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DERMATOLOGICALS › PREPARATIONS FOR TREATMENT OF WOUNDS AND ULCERS › CICATRIZANTS › Other cicatrizants
beremagene geperpavec
D03AX16
Forms & Strengths
- Topical gel: 5 x 10^9 viral copies/mL (prepared as a suspension in excipient gel)
Adult Dosing
- Topical application: Apply evenly to wounds once weekly by a healthcare provider at a dose calculated based on total wound surface area
- Dosing volume is determined by baseline wound surface area measurements up to a maximum recommended total volume per application
Pediatric Dosing
- Topical application: Same as adult dosing, calculated based on total wound surface area in pediatric patients with dystrophic epidermolysis bullosa of any age
- Safety and efficacy established down to newborn age groups
Indications
- Treatment of wounds in patients with dystrophic epidermolysis bullosa with mutation(s) in the COL7A1 gene
Mechanism of Action
- Genetically modified replication-defective herpes simplex virus type 1 (HSV-1) vector designed to deliver functional human COL7A1 genes encoding type VII collagen
- Restores production of anchoring fibrils at the dermal-epidermal junction to improve wound healing and tissue integrity
Contraindications
- History of life-threatening hypersensitivity to beremagene geperpavec or any of its components
- Active systemic herpes simplex virus infection
Adverse Reactions
- Pruritus
- Chills
- Erythema
- Pain at application site
- Wound complication
- Cough
- Hypersensitivity reactions
Drug Interactions
- Avoid concurrent application of other topical products or wound dressings containing active pharmacological agents on the same target wounds unless directed
- Potential interference with topical anti-herpetic medications (e.g., acyclovir, valacyclovir); systemic or topical antivirics active against HSV-1 may reduce vector efficacy
Curated Content: Needs Vetting Before Put to Clinical Use