BABYBIG SIDE EFFECTS

SIDE EFFECTS

• • Serious adverse reactions were not observed in clinical trials using BabyBIG.
  • The most common adverse reaction observed with BabyBIG treatment during clinical trials (>5%) was skin rash.
  • Other reactions such as chills, muscle cramps, back pain, fever, nausea, vomiting, and wheezing were the most frequent adverse reactions observed during the clinical trials of similarly-prepared human IGIV products^[21]. The incidence of these reactions was less than 5% of all infusions in BabyBIG clinical trials, and these reactions were most often related to infusion rates.

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Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.

Two clinical studies of BabyBIG were performed: (1) an adequate and well-controlled study to evaluate safety and efficacy of BabyBIG, which used BabyBIG Lot 1, and (2) an open label study to collect additional safety data and confirm efficacy, which used BabyBIG Lot 2 [see Clinical Studies].^[14,15] Different methodolog₁₀ies were used to collect adverse events in the controlled study and open label study. Minor clinical events that were not recorded as adverse events in the controlled study were recorded as adverse events in the open label study.

The only adverse event considered possibly related to BabyBIG administration was a mild, transient erythematous rash of the face or trunk. The following table summarizes the occurrence of rash by day of study relative to day of treatment for the randomized, controlled clinical trial (RCT) and for the open label study (OLS).

In the controlled study, when only treatment emergent events are considered, 14% of the BabyBIGtreated patients experienced erythematous rash during or after study infusion. Eight percent of placebotreated patients also experienced erythematous rash in this study. A similar rash is known to occur both in infant botulism patients who have not received any IGIV products^[16] and in patients treated with other IGIVs,^[2,3] making it difficult to ascertain the causality of the rash.

In the controlled study only, the following adverse events occurred in at least 5% of the patients receiving BabyBIG or placebo:

In the open label study only, the following adverse events occurred in at least 5% of the patients:

Adverse event coding was used in the open label study to distinguish between minor clinical events that required no intervention and more significant events that required intervention. For example, “increased blood pressure” or “decreased blood pressure” was assigned when transient changes in blood pressure were observed, whereas “hypertension” or “hypotension” was assigned when more prolonged or significant changes were observed.

Postmarketing Experience

Because postmarketing reporting of adverse reactions is voluntary and from a population of uncertain size, it is not always possible to reliably estimate the frequency of these reactions or establish a causal relationship to product exposure.

Experience with BabyBIG. No adverse reactions have been identified or reported that are ascribed to the use of BabyBIG during postapproval use. Retrospective publications have shown safety-related information consistent with the safety-related information in the approved product labeling, and no new safety-related information has been presented for BabyBIG.^{[22. 23]}

Experience with Other IGIV Products. Some classes of adverse reactions that have not been reported in BabyBIG clinical studies or postmarketing experience have been observed with the overall postapproval use of other IGIV products, as shown in the following table.