cell Aplasia	Route of Administration: Intravenous 2g/kg divided over 2 to 5 consecutive days; For HIV patients with CD4 count <100 cells/mm3, maintenance dose of 400 mg/kg every 4 weeks
Gammaked Immune Globulin Intravenous (Human)	Pediatric Acute-onset Neuropsychiatric Syndrome (PANS)/Pediatric Autoimmune Neuropsychiatric Disorder Associated with Streptococcal Infections (PANDAS)	Route of Administration: Intravenous 800mg/kg every 3 weeks
Gammaked Immune Globulin Intravenous (Human)	Polymyositis	Route of Administration: Intravenous 2g/kg divided over 1 to 5 consecutive days every 4 weeks
Gammaked Immune Globulin Intravenous (Human)	Post-Transfusion Purpura	Route of Administration: Intravenous 2g/kg divided over 2 to 5 consecutive days
Gammaked Immune Globulin Intravenous (Human)	Primary Immunodeficiency	Route of Administration: Intravenous, Subcutaneous 800mg/kg every 3 weeks
Gammaked Immune Globulin Intravenous (Human)	Prophylaxis of Bacterial Infections in Pediatric HIV Infection	Route of Administration: Intravenous <18year(s) 400mg/kg every 2 weeks
Gammaked Immune Globulin Intravenous (Human)	Rasmussen Encephalitis	Route of Administration: Intravenous 400mg/kg daily for 5 days every 4 weeks
Gammaked Immune Globulin Intravenous (Human)	Renal Transplantation from a Live Donor with ABO Incompatibility or Positive Cross Match	Route of Administration: Intravenous 2g/kg per dose
Gammaked Immune Globulin Intravenous (Human)	Retinocochleocerebral Vasculopathy, Central Nervous System-Predominant	Route of Administration: Intravenous Initial dosage: 2g/kg 2 g/kg IV over 2 days, followed by 1 g/kg every 2 weeks until stable; then, 1.5 g/kg every 3 weeks until further stable. Maintenance dosage: 2 g/kg every 4 weeks for 6 months; then, 1 g/kg every 4 weeks for at least 6 months
Gammaked Immune Globulin Intravenous (Human)	Secondary Immunosuppression Associated with Major Surgery, Hematological Malignancy, Major Burns, and Collagen-Vascular Diseases	Route of Administration: Intravenous 800mg/kg every 3 weeks
Gammaked Immune Globulin Intravenous (Human)	Solid Organ Transplantation, for Allosensitized Members	Route of Administration: Intravenous 3g/kg divided over 2-5 days (max 1 g/kg/day) every 2-4 weeks
Gammaked Immune Globulin Intravenous (Human)	Stevens-Johnson Syndrome or Toxic Epidermal Necrolysis	Route of Administration: Intravenous 3g/kg divided over 1 to 5 consecutive days. Repeat if needed.
Gammaked Immune Globulin Intravenous (Human)	Stiff-Person Syndrome	Route of Administration: Intravenous 2g/kg divided over 2 to 5 consecutive days every month
Gammaked Immune Globulin Intravenous (Human)	Systemic Lupus Erythematosus (SLE)	Route of Administration: Intravenous 2g/kg divided over 2 to 5 consecutive days every 4 weeks
Gammaked Immune Globulin Intravenous (Human)	Tetanus Treatment and Prophylaxis	Route of Administration: Intravenous 400mg/kg once if tetanus immune globulin is not available
Gammaked Immune Globulin Intravenous (Human)	Toxic Necrotizing Fasciitis due to Group A Streptococcus	Route of Administration: Intravenous 2g/kg divided over 1 to 5 consecutive days
Gammaked Immune Globulin Intravenous (Human)	Toxic Shock Syndrome	Route of Administration: Intravenous 2g/kg divided over 1 to 5 consecutive days
Gammaked Immune Globulin Intravenous (Human)	Varicella Prophylaxis	Route of Administration: Intravenous 400mg/kg once as soon as possible and within 10 days after exposure
Gammaplex Immune Globulin Intravenous (Human)	Acquired Red Cell Aplasia	Route of Administration: Intravenous 2g/kg per treatment, divided over 2 to 5 consecutive days
Gammaplex Immune Globulin Intravenous (Human)	Acute Disseminated Encephalomyelitis	Route of Administration: Intravenous 2g/kg per treatment, divided over 2 to 5 consecutive days
Gammaplex Immune Globulin Intravenous (Human)	Autoimmune Hemolytic Anemia	Route of Administration: Intravenous 2g/kg per treatment, divided over 2 to 5 consecutive days
Gammaplex Immune Globulin Intravenous (Human)	Autoimmune Mucocutaneous Blistering Diseases	Route of Administration: Intravenous 2g/kg divided over 2 to 5 consecutive days every 4 weeks
Gammaplex Immune Globulin Intravenous (Human)	Autoimmune Neutropenia	Route of Administration: Intravenous 1g/kg per day
Gammaplex Immune Globulin Intravenous (Human)	B-Cell Chronic Lymphocytic Leukemia (CLL)	Route of Administration: Intravenous 400mg/kg every 3 weeks
Gammaplex Immune Globulin Intravenous (Human)	Birdshot Retinochoroidopathy	Route of Administration: Intravenous 2g/kg divided over 2 to 5 consecutive days every 4 weeks
Gammaplex Immune Globulin Intravenous (Human)	BK Virus Associated Nephropathy	Route of Administration: Intravenous 2g/kg per dose
Gammaplex Immune Globulin Intravenous (Human)	Bone Marrow Transplant (BMT)/ Hematopoietic Stem Cell Transplant (HSCT)	Route of Administration: Intravenous 800mg/kg every week
Gammaplex Immune Globulin Intravenous (Human)	Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)	Route of Administration: Intravenous Initial: 2g/kg divided over 2 to 5 consecutive days Maintenance: 1g/kg divided over 1 to 2 consecutive days every 3 weeks
Gammaplex Immune Globulin Intravenous (Human)	Churg-Strauss Syndrome	Route of Administration: Intravenous 2g/kg divided over 2 to 5 days every 3 weeks
Gammaplex Immune Globulin Intravenous (Human)	Dermatomyositis	Route of Administration: Intravenous 2g/kg divided over 1 to 5 consecutive days every 4 weeks
Gammaplex Immune Globulin Intravenous (Human)	Enteroviral Meningoencephalitis	Route of Administration: Intravenous 2g/kg per dose
Gammaplex Immune Globulin Intravenous (Human)	Fetal/Neonatal Alloimmune Thrombocytopenia	Route of Administration: Intravenous 2g/kg per week (maternal administration) 1g/kg once (neonatal administration). Repeat if needed.
Gammaplex Immune Globulin Intravenous (Human)	Guillain-Barré Syndrome	Route of Administration: Intravenous 2g/kg divided over 1 to 5 consecutive days
Gammaplex Immune Globulin Intravenous (Human)	Hematophagocytic Lymphohistiocytosis (HLH) or Macrophage Activation Syndrome (MAS)	Route of Administration: Intravenous 2g/kg per dose
Gammaplex Immune Globulin Intravenous (Human)	Hemolytic Disease of Newborn	Route of Administration: Intravenous 1g/kg as a single dose; repeat in 12 hours if needed
Gammaplex Immune Globulin Intravenous (Human)	HIV-Associated Thrombocytopenia	Route of Administration: Intravenous 1g/kg daily for 2 days. Repeat if needed
Gammaplex Immune Globulin Intravenous (Human)	Hyperimmunoglobulinemia E Syndrome	Route of Administration: Intravenous 2mg/kg divided over 2-5 days
Gammaplex Immune Globulin Intravenous (Human)	Hypogammaglobulinemia from CAR-T Therapy	Route of Administration: Intravenous 500mg/kg every 4 weeks
Gammaplex Immune Globulin Intravenous (Human)	Idiopathic Thrombocytopenic Purpura (ITP)	Route of Administration: Intravenous 1g/kg once daily for 2 days 400mg/kg every day for 5 days
Gammaplex Immune Globulin Intravenous (Human)	Kawasaki Syndrome	Route of Administration: Intravenous <18year(s) 2g/kg as a single dose; repeat if needed
Gammaplex Immune Globulin Intravenous (Human)	Lambert-Eaton Myasthenic Syndrome	Route of Administration: Intravenous 2g/kg divided over 2 to 5 days, may repeat every 4 to 12 weeks
