| Congenital agammaglobulinemia

Gammaked vs Gammagard Liquid

Side-by-side clinical, coverage, and cost comparison for congenital agammaglobulinemia.

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Safety signalsGammagard Liquid has a higher rate of injection site reactions vs Gammaked based on FDA-approved prescribing information

Coverage gaps3 major payers require step therapy for Gammagard Liquid but not Gammaked, including UnitedHealthcare

Category

Gammaked

Gammagard Liquid

At A Glance

RouteIV infusion

ClassImmune globulin

RouteIV infusion or SC injection

FrequencyEvery 3-4 weeks (IV) or weekly (SC)

ClassImmune globulin replacement

Indications

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

Common Variable Immunodeficiency
X-linked agammaglobulinemia
Congenital agammaglobulinemia
Wiskott-Aldrich Syndrome
Severe Combined Immunodeficiency
Multifocal motor neuropathy
Polyradiculoneuropathy, Chronic Inflammatory Demyelinating

Dosing

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).

Primary Immunodeficiency (IV) 300-600 mg/kg every 3-4 weeks by IV infusion; start at 0.5 mL/kg/hr, increase every 30 minutes if tolerated up to 5 mL/kg/hr.

Primary Immunodeficiency (SC) Initial dose 1.37 x previous IV dose divided by weeks between IV doses, given weekly; 20-30 mL/site at 20-30 mL/hr/site (>=40 kg) or 20 mL/site at 15-20 mL/hr/site (<40 kg).

Multifocal Motor Neuropathy 0.5-2.4 g/kg/month by IV infusion; start at 0.5 mL/kg/hr, may increase if tolerated up to 5.4 mL/kg/hr.

Chronic Inflammatory Demyelinating Polyneuropathy Induction 2 g/kg divided over 2-5 consecutive days, then maintenance 1 g/kg divided over 1-4 consecutive days every 3 weeks by IV infusion; start at 0.5 mL/kg/hr, may increase if tolerated up to 5.4 mL/kg/hr.

Contraindications

Previous anaphylactic or severe systemic reaction to human immune globulin
IgA deficiency with antibodies against IgA and history of hypersensitivity reaction

Anaphylactic or severe systemic hypersensitivity to human immune globulin
IgA deficiency with antibodies to IgA and history of hypersensitivity

Drug Interactions

163View drug interactions

Adverse Reactions

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

Most common (>=5%) - Primary Immunodeficiency (IV) Headache, fatigue, pyrexia, nausea, chills, rigors, pain in extremity, diarrhea, migraine, dizziness, vomiting, cough, urticaria, asthma, pharyngolaryngeal pain, rash, arthralgia, myalgia, edema peripheral, pruritus, cardiac murmur

Most common (>=5%) - Primary Immunodeficiency (SC) Infusion site events, headache, fatigue, heart rate increased, pyrexia, abdominal pain upper, nausea, vomiting, asthma, blood pressure systolic increased, diarrhea, ear pain, aphthous stomatitis, migraine, oropharyngeal pain, pain in extremity

Most common (>=5%) - Multifocal Motor Neuropathy Headache, chest discomfort, muscle spasms, muscular weakness, nausea, oropharyngeal pain, pain in extremity

Most common (>=5%) - Chronic Inflammatory Demyelinating Polyneuropathy Headache, pyrexia, anemia, leukopenia, neutropenia, illness, blood creatinine increased, dizziness, migraine, somnolence, tremor, nasal dryness, abdominal pain upper, vomiting, chills, nasopharyngitis, pain in extremity

Serious Aseptic meningitis (IV for PI), pulmonary embolism, blurred vision (MMN)

Postmarketing Hemolysis, anaphylactic shock, cerebrovascular accident, transient ischemic attack, tremor, myocardial infarction, deep vein thrombosis, hypotension, pulmonary embolism, pulmonary edema, hyperhidrosis, chest pain, transfusion-related acute lung injury, hypersensitivity, myalgia, chills

Pharmacology

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.

GAMMAGARD LIQUID supplies a broad spectrum of opsonizing and neutralizing IgG antibodies against bacterial and viral agents and contains antibodies that interact with immune system cells; the mechanism in CIDP may include immunomodulatory effects.

View Full FDA Information

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Most Common Insurance

Anthem BCBS

Gammaked