Immunoglobulin-G Human + Maltose

Indications

Immunoglobulin-G Human + Maltose is used for: 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 of idiopathic thrombocytopenic purpura (ITP), in childn or adults at high risk of bleeding or prior surgery to correct the platelet count; Guillain-Barre syndrome; Kawasaki disease. Allogeneic bone marrow transplantation.

Adult Dose

Replacement therapy in primary immunodeficiency syndromes Starting dose: 0.4-0.8 g/kg followed by 0.2-0.8 g/kg 2-4 wkly to achieve IgG trough level of 4.6 g/L. Replacement therapy in myeloma or chronic lymphotic leukaemia w/ severe secondary hypogammaglobulinaemia & recurrent infections; replacement therapy in childn w/ AIDS & recurrent infections 0.2-0.4 g/kg 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 over 2-5 days or 2 g/kg as a single-dose in combination w/ acetylsalicylic acid. Allogeneic bone marrow transplantation 0.5 g/kg wkly starting 7 days before & up to 3 mth after transplantation for the treatment of infections & prophylaxis of graft versus host disease, & mthly until Ab levels return to normal in persistent lack of Ab production.

Child Dose

Renal Dose

Administration

Contra Indications

Hypersensitivity to homologous Ig esp in IgA deficiency due to Ab against Ig (rare). Fructose intolerance.

Precautions

High rate of infusion; patients w/ hypo- or agammaglobulinaemia w/ or w/o IgA deficiency, receiving human normal Ig therapy for the 1st time, or when human normal Ig is switched or during a long interval since the previous infusion (rare). Obese patients; preexisting risk for thrombotic events. Discontinue use in case of renal impairment. Maintain adequate hydration prior to initiation; monitor urine output & serum creatinine levels; avoid concomitant use w/ loop diuretics. Perform appropriate tests for the presence of antineutrophil Ab if transfusion-related acute lung injury (TRALI) is suspected. May interfere w/ serological test for red cell Ab eg Coomb's test. May impair ability to drive or operate machinery. Pregnancy & lactation.

Pregnancy-Lactation

Interactions

May interfere with the immune response to live measles vaccine, live mumps vaccine, live rubella vaccine and live varicella vaccine, therefore these vaccines should be given at least 3 wk before or 3 mth after the admin of the immunoglobulins.

Adverse Effects

Side effects of Immunoglobulin-G Human + Maltose : Headache, cough, inj site reaction, nausea, pharyngitis & urticaria; fatigue, arthralgia & pyrexia; vomiting, fever, back pain & rash; chills, HTN, asthenia.

Mechanism of Action

Human normal immunoglobulin is derived from donations of pooled human plasma. It contains antibodies, mainly immunoglobulin G (IgG), to various bacteria and viruses present in the general population such as hepatitis A, measles, mumps, rubella and varicella. It has a distribution of IgG subclasses that is very close to that of the normal human plasma. It is therefore, used to provide passive immunisation against such diseases.