Botulinum antitoxin solution for injection contains antibodies specific for botulinum neurotoxin types A and B that bind to and neutralize circulating toxin types A and B in the patient.
Formal studies on pharmacodynamics have not been conducted with botulinum antitoxin.
Botulinum antitoxin solution for injection contains IgG antibodies from the immunized donors who contributed to the plasma pool from which the product was derived. The titer of antibodies in the reconstituted product against type A botulinum toxin is at least 15 IU/mL and against type B toxin is at least 4.0 IU/mL. For toxin types A and B, by definition, 1 IU of botulinum antitoxin neutralizes 10,000 intraperitoneal mouse LD50 of botulinum toxin. The titers of antibody against botulinum neurotoxins C, D, and E have not been determined. In the case of infants who may be exposed to botulinum neurotoxin type A or B, this product is expected to provide the relevant antibodies at levels sufficient to neutralize the expected levels of circulating neurotoxin.
Traditional pharmacokinetic studies of botulinum antitoxin have not been performed. However, the following table summarizes the mean serum titer of the anti-A component of botulinum antitoxin following administration.
| Time | Botulinum antitoxin Lot 1 Anti-A Titer (mean ± S.D.) | Botulinum antitoxin Lot 2 Anti-A Titer (mean ± S.D.) |
|---|---|---|
| mIU/mL | ||
| Day 1 | Not done | 537.1 ± 213.4 |
| Week 2 | 106.7 ± 44.6 | 192.2 ± 71.2 |
| Week 4 | 90.0 ± 39.2 | 155.5 ± 56.7 |
| Week 8 | 54.9 ± 22.8 | 96.0 ± 33.2 |
| Week 12 | 26.0 ± 20.5 | 61.4 ± 32.3 |
| Week 16 | 15.6 ± 10.4 | 33.0 ± 22.3 |
| Week 20 | 7.6 ± 6.6 | 19.3 ± 14.1 |
NOTE: 1 IU of anti-type A or anti-type B antibody neutralizes, by definition104, mouse LD50 of botulinum toxin.
The half-life of injected botulinum antitoxin has been shown to be approximately 28 days in infants, which is in agreement with existing data for other immunoglobulin preparations.
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