Concise Prescribing Info
Contents
Human Ig (IVIg)
Indications/Uses
Replacement therapy for adults, adolescents & childn 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 plateau phase multiple myeloma who failed to respond to pneumococcal immunisation; hypogammaglobulinaemia in patients after allogeneic haematopoietic stem cell transplantation (HSCT); congenital AIDS w/ recurrent bacterial infections. Immunomodulation for adults, adolescents & childn 0-18 yr in primary immune thrombocytopenia (ITP) at high risk of bleeding or prior to surgery to correct platelet count; Guillain-Barré syndrome; Kawasaki disease.
Dosage/Direction for Use
Replacement therapy in primary immunodeficiency syndrome Recommended starting dose: 0.4-0.8 g/kg once daily followed by at least 0.2 g/kg every 3-4 wk. Replacement therapy in secondary immunodeficiency; congenital AIDS w/ recurrent bacterial infections 0.2-0.4 g/kg every 3-4 wk. Hypogammaglobulinaemia after allogeneic HSCT 0.2-0.4 g/kg every 3-4 wk & maintain IgG trough level >5 g/L. ITP 0.8-1 g/kg on day 1, may be repeated once w/in 3 days or 0.4 g/kg daily for 2-5 days. Guillain-Barré syndrome 0.4 g/kg daily for 5 days. Kawasaki disease 1.6-2 g/kg in divided doses over 2-5 days or 2 g/kg as single dose.
Contraindications
Hypersensitivity to human Ig & patients w/ Ab against IgA.
Special Precautions
Hypersensitivity. Not indicated in patients w/ selective IgA deficiency. Obese patients & patients w/ pre-existing risk factors for thrombotic events eg, advanced age, HTN, DM, history of vascular disease or thrombotic episodes, acquired or inherited thrombophilic disorders, prolonged periods of immobilisation, severe hypovolemia, diseases increasing blood viscosity. Aseptic meningitis syndrome; haemolytic anaemia. Exclude possibility of transmitting infective agents prior to therapy. Ensure adequate hydration prior to initiation. Monitor urine output & serum creatinine levels during therapy; clinical signs & symptoms of haemolysis. Patients on controlled Na diet & 1st-time infusion recipients. High-rate infusion. May cause falsely elevated glucose readings; misleading +ve results in serological testing. Interference w/ red cell Ab serological tests ie, direct antiglobulin test. Avoid concomitant use of loop diuretics. Concomitant use w/ nephrotoxic medicinal products. May affect ability to drive & use machines. Acute renal failure, pre-existing renal insufficiency. Pregnancy & lactation. Elderly >65 yr.
Adverse Reactions
Hypersensitivity; headache; nausea; fever, fatigue, inj site reaction.
Drug Interactions
Impaired efficacy of live attenuated virus vaccine.
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
Octagam infusion (bottle) 2.5 g/50 mL
Packing/Price
1's
Form
Octagam infusion (bottle) 5 g/100 mL
Packing/Price
1's
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