Jane S. Ricciuti, RPh, MS


January 29, 2004

In This Article

Immune Globulin

(Botulism Immune Globulin Intravenous [Human])

Manufacturer: California Department of Health Services

Drug Approval Classification: Biologics License Application (Approval Date: 10/23/03)

Indication: BabyBIG (Botulism Immune Globulin Intravenous [Human]) is indicated for the treatment of patients below 1 year of age with infant botulism caused by toxin type A or B.

Dosing: The recommended total dosage of BabyBIG is 1 mL/kg (50 mg/kg), given as a single intravenous infusion as soon as the clinical diagnosis of infant botulism is made. BabyBIG should be used with caution in patients with preexisting renal insufficiency and in patients judged to be at increased risk of developing renal insufficiency (including, but not limited to, those with diabetes mellitus, volume depletion, paraproteinemia, sepsis, or who are receiving known nephrotoxic drugs).

Clinical Summary: Botulism immune globulin intravenous (human) (BIG-IV) is a sterile, lyophilized powder of immunoglobulin G (IgG). The purified immunoglobulin is derived from pooled adult plasma from persons immunized with pentavalent botulinum toxoid who were selected for their high titers of neutralizing antibody against botulinum neurotoxins type A and B. All donors were tested and found negative for antibodies against the human immunodeficiency virus and the hepatitis B and hepatitis C viruses.

The safety and efficacy of BabyBIG were tested in 2 clinical studies (n = 422). BabyBIG, given within the first 3 days of hospital admission to 59 patients younger than 1 year of age with laboratory-confirmed infant botulism, has been shown to reduce the average length of hospital stay, from 5.7 weeks (placebo group) to 2.6 weeks.

Adverse Effects: Administration was associated with a mild, transient erythematous rash of the face or trunk in 14% of patients. Other observed reactions included chills, muscle cramps, back pain, fever, nausea, vomiting, and wheezing.

Pharmacokinetics: The half-life of BabyBIG is approximately 28 days in infants. No other pharmacokinetic studies have been performed.

BabyBIG (botulism immune globulin intravenous [human]) Labeling