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The following text is from an archived Red Book® edition and may not reflect current recommendations or information. To view the current edition, click here.

Section 1. Active and Passive Immunization

PASSIVE IMMUNIZATION

Immune Globulin Intravenous

Immune Globulin Intravenous is derived from pooled plasma of adults by an alcohol-fractionation procedure, which is modified by individual manufacturers to a product suitable for IV use. The donor pool is like that of IG. The FDA specifies that all preparations must have a minimum concentration of measles, diphtheria, poliovirus, and hepatitis B antibodies. Antibody concentrations against common pathogens, such as Streptococcus pneumoniae, vary widely among products and even among lots of the same product. Immune Globulin Intravenous consists primarily of the immunoglobulin fraction (more than 95% IgG and trace amounts of IgA and IgM). Protein content varies, depending on the product; liquid and dried products are available. Immune Globulin Intravenous does not contain thimerosal.

INDICATIONS FOR THE USE OF IGIV
ADVERSE REACTIONS TO IGIV
PRECAUTIONS FOR THE USE OF IGIV

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INDICATIONS FOR THE USE OF IGIV

Initially, IGIV was developed as an infusion product that allowed patients with primary immunodeficiencies to receive enough IG at monthly intervals to protect them from infection until their next infusion. Subsequently, the FDA and the National Institutes of Health, through a consensus development conference, have expanded the recommended uses for IGIV (see Table 1.8, p 58). This product also may be useful for other conditions, although demonstrated efficacy from controlled trials is not available in all cases. Since November 1997, periodic shortages of IGIV have existed in the United States because of production impediments related to compliance and product recall based on the theoretic risk of contamination with the Creutzfeldt-Jakob disease (CJD) agent. Other problems causing short supply of IGIV include increased administration for approved and unapproved uses, wastage, and export of IGIV. . . . [Go to Full Text]


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