Source: European Medicines Agency (EU) Revision Year: 2025 Publisher: Krystal Biotech Netherlands, B.V., Atrium Gebouw, Strawinskylaan 3051, Amsterdam 1077 ZX, Netherlands
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
In order to improve the traceability of the biological medicinal product, the name and the batch number of the administered medicinal product should be clearly recorded.
Vyjuvek should not be applied to wounds with a confirmed or suspicious diagnosis of squamous cell carcinoma (SCC). Vyjuvek may still be applied to other wounds in patients who develop SCC.
Beremagene geperpavec will not replicate in cells and does not integrate into or otherwise interact with the native DNA.
Although beremagene geperpavec is tested for sterility, a risk of transmission of infectious agents exists. Healthcare professionals administering Vyjuvek must, therefore, monitor patients for signs and symptoms of infections after treatment and treat appropriately, if needed.
Individuals handling beremagene geperpavec or assisting with dressing changes should wear protective equipment (see section 6.6).
Pregnant women should not handle dressing waste. Carers or HCPs applying the gel should comply with the requirement to cover wounds with dressings. Patients should also be advised to avoid touching or scratching wound sites to avoid contamination of other areas of the body or close contacts.
Patients are expected to enroll in a non-interventional multi-country study, to assess the long-term safety of beremagene geperpavec in a real-life setting.
No interaction studies have been conducted with Vyjuvek. Interactions with topical medicinal products have not been investigated in clinical trials. Other topical medicinal products should not be concomitantly administered with Vyjuvek.
The safety of immunisation with live viral vaccines during or following Vyjuvek treatment has not been studied. There is no data to suggest that Vyjuvek may interfere with the body’s ability to appropriately respond to a live virus vaccines.
There are no data from the use of beremagene geperpavec in pregnant women. Animal studies are insufficient with respect to reproductive toxicity (see section 5.3).
The use of Vyjuvek 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 Vyjuvek 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.
Vyjuvek 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. See section 5.1 for information on the main characteristics of patients in clinical trial.
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).
Table 3. 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 Vyjuvek. 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 Vyjuvek. 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 Vyjuvek for up to 26 weeks. Neutralizing immunity was not observed at first or repeated Vyjuvek exposure. The impact of seroconversion on maintenance of treatment effect is unknown as data are not available after 26 weeks.
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.
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