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)IV300-600 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.
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