Criteria for the appropriate drug utilisation of immunoglobulin.

Intravenous immunoglobulins (IVIGs) are prepared from human plasma pools and further modified enzymatically or chemically. Despite careful selection of donors and inclusion of effective virus elimination steps in the production process, contamination with hepatitis C virus can still occur. IVIGs possess most of the characteristics of native immunoglobulins, such as antigen neutralisation and complement activation. The serum half-life of native immunoglobulin is about 21 days, and comparable half-lives have been reported for several IVIG preparations. IVIGs have received general approval for the treatment of primary immuno-deficiencies such as agammaglobulinaemia. Of the secondary immuno-deficiencies, only paediatric AIDS, chronic lymphocytic leukaemia and multiple myeloma, as well as allogeneic bone marrow transplantation, are accepted indications for IVIGs. Because of their immunomodulatory action, IVIGs are also recommended for the treatment of idiopathic thrombocytopenic purpura, Kawasaki disease (mucocutaneous lymph node syndrome) and, recently, Guillain Barre syndrome IVIGs have been investigated in a wide range of immunodeficient states (e.g. prematurity) and autoimmune diseases (e.g. multiple sclerosis), but conclusive results are not available. Since IVIGs are associated with a certain risk of transmission of viral infections and, secondly, because they are generally acknowledged as expensive drugs, their use requires careful consideration of risk, benefit and cost.