Beremagene Geperpavec Gel

What is this medication?

BEREMAGENE GEPERPAVEC (ber EM a jeen jep ER pa vek) treats skin wounds in people with epidermolysis bullosa (EB), a condition that causes fragile skin. It works by helping your body make more of a protein needed to support and strengthen skin. This helps reduce blistering and heals wounds.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

COMMON BRAND NAME(S): VYJUVEK

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

• An unusual or allergic reaction to beremagene geperpavec, other medications, foods, dyes, or preservatives
• If you or your partner are pregnant or trying to get pregnant
• Breastfeeding

How should I use this medication?

This medication is for external use only. It is usually given by your care team in a hospital or clinic setting. It may also be given at home.

If you get this medication at home, you will be taught how to prepare and use it. Use it as directed on the prescription label. Keep using it unless your care team tells you to stop.

Handling this medication may be harmful. Wash your hands before and after you apply this medication. Wear gloves while you apply the medication and change the dressings. Avoid direct contact with the treated wound and the dressings of treated wounds until the next dressing change. Talk to your care team about how to handle this medication. Special instructions may apply.

A special MedGuide will be given to you by the pharmacist with each prescription and refill. Be sure to read this information carefully each time.

This medication comes with INSTRUCTIONS FOR USE. Ask your pharmacist for directions on how to use this medication. Read the information carefully. Talk to your pharmacist or care team if you have questions.

Talk to your care team about the use of this medication in children. While it may be given to children as young as newborns for selected conditions, precautions do apply.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you get this medication at the hospital or clinic: It is important not to miss your dose. Call your care team if you are not able to keep your appointment.

If you get this medication at home: If you miss a dose, use it as soon as you can. Then resume weekly dosing from that dose. Do not use double or extra doses. Call your care team with questions.

What may interact with this medication?

Interactions have not been studied. Do not use any other skin products on the same area of skin without talking to your care team.

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Visit your care team for regular checks on your progress. Tell your care team if your symptoms do not start to get better or if they get worse.

Avoid touching or scratching treated wounds and dressings of treated wounds after application until the next dressing change. If another person comes in contact with the medication, flush the area with clean water for at least 15 minutes.

People who are pregnant or breastfeeding should not prepare or help apply this medication. They should also avoid direct contact with the treated wounds and the dressings from treated wounds.

Talk to your care team if you may be pregnant. Contraception is recommended while taking this medication. Your care team can help you find the option that works for you.

Discuss this medication with your care team before breastfeeding. There are benefits and risks to taking medications while breastfeeding. Your care team can help you find the option that works for you.

What side effects may I notice from receiving this medication?

Side effects that you should report to your care team as soon as possible:

• Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat

Side effects that usually do not require medical attention (report these to your care team if they continue or are bothersome):

• Chills
• Cough
• Itching
• Runny or stuffy nose

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medication?

Keep out of the reach of children and pets.

If you are using this medication at home, you will be instructed on how to store this medication. Get rid of any unused medication after the expiration date.

Disinfect bandages from the first dressing change with 70% isopropyl alcohol, 6% hydrogen peroxide, or less than 0.4% ammonium chloride. Dispose of the bandages in a sealed plastic bag in your household trash.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.