| Congenital agammaglobulinemia
Gammaplex vs Gammaked
Side-by-side clinical, coverage, and cost comparison for congenital agammaglobulinemia.Deep comparison between: Gammaplex 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 Gammaplex based on FDA-approved prescribing information
Coverage gaps3 major payers require step therapy for Gammaked but not Gammaplex, including UnitedHealthcare
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Category
Gammaplex
Gammaked
At A Glance
IV infusion
Every 3-4 weeks
Immune globulin (IgG replacement)
IV infusion
Immune globulin
Indications
- Common Variable Immunodeficiency
- X-linked agammaglobulinemia
- Congenital agammaglobulinemia
- Wiskott-Aldrich Syndrome
- Severe Combined Immunodeficiency
- Immune thrombocytopenic purpura
- 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 300-800 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.
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%) 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
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
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.
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
Gammaplex
- 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
Gammaplex
- Covered on 4 commercial plans
- PA (1/8) · Step Therapy (1/8) · Qty limit (0/8)
Gammaked
- Covered on 4 commercial plans
- PA (0/8) · Step Therapy (0/8) · Qty limit (0/8)
Humana
Gammaplex
- 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
No savings programs available for Gammaplex.
No savings programs available for Gammaked.
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Clinical data sourced from FDA-approved labeling. Coverage data via MMIT. Updated monthly.