| X-linked agammaglobulinemia

Bivigam vs Gamunex - C

Side-by-side clinical, coverage, and cost comparison for x-linked agammaglobulinemia.
Deep comparison between: Bivigam vs Gamunex-C with Prescriber.AI
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Safety signalsGamunex-C has a higher rate of injection site reactions vs Bivigam based on FDA-approved prescribing information
Coverage gaps3 major payers require step therapy for Gamunex-C but not Bivigam, including UnitedHealthcare
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Bivigam
Gamunex-C
At A Glance
IV infusion
Every 3-4 weeks
Intravenous immune globulin (IVIG)
IV infusion / SC injection
Every 3-4 weeks
Immune globulin
Indications
  • Common Variable Immunodeficiency
  • X-linked agammaglobulinemia
  • Congenital agammaglobulinemia
  • Wiskott-Aldrich Syndrome
  • Severe Combined Immunodeficiency
  • Common Variable Immunodeficiency
  • X-linked agammaglobulinemia
  • Wiskott-Aldrich Syndrome
  • Severe Combined Immunodeficiency
  • Congenital agammaglobulinemia
  • Immune thrombocytopenic purpura
  • Polyradiculoneuropathy, Chronic Inflammatory Demyelinating
Dosing
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.
Common Variable Immunodeficiency, X-linked agammaglobulinemia, Wiskott-Aldrich Syndrome, Severe Combined Immunodeficiency, Congenital agammaglobulinemia IV: 300-600 mg/kg every 3-4 weeks; SC: initial weekly dose = prior monthly IGIV dose (g) x 1.37 divided by the number of weeks between IV doses, adjusted based on clinical response and IgG trough levels.
Immune thrombocytopenic purpura IV only: total dose of 2 g/kg given as 1 g/kg on two consecutive days or 0.4 g/kg on five consecutive days; do not administer subcutaneously.
Polyradiculoneuropathy, Chronic Inflammatory Demyelinating IV loading dose: 2 g/kg over 2-4 consecutive days; maintenance: 1 g/kg every 3 weeks (or 0.5 g/kg on two consecutive days every 3 weeks).
Contraindications
  • Previous anaphylactic or severe systemic reaction to human immune globulin
  • IgA deficiency with antibodies to IgA and a history of hypersensitivity
  • Previous anaphylactic or severe systemic reaction to human immune globulin
  • IgA deficiency with antibodies against IgA and history of hypersensitivity reaction
Adverse Reactions
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
Most common (>=5%) Headache, pyrexia, nausea, cough, rhinitis, pharyngitis, asthma, diarrhea, sinusitis, vomiting, ecchymosis, rash, arthralgia, chills, hypertension, asthenia, fatigue, local infusion site reactions (SC administration), upper respiratory tract infection, back pain, dyspepsia, abdominal pain.
Serious Exacerbation of autoimmune pure red cell aplasia, pulmonary embolism, hemolytic anemia.
Postmarketing Anaphylaxis, tachycardia, acute renal dysfunction/failure, acute respiratory distress syndrome, TRALI, pulmonary edema, bronchospasm, cardiac arrest, thromboembolism, vascular collapse, coma, seizures, aseptic meningitis, tremor, Stevens-Johnson syndrome, epidermolysis, erythema multiforme, pancytopenia, leukopenia, hemolytic anemia, hepatic dysfunction.
Pharmacology
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.
GAMUNEX-C supplies a broad spectrum of opsonic and neutralizing IgG antibodies against bacterial, viral, parasitic, and mycoplasmal agents and their toxins; the precise mechanisms of action in ITP and CIDP have not been fully elucidated.
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Most Common Insurance
Anthem BCBS
Bivigam
  • Covered on 5 commercial plans
  • PA (10/12) · Step Therapy (10/12) · Qty limit (0/12)
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Gamunex-C
  • Covered on 5 commercial plans
  • PA (11/12) · Step Therapy (7/12) · Qty limit (0/12)
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UnitedHealthcare
Bivigam
  • Covered on 4 commercial plans
  • PA (1/8) · Step Therapy (0/8) · Qty limit (0/8)
View full coverage details ›
Gamunex-C
  • Covered on 4 commercial plans
  • PA (1/8) · Step Therapy (1/8) · Qty limit (0/8)
View full coverage details ›
Humana
Bivigam
  • Covered on 0 commercial plans
  • PA (3/3) · Step Therapy (3/3) · Qty limit (0/3)
View full coverage details ›
Gamunex-C
  • 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
Cost estimate not availableAccessia Health: Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) - Private Insurance
Commercial or private insurance
Medicare, Medicaid, VA, TRICARE
No savings programs available for Gamunex-C.
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Clinical data sourced from FDA-approved labeling. Coverage data via MMIT. Updated monthly.