Gammaplex Immune Globulin Intravenous (Human)	Management of Immune Checkpoint Inhibitor-Related Toxicities	Route of Administration: Intravenous 2g/kg per treatment, divided over 2 to 5 consecutive days
Gammaplex Immune Globulin Intravenous (Human)	Measles (Rubeola) Prophylaxis	Route of Administration: Intravenous 400mg/kg once as soon as possible and within 6 days after exposure
Gammaplex Immune Globulin Intravenous (Human)	Multifocal Motor Neuropathy	Route of Administration: Intravenous 2g/kg divided over 2 to 5 consecutive days, followed by 1-2 g/kg every 2-6 weeks (max 1 g/kg/day)
Gammaplex Immune Globulin Intravenous (Human)	Multiple Myeloma	Route of Administration: Intravenous 800mg/kg every 3 weeks
Gammaplex Immune Globulin Intravenous (Human)	Myasthenia Gravis	Route of Administration: Intravenous 2g/kg divided over 1 to 5 consecutive days per treatment course for worsening weakness, acute exacerbation, or in preparation for surgery 1g/kg every 2-6 weeks for maintenance of refractory disease
Gammaplex Immune Globulin Intravenous (Human)	Neonatal Hemochromatosis, Prophylaxis	Route of Administration: Intravenous 1g/kg every week beginning on the 18th week of gestation until delivery
Gammaplex Immune Globulin Intravenous (Human)	Opsoclonus-Myoclonus or Paraneoplastic Opsoclonus-Myoclonus-Ataxia Associated with Neuroblastoma	Route of Administration: Intravenous 2g/kg divided over 2 to 5 consecutive days every 4 weeks
Gammaplex Immune Globulin Intravenous (Human)	Parvovirus B19-Induced Pure Red Cell Aplasia	Route of Administration: Intravenous 2g/kg divided over 2 to 5 consecutive days; For HIV patients with CD4 count <100 cells/mm3, maintenance dose of 400 mg/kg every 4 weeks
Gammaplex Immune Globulin Intravenous (Human)	Pediatric Acute-onset Neuropsychiatric Syndrome (PANS)/Pediatric Autoimmune Neuropsychiatric Disorder Associated with Streptococcal Infections (PANDAS)	Route of Administration: Intravenous 800mg/kg every 3 weeks
Gammaplex Immune Globulin Intravenous (Human)	Polymyositis	Route of Administration: Intravenous 2g/kg divided over 1 to 5 consecutive days every 4 weeks
Gammaplex Immune Globulin Intravenous (Human)	Post-Transfusion Purpura	Route of Administration: Intravenous 2g/kg divided over 2 to 5 consecutive days
Gammaplex Immune Globulin Intravenous (Human)	Primary Immunodeficiency	Route of Administration: Intravenous 800mg/kg every 3 weeks
Gammaplex Immune Globulin Intravenous (Human)	Prophylaxis of Bacterial Infections in Pediatric HIV Infection	Route of Administration: Intravenous <18year(s) 400mg/kg every 2 weeks
Gammaplex Immune Globulin Intravenous (Human)	Rasmussen Encephalitis	Route of Administration: Intravenous 400mg/kg daily for 5 days every 4 weeks
Gammaplex Immune Globulin Intravenous (Human)	Renal Transplantation from a Live Donor with ABO Incompatibility or Positive Cross Match	Route of Administration: Intravenous 2g/kg per dose
Gammaplex Immune Globulin Intravenous (Human)	Retinocochleocerebral Vasculopathy, Central Nervous System-Predominant	Route of Administration: Intravenous Initial dosage: 2g/kg 2 g/kg IV over 2 days, followed by 1 g/kg every 2 weeks until stable; then, 1.5 g/kg every 3 weeks until further stable. Maintenance dosage: 2 g/kg every 4 weeks for 6 months; then, 1 g/kg every 4 weeks for at least 6 months
Gammaplex Immune Globulin Intravenous (Human)	Secondary Immunosuppression Associated with Major Surgery, Hematological Malignancy, Major Burns, and Collagen-Vascular Diseases	Route of Administration: Intravenous 800mg/kg every 3 weeks
Gammaplex Immune Globulin Intravenous (Human)	Solid Organ Transplantation, for Allosensitized Members	Route of Administration: Intravenous 3g/kg divided over 2-5 days (max 1 g/kg/day) every 2-4 weeks
Gammaplex Immune Globulin Intravenous (Human)	Stevens-Johnson Syndrome or Toxic Epidermal Necrolysis	Route of Administration: Intravenous 3g/kg divided over 1 to 5 consecutive days. Repeat if needed.
Gammaplex Immune Globulin Intravenous (Human)	Stiff-Person Syndrome	Route of Administration: Intravenous 2g/kg divided over 2 to 5 consecutive days every month
Gammaplex Immune Globulin Intravenous (Human)	Systemic Lupus Erythematosus (SLE)	Route of Administration: Intravenous 2g/kg divided over 2 to 5 consecutive days every 4 weeks
Gammaplex Immune Globulin Intravenous (Human)	Tetanus Treatment and Prophylaxis	Route of Administration: Intravenous 400mg/kg once if tetanus immune globulin is not available
Gammaplex Immune Globulin Intravenous (Human)	Toxic Necrotizing Fasciitis due to Group A Streptococcus	Route of Administration: Intravenous 2g/kg divided over 1 to 5 consecutive days
Gammaplex Immune Globulin Intravenous (Human)	Toxic Shock Syndrome	Route of Administration: Intravenous 2g/kg divided over 1 to 5 consecutive days
Gammaplex Immune Globulin Intravenous (Human)	Varicella Prophylaxis	Route of Administration: Intravenous 400mg/kg once as soon as possible and within 10 days after exposure
Gamunex-C Immune Globulin Intravenous (Human)	Acquired Red Cell Aplasia	Route of Administration: Intravenous 2g/kg per treatment, divided over 2 to 5 consecutive days
Gamunex-C Immune Globulin Intravenous (Human)	Acute Disseminated Encephalomyelitis	Route of Administration: Intravenous 2g/kg per treatment, divided over 2 to 5 consecutive days
Gamunex-C Immune Globulin Intravenous (Human)	Autoimmune Hemolytic Anemia	Route of Administration: Intravenous 2g/kg per treatment, divided over 2 to 5 consecutive days
Gamunex-C Immune Globulin Intravenous (Human)	Autoimmune Mucocutaneous Blistering Diseases	Route of Administration: Intravenous 2g/kg divided over 2 to 5 consecutive days every 4 weeks
Gamunex-C Immune Globulin Intravenous (Human)	Autoimmune Neutropenia	Route of Administration: Intravenous 1g/kg per day
Gamunex-C Immune Globulin Intravenous (Human)	B-Cell Chronic Lymphocytic Leukemia (CLL)	Route of Administration: Intravenous 400mg/kg every 3 weeks
Gamunex-C Immune Globulin Intravenous (Human)	Birdshot Retinochoroidopathy	Route of Administration: Intravenous 2g/kg divided over 2 to 5 consecutive days every 4 weeks
Gamunex-C Immune Globulin Intravenous (Human)	BK Virus Associated Nephropathy	Route of Administration: Intravenous 2g/kg per dose
Gamunex-C Immune Globulin Intravenous (Human)	Bone Marrow Transplant (BMT)/ Hematopoietic Stem Cell Transplant (HSCT)	Route of Administration: Intravenous 800mg/kg every week
Gamunex-C Immune Globulin Intravenous (Human)	Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)	Route of Administration: Intravenous Initial: 2g/kg divided over 2 to 5 consecutive days Maintenance: 1g/kg divided over 1 to 2 consecutive days every 3 weeks
Gamunex-C Immune Globulin Intravenous (Human)	Churg-Strauss Syndrome	Route of Administration: Intravenous 2g/kg divided over 2 to 5 days every 3 weeks
Gamunex-C Immune Globulin Intravenous (Human)	Dermatomyositis	Route of Administration: Intravenous 2g/kg divided over 1 to 5 consecutive days every 4 weeks
Gamunex-C Immune Globulin Intravenous (Human)	Enteroviral Meningoencephalitis	Route of Administration: Intravenous 2g/kg per dose
Gamunex-C Immune Globulin Intravenous (Human)	Fetal/Neonatal Alloimmune Thrombocytopenia	Route of Administration: Intravenous 2g/kg per week (maternal administration) 1g/kg once (neonatal administration). Repeat if needed.
