| Congenital agammaglobulinemia
Bivigam vs Gammaked
Side-by-side clinical, coverage, and cost comparison for congenital agammaglobulinemia.Deep comparison between: Bivigam vs Gammaked 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 signalsGammaked has a higher rate of injection site reactions vs Bivigam based on FDA-approved prescribing information
Coverage gaps3 major payers require step therapy for Gammaked but not Bivigam, including UnitedHealthcare
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Category
Bivigam
Gammaked
At A Glance
IV infusion
Every 3-4 weeks
Intravenous immune globulin (IVIG)
IV infusion
Immune globulin
Indications
- Common Variable Immunodeficiency
- X-linked agammaglobulinemia
- Congenital agammaglobulinemia
- Wiskott-Aldrich Syndrome
- Severe Combined Immunodeficiency
- Primary immune deficiency disorder
- Immune thrombocytopenic purpura
- Polyradiculoneuropathy, Chronic Inflammatory Demyelinating
- Congenital agammaglobulinemia
- Common Variable Immunodeficiency
- X-linked agammaglobulinemia
- Wiskott-Aldrich Syndrome
- Severe Combined Immunodeficiency
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.
Primary immune deficiency disorder IV: 300-600 mg/kg every 3-4 weeks; SC (PI only): individualized weekly dose calculated as previous IGIV dose (g) x 1.37 divided by number of weeks between IV doses.
Immune thrombocytopenic purpura IV only: total dose 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 only: loading dose 2 g/kg over two to four 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%) PI (IV): cough, rhinitis, pharyngitis, headache, asthma, nausea, fever, diarrhea, sinusitis; PI (SC): local infusion site reactions, fatigue, headache, upper respiratory tract infection, arthralgia, diarrhea, nausea, sinusitis, bronchitis, depression, allergic dermatitis, erythema, migraine, myalgia, viral infection, pyrexia; ITP: headache, ecchymosis, vomiting, fever, nausea, rash, abdominal pain, back pain, dyspepsia; CIDP: headache, pyrexia, hypertension, chills, rash, nausea, arthralgia, asthenia
Serious Pulmonary embolism (CIDP), exacerbation of autoimmune pure red cell aplasia (PI), hemolytic anemia
Postmarketing Anaphylaxis, tachycardia, acute renal dysfunction/failure, ARDS, TRALI, pulmonary edema, cardiac arrest, thromboembolism, coma, seizures, aseptic meningitis, Stevens-Johnson syndrome, pancytopenia, 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.
GAMMAKED is an immune globulin that supplies a broad spectrum of opsonic and neutralizing IgG antibodies against bacterial, viral, parasitic, and mycoplasmal agents and their toxins; the precise mechanism of action in ITP and CIDP 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)
Gammaked
- 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)
Gammaked
- Covered on 4 commercial plans
- PA (0/8) · Step Therapy (0/8) · Qty limit (0/8)
Humana
Bivigam
- Covered on 0 commercial plans
- PA (3/3) · Step Therapy (3/3) · Qty limit (0/3)
Gammaked
- 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 Gammaked.
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Clinical data sourced from FDA-approved labeling. Coverage data via MMIT. Updated monthly.