Prademagene Zamikeracel Topical Sheets

What is this medication?

PRADEMAGENE ZAMIKERACEL (pra DEM a jeen ZAM i KER a sel) 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. It is a gene therapy.

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

COMMON BRAND NAME(S): ZEVASKYN

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 prademagene zamikeracel, vancomycin, amikacin, other medications, foods, dyes, or preservatives
• Pregnant or trying to get pregnant
• Breastfeeding

How should I use this medication?

This medication is for external use only. It is applied by your care team in a hospital or clinic setting.

Talk to your care team about the use of this medication in children. While it may be prescribed for children 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?

This does not apply.

What may interact with this medication?

Interactions are not expected. 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. It is normal to have pain and itching at the treatment site during the healing process. Talk to your care team right away if you have fever, excess drainage, swelling, worsening pain, or any other unusual effects at or around the treatment site.

Do not touch or take off the bandage for 5 to 10 days. Keep it in place unless your care team tells you something different.

Keep the bandage dry. Do not soak the treated site in water until the gauze falls off. This should happen 2 to 3 weeks after it is placed.

This medication is made using your skin cells and other human and animal-based substances. These substances are tested before use, but there is a small risk of passing on infections. Talk to your care team if you have questions about your risk of infection.

Talk to your care team about your risk of cancer. You may be more at risk for certain types of cancer if you take this medication.

Talk to your care team if you may be pregnant. This medication has not been well studied during pregnancy. Contraception is recommended at the time of treatment. Your care team can help find the option that works for you.

Talk to your care team about this medication if you are 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):

• Itching
• Pain at application site

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?

This medication is applied in a hospital or clinic. It will not be stored at home.

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.