Gamunex-C Immune Globulin Intravenous (Human)	Guillain-Barré Syndrome	Route of Administration: Intravenous 2g/kg divided over 1 to 5 consecutive days
Gamunex-C Immune Globulin Intravenous (Human)	Hematophagocytic Lymphohistiocytosis (HLH) or Macrophage Activation Syndrome (MAS)	Route of Administration: Intravenous 2g/kg per dose
Gamunex-C Immune Globulin Intravenous (Human)	Hemolytic Disease of Newborn	Route of Administration: Intravenous 1g/kg as a single dose; repeat in 12 hours if needed
Gamunex-C Immune Globulin Intravenous (Human)	HIV-Associated Thrombocytopenia	Route of Administration: Intravenous 1g/kg daily for 2 days. Repeat if needed
Gamunex-C Immune Globulin Intravenous (Human)	Hyperimmunoglobulinemia E Syndrome	Route of Administration: Intravenous 2mg/kg divided over 2-5 days
Gamunex-C Immune Globulin Intravenous (Human)	Hypogammaglobulinemia from CAR-T Therapy	Route of Administration: Intravenous 500mg/kg every 4 weeks
Gamunex-C Immune Globulin Intravenous (Human)	Idiopathic Thrombocytopenic Purpura (ITP)	Route of Administration: Intravenous 1g/kg once daily for 2 days 400mg/kg every day for 5 days
Gamunex-C Immune Globulin Intravenous (Human)	Kawasaki Syndrome	Route of Administration: Intravenous <18year(s) 2g/kg as a single dose; repeat if needed
Gamunex-C Immune Globulin Intravenous (Human)	Lambert-Eaton Myasthenic Syndrome	Route of Administration: Intravenous 2g/kg divided over 2 to 5 days, may repeat every 4 to 12 weeks
Gamunex-C Immune Globulin Intravenous (Human)	Management of Immune Checkpoint Inhibitor-Related Toxicities	Route of Administration: Intravenous 2g/kg per treatment, divided over 2 to 5 consecutive days
Gamunex-C Immune Globulin Intravenous (Human)	Measles (Rubeola) Prophylaxis	Route of Administration: Intravenous 400mg/kg once as soon as possible and within 6 days after exposure
Gamunex-C Immune Globulin Intravenous (Human)	Multifocal Motor Neuropathy	Route of Administration: Intravenous 2g/kg divided over 2 to 5 consecutive days, followed by 1-2 g/kg every 2-6 weeks (max 1 g/kg/day)
Gamunex-C Immune Globulin Intravenous (Human)	Multiple Myeloma	Route of Administration: Intravenous 800mg/kg every 3 weeks
Gamunex-C Immune Globulin Intravenous (Human)	Myasthenia Gravis	Route of Administration: Intravenous 2g/kg divided over 1 to 5 consecutive days per treatment course for worsening weakness, acute exacerbation, or in preparation for surgery 1g/kg every 2-6 weeks for maintenance of refractory disease
Gamunex-C Immune Globulin Intravenous (Human)	Neonatal Hemochromatosis, Prophylaxis	Route of Administration: Intravenous 1g/kg every week beginning on the 18th week of gestation until delivery
Gamunex-C Immune Globulin Intravenous (Human)	Opsoclonus-Myoclonus or Paraneoplastic Opsoclonus-Myoclonus-Ataxia Associated with Neuroblastoma	Route of Administration: Intravenous 2g/kg divided over 2 to 5 consecutive days every 4 weeks
Gamunex-C Immune Globulin Intravenous (Human)	Parvovirus B19-Induced Pure Red Cell Aplasia	Route of Administration: Intravenous 2g/kg divided over 2 to 5 consecutive days; For HIV patients with CD4 count <100 cells/mm3, maintenance dose of 400 mg/kg every 4 weeks
Gamunex-C Immune Globulin Intravenous (Human)	Pediatric Acute-onset Neuropsychiatric Syndrome (PANS)/Pediatric Autoimmune Neuropsychiatric Disorder Associated with Streptococcal Infections (PANDAS)	Route of Administration: Intravenous 800mg/kg every 3 weeks
Gamunex-C Immune Globulin Intravenous (Human)	Polymyositis	Route of Administration: Intravenous 2g/kg divided over 1 to 5 consecutive days every 4 weeks
Gamunex-C Immune Globulin Intravenous (Human)	Post-Transfusion Purpura	Route of Administration: Intravenous 2g/kg divided over 2 to 5 consecutive days
Gamunex-C Immune Globulin Intravenous (Human)	Primary Immunodeficiency	Route of Administration: Intravenous, Subcutaneous 800mg/kg every 3 weeks
Gamunex-C Immune Globulin Intravenous (Human)	Prophylaxis of Bacterial Infections in Pediatric HIV Infection	Route of Administration: Intravenous <18year(s) 400mg/kg every 2 weeks
Gamunex-C Immune Globulin Intravenous (Human)	Rasmussen Encephalitis	Route of Administration: Intravenous 400mg/kg daily for 5 days every 4 weeks
Gamunex-C Immune Globulin Intravenous (Human)	Renal Transplantation from a Live Donor with ABO Incompatibility or Positive Cross Match	Route of Administration: Intravenous 2g/kg per dose
Gamunex-C Immune Globulin Intravenous (Human)	Retinocochleocerebral Vasculopathy, Central Nervous System-Predominant	Route of Administration: Intravenous Initial dosage: 2g/kg 2 g/kg IV over 2 days, followed by 1 g/kg every 2 weeks until stable; then, 1.5 g/kg every 3 weeks until further stable. Maintenance dosage: 2 g/kg every 4 weeks for 6 months; then, 1 g/kg every 4 weeks for at least 6 months
Gamunex-C Immune Globulin Intravenous (Human)	Secondary Immunosuppression Associated with Major Surgery, Hematological Malignancy, Major Burns, and Collagen-Vascular Diseases	Route of Administration: Intravenous 800mg/kg every 3 weeks
Gamunex-C Immune Globulin Intravenous (Human)	Solid Organ Transplantation, for Allosensitized Members	Route of Administration: Intravenous 3g/kg divided over 2-5 days (max 1 g/kg/day) every 2-4 weeks
Gamunex-C Immune Globulin Intravenous (Human)	Stevens-Johnson Syndrome or Toxic Epidermal Necrolysis	Route of Administration: Intravenous 3g/kg divided over 1 to 5 consecutive days. Repeat if needed.
Gamunex-C Immune Globulin Intravenous (Human)	Stiff-Person Syndrome	Route of Administration: Intravenous 2g/kg divided over 2 to 5 consecutive days every month
Gamunex-C Immune Globulin Intravenous (Human)	Systemic Lupus Erythematosus (SLE)	Route of Administration: Intravenous 2g/kg divided over 2 to 5 consecutive days every 4 weeks
Gamunex-C Immune Globulin Intravenous (Human)	Tetanus Treatment and Prophylaxis	Route of Administration: Intravenous 400mg/kg once if tetanus immune globulin is not available
Gamunex-C Immune Globulin Intravenous (Human)	Toxic Necrotizing Fasciitis due to Group A Streptococcus	Route of Administration: Intravenous 2g/kg divided over 1 to 5 consecutive days
Gamunex-C Immune Globulin Intravenous (Human)	Toxic Shock Syndrome	Route of Administration: Intravenous 2g/kg divided over 1 to 5 consecutive days
Gamunex-C Immune Globulin Intravenous (Human)	Varicella Prophylaxis	Route of Administration: Intravenous 400mg/kg once as soon as possible and within 10 days after exposure
Octagam Immune Globulin Intravenous (Human)	Acquired Red Cell Aplasia	Route of Administration: Intravenous 2g/kg per treatment, divided over 2 to 5 consecutive days
Octagam Immune Globulin Intravenous (Human)	Acute Disseminated Encephalomyelitis	Route of Administration: Intravenous 2g/kg per treatment, divided over 2 to 5 consecutive days
Octagam Immune Globulin Intravenous (Human)	Autoimmune Hemolytic Anemia	Route of Administration: Intravenous 2g/kg per treatment, divided over 2 to 5 consecutive days
Octagam Immune Globulin Intravenous (Human)	Autoimmune Mucocutaneous Blistering Diseases	Route of Administration: Intravenous 2g/kg divided over 2 to 5 consecutive days every 4 weeks
Octagam Immune Globulin Intravenous (Human)	Autoimmune Neutropenia	Route of Administration: Intravenous 1g/kg per day
Octagam Immune Globulin Intravenous (Human)	B-Cell Chronic Lymphocytic Leukemia (CLL)	Route of Administration: Intravenous 400mg/kg every 3 weeks
Octagam Immune Globulin Intravenous (Human)	Birdshot Retinochoroidopathy	Route of Administration: Intravenous 2g/kg divided over 2 to 5 consecutive days every 4 weeks
Octagam Immune Globulin Intravenous (Human)	BK Virus Associated Nephropathy	Route of Administration: Intravenous 2g/kg per dose
Octagam Immune Globulin Intravenous (Human)	Bone Marrow Transplant (BMT)/ Hematopoietic Stem Cell Transplant (HSCT)	Route of Administration: Intravenous 800mg/kg every week
Octagam Immune Globulin Intravenous (Human)	Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)	Route of Administration: Intravenous Initial: 2g/kg divided over 2 to 5 consecutive days Maintenance: 1g/kg divided over 1 to 2 consecutive days every 3 weeks
Octagam Immune Globulin Intravenous (Human)	Churg-Strauss Syndrome	Route of Administration: Intravenous 2g/kg divided over 2 to 5 days every 3 weeks
Octagam Immune Globulin Intravenous (Human)	Dermatomyositis	Route of Administration: Intravenous 2g/kg divided over 1 to 5 consecutive days every 4 weeks
Octagam Immune Globulin Intravenous (Human)	Enteroviral Meningoencephalitis	Route of Administration: Intravenous 2g/kg per dose
Octagam Immune Globulin Intravenous (Human)	Fetal/Neonatal Alloimmune Thrombocytopenia	Route of Administration: Intravenous 2g/kg per week (maternal administration) 1g/kg once (neonatal administration). Repeat if needed.
