There are no data from the use of beremagene geperpavec in pregnant women. Animal studies are insufficient with respect to reproductive toxicity.
The use of beremagene geperpavec is not recommended during pregnancy.
It is unknown whether beremagene geperpavec is excreted in human milk.
A risk to the newborns/infants cannot be excluded.
A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from beremagene geperpavec therapy taking into account the benefit of breast feeding for the child and the benefit of therapy for the woman.
No nonclinical or clinical studies have been performed to evaluate the effect of beremagene geperpavec on fertility.
Beremagene geperpavec has no or negligible influence on the ability to drive or use machines.
Eighteen patients (58%) in the clinical trial reported at least one adverse reaction. The most commonly reported adverse reactions were chills (9.7%) and pruritus (9.7%).
No adverse reactions led to discontinuation.
Unless otherwise stated, the frequencies of adverse reactions are based on all causal adverse event frequencies identified in 31 patients exposed to beremagene geperpavec during a median duration of 25 weeks in the Phase 3 randomised, intra-subject placebo-controlled study.
In the following table, adverse reactions are listed by MedDRA system organ class (SOC), preferred term, and by frequency. Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
The frequency of adverse reactions is defined as follows: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1 000 to <1/100); rare (≥1/10 000 to <1/1 000); very rare (<1/10 000), not known (cannot be estimated from the available data).
Adverse reactions:
| System organ class Preferred term | All subjects (N=31) |
|---|---|
| Respiratory, thoracic and mediastinal disorders | |
| Cough | Common |
| Rhinorrhea | Common |
| Skin and subcutaneous tissue disorders | |
| Pruritus | Common |
| Erythema | Common |
| Rash | Common |
| General disorders and administration site conditions | |
| Chills | Common |
Of the 31 subjects in the Phase 3 study, 19 (61%) were paediatric subjects (17 years of age or less), including 3 (9.7%) aged 3 years or less. Of the 19 paediatric subjects, 8 were female (42%).
Given the identity of the product, and its route of administration and localized containment, frequency, type and severity of adverse reactions in children are expected to be the same as in adults.
There was minimal evidence of systemic vector exposure after cutaneous application of beremagene geperpavec. Antibodies against the viral vector (HSV-1) and transgene protein (COL7) were evaluated in a subset of subjects in the randomised, intra-subject placebo-controlled clinical study. A total of 64% of evaluated subjects (14/22) were anti-HSV-1 antibody positive at baseline. Six of the 8 anti-HSV-1 seronegative subjects seroconverted by week 26 following treatment with beremagene geperpavec. For subjects with available matched baseline and end-of-study serum samples, anti-drug antibodies (ADAs) to COL7 were detected in 72% (13/18) of subjects treated with beremagene geperpavec for up to 26 weeks. Neutralizing immunity was not observed at first or repeated beremagene geperpavec exposure. The impact of seroconversion on maintenance of treatment effect is unknown as data are not available after 26 weeks.
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