Flebogamma 5% DIF

Human normal Ig

Replacement therapy in primary immunodeficiency syndromes (eg, congenital agammaglobulinaemia & hypogammaglobulinaemia, common variable immunodeficiency, severe combined immunodeficiency & Wiskott-Aldrich syndrome), myeloma or chronic lymphocytic leukaemia w/ severe secondary hypogammaglobulinaemia & recurrent infections, & childn w/ congenital AIDS & recurrent infections. Immunomodulation in ITP in childn or adults at high risk of bleeding or prior to surgery to correct platelet count, Guillain-Barré syndrome, Kawasaki disease. Allogenic bone marrow transplantation.

IV Infuse at initial rate of 0.01-0.02 mL/kg/min for 1st 30 min; may gradually increase to max 0.1 mL/kg/min. Replacement therapy in primary immunodeficiency syndrome Initially 0.4-0.8 g/kg followed by at least 0.2 g/kg every 3 wk, thereafter 0.2-0.8 g/kg/mth every 2-4 wk. Replacement therapy in myeloma or chronic lymphocytic leukaemia w/ severe secondary hypogammaglobulinaemia & recurrent infection; childn w/ AIDS & recurrent infection 0.2-0.4 g/kg every 3-4 wk. 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 3-7 days. Kawasaki disease 1.6-2 g/kg in divided doses for 2-5 days or 2 g/kg as single dose concomitantly w/ ASA. Allogenic bone marrow transplantation: Treatment of infection & prophylaxis of graft versus host disease Initially 0.5 g/kg every wk from 7 days before & up to 3 mth after transplantation. Persistent lack of Ab production 0.5 g/kg every mth until Ab level return to normal.

Hypersensitivity to human normal Ig & homologous Ig, especially in very rare cases of IgA deficiency. Fructose intolerance.

Stop infusion or reduce rate of administration in case of adverse reaction. High rate of infusion. IgA deficiency w/ anti-IgA Abs. Fall in BP w/ anaphylactic reaction; shock. Thromboembolic events eg, MI, stroke, pulmonary embolism & DVT. Possibility of transmitting infective agents. Patients w/ hypo- or agammaglobulinaemia w/ or w/o IgA deficiency; who receive human normal Ig for the 1st time, or when human normal Ig is switched or there has been long interval since previous infusion. Obese patients, w/ pre-existing risk factors for thrombotic events eg, advanced age, HTN, DM & history of vascular disease or thrombotic episodes, patients w/ acquired or inherited thrombophilic disorders, prolonged immobilisation, severely hypovolemic, & w/ diseases increasing blood viscosity. Monitor patients naive to human normal Ig, switched from alternative IVIg product or when there has been long interval since previous infusion during 1st infusion & for 1st hr after 1st infusion & all other patients for at least 20 min after administration; urine output; serum creatinine levels. Ensure adequate hydration prior to initiation of infusion. Not to be taken by patients w/ rare hereditary problems of fructose intolerance. Concomitant use w/ nephrotoxic medicinal products. Avoid concomitant use w/ loop diuretics. May impair ability to drive & use machines. Acute renal failure & pre-existing renal insufficiency. Consider treatment discontinuation in case of renal impairment. Pregnancy & lactation. Babies & young childn. Elderly >65 yr.

Chills, headache, fever, vomiting, allergic reactions, nausea, arthralgia, low BP, moderate low back pain. Increased serum creatinine, acute renal failure. Reversible aseptic meningitis & haemolytic anaemia/haemolysis.

Impaired efficacy of live attenuated virus vaccines eg, MMR, varicella. Interference w/ serological tests eg, antiglobulin test (Coomb's test).

Vaccines, Antisera & Immunologicals

J06BA - Immunoglobulins, normal human ; Used in passive immunizations.

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