Gamunex-C

Gamunex-C

human normal immunoglobulin

Manufacturer:

Grifols

Distributor:

Grifols Asia Pacific
Concise Prescribing Info
Contents
Ig inj (human) 10% caprylate/chromatography purified (consists of 9-11% protein in 0.16-0.24 M glycine)
Indications/Uses
Replacement therapy for primary humoral immunodeficiency (PI). Idiopathic thrombocytopenic purpura (ITP). Chronic inflammatory demyelinating polyneuropathy (CIDP) to improve neuromuscular disability & impairment & for maintenance therapy to prevent relapse.
Dosage/Direction for Use
PI IV 300-600 mg/kg every 3-4 wk. Initial infusion rate: 1 mg/kg/min, then may be gradually increased to a max of 8 mg/kg/min. Patient routinely receives <400 mg/kg dose every 3-4 wk & at risk of measles exposure Administer at least 400 mg/kg prior to expected measles exposure. Patient exposed to measles Administer 400 mg/kg immediately after exposure. SC Individualized dosage based on clinical response & serum IgG trough levels, 1 wk after last IV infusion. 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 on 5 consecutive days. Initial infusion rate: 1 mg/kg/min, then may be gradually increased to a max of 8 mg/kg/min. CIDP IV Total loading dose: 2 g/kg in divided doses over 2-4 consecutive days. Maintenance dose: 1 g/kg over 1 day or in 2 divided doses of 0.5 g/kg given on 2 consecutive days every 3 wk. Initial infusion rate: 2 mg/kg/min, then may be gradually increased to a max of 8 mg/kg/min.
Contraindications
Hypersensitivity. IgA-deficient patients w/ Ab against IgA & history of hypersensitivity.
Special Precautions
Immediately discontinue if severe hypersensitivity occurs. Do not administer SC to patients w/ ITP. Hyperproteinemia, increased serum viscosity & hyponatremia may occur. Ensure adequate hydration before administration. Consider baseline assessment of blood viscosity in patients at risk for hyperviscosity. Monitor for signs & symptoms of thrombosis & assess blood viscosity. Conduct a thorough neurological examination on patients exhibiting aseptic meningitis syndrome (AMS) symptoms & signs including CSF studies, to rule out other causes of meningitis. AMS may occur more frequently at high doses (2 g/kg) &/or rapid infusion. Delayed hemolytic anemia may develop w/ subsequent to IGIV therapy. Monitor patients for clinical signs & symptoms of hemolysis; consider appropriate laboratory testing in higher risk patients, including measurement of Hb or hematocrit prior to infusion & w/in approx 36-96 hr post infusion. Monitor patients for pulmonary adverse reactions. Perform appropriate tests for the presence of anti-neutrophil & anti-HLA Ab in both Gamunex-C & patient serum if transfusion-related acute lung injury is suspected. High-dose regimen is not recommended for individuals w/ expanded fluid vol or where fluid vol may be a concern. Made from human blood; may carry a risk of transmitting infectious agents eg, viruses, & the Creutzfeldt-Jakob disease agent. Passive transmission of Ab to erythrocyte antigens (eg, A, B & D) may cause positive direct or indirect antiglobulin (Coombs') test. Assess renal function & measure BUN/serum creatinine prior to initial infusion. Consider discontinuation if renal function deteriorates. Pregnancy & lactation. Childn. Elderly ≥65 yr.
Adverse Reactions
Inj/infusion site reaction, nausea, headache, vomiting, fever, rash. Cough, pharyngitis, urticaria; fatigue, arthralgia, pyrexia; back pain; chills, HTN, asthenia.
Drug Interactions
Do not dilute w/ saline. Incompatibilities w/ heparin. Results of serological tests may be confounded w/ various passively transferred Ab. Immune response to live virus vaccines eg, measles, mumps, rubella & varicella, may be transiently interfered by passive transfer of Ab.
MIMS Class
Vaccines, Antisera & Immunologicals
ATC Classification
J06BA02 - immunoglobulins, normal human, for intravascular adm. ; Belongs to the class of normal human immunoglobulins. Used in passive immunizations.
Presentation/Packing
Form
Gamunex-C infusion 10%
Packing/Price
10 mL x 1's;100 mL x 1's;200 mL x 1's;25 mL x 1's;50 mL x 1's
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