Gamunex-C

Gamunex-C

Manufacturer:

Grifols

Distributor:

DKSH
Concise Prescribing Info
Contents
Human Ig [10% purified caprylate/chromatography (consist of 9-11% protein in 0.16-0.24 M glycine) (not less than 98% of the protein has the electrophoretic mobility of γ globulin)]
Indications/Uses
Primary humoral immunodefficiency (PI), idiopathic thrombocytopenic purpura (ITP) & chronic inflammatory demyelinating polyneuropathy (CIDP). 
Dosage/Direction for Use
PI IV 300-600 mg/kg 3-4 wkly. Initial infusion rate: 1 mg/kg/min, may gradually increase to a max of 8 mg/kg/min if tolerated. SC Individualized dosage. ITP IV 2 g/kg divided in 2 doses of 1 g/kg given on 2 consecutive days or into 5 doses of 0.4 g/kg given on 5 consecutive days. Initial infusion rate: 1 mg/kg/min, then may gradually increase to a max of 8 mg/kg/min, if tolerated. CIDP Initially 2 g/kg given in divided doses over 2-4 consecutive days. Maintenance infusion: 1 g/kg administered over 1 day or divided into 2 doses of 0.5 g/kg given on 2 consecutive days every 3 wk. Initial infusion rate: 2 mg/kg/min, then may gradually increased to a max of 8 mg/kg/min, if tolerated.
Contraindications
Anaphylactic or severe systemic reaction to human Ig. IgA-deficient patients w/ antibodies against IgA & history of hypersensitivity.
Special Precautions
Severe hypersensitivity. Ensure patients are not vol depleted prior to initiation of infusion. Monitor periodically renal function & urine output in patient in potential risk of acute renal failure. Hyperproteinemia, increased serum viscosity & hyponatremia. Monitor for signs & symptoms of thrombosis & assess blood viscosity. Ensure adequate hydration prior to administration. Consider baseline assessment of blood viscosity. Aseptic meningitis syndrome (AMS) may occur at high doses (2 g/kg) &/or rapid infusion. Delayed hemolytic anemia may develop w/ subsequent IGIV therapy. Transfusion-related acute lung injury. Monitor patients for pulmonary adverse reactions. Patients w/ expanded fluid vol. Do not administer SC in patients w/ ITP. May cause positive direct or indirect antiglobulin (Coombs') test. Do not dilute w/ saline. Pregnancy & lactation. Childn. Elderly ≥65 yr.
Adverse Reactions
Headache, cough, inj site reaction, nausea, pharyngitis & urticaria. Fatigue, arthralgia & pyrexia. Fever, back pain & rash. Chills, HTN & asthenia.
Drug Interactions
Heparin, live virus vaccines (eg, measles, mumps, rubella & varicella).
MIMS Class
Vaccines, Antisera & Immunologicals
ATC Classification
J06BA - Immunoglobulins, normal human ; Used in passive immunizations.
Presentation/Packing
Form
Gamunex-C infusion soln 1 g/10 mL
Packing/Price
1's
Form
Gamunex-C infusion soln 10 g/100 mL
Packing/Price
1's
Form
Gamunex-C infusion soln 2.5 g/25 mL
Packing/Price
1's
Form
Gamunex-C infusion soln 5 g/50 mL
Packing/Price
1's
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