Octagam Immune Globulin Intravenous (Human)	Guillain-Barré Syndrome	Route of Administration: Intravenous 2g/kg divided over 1 to 5 consecutive days
Octagam Immune Globulin Intravenous (Human)	Hematophagocytic Lymphohistiocytosis (HLH) or Macrophage Activation Syndrome (MAS)	Route of Administration: Intravenous 2g/kg per dose
Octagam Immune Globulin Intravenous (Human)	Hemolytic Disease of Newborn	Route of Administration: Intravenous 1g/kg as a single dose; repeat in 12 hours if needed
Octagam Immune Globulin Intravenous (Human)	HIV-Associated Thrombocytopenia	Route of Administration: Intravenous 1g/kg daily for 2 days. Repeat if needed
Octagam Immune Globulin Intravenous (Human)	Hyperimmunoglobulinemia E Syndrome	Route of Administration: Intravenous 2mg/kg divided over 2-5 days
Octagam Immune Globulin Intravenous (Human)	Hypogammaglobulinemia from CAR-T Therapy	Route of Administration: Intravenous 500mg/kg every 4 weeks
Octagam Immune Globulin Intravenous (Human)	Idiopathic Thrombocytopenic Purpura (ITP)	Route of Administration: Intravenous 1g/kg once daily for 2 days 400mg/kg every day for 5 days
Octagam Immune Globulin Intravenous (Human)	Kawasaki Syndrome	Route of Administration: Intravenous <18year(s) 2g/kg as a single dose; repeat if needed
Octagam Immune Globulin Intravenous (Human)	Lambert-Eaton Myasthenic Syndrome	Route of Administration: Intravenous 2g/kg divided over 2 to 5 days, may repeat every 4 to 12 weeks
Octagam Immune Globulin Intravenous (Human)	Management of Immune Checkpoint Inhibitor-Related Toxicities	Route of Administration: Intravenous 2g/kg per treatment, divided over 2 to 5 consecutive days
Octagam Immune Globulin Intravenous (Human)	Measles (Rubeola) Prophylaxis	Route of Administration: Intravenous 400mg/kg once as soon as possible and within 6 days after exposure
Octagam Immune Globulin Intravenous (Human)	Multifocal Motor Neuropathy	Route of Administration: Intravenous 2g/kg divided over 2 to 5 consecutive days, followed by 1-2 g/kg every 2-6 weeks (max 1 g/kg/day)
Octagam Immune Globulin Intravenous (Human)	Multiple Myeloma	Route of Administration: Intravenous 800mg/kg every 3 weeks
Octagam Immune Globulin Intravenous (Human)	Myasthenia Gravis	Route of Administration: Intravenous 2g/kg divided over 1 to 5 consecutive days per treatment course for worsening weakness, acute exacerbation, or in preparation for surgery 1g/kg every 2-6 weeks for maintenance of refractory disease
Octagam Immune Globulin Intravenous (Human)	Neonatal Hemochromatosis, Prophylaxis	Route of Administration: Intravenous 1g/kg every week beginning on the 18th week of gestation until delivery
Octagam Immune Globulin Intravenous (Human)	Opsoclonus-Myoclonus or Paraneoplastic Opsoclonus-Myoclonus-Ataxia Associated with Neuroblastoma	Route of Administration: Intravenous 2g/kg divided over 2 to 5 consecutive days every 4 weeks
Octagam Immune Globulin Intravenous (Human)	Parvovirus B19-Induced Pure Red Cell Aplasia	Route of Administration: Intravenous 2g/kg divided over 2 to 5 consecutive days; For HIV patients with CD4 count <100 cells/mm3, maintenance dose of 400 mg/kg every 4 weeks
Octagam Immune Globulin Intravenous (Human)	Pediatric Acute-onset Neuropsychiatric Syndrome (PANS)/Pediatric Autoimmune Neuropsychiatric Disorder Associated with Streptococcal Infections (PANDAS)	Route of Administration: Intravenous 800mg/kg every 3 weeks
Octagam Immune Globulin Intravenous (Human)	Polymyositis	Route of Administration: Intravenous 2g/kg divided over 1 to 5 consecutive days every 4 weeks
Octagam Immune Globulin Intravenous (Human)	Post-Transfusion Purpura	Route of Administration: Intravenous 2g/kg divided over 2 to 5 consecutive days
Octagam Immune Globulin Intravenous (Human)	Primary Immunodeficiency	Route of Administration: Intravenous 800mg/kg every 3 weeks
Octagam Immune Globulin Intravenous (Human)	Prophylaxis of Bacterial Infections in Pediatric HIV Infection	Route of Administration: Intravenous <18year(s) 400mg/kg every 2 weeks
Octagam Immune Globulin Intravenous (Human)	Rasmussen Encephalitis	Route of Administration: Intravenous 400mg/kg daily for 5 days every 4 weeks
Octagam Immune Globulin Intravenous (Human)	Renal Transplantation from a Live Donor with ABO Incompatibility or Positive Cross Match	Route of Administration: Intravenous 2g/kg per dose
Octagam Immune Globulin Intravenous (Human)	Retinocochleocerebral Vasculopathy, Central Nervous System-Predominant	Route of Administration: Intravenous Initial dosage: 2g/kg 2 g/kg IV over 2 days, followed by 1 g/kg every 2 weeks until stable; then, 1.5 g/kg every 3 weeks until further stable. Maintenance dosage: 2 g/kg every 4 weeks for 6 months; then, 1 g/kg every 4 weeks for at least 6 months
Octagam Immune Globulin Intravenous (Human)	Secondary Immunosuppression Associated with Major Surgery, Hematological Malignancy, Major Burns, and Collagen-Vascular Diseases	Route of Administration: Intravenous 800mg/kg every 3 weeks
Octagam Immune Globulin Intravenous (Human)	Solid Organ Transplantation, for Allosensitized Members	Route of Administration: Intravenous 3g/kg divided over 2-5 days (max 1 g/kg/day) every 2-4 weeks
Octagam Immune Globulin Intravenous (Human)	Stevens-Johnson Syndrome or Toxic Epidermal Necrolysis	Route of Administration: Intravenous 3g/kg divided over 1 to 5 consecutive days. Repeat if needed.
Octagam Immune Globulin Intravenous (Human)	Stiff-Person Syndrome	Route of Administration: Intravenous 2g/kg divided over 2 to 5 consecutive days every month
Octagam Immune Globulin Intravenous (Human)	Systemic Lupus Erythematosus (SLE)	Route of Administration: Intravenous 2g/kg divided over 2 to 5 consecutive days every 4 weeks
Octagam Immune Globulin Intravenous (Human)	Tetanus Treatment and Prophylaxis	Route of Administration: Intravenous 400mg/kg once if tetanus immune globulin is not available
Octagam Immune Globulin Intravenous (Human)	Toxic Necrotizing Fasciitis due to Group A Streptococcus	Route of Administration: Intravenous 2g/kg divided over 1 to 5 consecutive days
Octagam Immune Globulin Intravenous (Human)	Toxic Shock Syndrome	Route of Administration: Intravenous 2g/kg divided over 1 to 5 consecutive days
Octagam Immune Globulin Intravenous (Human)	Varicella Prophylaxis	Route of Administration: Intravenous 400mg/kg once as soon as possible and within 10 days after exposure
Panzyga Immune Globulin Intravenous (Human) - ifas	Acquired Red Cell Aplasia	Route of Administration: Intravenous 2g/kg per treatment, divided over 2 to 5 consecutive days
Panzyga Immune Globulin Intravenous (Human) - ifas	Acute Disseminated Encephalomyelitis	Route of Administration: Intravenous 2g/kg per treatment, divided over 2 to 5 consecutive days
Panzyga Immune Globulin Intravenous (Human) - ifas	Autoimmune Hemolytic Anemia	Route of Administration: Intravenous 2g/kg per treatment, divided over 2 to 5 consecutive days
Panzyga Immune Globulin Intravenous (Human) - ifas	Autoimmune Mucocutaneous Blistering Diseases	Route of Administration: Intravenous 2g/kg divided over 2 to 5 consecutive days every 4 weeks
Panzyga Immune Globulin Intravenous (Human) - ifas	Autoimmune Neutropenia	Route of Administration: Intravenous 1g/kg per day
Panzyga Immune Globulin Intravenous (Human) - ifas	B-Cell Chronic Lymphocytic Leukemia (CLL)	Route of Administration: Intravenous 400mg/kg every 3 weeks
Panzyga Immune Globulin Intravenous (Human) - ifas	Birdshot Retinochoroidopathy	Route of Administration: Intravenous 2g/kg divided over 2 to 5 consecutive days every 4 weeks
Panzyga Immune Globulin Intravenous (Human) - ifas	BK Virus Associated Nephropathy	Route of Administration: Intravenous 2g/kg per dose
Panzyga Immune Globulin Intravenous (Human) - ifas	Bone Marrow Transplant (BMT)/ Hematopoietic Stem Cell Transplant (HSCT)	Route of Administration: Intravenous 800mg/kg every week
Panzyga Immune Globulin Intravenous (Human) - ifas	Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)	Route of Administration: Intravenous 2g/kg divided over 2 consecutive days every 3 weeks Initial: 2g/kg divided over 2 to 5 consecutive days Maintenance: 1g/kg divided over 1 to 2 consecutive days every 3 weeks
Panzyga Immune Globulin Intravenous (Human) - ifas	Churg-Strauss Syndrome	Route of Administration: Intravenous 2g/kg divided over 2 to 5 days every 3 weeks
Panzyga Immune Globulin Intravenous (Human) - ifas	Dermatomyositis	Route of Administration: Intravenous 2g/kg divided over 1 to 5 consecutive days every 4 weeks
Panzyga Immune Globulin Intravenous (Human) - ifas	Enteroviral Meningoencephalitis	Route of Administration: Intravenous 2g/kg per dose
Panzyga Immune Globulin Intravenous (Human) - ifas	Fetal/Neonatal Alloimmune Thrombocytopenia	Route of Administration: Intravenous 2g/kg per week (maternal administration) 1g/kg once (neonatal administration). Repeat if needed.
