| Polyradiculoneuropathy, Chronic Inflammatory Demyelinating

Gammaked vs Gamunex - C

Side-by-side clinical, coverage, and cost comparison for polyradiculoneuropathy, chronic inflammatory demyelinating.

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

Coverage gaps3 major payers require step therapy for Gamunex-C but not Gammaked, including UnitedHealthcare

Category

Gammaked

Gamunex-C

At A Glance

RouteIV infusion

ClassImmune globulin

RouteIV infusion / SC injection

FrequencyEvery 3-4 weeks

ClassImmune globulin

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
Wiskott-Aldrich Syndrome
Severe Combined Immunodeficiency
Congenital agammaglobulinemia
Immune thrombocytopenic purpura
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).

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 against IgA and history of hypersensitivity reaction

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

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%) 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

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.

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.

View Full FDA Information

View full FDA information

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Most Common Insurance

Anthem BCBS

Gammaked