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What is ZEVASKYN?
ZEVASKYN™ (prademagene zamikeracel) is a type of gene therapy made from your own skin cells that is surgically applied to treat wounds in both children and adults who have recessive dystrophic epidermolysis bullosa (RDEB).

Important Safety Information

• Serious allergic reactions to ZEVASKYN can occur. Get medical help right away if you or your child experience symptoms like itching, swelling, hives, difficulty breathing, runny nose, watery eyes, or nausea. In rare cases, a severe reaction called anaphylaxis may happen.
• There is a potential risk that treatment with ZEVASKYN may contribute to the development of cancer because of how the therapy works. Patients should be monitored for the rest of their lives to check for any signs of cancer.
• ZEVASKYN is made using human and animal materials. Although these materials are tested before use, the risk of passing on infections cannot be eliminated.
• The most common side effects are pain from the procedure and itching.

This is not a complete list of side effects. Call your care team for medical advice about side effects. You may report side effects to Abeona at 1-844-888-2236 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Post-Application Care

• You may feel pain or itching at the treated area as it heals. Contact your doctor if you have: fever, increased drainage, worsening pain or swelling, or any other symptoms at or near the treated area.
• Do not disturb the surgical dressing for 5–10 days, unless your doctor tells you otherwise.
• Keep the dressing(s) dry. Do not soak the treated area(s) in water (like in a bath or pool) until the gauze backing falls off of the treated area(s), approximately 2–3 weeks after the surgery.

Product Manufacturing

• ZEVASKYN is made from your own skin cells. In rare cases, the manufacturing process may not work. If this happens, your doctor may suggest taking another skin biopsy to repeat the manufacturing process.

Please see full Prescribing Information.