Panzyga Immune Globulin Intravenous (Human) - ifas	Guillain-Barré Syndrome	Route of Administration: Intravenous 2g/kg divided over 1 to 5 consecutive days
Panzyga Immune Globulin Intravenous (Human) - ifas	Hematophagocytic Lymphohistiocytosis (HLH) or Macrophage Activation Syndrome (MAS)	Route of Administration: Intravenous 2g/kg per dose
Panzyga Immune Globulin Intravenous (Human) - ifas	Hemolytic Disease of Newborn	Route of Administration: Intravenous 1g/kg as a single dose; repeat in 12 hours if needed
Panzyga Immune Globulin Intravenous (Human) - ifas	HIV-Associated Thrombocytopenia	Route of Administration: Intravenous 1g/kg daily for 2 days. Repeat if needed
Panzyga Immune Globulin Intravenous (Human) - ifas	Hyperimmunoglobulinemia E Syndrome	Route of Administration: Intravenous 2mg/kg divided over 2-5 days
Panzyga Immune Globulin Intravenous (Human) - ifas	Hypogammaglobulinemia from CAR-T Therapy	Route of Administration: Intravenous 500mg/kg every 4 weeks
Panzyga Immune Globulin Intravenous (Human) - ifas	Idiopathic Thrombocytopenic Purpura (ITP)	Route of Administration: Intravenous 1g/kg once daily for 2 days 400mg/kg every day for 5 days
Panzyga Immune Globulin Intravenous (Human) - ifas	Kawasaki Syndrome	Route of Administration: Intravenous <18 year(s) 2g/kg as a single dose; repeat if needed
Panzyga Immune Globulin Intravenous (Human) - ifas	Lambert-Eaton Myasthenic Syndrome	Route of Administration: Intravenous 2g/kg divided over 2 to 5 days, may repeat every 4 to 12 weeks
Panzyga Immune Globulin Intravenous (Human) - ifas	Management of Immune Checkpoint Inhibitor-Related Toxicities	Route of Administration: Intravenous 2g/kg per treatment, divided over 2 to 5 consecutive days
Panzyga Immune Globulin Intravenous (Human) - ifas	Measles (Rubeola) Prophylaxis	Route of Administration: Intravenous 400mg/kg once as soon as possible and within 6 days after exposure
Panzyga Immune Globulin Intravenous (Human) - ifas	Multifocal Motor Neuropathy	Route of Administration: Intravenous 2g/kg divided over 2 to 5 consecutive days, followed by 1-2 g/kg every 2-6 weeks (max 1 g/kg/day)
Panzyga Immune Globulin Intravenous (Human) - ifas	Multiple Myeloma	Route of Administration: Intravenous 800mg/kg every 3 weeks
Panzyga Immune Globulin Intravenous (Human) - ifas	Myasthenia Gravis	Route of Administration: Intravenous 2g/kg divided over 1 to 5 consecutive days per treatment course for worsening weakness, acute exacerbation, or in preparation for surgery 1g/kg every 2-6 weeks for maintenance of refractory disease
Panzyga Immune Globulin Intravenous (Human) - ifas	Neonatal Hemochromatosis, Prophylaxis	Route of Administration: Intravenous 1g/kg every week beginning on the 18th week of gestation until delivery
Panzyga Immune Globulin Intravenous (Human) - ifas	Opsoclonus-Myoclonus or Paraneoplastic Opsoclonus-Myoclonus-Ataxia Associated with Neuroblastoma	Route of Administration: Intravenous 2g/kg divided over 2 to 5 consecutive days every 4 weeks
Panzyga Immune Globulin Intravenous (Human) - ifas	Parvovirus B19-Induced Pure Red Cell Aplasia	Route of Administration: Intravenous 2g/kg divided over 2 to 5 consecutive days; For HIV patients with CD4 count <100 cells/mm3, maintenance dose of 400 mg/kg every 4 weeks
Panzyga Immune Globulin Intravenous (Human) - ifas	Pediatric Acute-onset Neuropsychiatric Syndrome (PANS)/Pediatric Autoimmune Neuropsychiatric Disorder Associated with Streptococcal Infections (PANDAS)	Route of Administration: Intravenous 800mg/kg every 3 weeks
Panzyga Immune Globulin Intravenous (Human) - ifas	Polymyositis	Route of Administration: Intravenous 2g/kg divided over 1 to 5 consecutive days every 4 weeks
Panzyga Immune Globulin Intravenous (Human) - ifas	Post-Transfusion Purpura	Route of Administration: Intravenous 2g/kg divided over 2 to 5 consecutive days
Panzyga Immune Globulin Intravenous (Human) - ifas	Primary Immunodeficiency	Route of Administration: Intravenous 800mg/kg every 3 weeks
Panzyga Immune Globulin Intravenous (Human) - ifas	Prophylaxis of Bacterial Infections in Pediatric HIV Infection	Route of Administration: Intravenous <18 year(s) 400mg/kg every 2 weeks
Panzyga Immune Globulin Intravenous (Human) - ifas	Rasmussen Encephalitis	Route of Administration: Intravenous 400mg/kg daily for 5 days every 4 weeks
Panzyga Immune Globulin Intravenous (Human) - ifas	Renal Transplantation from a Live Donor with ABO Incompatibility or Positive Cross Match	Route of Administration: Intravenous 2g/kg per dose
Panzyga Immune Globulin Intravenous (Human) - ifas	Retinocochleocerebral Vasculopathy, Central Nervous System-Predominant	Route of Administration: Intravenous Initial dosage: 2g/kg 2 g/kg IV over 2 days, followed by 1 g/kg every 2 weeks until stable; then, 1.5 g/kg every 3 weeks until further stable. Maintenance dosage: 2 g/kg every 4 weeks for 6 months; then, 1 g/kg every 4 weeks for at least 6 months
Panzyga Immune Globulin Intravenous (Human) - ifas	Secondary Immunosuppression Associated with Major Surgery, Hematological Malignancy, Major Burns, and Collagen-Vascular Diseases	Route of Administration: Intravenous 800mg/kg every 3 weeks
Panzyga Immune Globulin Intravenous (Human) - ifas	Solid Organ Transplantation, for Allosensitized Members	Route of Administration: Intravenous 3g/kg divided over 2-5 days (max 1 g/kg/day) every 2-4 weeks
Panzyga Immune Globulin Intravenous (Human) - ifas	Stevens-Johnson Syndrome or Toxic Epidermal Necrolysis	Route of Administration: Intravenous 3g/kg divided over 1 to 5 consecutive days. Repeat if needed.
Panzyga Immune Globulin Intravenous (Human) - ifas	Stiff-Person Syndrome	Route of Administration: Intravenous 2g/kg divided over 2 to 5 consecutive days every month
Panzyga Immune Globulin Intravenous (Human) - ifas	Systemic Lupus Erythematosus (SLE)	Route of Administration: Intravenous 2g/kg divided over 2 to 5 consecutive days every 4 weeks
Panzyga Immune Globulin Intravenous (Human) - ifas	Tetanus Treatment and Prophylaxis	Route of Administration: Intravenous 400mg/kg once if tetanus immune globulin is not available
Panzyga Immune Globulin Intravenous (Human) - ifas	Toxic Necrotizing Fasciitis due to Group A Streptococcus	Route of Administration: Intravenous 2g/kg divided over 1 to 5 consecutive days
Panzyga Immune Globulin Intravenous (Human) - ifas	Toxic Shock Syndrome	Route of Administration: Intravenous 2g/kg divided over 1 to 5 consecutive days
Panzyga Immune Globulin Intravenous (Human) - ifas	Varicella Prophylaxis	Route of Administration: Intravenous 400mg/kg once as soon as possible and within 10 days after exposure
Privigen Immune Globulin Intravenous (Human)	Acquired Red Cell Aplasia	Route of Administration: Intravenous 2g/kg per treatment, divided over 2 to 5 consecutive days
Privigen Immune Globulin Intravenous (Human)	Acute Disseminated Encephalomyelitis	Route of Administration: Intravenous 2g/kg per treatment, divided over 2 to 5 consecutive days
Privigen Immune Globulin Intravenous (Human)	Autoimmune Hemolytic Anemia	Route of Administration: Intravenous 2g/kg per treatment, divided over 2 to 5 consecutive days
Privigen Immune Globulin Intravenous (Human)	Autoimmune Mucocutaneous Blistering Diseases	Route of Administration: Intravenous 2g/kg divided over 2 to 5 consecutive days every 4 weeks
Privigen Immune Globulin Intravenous (Human)	Autoimmune Neutropenia	Route of Administration: Intravenous 1g/kg per day
Privigen Immune Globulin Intravenous (Human)	B-Cell Chronic Lymphocytic Leukemia (CLL)	Route of Administration: Intravenous 400mg/kg every 3 weeks
Privigen Immune Globulin Intravenous (Human)	Birdshot Retinochoroidopathy	Route of Administration: Intravenous 2g/kg divided over 2 to 5 consecutive days every 4 weeks
Privigen Immune Globulin Intravenous (Human)	BK Virus Associated Nephropathy	Route of Administration: Intravenous 2g/kg per dose
Privigen Immune Globulin Intravenous (Human)	Bone Marrow Transplant (BMT)/ Hematopoietic Stem Cell Transplant (HSCT)	Route of Administration: Intravenous 800mg/kg every week
Privigen Immune Globulin Intravenous (Human)	Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)	Route of Administration: Intravenous Initial: 2g/kg divided over 2 to 5 consecutive days Maintenance: 1g/kg divided over 1 to 2 consecutive days every 3 weeks
Privigen Immune Globulin Intravenous (Human)	Churg-Strauss Syndrome	Route of Administration: Intravenous 2g/kg divided over 2 to 5 days every 3 weeks
Privigen Immune Globulin Intravenous (Human)	Dermatomyositis	Route of Administration: Intravenous 2g/kg divided over 1 to 5 consecutive days every 4 weeks
Privigen Immune Globulin Intravenous (Human)	Enteroviral Meningoencephalitis	Route of Administration: Intravenous 2g/kg per dose
Privigen Immune Globulin Intravenous (Human)	Fetal/Neonatal Alloimmune Thrombocytopenia	Route of Administration: Intravenous 2g/kg per week (maternal administration) 1g/kg once (neonatal administration). Repeat if needed.
