There are no data with beremagene geperpavec gel use in pregnant women to inform a drug-associated risk. Animal developmental and reproductive toxicity studies have not been conducted with beremagene geperpavec.
The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risks of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively.
If the patient becomes pregnant while being administered beremagene geperpavec gel, the patient should be apprised of the potential hazards to the fetus and neonate. Women of childbearing potential should be advised to use an effective method of contraception to prevent pregnancy during treatment with beremagene geperpavec gel.
There is no information available on the presence of beremagene geperpavec in human milk, the effects on the breastfed infant, or the effects on milk production. Animal lactation studies have not been conducted with beremagene geperpavec.
The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for beremagene geperpavec and any potential adverse effects on the breastfed child from beremagene geperpavec or from the underlying maternal condition.
No animal studies have been conducted to evaluate the effects of beremagene geperpavec on carcinogenesis, mutagenesis, or impairment of fertility.
The most common adverse reactions (>5%) were itching, chills, redness, rash, cough, and runny nose.
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 practice.
The safety data described in this section primarily reflect exposure to beremagene geperpavec gel in a randomized, intra-subject placebo‑controlled study. A total of 31 subjects with dystrophic epidermolysis bullosa (DEB), including 30 subjects with autosomal recessive DEB and one subject with autosomal dominant DEB received topical administration of beremagene geperpavec gel to their wounds. The age of the subjects ranged from 1 year to 44 years (mean age 17 years). Of the 31 subjects, 19 (61%) were pediatric subjects (less than 17 years of age), and 11 (36%) were females. Each subject received weekly topical application of beremagene geperpavec gel at one or more wound sites and placebo at a matching wound site as an intra-subject comparator. The median duration of exposure to beremagene geperpavec gel was 25 weeks. The most frequent adverse reactions (incidence >5%) observed in the study are summarized in the following table. There were no discontinuations due to adverse reactions.
Adverse Reactions (incidence >5%) Following Treatment with Beremagene geperpavec gel (n=31):
| Adverse Reactions | Subjects n (%) |
|---|---|
| Itching | 3 (10) |
| Chills | 3 (10) |
| Redness | 2 (6) |
| Rash | 2 (6) |
| Cough | 2 (6) |
| Runny Nose | 2 (6) |
In addition, the safety profile of beremagene geperpavec in two subjects with autosomal recessive DEB (RDEB) of six and seven months of age, respectively, who received topical beremagene geperpavec gel weekly in an open-label study was similar to the safety profile of beremagene geperpavec observed in the randomized, intra-subject placebo‑controlled study described above.
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