| Congenital agammaglobulinemia
Bivigam vs Gammaplex
Side-by-side clinical, coverage, and cost comparison for congenital agammaglobulinemia.Deep comparison between: Bivigam vs Gammaplex with Prescriber.AI
AI compares prescribing info and payer-specific access barriers across 1,200+ formularies. Here's a preview of what prescribers are already asking.Safety signalsGammaplex has a higher rate of injection site reactions vs Bivigam based on FDA-approved prescribing information
Coverage gaps3 major payers require step therapy for Gammaplex but not Bivigam, including UnitedHealthcare
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Category
Bivigam
Gammaplex
At A Glance
IV infusion
Every 3-4 weeks
Intravenous immune globulin (IVIG)
IV infusion
Every 3-4 weeks
Immune globulin (IgG replacement)
Indications
- Common Variable Immunodeficiency
- X-linked agammaglobulinemia
- Congenital agammaglobulinemia
- Wiskott-Aldrich Syndrome
- Severe Combined Immunodeficiency
- Common Variable Immunodeficiency
- X-linked agammaglobulinemia
- Congenital agammaglobulinemia
- Wiskott-Aldrich Syndrome
- Severe Combined Immunodeficiency
- Immune thrombocytopenic purpura
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, 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
- 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 to IgA and a history of hypersensitivity
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%) 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
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.
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.
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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)
Gammaplex
- Covered on 5 commercial plans
- PA (10/12) · Step Therapy (10/12) · Qty limit (0/12)
UnitedHealthcare
Bivigam
- Covered on 4 commercial plans
- PA (1/8) · Step Therapy (0/8) · Qty limit (0/8)
Gammaplex
- Covered on 4 commercial plans
- PA (1/8) · Step Therapy (1/8) · Qty limit (0/8)
Humana
Bivigam
- Covered on 0 commercial plans
- PA (3/3) · Step Therapy (3/3) · Qty limit (0/3)
Gammaplex
- Covered on 0 commercial plans
- PA (3/3) · Step Therapy (3/3) · Qty limit (0/3)
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 Gammaplex.
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Clinical data sourced from FDA-approved labeling. Coverage data via MMIT. Updated monthly.