Privigen Immune Globulin Intravenous (Human)	Guillain-Barré Syndrome	Route of Administration: Intravenous 2g/kg divided over 1 to 5 consecutive days
Privigen Immune Globulin Intravenous (Human)	Hematophagocytic Lymphohistiocytosis (HLH) or Macrophage Activation Syndrome (MAS)	Route of Administration: Intravenous 2g/kg per dose
Privigen Immune Globulin Intravenous (Human)	Hemolytic Disease of Newborn	Route of Administration: Intravenous 1g/kg as a single dose; repeat in 12 hours if needed
Privigen Immune Globulin Intravenous (Human)	HIV-Associated Thrombocytopenia	Route of Administration: Intravenous 1g/kg daily for 2 days. Repeat if needed
Privigen Immune Globulin Intravenous (Human)	Hyperimmunoglobulinemia E Syndrome	Route of Administration: Intravenous 2mg/kg divided over 2-5 days
Privigen Immune Globulin Intravenous (Human)	Hypogammaglobulinemia from CAR-T Therapy	Route of Administration: Intravenous 500mg/kg every 4 weeks
Privigen Immune Globulin Intravenous (Human)	Idiopathic Thrombocytopenic Purpura (ITP)	Route of Administration: Intravenous 1g/kg once daily for 2 days 400mg/kg every day for 5 days
Privigen Immune Globulin Intravenous (Human)	Kawasaki Syndrome	Route of Administration: Intravenous <18year(s) 2g/kg as a single dose; repeat if needed
Privigen Immune Globulin Intravenous (Human)	Lambert-Eaton Myasthenic Syndrome	Route of Administration: Intravenous 2g/kg divided over 2 to 5 days, may repeat every 4 to 12 weeks
Privigen Immune Globulin Intravenous (Human)	Management of Immune Checkpoint Inhibitor-Related Toxicities	Route of Administration: Intravenous 2g/kg per treatment, divided over 2 to 5 consecutive days
Privigen Immune Globulin Intravenous (Human)	Measles (Rubeola) Prophylaxis	Route of Administration: Intravenous 400mg/kg once as soon as possible and within 6 days after exposure
Privigen Immune Globulin Intravenous (Human)	Multifocal Motor Neuropathy	Route of Administration: Intravenous 2g/kg divided over 2 to 5 consecutive days, followed by 1-2 g/kg every 2-6 weeks (max 1 g/kg/day)
Privigen Immune Globulin Intravenous (Human)	Multiple Myeloma	Route of Administration: Intravenous 800mg/kg every 3 weeks
Privigen Immune Globulin Intravenous (Human)	Myasthenia Gravis	Route of Administration: Intravenous 2g/kg divided over 1 to 5 consecutive days per treatment course for worsening weakness, acute exacerbation, or in preparation for surgery 1g/kg every 2-6 weeks for maintenance of refractory disease
Privigen Immune Globulin Intravenous (Human)	Neonatal Hemochromatosis, Prophylaxis	Route of Administration: Intravenous 1g/kg every week beginning on the 18th week of gestation until delivery
Privigen Immune Globulin Intravenous (Human)	Opsoclonus-Myoclonus or Paraneoplastic Opsoclonus-Myoclonus-Ataxia Associated with Neuroblastoma	Route of Administration: Intravenous 2g/kg divided over 2 to 5 consecutive days every 4 weeks
Privigen Immune Globulin Intravenous (Human)	Parvovirus B19-Induced Pure Red Cell Aplasia	Route of Administration: Intravenous 2g/kg divided over 2 to 5 consecutive days; For HIV patients with CD4 count <100 cells/mm3, maintenance dose of 400 mg/kg every 4 weeks
Privigen Immune Globulin Intravenous (Human)	Pediatric Acute-onset Neuropsychiatric Syndrome (PANS)/Pediatric Autoimmune Neuropsychiatric Disorder Associated with Streptococcal Infections (PANDAS)	Route of Administration: Intravenous 800mg/kg every 3 weeks
Privigen Immune Globulin Intravenous (Human)	Polymyositis	Route of Administration: Intravenous 2g/kg divided over 1 to 5 consecutive days every 4 weeks
Privigen Immune Globulin Intravenous (Human)	Post-Transfusion Purpura	Route of Administration: Intravenous 2g/kg divided over 2 to 5 consecutive days
Privigen Immune Globulin Intravenous (Human)	Primary Immunodeficiency	Route of Administration: Intravenous 800mg/kg every 3 weeks
Privigen Immune Globulin Intravenous (Human)	Prophylaxis of Bacterial Infections in Pediatric HIV Infection	Route of Administration: Intravenous <18year(s) 400mg/kg every 2 weeks
Privigen Immune Globulin Intravenous (Human)	Rasmussen Encephalitis	Route of Administration: Intravenous 400mg/kg daily for 5 days every 4 weeks
Privigen Immune Globulin Intravenous (Human)	Renal Transplantation from a Live Donor with ABO Incompatibility or Positive Cross Match	Route of Administration: Intravenous 2g/kg per dose
Privigen Immune Globulin Intravenous (Human)	Retinocochleocerebral Vasculopathy, Central Nervous System-Predominant	Route of Administration: Intravenous Initial dosage: 2g/kg 2 g/kg IV over 2 days, followed by 1 g/kg every 2 weeks until stable; then, 1.5 g/kg every 3 weeks until further stable. Maintenance dosage: 2 g/kg every 4 weeks for 6 months; then, 1 g/kg every 4 weeks for at least 6 months
Privigen Immune Globulin Intravenous (Human)	Secondary Immunosuppression Associated with Major Surgery, Hematological Malignancy, Major Burns, and Collagen-Vascular Diseases	Route of Administration: Intravenous 800mg/kg every 3 weeks
Privigen Immune Globulin Intravenous (Human)	Solid Organ Transplantation, for Allosensitized Members	Route of Administration: Intravenous 3g/kg divided over 2-5 days (max 1 g/kg/day) every 2-4 weeks
Privigen Immune Globulin Intravenous (Human)	Stevens-Johnson Syndrome or Toxic Epidermal Necrolysis	Route of Administration: Intravenous 3g/kg divided over 1 to 5 consecutive days. Repeat if needed.
Privigen Immune Globulin Intravenous (Human)	Stiff-Person Syndrome	Route of Administration: Intravenous 2g/kg divided over 2 to 5 consecutive days every month
Privigen Immune Globulin Intravenous (Human)	Systemic Lupus Erythematosus (SLE)	Route of Administration: Intravenous 2g/kg divided over 2 to 5 consecutive days every 4 weeks
Privigen Immune Globulin Intravenous (Human)	Tetanus Treatment and Prophylaxis	Route of Administration: Intravenous 400mg/kg once if tetanus immune globulin is not available
Privigen Immune Globulin Intravenous (Human)	Toxic Necrotizing Fasciitis due to Group A Streptococcus	Route of Administration: Intravenous 2g/kg divided over 1 to 5 consecutive days
Privigen Immune Globulin Intravenous (Human)	Toxic Shock Syndrome	Route of Administration: Intravenous 2g/kg divided over 1 to 5 consecutive days
Privigen Immune Globulin Intravenous (Human)	Varicella Prophylaxis	Route of Administration: Intravenous 400mg/kg once as soon as possible and within 10 days after exposure
Qivigy Immune Globulin Intravenous (Human) - kthm	Acquired Red Cell Aplasia	Route of Administration: Intravenous 2g/kg per treatment, divided over 2 to 5 consecutive days
Qivigy Immune Globulin Intravenous (Human) - kthm	Acute Disseminated Encephalomyelitis	Route of Administration: Intravenous 2g/kg per treatment, divided over 2 to 5 consecutive days
Qivigy Immune Globulin Intravenous (Human) - kthm	Autoimmune Hemolytic Anemia	Route of Administration: Intravenous 2g/kg per treatment, divided over 2 to 5 consecutive days
Qivigy Immune Globulin Intravenous (Human) - kthm	Autoimmune Mucocutaneous Blistering Diseases	Route of Administration: Intravenous 2g/kg divided over 2 to 5 consecutive days every 4 weeks
Qivigy Immune Globulin Intravenous (Human) - kthm	Autoimmune Neutropenia	Route of Administration: Intravenous 1g/kg per day
Qivigy Immune Globulin Intravenous (Human) - kthm	B-Cell Chronic Lymphocytic Leukemia (CLL)	Route of Administration: Intravenous 400mg/kg every 3 weeks
Qivigy Immune Globulin Intravenous (Human) - kthm	Birdshot Retinochoroidopathy	Route of Administration: Intravenous 2g/kg divided over 2 to 5 consecutive days every 4 weeks
Qivigy Immune Globulin Intravenous (Human) - kthm	BK Virus Associated Nephropathy	Route of Administration: Intravenous 2g/kg per dose
Qivigy Immune Globulin Intravenous (Human) - kthm	Bone Marrow Transplant (BMT)/ Hematopoietic Stem Cell Transplant (HSCT)	Route of Administration: Intravenous 800mg/kg every week
Qivigy Immune Globulin Intravenous (Human) - kthm	Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)	Route of Administration: Intravenous Initial: 2g/kg divided over 2 to 5 consecutive days Maintenance: 1g/kg divided over 1 to 2 consecutive days every 3 weeks
Qivigy Immune Globulin Intravenous (Human) - kthm	Churg-Strauss Syndrome	Route of Administration: Intravenous 2g/kg divided over 2 to 5 days every 3 weeks
Qivigy Immune Globulin Intravenous (Human) - kthm	Dermatomyositis	Route of Administration: Intravenous 2g/kg divided over 1 to 5 consecutive days every 4 weeks
Qivigy Immune Globulin Intravenous (Human) - kthm	Enteroviral Meningoencephalitis	Route of Administration: Intravenous 2g/kg per dose
Qivigy Immune Globulin Intravenous (Human) - kthm	Fetal/Neonatal Alloimmune Thrombocytopenia	Route of Administration: Intravenous 2g/kg per week (maternal administration) 1g/kg once (neonatal administration). Repeat if needed.
