Gamunex-C

Gamunex-C

human normal immunoglobulin

Manufacturer:

Grifols

Distributor:

Luen Cheong Hong (M)
/
Luen Cheong Hong
Concise Prescribing Info
Contents
Ig inj (human) 10% purified caprylate/chromatography [consists of glycine (9-11% protein in 0.16-0.24 M)]
Indications/Uses
Listed in Dosage.
Dosage/Direction for Use
Primary humoral immunodeficiency (PI) IV 300-600 mg/kg 3-4 wkly. Initial infusion rate: 1 mg/kg/min. Maintenance infusion rate (if tolerable): 8 mg/kg/min 3-4 wkly. SC Individualised dosage. Idiopathic thrombocytopenic purpura (ITP) 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 on 5 consecutive days. Initial infusion rate of 1 mg/kg/min, then may increase up to max of 8 mg/kg/min. Chronic inflammatory demyelinating polyneuropathy (CIDP) 2 g/kg loading dose in divided doses over 2-4 consecutive days. Then, 1 g/kg maintenance dose administered over 1 day or in 2 divided doses of 0.5 g/kg given on 2 consecutive days every 2 wk. Initial infusion rate of 2 mg/kg/min, then may increase up to max of 8 mg/kg/min.
Contraindications
Hypersensitivity. IgA-deficient patients w/ antibodies against IgA. Anaphylactic or severe systemic reactions to human Ig.
Special Precautions
Severe hypersensitivity. Monitor renal function. Hyperproteinemia, increased serum viscosity & hyponatremia. Consider baseline assessment of blood viscosity. Ensure adequate hydration before administration. Monitor for signs & symptoms of thrombosis & assess blood viscosity. Aseptic meningitis syndrome (AMS) may occur at high doses (2 g/kg) &/or rapid infusion. 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 to patients w/ ITP. Do not dilute w/ saline soln. Pregnancy & lactation. Childn. Elderly ≥65 yr.
Adverse Reactions
Headache, cough, inj site reactions, nausea, pharyngitis, urticaria, infusion site reactions, fatigue, arthralgia, pyrexia, vomiting, fever, back pain, rash, chills, HTN, asthenia.
Drug Interactions
Heparin, live virus vaccines (MMR & varicella).
ATC Classification
J06BA01 - immunoglobulins, normal human, for extravascular adm. ; Belongs to the class of normal human immunoglobulins. Used in passive immunizations.
Presentation/Packing
Form
Gamunex-C infusion 10%
Packing/Price
50 mL x 1's
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