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      Information for healthcare providers on general features of IGIV with emphasis on differences between commercially available products.

      Autoimmunity Reviews
      Consumer Product Safety, standards, Drug Compounding, methods, Drug Contamination, statistics & numerical data, Humans, Immunoglobulins, Intravenous, Immunologic Deficiency Syndromes, drug therapy, Product Surveillance, Postmarketing

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          Abstract

          Intravenous immunoglobulin (IGIV) has provided an essential replacement therapy for primary and secondary immunodeficiencies patients and prophylaxis of infectious diseases in them. It is also used in several autoimmune and chronic inflammatory disorders. An overview of IGIV with information on several commercially available IGIV products is discussed. Medline databases and literature provided by the manufacturer for each product presented in the manuscript. From the vast body of information on IGIV, only those studies were selected that were pertinent to general features of IGIV (as presented below) or information provided by the manufacturer that facilitated comparing one product to the other. Data was extracted on production, and purification procedures, removal of infectious agents, physical and biochemical properties and issues of safety. Data was extracted only for products available in the US. IGIV is prepared using pooled plasma. The purification of IGIV is a complex and multi-step process. There is a reciprocal relationship between the purity of IgG in the product and the recovery rate from the total plasma. It is quite possible that some of the biological mediators of the inflammatory and immune systems may be present in trace amounts. Screening and removal of blood borne pathogens is necessary and there are several different techniques available. The specifics of the administration are often variable and no consistent pattern or protocol has been used. When limited dosages are required IGIV may be administered subcutaneously. The side effects associated with IGIV are usually mild and self-limiting. There are differences in products produced by different manufacturers. The current data does not provide sufficient detail or information to be able to make specific recommendations for the use of a given commercial preparation in a specific disease state. The use of IGIV is associated with certain common and uncommon side effects. The identification of risk factors that might predispose a patient to developing them have been studied and reported. In choosing a IGIV preparation the user may avoid features that may predispose to certain side effects. Equally important is monitoring of patients during and after the IGIV therapy. Copyright 2010 Elsevier B.V. All rights reserved.

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