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 Information on IVIg

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What Are the IVIG preprations?

Are all IVIG Preparations Equally Efficacious?

Seven IVIG preparations have been licensed in the U.S.: all seven for use in primary immunodeficiencies, five for idiopathic thrombocytopenia, and one for chronic lymphocytic leukemia. For these disease groups, the limited comparative data available reveal no differences in efficacy among the licensed preparations. For the other uses of IVIG, there is insufficient information to choose one product over another or to know whether each has comparable activity. Given the large number of conditions for which IVIG may have potential value, the prescribing physician should be aware of the demonstrated efficacy of each IVIG preparation to treat a specific disorder. The products and their quality are under the control of commercial firms who must meet general regulatory guidelines of the Center for Biologics Evaluation and Research of the Food and Drug Administration. These include tests for sterility, pyrogenicity, purity, and safety. It is required also to measure antibody levels against polio, measles, hepatitis B, and diphtheria. At the present time, there is no requirement to identify hepatitis C virus in IVIG preparations. Epidemiologic data support the quality and safety of current products. However, guidelines and monitoring methods must be developed as information about transmission of hepatitis C virus and other infectious diseases becomes better defined. Consideration should be given to screening donors for hepatitis C.

Confidence in the capacity of a given preparation to accomplish the desired end result would be enhanced if a more rigorous procedure were established for using IVIG to prevent or treat infections caused by specific microorganisms. The availability of antibody titers to a wider range of pathogens would permit a more rational basis for the choice of a specific product in situations where immunotherapy is directed to a restricted number of infectious agents. Because the factor essential for the effectiveness of IVIG in a number of disorders, such as ITP and Kawasaki syndrome, is unknown, it is not possible to predict efficacy of a given preparation of IVIG for any of these disease processes

 In conclusion, this shows that IVIG preparations are not all equally well tolerated in patients. The data suggest that, perhaps to a comparable extent to the preparation itself, the infusion rate has a major effect. If a reduction in the infusion rate does not minimize side-effects, one should consider switching the IVIG formulation







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