| Wiskott-Aldrich Syndrome

Flebogamma DIF 5% vs Gammaplex

Side-by-side clinical, coverage, and cost comparison for wiskott-aldrich syndrome.

Deep comparison between: Flebogamma vs Gammaplex with Prescriber.AI

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Safety signalsGammaplex has a higher rate of injection site reactions vs Flebogamma based on FDA-approved prescribing information

Coverage gaps3 major payers require step therapy for Gammaplex but not Flebogamma, including UnitedHealthcare

Category

Flebogamma

Gammaplex

At A Glance

RouteIV infusion

FrequencyEvery 3-4 weeks

ClassImmune globulin (IGIV)

RouteIV infusion

FrequencyEvery 3-4 weeks

ClassImmune globulin (IgG replacement)

Indications

Common Variable Immunodeficiency
X-linked agammaglobulinemia
Severe Combined Immunodeficiency
Wiskott-Aldrich Syndrome

Common Variable Immunodeficiency
X-linked agammaglobulinemia
Congenital agammaglobulinemia
Wiskott-Aldrich Syndrome
Severe Combined Immunodeficiency
Immune thrombocytopenic purpura

Dosing

Common Variable Immunodeficiency, X-linked agammaglobulinemia, Severe Combined Immunodeficiency, Wiskott-Aldrich Syndrome 300-600 mg per kg body weight IV every 3-4 weeks; initial infusion rate 0.01 mL/kg/min (0.5 mg/kg/min), increased to maximum 0.10 mL/kg/min (5 mg/kg/min) if tolerated.

Common Variable Immunodeficiency, X-linked agammaglobulinemia, Congenital agammaglobulinemia, Wiskott-Aldrich Syndrome, Severe Combined Immunodeficiency 300-800 mg/kg (3-8 mL/kg) IV every 3-4 weeks; initial infusion rate 0.5 mg/kg/min for 15 minutes, then increase gradually every 15 minutes to 8 mg/kg/min.

Immune thrombocytopenic purpura 1 g/kg (10 mL/kg) IV on 2 consecutive days (total dose 2 g/kg); initial infusion rate 0.5 mg/kg/min for 15 minutes, then increase gradually every 15 minutes to 8 mg/kg/min.

Contraindications

History of anaphylactic or severe systemic hypersensitivity reactions to human immune globulin
IgA-deficient patients with antibodies to IgA and a history of hypersensitivity

Previous anaphylactic or severe systemic reaction to human immune globulin
IgA deficiency with antibodies to IgA and a history of hypersensitivity

Drug Interactions

163View drug interactions

Adverse Reactions

Most common, adults (>=5%) Headache, pyrexia, pain, injection site reactions, diarrhea, rigors, urticaria, infusion site inflammation

Most common, pediatrics (>=5%) Headache, pyrexia, hypotension, tachycardia, diastolic hypotension, nausea, abdominal pain, diarrhea, pain, vomiting

Postmarketing Hypersensitivity/anaphylaxis, acute renal dysfunction/failure, ARDS, TRALI, cardiac arrest, thromboembolism, coma, seizures, aseptic meningitis syndrome, Stevens-Johnson Syndrome, pancytopenia, hemolysis

Most common (>=5%) in PI Headache, migraine, pyrexia

Most common (>=5%) in ITP Headache, vomiting, pyrexia, nausea, arthralgia, dehydration

Serious Thrombotic events, hemolysis; in ITP subjects: headache, vomiting, dehydration

Postmarketing Tachycardia, thromboembolism, hypertension, flushing, nausea, chills, chest discomfort, pyrexia, back pain, polymyositis, headache, dyspnea, rash, urticaria

Pharmacology

Flebogamma 5% DIF is an intravenous immune globulin (IGIV) that provides replacement therapy for primary immunodeficiency by supplying a broad spectrum of opsonizing and neutralizing IgG antibodies against a wide variety of bacterial and viral agents.

Polyclonal human IgG that provides replacement therapy for primary humoral immunodeficiency via a broad spectrum of opsonic and neutralizing IgG antibodies against pathogens and their toxins through antigen binding and effector functions; the mechanism of action in both PI and ITP has not been fully elucidated.

View Full FDA Information

View full FDA information

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Most Common Insurance

Anthem BCBS

Flebogamma