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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.

The first 20% of the full text of this section appears below.

Section 1. Active and Passive Immunization

PASSIVE IMMUNIZATION

Immune Globulin Intravenous

Immune Globulin Intravenous is made by individual manufacturers from pooled plasma of adults using methods designed to prepare a product suitable for IV use. The donor pool is similar to that of IG. Immune Globulin Intravenous consists primarily of the immunoglobulin fraction (more than 95% IgG and trace amounts of IgA and IgM). Protein content varies between 3% and 12%, depending on the product; liquid and dried products are available. Immune Globulin Intravenous does not contain thimerosal. The FDA specifies that all IGIV preparations must have a minimum concentration of antibodies to measles virus, Corynebacterium diphtheriae, poliovirus, and hepatitis B virus. Antibody concentrations against common pathogens such as Streptococcus pneumoniae vary widely among products and even among lots of the same product.

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 convened a consensus development conference; panel members concluded that there were data to support some of the uses for IGIV listed in Table 1.9. Immune Globulin Intravenous products also may be useful for other conditions, although demonstrated efficacy from controlled trials is not available in all cases.


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  		Table 1.9. Uses of Immune Globulin Intravenous (IGIV) for Which There Are Data to Suggest Efficacy (NIH Consensus Conference)1

Licensure by the FDA of specific indications for a manufacturer’s IGIV product is based on availability of data from one or more . . . [Go to Full Text]


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