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11/12/2003

Infant Botulism Treatment Approved by FDA

Cheryl A. Thompson

The Food and Drug Administration recently approved the biological license for a special immunoglobulin to counter infant botulism, the most common type of naturally occurring botulism in the United States.

Known by the generic name botulism immune globulin and the brand name BabyBIG, the product contains immunoglobulins, primarily class G, derived from the plasma of adults with high titers of antibodies to botulinum neurotoxin types A and B. The product's labeling states that the high titers are achieved by immunizing volunteers with pentavalent botulinum toxoid. After collection, the plasma undergoes several processing steps to purify the immunoglobulins and inactivate or remove viruses.

The Centers for Disease Control and Prevention in 2001 reported that the average incidence of botulism in the United States was 110 cases per year. About 72 percent of these cases involved infant botulism, caused by the ingestion of honey or another food containing Clostridium botulinum spores that then grow in the gastrointestinal tract and release botulism toxin. Four of the seven types of botulism toxin can make humans ill.

The labeling for the product states that it is to be used to treat patients younger than age 1 year with infant botulism caused by toxin type A or B.

Botulism immune globulin must not be given to patients who have had a severe reaction to another human-derived preparation of immunoglobulins. The labeling for the product also states it is possible for patients with immunoglobulin A (IgA) deficiency to have an anaphylactic reaction to botulism immune globulin, which contains a trace amount of IgA.

Development of a mild, transient erythematous rash on the face or trunk is the "only adverse event possibly related to BabyBIG administration," according to the product's labeling. This event occurred in 14 percent of the infants who received the product in a controlled study. 

According to the product's labeling, the recommended dose is 1 mL of reconstituted botulism immune globulin per kilogram of body weight. This dose is to be delivered as a single intravenous infusion as soon as infant botulism is diagnosed. The infusion should start at the rate of 0.5 mL per kilogram of body weight per hour and, if no untoward reactions occur in the first 15 minutes, the rate may be increased to 1 mL per kilogram per hour; these rates result in a total infusion time of 68 minutes.

BabyBIG will be supplied in single-use vials containing about 100 mg of lyophilized immunoglobulins, 5 percent sucrose, and 1 percent albumin and requiring storage at 2–8 degrees C. Reconstitution with 2 mL of Sterile Water for Injection, USP, yields a 50-mg/mL solution.

The product's labeling says to allow about 30 minutes for the powder to dissolve. An inline or syringe-tip needle with a 18-micrometer filter should be used during the infusion.

BabyBIG was brought to market by the Infant Botulism Treatment and Prevention Program at the California Department of Health Services. According to the labeling, the product is manufactured by Massachusetts Public Health Biologic Laboratories and Cangene Corp. and distributed by FFF Enterprises Inc.

An FFF spokeswoman said the company would start distributing the product on Dec. 1. Until then, orders must be placed with the Infant Botulism Treatment and Prevention Program at 510-231-7600.