| Primary immune deficiency disorder

Gammaked vs Hizentra

Side-by-side clinical, coverage, and cost comparison for primary immune deficiency disorder.

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

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

Category

Gammaked

Hizentra

At A Glance

RouteIV infusion

ClassImmune globulin

RouteSC injection

FrequencyDaily to every 2 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

Primary immune deficiency disorder
Polyradiculoneuropathy, Chronic Inflammatory Demyelinating
Wiskott-Aldrich Syndrome
Common Variable Immunodeficiency
X-linked agammaglobulinemia
Severe Combined Immunodeficiency

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 immune deficiency disorder, Wiskott-Aldrich Syndrome, Common Variable Immunodeficiency, X-linked agammaglobulinemia, Severe Combined Immunodeficiency Individualized SC dose administered daily to every 2 weeks; when switching from IGIV, initial weekly dose = prior IGIV dose (g) divided by weeks between doses, multiplied by 1.37.

Polyradiculoneuropathy, Chronic Inflammatory Demyelinating 0.2 g/kg (1 mL/kg) SC per week in 1-2 infusion sessions over 1-2 consecutive days; may increase to 0.4 g/kg per week if symptoms worsen on the lower dose.

Contraindications

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

History of anaphylactic or severe systemic reaction to human immune globulin or inactive ingredients of HIZENTRA, including polysorbate 80
Hyperprolinemia Type I or II (HIZENTRA contains L-proline as stabilizer)
IgA-deficiency with antibodies against IgA and a 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%) Local infusion-site reactions (swelling, redness, heat, pain, hematoma, itching), headache, diarrhea, fatigue, back pain, nausea, pain in extremity, cough, upper respiratory tract infection, rash, pruritus, vomiting, abdominal pain, migraine, arthralgia, pain, fall, nasopharyngitis

Postmarketing Allergic-anaphylactic reactions (swollen face or tongue, pharyngeal edema, pyrexia, chills, dizziness, hypertension, malaise, tachycardia, flushing), chest discomfort, dyspnea, tremor, burning sensation, infusion site ulcer, infusion site necrosis

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.

Immune Globulin Subcutaneous (Human), 20% Liquid that supplies a broad spectrum of opsonizing and neutralizing IgG antibodies against a wide variety of bacterial and viral agents; mechanism of action has not been fully elucidated but may include immunomodulatory effects.

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Most Common Insurance

Anthem BCBS

Gammaked