Source: FDA, National Drug Code (US) Revision Year: 2019
BabyBIG 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[14,30].
BabyBIG 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 BabyBIG.
Traditional pharmacokinetic studies of BabyBIG have not been performed. However, the following table summarizes the mean serum titer of the anti-A component of BabyBIG following administration.
| Time | BabyBIG Lot 1 Anti-A Titer (mean ± S.D.) | BabyBIG 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 BabyBIG has been shown to be approximately 28 days in infants14, which is in agreement with existing data for other immunoglobulin preparations[2,14].
Two clinical studies in infant botulism were performed: (1) an adequate and well-controlled study to evaluate the safety and efficacy of BabyBIG (N=129), and (2) an open label study to collect additional safety data and confirm efficacy (N=293). In the adequate and well-controlled clinical study, BabyBIG, given within the first 3 days of hospital admission to 59 patients with laboratory-confirmed infant botulism, has been shown to reduce the following:
| Average Length in Weeks | p-value | ||
|---|---|---|---|
| Placebo* N=63 | BabyBIG N=59 | ||
| Hospital stay | 5.7 | 2.6 | p<0.0001 |
| Intensive Care Unit stay | 3.6 | 1.3 | p<0.01 |
| Mechanical ventilation | 2.4 | 0.7 | p<0.05 |
| Tube-feeding | 10.0 | 3.6 | p<0.01 |
* Both Gammagard 5% and Gammagard S/D 5% were used as placebo in this study.
Length of hospital stay was also analyzed by patient age in both the adequate and well-controlled study and in an open label study.
| Age (days) | Mean Length of Hospital Stay in Weeks | ||
|---|---|---|---|
| Placebo* N=63 | BabyBIG (RCT) N=59 | BabyBIG (OLS) N=206 | |
| 0-60 | 3.8 (N=10) | 2.8 (N=10) | 2.0 (N=46) |
| 61-120 | 5.6 (N=29) | 1.9 (N=17) | 2.0 (N=68) |
| >120 | 6.6 (N=24) | 3.0 (N=32) | 1.8 (N=92) |
RCT = randomized clinical trial
OLS = open label study
* Both Gammagard 5% and Gammagard S/D 5% were used as placebo in this study.
The observed reduction in length of hospital stay was statistically significant (p<0.01) with the exception of the 0 to 60-day age stratum, where small patient numbers limited the statistical power.
Length of hospital stay was analyzed in the adequate and well-controlled study by race (white versus non-white):
| RACE | Mean Length of Hospital Stay in Weeks | |
|---|---|---|
| Placebo* | BabyBIG (RCT) | |
| White | 6.3 (N=40) | 2.8 (N=35) |
| Non-white | 4.6 (N=23) | 2.4 (N=24) |
* Both Gammagard 5% and Gammagard S/D 5% were used as placebo in this study.
Length of hospital stay was significantly reduced in both white and non-white patients (p=0.002).
BabyBIG has not been tested for safety and efficacy in adults.
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