Beremagene Geperpavec

Beremagene Geperpavec is a topical gene therapy indicated for the treatment of wounds in patients aged 6 months and older with dystrophic epidermolysis bullosa with mutation(s) in the collagen type VII alpha 1 chain (COL7A1) gene.

• Beremagene Geperpavec is available under the following different brand names: Vyjuvek, beremagene Geperpavec-svdt

Common side effects of Beremagene Geperpavec include:

• itching
• chills
• redness
• rash
• cough
• runny nose

Serious side effects of Beremagene Geperpavec include:

• not available

Rare side effects of Beremagene Geperpavec include:

• none 

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, coordination loss, unsteady, very stiff muscles, high fever, profuse sweating, or tremors.
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights.
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheadedness, or passing out.

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult and pediatric dosage

Topical biological suspension, mixed into the excipient gel

• Biological suspension (nominal concentration): 5 × 109 PFU/mL in a single-use vial
• Excipient gel: 1.5 mL
• The topical biological suspension (1 mL) is mixed into the excipient gel before administering

Epidermolysis bullosa

Adult dosage

• Maximum weekly dose: 3.2 × 109 (1.6 mL)
• Apply gel to wounds until they are closed before treating new wound(s)
• It may not be possible to apply gel to all wounds at each treatment visit
• Prioritize weekly treatment to previously treated wounds if they reopen

Pediatric dosage

• Children younger than 6 months: Safety and efficacy not established
• Maximum weekly dose
• Children aged between 6 months to less than 3 years: 1.6 × 109 (0.8 mL) after mixing excipient gel
• Children aged 3 years and older: 3.2 × 109 (1.6 mL) after mixing excipient gel
• Apply gel to wounds until they are closed before treating new wound(s)
• It may not be possible to apply gel to all wounds at each treatment visit
• Prioritize weekly treatment to previously treated wounds if they reopen

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, healthcare provider, or pharmacist first.

• Beremagene Geperpavec has no noted severe interactions with any other drugs
• Beremagene Geperpavec has no noted serious interactions with any other drugs
• Beremagene Geperpavec has no noted moderate interactions with any other drugs
• Beremagene Geperpavec has no noted minor interactions with any other drugs

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all the products you use. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your healthcare professional or doctor for additional medical advice, health questions, or concerns.

Contraindications

• None

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Beremagene Geperpavec?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Beremagene Geperpavec?”

Cautions

• Beremagene Geperpavec is a genetically modified, herpes simplex virus type 1 vector-based, replication-deficient, nonintegrating gene therapy; it will not replicate in the subject’s cells and does not integrate into the subject cells’ native genetic material
• Avoid direct contact with treated wounds (eg, touching or scratching) and dressings of treated wounds for approximately 24 hours following treatment
• Wear protective gloves when changing wound dressings and handling disposal
• If accidentally exposed (eg, through a splash to eyes or mucous membranes), flush with clean water for 15 minutes and more

Pregnancy and Lactation

• There are no data on topical gel use in pregnant women to inform a drug-associated risk
• No animal developmental and reproductive toxicity studies have been conducted
• Clinical considerations
  • If the patient becomes pregnant during treatment, advise the patient of potential hazards to the fetus and neonate
  • Advise women of childbearing potential to use an effective method of contraception to prevent pregnancy during treatment
• Lactation
  • There is no information available on drug presence in human milk, its effects on breastfed infants, or milk production