Qivigy Immune Globulin Intravenous (Human) - kthm	Guillain-Barré Syndrome	Route of Administration: Intravenous 2g/kg divided over 1 to 5 consecutive days
Qivigy Immune Globulin Intravenous (Human) - kthm	Hematophagocytic Lymphohistiocytosis (HLH) or Macrophage Activation Syndrome (MAS)	Route of Administration: Intravenous 2g/kg per dose
Qivigy Immune Globulin Intravenous (Human) - kthm	Hemolytic Disease of Newborn	Route of Administration: Intravenous 1g/kg as a single dose; repeat in 12 hours if needed
Qivigy Immune Globulin Intravenous (Human) - kthm	HIV-Associated Thrombocytopenia	Route of Administration: Intravenous 1g/kg daily for 2 days. Repeat if needed
Qivigy Immune Globulin Intravenous (Human) - kthm	Hyperimmunoglobulinemia E Syndrome	Route of Administration: Intravenous 2mg/kg divided over 2-5 days
Qivigy Immune Globulin Intravenous (Human) - kthm	Hypogammaglobulinemia from CAR-T Therapy	Route of Administration: Intravenous 500mg/kg every 4 weeks
Qivigy Immune Globulin Intravenous (Human) - kthm	Idiopathic Thrombocytopenic Purpura (ITP)	Route of Administration: Intravenous 1g/kg once daily for 2 days 400mg/kg every day for 5 days
Qivigy Immune Globulin Intravenous (Human) - kthm	Kawasaki Syndrome	Route of Administration: Intravenous <18 year(s) 2g/kg as a single dose; repeat if needed
Qivigy Immune Globulin Intravenous (Human) - kthm	Lambert-Eaton Myasthenic Syndrome	Route of Administration: Intravenous 2g/kg divided over 2 to 5 days, may repeat every 4 to 12 weeks
Qivigy Immune Globulin Intravenous (Human) - kthm	Management of Immune Checkpoint Inhibitor-Related Toxicities	Route of Administration: Intravenous 2g/kg per treatment, divided over 2 to 5 consecutive days
Qivigy Immune Globulin Intravenous (Human) - kthm	Measles (Rubeola) Prophylaxis	Route of Administration: Intravenous 400mg/kg once as soon as possible after exposure
Qivigy Immune Globulin Intravenous (Human) - kthm	Multifocal Motor Neuropathy	Route of Administration: Intravenous 2g/kg divided over 2 to 5 consecutive days, followed by 1-2 g/kg every 2-6 weeks (max 1 g/kg/day)
Qivigy Immune Globulin Intravenous (Human) - kthm	Multiple Myeloma	Route of Administration: Intravenous 800mg/kg every 3 weeks
Qivigy Immune Globulin Intravenous (Human) - kthm	Myasthenia Gravis	Route of Administration: Intravenous 2g/kg divided over 1 to 5 consecutive days per treatment course for worsening weakness, acute exacerbation, or in preparation for surgery 1g/kg every 2-6 weeks for maintenance of refractory disease
Qivigy Immune Globulin Intravenous (Human) - kthm	Neonatal Hemochromatosis, Prophylaxis	Route of Administration: Intravenous 1g/kg every week beginning on the 18th week of gestation until delivery
Qivigy Immune Globulin Intravenous (Human) - kthm	Opsoclonus-Myoclonus or Paraneoplastic Opsoclonus-Myoclonus-Ataxia Associated with Neuroblastoma	Route of Administration: Intravenous 2g/kg divided over 2 to 5 consecutive days every 4 weeks
Qivigy Immune Globulin Intravenous (Human) - kthm	Parvovirus B19-Induced Pure Red Cell Aplasia	Route of Administration: Intravenous 2g/kg divided over 2 to 5 consecutive days; For HIV patients with CD4 count <100 cells/mm3, maintenance dose of 400 mg/kg every 4 weeks
Qivigy Immune Globulin Intravenous (Human) - kthm	Pediatric Acute-onset Neuropsychiatric Syndrome (PANS)/Pediatric Autoimmune Neuropsychiatric Disorder Associated with Streptococcal Infections (PANDAS)	Route of Administration: Intravenous 800mg/kg every 3 weeks
Qivigy Immune Globulin Intravenous (Human) - kthm	Polymyositis	Route of Administration: Intravenous 2g/kg divided over 1 to 5 consecutive days every 4 weeks
Qivigy Immune Globulin Intravenous (Human) - kthm	Post-Transfusion Purpura	Route of Administration: Intravenous 2g/kg divided over 2 to 5 consecutive days
Qivigy Immune Globulin Intravenous (Human) - kthm	Primary Immunodeficiency	Route of Administration: Intravenous 800mg/kg every 3 weeks
Qivigy Immune Globulin Intravenous (Human) - kthm	Prophylaxis of Bacterial Infections in Pediatric HIV Infection	Route of Administration: Intravenous <18 year(s) 400mg/kg every 2 weeks
Qivigy Immune Globulin Intravenous (Human) - kthm	Rasmussen Encephalitis	Route of Administration: Intravenous 400mg/kg daily for 5 days every 4 weeks
Qivigy Immune Globulin Intravenous (Human) - kthm	Renal Transplantation from a Live Donor with ABO Incompatibility or Positive Cross Match	Route of Administration: Intravenous 2g/kg per dose
Qivigy Immune Globulin Intravenous (Human) - kthm	Retinocochleocerebral Vasculopathy, Central Nervous System-Predominant	Route of Administration: Intravenous Initial dosage: 2g/kg 2 g/kg IV over 2 days, followed by 1 g/kg every 2 weeks until stable; then, 1.5 g/kg every 3 weeks until further stable. Maintenance dosage: 2 g/kg every 4 weeks for 6 months; then, 1 g/kg every 4 weeks for at least 6 months
Qivigy Immune Globulin Intravenous (Human) - kthm	Secondary Immunosuppression Associated with Major Surgery, Hematological Malignancy, Major Burns, and Collagen-Vascular Diseases	Route of Administration: Intravenous 800mg/kg every 3 weeks
Qivigy Immune Globulin Intravenous (Human) - kthm	Solid Organ Transplantation, for Allosensitized Members	Route of Administration: Intravenous 3g/kg divided over 2-5 days (max 1 g/kg/day) every 2-4 weeks
Qivigy Immune Globulin Intravenous (Human) - kthm	Stevens-Johnson Syndrome or Toxic Epidermal Necrolysis	Route of Administration: Intravenous 3g/kg divided over 1 to 5 consecutive days. Repeat if needed.
Qivigy Immune Globulin Intravenous (Human) - kthm	Stiff-Person Syndrome	Route of Administration: Intravenous 2g/kg divided over 2 to 5 consecutive days every month
Qivigy Immune Globulin Intravenous (Human) - kthm	Systemic Lupus Erythematosus (SLE)	Route of Administration: Intravenous 2g/kg divided over 2 to 5 consecutive days every 4 weeks
Qivigy Immune Globulin Intravenous (Human) - kthm	Tetanus Treatment and Prophylaxis	Route of Administration: Intravenous 400mg/kg once if tetanus immune globulin is not available
Qivigy Immune Globulin Intravenous (Human) - kthm	Toxic Necrotizing Fasciitis due to Group A Streptococcus	Route of Administration: Intravenous 2g/kg divided over 1 to 5 consecutive days
Qivigy Immune Globulin Intravenous (Human) - kthm	Toxic Shock Syndrome	Route of Administration: Intravenous 2g/kg divided over 1 to 5 consecutive days
Qivigy Immune Globulin Intravenous (Human) - kthm	Varicella Prophylaxis	Route of Administration: Intravenous 400mg/kg once as soon as possible and within 10 days after exposure
Xembify Immune Globulin Subcutaneous (Human) - klhw	Primary Immunodeficiency	Route of Administration: Subcutaneous 365mg/kg every week, based on max IVIG dose of 800 mg/kg every 3 weeks. Provided the total weekly dose is maintained, any dosing interval from daily up to biweekly can be used.
Yimmugo Immune Globulin Intravenous (Human) - dira	Acquired Red Cell Aplasia	Route of Administration: Intravenous 2g/kg per treatment, divided over 2 to 5 consecutive days
Yimmugo Immune Globulin Intravenous (Human) - dira	Acute Disseminated Encephalomyelitis	Route of Administration: Intravenous 2g/kg per treatment, divided over 2 to 5 consecutive days
Yimmugo Immune Globulin Intravenous (Human) - dira	Autoimmune Hemolytic Anemia	Route of Administration: Intravenous 2g/kg per treatment, divided over 2 to 5 consecutive days
Yimmugo Immune Globulin Intravenous (Human) - dira	Autoimmune Mucocutaneous Blistering Diseases	Route of Administration: Intravenous 2g/kg divided over 2 to 5 consecutive days every 4 weeks
Yimmugo Immune Globulin Intravenous (Human) - dira	Autoimmune Neutropenia	Route of Administration: Intravenous 1g/kg per day
Yimmugo Immune Globulin Intravenous (Human) - dira	B-Cell Chronic Lymphocytic Leukemia (CLL)	Route of Administration: Intravenous 400mg/kg every 3 weeks
Yimmugo Immune Globulin Intravenous (Human) - dira	Birdshot Retinochoroidopathy	Route of Administration: Intravenous 2g/kg divided over 2 to 5 consecutive days every 4 weeks
Yimmugo Immune Globulin Intravenous (Human) - dira	BK Virus Associated Nephropathy	Route of Administration: Intravenous 2g/kg per dose
Yimmugo Immune Globulin Intravenous (Human) - dira	Bone Marrow Transplant (BMT)/ Hematopoietic Stem Cell Transplant (HSCT)	Route of Administration: Intravenous 800mg/kg every week
Yimmugo Immune Globulin Intravenous (Human) - dira	Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)	Route of Administration: Intravenous Initial: 2g/kg divided over 2 to 5 consecutive days Maintenance: 1g/kg divided over 1 to 2 consecutive days every 3 weeks
Yimmugo Immune Globulin Intravenous (Human) - dira	Churg-Strauss Syndrome	Route of Administration: Intravenous 2g/kg divided over 2 to 5 days every 3 weeks
Yimmugo Immune Globulin Intravenous (Human) - dira	Dermatomyositis	Route of Administration: Intravenous 2g/kg divided over 1 to 5 consecutive days every 4 weeks
Yimmugo Immune Globulin Intravenous (Human) - dira	Enteroviral Meningoencephalitis	Route of Administration: Intravenous 2g/kg per dose
Yimmugo Immune Globulin Intravenous (Human) - dira	Fetal/Neonatal Alloimmune Thrombocytopenia	Route of Administration: Intravenous 2g/kg per week (maternal administration) 1g/kg once (neonatal administration). Repeat if needed.
