The first intravenous preparation of intravenous immune globulin (IVIG [Gamimune, Bayer, Toronto]) was licensed in the United States in 1981 and 1982 in Canada. It was developed by Cutter Biological (now Bayer Corporation, Biological Products) with indications for use in immune deficiency syndromes. This preparation was extensively studied and confirmed to be safe, well tolerated and effective. IVIG supplies a broad spectrum of opsonic and neutralizing antibodies for the prevention or attenuation of a wide variety of infectious diseases. It also appears to exert other immuno-modulating effects. Other mechanisms of action of IVIG are not clearly understood but may include Fc receptor blockage, idiotype anti-idiotype interactions and the possib-lity of acting as a sump for activated complement components. Since the early 1980s new generations of IVIG have provided variations in formulation such that today IVIG is primarily composed of immune globulin G (IgG) with only trace amounts of IgA and IgM. birth control pills
Immune globulin preparations are prepared by the classic Cohn cold alcohol fractionation process, which was developed over 50 years ago using plasma from large human blood donor pools consisting of at least 1000 donors. Thus, IVIG is a precious and finite resource. However, in Canada, it has been reported that IVIG has been used in over 90 indications, even though the three IVIG preparations licensed in Canada (Gamimune N [10%], Bayer; Iveegam Immuno, Baxter, Mississauga; and Gammagard S/D, Baxter) are licensed for only six indications. All Canadian licensed IVIG products are labelled for use in primary immune deficiencies, and individual products have various labelling for idiopathic thrombocytopenic purpura; bone marrow transplant to reduce the risk of infection and graft versus host disease; pediatric human immunodeficiency virus infection to prevent bacterial infection; secondary immune deficiency (severe protein enteropathy, after major surgery, burn patients, malignancies, diseases of the hematopoetic and lymphoreticular systems, after radiation and cytostatic therapies); and lastly B-cell chronic lymphocytic leukemia.