human normal immunoglobulin




Firma Chun Cheong
Concise Prescribing Info
Human normal Ig
Replacement therapy in adults, childn & adolescents (0-18 yr) in primary immunodeficiency syndromes w/ impaired Ab production; hypogammaglobulinaemia & recurrent bacterial infections in patients w/ chronic lymphocytic leukaemia, in whom prophylactic antibiotics have failed or are contraindicated; hypogammaglobulinaemia & recurrent bacterial infections in multiple myeloma patients; hypogammaglobulinaemia in patients pre- & post-allogeneic haematopoietic stem cell transplantation.
Dosage/Direction for Use
SC Individualised dosage based on clinical response. Dose regimen should achieve IgG trough level of at least 5-6 g/L & aim to be w/in the reference interval of serum IgG for age. Infusion rate: Initially 10 mL/hr/site, may be increased at 10-min intervals to max 20 mL/hr/site for 1st 2 infusions if well tolerated. Each single dose may need to be injected at different anatomic sites. Loading dose: 0.2-0.5 g/kg (1-2.5 mL/kg), may be divided over several days. Max: 0.1-0.15 g/kg/day. Maintenance dose: After steady state IgG levels attained, administer at repeated intervals to reach cumulative mthly dose of 0.3-1 g/kg.
Current or history of hypersensitivity to human Ig. Severe IgA deficiency. Must not be given intravascularly or intramuscularly.
Special Precautions
Immediate discontinuation if severe hypersensitivity or anaphylactic-type reactions occur. Shock could develop if accidentally administered into a blood vessel. Monitor for any symptoms throughout infusion period. Risk of adverse reactions is more frequent when receiving human normal Ig for the 1st time or, in rare cases, when switching between human normal Ig products or when there has been long interval since the previous infusion. Patients w/ anti-IgA Ab should be treated under close medical supervision. Patients at risk for thrombosis should receive Cuvitru at the slowest infusion rate practicable; monitor for thrombotic complications. Aseptic Meningitis Syndrome may occur, more frequently in female patients. Monitor for hemolysis, particularly those at increased risk. Interference w/ serological testing (eg, misleading or false positive results). Possible transmission of infectious agents. May impair ability to drive or operate machinery. Renal impairment. Pregnancy & lactation. Childn <2 yr.
Adverse Reactions
Headache; diarrhoea, nausea; local reactions at infusion site, fatigue. Dizziness, migraine, somnolence; hypotension; abdominal pain; pruritus, urticaria; myalgia; pain.
Drug Interactions
Impaired efficacy of live attenuated virus vaccines eg, measles, rubella, mumps & varicella, for a period of at least 6 wk & up to 3 mth; for measles, impairment may persist up to 1 yr.
ATC Classification
J06BA01 - immunoglobulins, normal human, for extravascular adm. ; Belongs to the class of normal human immunoglobulins. Used in passive immunizations.
Cuvitru soln for SC inj 4 g/20 mL
20 mL x 1's
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