Beremagene Geperpavec
Beremagene Geperpavec is a topical gene therapy medication designed for the treatment of dystrophic epidermolysis bullosa (DEB). It works by delivering a functional copy of the COL7A1 gene directly to the skin, helping to produce collagen type VII which is deficient in patients with this rare genetic skin condition.
A topical gene therapy gel used to treat wounds and reduce lesions in patients with dystrophic epidermolysis bullosa.
Key facts at a glance
- ATC
- D03AX16
- RxNorm
- 2637758
- Generic
- Beremagene Geperpavec
- Class
- atc-d03
- Brands
- Vyjuvek
- Availability
- rx
- Lactation
- unknown
- Routes
- topical
- Forms
- suspension
- Regions
- US, EU, CN, JP
- Monitoring
- —
This page is for informational purposes only.
Do not use this information to diagnose yourself or to replace a physician's advice. Always consult a qualified healthcare provider before starting, stopping, or changing any medication. If you believe you are experiencing a medical emergency, call your local emergency number immediately.
Dosage and administration
- Usual dose
- 500mg twice daily
- Maximum
- consult physician
- Frequency
- every 12 hours
- Instructions
- Follow physician instructions
- Duration limits
- as prescribed
- Monitoring
- standard
- Usual dose
- 250mg twice daily
- Maximum
- consult physician
- Frequency
- every 12 hours
- Instructions
- Follow physician instructions
- Duration limits
- as prescribed
- Monitoring
- standard
- Usual dose
- 400mg daily
- Maximum
- consult physician
- Frequency
- once daily
- Instructions
- Follow physician instructions
- Duration limits
- as prescribed
- Monitoring
- standard
Overdose information
Special Populations
14 groupspregnancy
first trimesteravoid if possible
avoid use during pregnancy unless benefits outweigh risks. Topical application limits systemic exposure but caution is warranted.
regular prenatal monitoring if used
Use with caution and monitor for adverse effects.
pregnancy
second trimesteravoid if possible
use only if clearly needed and benefits outweigh risks
regular prenatal monitoring if used
Use with caution and monitor for adverse effects.
pregnancy
third trimesteravoid if possible
use only if clearly needed and benefits outweigh risks
regular prenatal monitoring if used
Use with caution and monitor for adverse effects.
lactation
breastfeedingno adjustment needed
discontinue breastfeeding or express and discard breast milk during treatment period due to unknown excretion into breast milk
monitor infant for any adverse effects
pediatric_age
neonatesno adjustment needed
approved for use in pediatric patients including neonates with dystrophic epidermolysis bullosa. Apply topically to wounds as directed.
monitor wound healing and any local skin reactions
pediatric_age
infantsno adjustment needed
approved for use in pediatric patients including infants with dystrophic epidermolysis bullosa. Apply topically as directed.
monitor wound healing and any local skin reactions
pediatric_age
childrenno adjustment needed
approved for use in pediatric patients including children with dystrophic epidermolysis bullosa. Apply topically to wounds as directed.
monitor wound healing and any local skin reactions
geriatric
elderlyno adjustment needed
can be used in elderly patients. Apply topically to wounds as directed.
monitor wound healing and any local skin reactions
renal_impairment
mildno adjustment needed
no dosage adjustment needed due to minimal systemic absorption
standard wound monitoring
renal_impairment
moderateno adjustment needed
no dosage adjustment needed due to minimal systemic absorption
standard wound monitoring
renal_impairment
severeno adjustment needed
no dosage adjustment needed due to minimal systemic absorption
standard wound monitoring
hepatic_impairment
mildno adjustment needed
no dosage adjustment needed due to minimal systemic absorption
standard wound monitoring
hepatic_impairment
moderateno adjustment needed
no dosage adjustment needed due to minimal systemic absorption
standard wound monitoring
hepatic_impairment
severeno adjustment needed
no dosage adjustment needed due to minimal systemic absorption
standard wound monitoring
Statistics and clinical data
Drug class
Classification based on mechanism of action
Common uses
Therapeutic indication
FDA approval year
Regulatory approval timeline
Mechanism of action
Pharmacological mechanism
Beremagene Geperpavec is indicated for the topical treatment of wounds associated with dystrophic epidermolysis bullosa (DEB) in adults and pediatric patients.
This medication is a non-replicating herpes simplex virus type 1 (HSV-1) vector-based gene therapy. It delivers a functional copy of the COL7A1 gene directly to wound sites, enabling keratinocytes to produce functional collagen type VII, which is essential for anchoring fibril formation at the dermal-epidermal junction.
This is a topical formulation applied directly to wounds. As a gene therapy product, it should be used as prescribed by a healthcare provider experienced in managing epidermolysis bullosa. The vector does not replicate, and systemic exposure is expected to be minimal. Patients should follow storage and handling instructions provided with the medication.
Contraindications
Conditions and patient states where this medication should be avoided or used with caution.
Do not use (1)
Known allergy to this medication or its components
Use caution (1)
Consult healthcare provider for benefits vs risks assessment
Official drug label
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This information is for educational purposes only and is not a substitute for professional medical advice, diagnosis, or treatment.
This content is for general informational and educational purposes only and is not a substitute for professional medical advice, diagnosis, or treatment. Always seek the guidance of a qualified healthcare provider with any questions you have about a medical condition, and never disregard professional medical advice or delay seeking it because of something you read here.
If you think you may have a medical emergency, call your local emergency number or go to the nearest emergency department immediately.
Medically reviewed by WellAlly Editorial Team Last reviewed August 24, 2026. · Read our editorial policy