Beremagene geperpavec-svdt is used to treat certain adults and children 6 months of age or older who have dystrophic epidermolysis bullosa (an inherited disorder that causes the skin to be fragile leading to blisters, wounds, skin infections, and scarring). Beremagene geperpavec-svdt is in a class of medications called gene therapy. It works by replacing a gene that promotes wound healing by strengthening and stabilizing the skin.

Beremagene geperpavec-svdt comes as a gel to be applied to the skin by a healthcare professional at a clinic or at home. It is usually applied directly to wounds once a week. Treatment is continued until the wound is completely healed.

It may not be possible for your doctor to treat all of your wounds at one appointment. Your doctor will decide which wounds to treat and will probably create a wound treatment plan to prioritize your treatment based on the severity of your wounds. It is important to continue weekly treatments of each wound(s) until it is completely healed. When a wound is completely healed, your doctor will probably treat other wounds.

Avoid contact with treated wounds and wound dressings or bandages for about 24 hours after treatment with beremagene geperpavec-svdt. Do not touch or scratch treated wounds or wound dressings or bandages. If contact occurs, wash the affected area well with water.

Your doctor will tell you or a caregiver how to change your wound dressings. Wash your hands and wear protective gloves when you change wound dressings. Your doctor will tell you to dispose of your gloves and used wound dressings. Follow these instructions carefully. Ask your doctor or pharmacist if you have any questions about disposing of wound dressings.

Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient.

Before receiving beremagene geperpavec-svdt,

• tell your doctor and pharmacist if you are allergic to beremagene geperpavec-svdt, any other medications, or any of the ingredients in beremagene geperpavec-svdt gel. Ask your pharmacist for a list of the ingredients.
• tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take.
• tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while receiving beremagene geperpavec-svdt, call your doctor.

If you miss an appointment to receive a dose of beremagene geperpavec-svdt, call your doctor right away.

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

Unless your doctor tells you otherwise, continue your normal diet.

Beremagene geperpavec-svdt may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

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

Beremagene geperpavec-svdt may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

Keep all appointments with your doctor.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

• Vyjuvek®