Yimmugo Immune Globulin Intravenous (Human) - dira	Guillain-Barré Syndrome	Route of Administration: Intravenous 2g/kg divided over 1 to 5 consecutive days
Yimmugo Immune Globulin Intravenous (Human) - dira	Hematophagocytic Lymphohistiocytosis (HLH) or Macrophage Activation Syndrome (MAS)	Route of Administration: Intravenous 2g/kg per dose
Yimmugo Immune Globulin Intravenous (Human) - dira	Hemolytic Disease of Newborn	Route of Administration: Intravenous 1g/kg as a single dose; repeat in 12 hours if needed
Yimmugo Immune Globulin Intravenous (Human) - dira	HIV-Associated Thrombocytopenia	Route of Administration: Intravenous 1g/kg daily for 2 days. Repeat if needed
Yimmugo Immune Globulin Intravenous (Human) - dira	Hyperimmunoglobulinemia E Syndrome	Route of Administration: Intravenous 2mg/kg divided over 2-5 days
Yimmugo Immune Globulin Intravenous (Human) - dira	Hypogammaglobulinemia from CAR-T Therapy	Route of Administration: Intravenous 500mg/kg every 4 weeks
Yimmugo Immune Globulin Intravenous (Human) - dira	Idiopathic Thrombocytopenic Purpura (ITP)	Route of Administration: Intravenous 1g/kg once daily for 2 days 400mg/kg every day for 5 days
Yimmugo Immune Globulin Intravenous (Human) - dira	Kawasaki Syndrome	Route of Administration: Intravenous <18 year(s) 2g/kg as a single dose; repeat if needed
Yimmugo Immune Globulin Intravenous (Human) - dira	Lambert-Eaton Myasthenic Syndrome	Route of Administration: Intravenous 2g/kg divided over 2 to 5 days, may repeat every 4 to 12 weeks
Yimmugo Immune Globulin Intravenous (Human) - dira	Management of Immune Checkpoint Inhibitor-Related Toxicities	Route of Administration: Intravenous 2g/kg per treatment, divided over 2 to 5 consecutive days
Yimmugo Immune Globulin Intravenous (Human) - dira	Measles (Rubeola) Prophylaxis	Route of Administration: Intravenous 400mg/kg once as soon as possible and within 6 days after exposure
Yimmugo Immune Globulin Intravenous (Human) - dira	Multifocal Motor Neuropathy	Route of Administration: Intravenous 2g/kg divided over 2 to 5 consecutive days, followed by 1-2 g/kg every 2-6 weeks (max 1 g/kg/day)
Yimmugo Immune Globulin Intravenous (Human) - dira	Multiple Myeloma	Route of Administration: Intravenous 800mg/kg every 3 weeks
Yimmugo Immune Globulin Intravenous (Human) - dira	Myasthenia Gravis	Route of Administration: Intravenous 2g/kg divided over 1 to 5 consecutive days per treatment course for worsening weakness, acute exacerbation, or in preparation for surgery 1g/kg every 2-6 weeks for maintenance of refractory disease
Yimmugo Immune Globulin Intravenous (Human) - dira	Neonatal Hemochromatosis, Prophylaxis	Route of Administration: Intravenous 1g/kg every week beginning on the 18th week of gestation until delivery
Yimmugo Immune Globulin Intravenous (Human) - dira	Opsoclonus-Myoclonus or Paraneoplastic Opsoclonus-Myoclonus-Ataxia Associated with Neuroblastoma	Route of Administration: Intravenous 2g/kg divided over 2 to 5 consecutive days every 4 weeks
Yimmugo Immune Globulin Intravenous (Human) - dira	Parvovirus B19-Induced Pure Red Cell Aplasia	Route of Administration: Intravenous 2g/kg divided over 2 to 5 consecutive days; For HIV patients with CD4 count <100 cells/mm3, maintenance dose of 400 mg/kg every 4 weeks
Yimmugo Immune Globulin Intravenous (Human) - dira	Pediatric Acute-onset Neuropsychiatric Syndrome (PANS)/Pediatric Autoimmune Neuropsychiatric Disorder Associated with Streptococcal Infections (PANDAS)	Route of Administration: Intravenous 800mg/kg every 3 weeks
Yimmugo Immune Globulin Intravenous (Human) - dira	Polymyositis	Route of Administration: Intravenous 2g/kg divided over 1 to 5 consecutive days every 4 weeks
Yimmugo Immune Globulin Intravenous (Human) - dira	Post-Transfusion Purpura	Route of Administration: Intravenous 2g/kg divided over 2 to 5 consecutive days
Yimmugo Immune Globulin Intravenous (Human) - dira	Primary Immunodeficiency	Route of Administration: Intravenous 800mg/kg every 3 weeks
Yimmugo Immune Globulin Intravenous (Human) - dira	Prophylaxis of Bacterial Infections in Pediatric HIV Infection	Route of Administration: Intravenous <18 year(s) 400mg/kg every 2 weeks
Yimmugo Immune Globulin Intravenous (Human) - dira	Rasmussen Encephalitis	Route of Administration: Intravenous 400mg/kg daily for 5 days every 4 weeks
Yimmugo Immune Globulin Intravenous (Human) - dira	Renal Transplantation from a Live Donor with ABO Incompatibility or Positive Cross Match	Route of Administration: Intravenous 2g/kg per dose
Yimmugo Immune Globulin Intravenous (Human) - dira	Retinocochleocerebral Vasculopathy, Central Nervous System-Predominant	Route of Administration: Intravenous Initial dosage: 2g/kg 2 g/kg IV over 2 days, followed by 1 g/kg every 2 weeks until stable; then, 1.5 g/kg every 3 weeks until further stable. Maintenance dosage: 2 g/kg every 4 weeks for 6 months; then, 1 g/kg every 4 weeks for at least 6 months
Yimmugo Immune Globulin Intravenous (Human) - dira	Secondary Immunosuppression Associated with Major Surgery, Hematological Malignancy, Major Burns, and Collagen-Vascular Diseases	Route of Administration: Intravenous 800mg/kg every 3 weeks
Yimmugo Immune Globulin Intravenous (Human) - dira	Solid Organ Transplantation, for Allosensitized Members	Route of Administration: Intravenous 3g/kg divided over 2-5 days (max 1 g/kg/day) every 2-4 weeks
Yimmugo Immune Globulin Intravenous (Human) - dira	Stevens-Johnson Syndrome or Toxic Epidermal Necrolysis	Route of Administration: Intravenous 3g/kg divided over 1 to 5 consecutive days. Repeat if needed.
Yimmugo Immune Globulin Intravenous (Human) - dira	Stiff-Person Syndrome	Route of Administration: Intravenous 2g/kg divided over 2 to 5 consecutive days every month
Yimmugo Immune Globulin Intravenous (Human) - dira	Systemic Lupus Erythematosus (SLE)	Route of Administration: Intravenous 2g/kg divided over 2 to 5 consecutive days every 4 weeks
Yimmugo Immune Globulin Intravenous (Human) - dira	Tetanus Treatment and Prophylaxis	Route of Administration: Intravenous 400mg/kg once if tetanus immune globulin is not available
Yimmugo Immune Globulin Intravenous (Human) - dira	Toxic Necrotizing Fasciitis due to Group A Streptococcus	Route of Administration: Intravenous 2g/kg divided over 1 to 5 consecutive days
Yimmugo Immune Globulin Intravenous (Human) - dira	Toxic Shock Syndrome	Route of Administration: Intravenous 2g/kg divided over 1 to 5 consecutive days
Yimmugo Immune Globulin Intravenous (Human) - dira	Varicella Prophylaxis	Route of Administration: Intravenous 400mg/kg once as soon as possible and within 10 days after exposure

APPLICABLE TENNESSEE STATE MANDATE REQUIREMENTS

BlueCross BlueShield of Tennessee’s Medical Policy complies with Tennessee Code Annotated Section 56-7-2352 regarding coverage of off-label indications of Food and Drug Administration (FDA) approved drugs when the off-label use is recognized in one of the statutorily recognized standard reference compendia or in the published peer-reviewed medical literature.

ADDITIONAL INFORMATION

For appropriate chemotherapy regimens, dosage information, contraindications, precautions, warnings, and monitoring information, please refer to one of the standard reference compendia (e.g., the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) published by the National Comprehensive Cancer Network®, Drugdex Evaluations of Micromedex Solutions at Truven Health, or The American Hospital Formulary Service Drug Information).

REFERENCES

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Patwa HS, Chaudhry V, Katzberg H, et al. Evidence-based guideline: intravenous immunoglobulin in the treatment of neuromuscular disorders: report of the Therapeutics and Technology Assessment Subcommittee of the American Academy of Neurology. Neurology. 2012;78(13);1009-1015.
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Van den Bergh PY, Hadden RD, van Doorn PA, et al. European Federation of Neurological Societies/Peripheral Nerve Society guideline on management of chronic inflammatory demyelinating polyradiculoneuropathy: report of a joint task force of the European Federation of Neurological Societies and the Peripheral Nerve Society - second revision. Eur J Neurol. 2021;28(11):3556-3583.
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ORIGINAL EFFECTIVE DATE: 12/4/97

MOST RECENT REVIEW DATE: 6/30/2026

ID_CHS_2025

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