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Investigational Heptavalent Botulinum Antitoxin (HBAT) to Replace Licensed Botulinum Antitoxin AB and Investigational Botulinum Antitoxin E
CDC announces the availability of a new heptavalent botulinum antitoxin (HBAT, Cangene Corporation) through a CDC-sponsored Food and Drug Administration (FDA) Investigational New Drug (IND) protocol. HBAT replaces a licensed bivalent botulinum antitoxin AB and an investigational monovalent botulinum antitoxin E (BAT-AB and BAT-E, Sanofi Pasteur) with expiration of these products on March 12, 2010. As of March 13, 2010, HBAT became the only botulinum antitoxin available in the United States for naturally occurring noninfant botulism.
Botulinum antitoxin for treatment of naturally occurring noninfant botulism is available only from CDC. The transition to HBAT ensures uninterrupted availability of antitoxin. BabyBIG (botulism immune globulin) remains available for infant botulism through the California Infant Botulism Treatment and Prevention Program (1). BabyBIG is an orphan drug that consists of human-derived botulism antitoxin antibodies and is approved by FDA for the treatment of infant botulism types A and B.
HBAT contains equine-derived antibody to the seven known botulinum toxin types (A--G) with the following nominal potency values: 7,500 U anti-A; 5,500 U anti-B; 5,000 U anti-C; 1,000 U anti-D; 8,500 U anti-E; 5,000 U anti-F; and 1,000 U anti-G. HBAT is composed of <2% intact immunoglobulin G (IgG) and ≥90% Fab and F(ab')2 immunoglobulin fragments; these fragments are created by the enzymatic cleavage and removal of Fc immunoglobulin components in a process sometimes referred to as despeciation. Fab and F(ab')2 fragments are cleared from circulation more rapidly than intact IgG (2), and repeat HBAT dosing might be indicated for some wound or intestinal colonization patients if in situ botulinum toxin production continues after clearance of antitoxin.
The HBAT FDA IND treatment protocol includes specific, detailed instructions for intravenous administration of antitoxin and return of required paperwork to CDC. Health-care providers should report suspected botulism cases immediately to their state health department; all states maintain 24-hour telephone services for reporting of botulism and other public health emergencies. Additional emergency consultation is available from the CDC botulism duty officer via the CDC Emergency Operations Center, telephone, 770-488-7100 (3). Additional information regarding CDC's botulism treatment program is available at http://www.bt.cdc.gov/agent/botulism.
References
- Arnon SS, Schechter R, Maslanka SE, Jewell NP, Hatheway CL. Human botulism immune globulin for the treatment of infant botulism. N Engl J Med 2006;354:462--71.
- Sevcik C, Salazar V, Diaz P, D'Suze G. Initial volume of a drug before it reaches the volume of distribution: pharmacokinetics of F(ab')2 antivenoms and other drugs. Toxicon 2007;50:653--65.
- CDC. New telephone number to report botulism cases and request antitoxin. MMWR 2003;52:774.
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