| Severe Combined Immunodeficiency

Flebogamma DIF 5% vs Bivigam

Side-by-side clinical, coverage, and cost comparison for severe combined immunodeficiency.
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Safety signalsBivigam has a higher rate of injection site reactions vs Flebogamma based on FDA-approved prescribing information
Coverage gaps3 major payers require step therapy for Bivigam but not Flebogamma, including UnitedHealthcare
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Flebogamma
Bivigam
At A Glance
IV infusion
Every 3-4 weeks
Immune globulin (IGIV)
IV infusion
Every 3-4 weeks
Intravenous immune globulin (IVIG)
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
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 to 800 mg/kg IV every 3 to 4 weeks; initial infusion rate 0.5 mg/kg/min, increase every 20 minutes if tolerated up to 6 mg/kg/min; adjust dose to maintain trough IgG >= 600 mg/dL.
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
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%) Headache, fatigue, infusion site reaction, nausea, sinusitis, blood pressure increased, diarrhea, dizziness, lethargy
Serious Vomiting, dehydration
Postmarketing Apnea, ARDS, TRALI, cyanosis, hypoxemia, pulmonary edema, dyspnea, bronchospasm, cardiac arrest, thromboembolism, vascular collapse, hypotension, coma, loss of consciousness, seizures, tremor, Stevens-Johnson syndrome, epidermolysis, erythema multiforme, bullous dermatitis, pancytopenia, leukopenia, hemolysis, positive direct antiglobulin test, pyrexia, rigors, back pain, hepatic dysfunction, abdominal pain
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.
BIVIGAM is an intravenous IgG replacement therapy that provides a broad spectrum of neutralizing antibodies against bacterial and viral pathogens and their toxins; IgG antibodies act as opsonins, enhancing phagocytosis and elimination of pathogens from the circulation.
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Most Common Insurance
Anthem BCBS
Flebogamma
  • Covered on 5 commercial plans
  • PA (10/12) · Step Therapy (10/12) · Qty limit (0/12)
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Bivigam
  • Covered on 5 commercial plans
  • PA (10/12) · Step Therapy (10/12) · Qty limit (0/12)
View full coverage details ›
UnitedHealthcare
Flebogamma
  • Covered on 4 commercial plans
  • PA (0/8) · Step Therapy (0/8) · Qty limit (0/8)
View full coverage details ›
Bivigam
  • Covered on 4 commercial plans
  • PA (1/8) · Step Therapy (0/8) · Qty limit (0/8)
View full coverage details ›
Humana
Flebogamma
  • Covered on 0 commercial plans
  • PA (3/3) · Step Therapy (3/3) · Qty limit (0/3)
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Bivigam
  • Covered on 0 commercial plans
  • PA (3/3) · Step Therapy (3/3) · Qty limit (0/3)
View full coverage details ›
Coverage data sourced from MMIT. Updated monthly.
Savings
No savings programs available for Flebogamma.
Cost estimate not availableAccessia Health: Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) - Private Insurance
Commercial or private insurance
Medicare, Medicaid, VA, TRICARE
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FlebogammaView full Flebogamma profile
BivigamView full Bivigam profile
Clinical data sourced from FDA-approved labeling. Coverage data via MMIT. Updated monthly.