Healthcare
Professionals
Abeona Assist is here to support you and your patients considering ZEVASKYN™ (prademagene zamikeracel) for the treatment of wounds in adult and pediatric patients with recessive dystrophic epidermolysis bullosa (RDEB).
Enrolling a Patient
If you’d like to enroll a patient, simply complete the Abeona Assist Enrollment Form. A Patient Navigator will then reach out to your patient to further explain the program and confirm their interest in enrollment.
ZEVASKYN Healthcare Professionals Website
For more information about ZEVASKYN for the treatment of wounds in adult and pediatric patients with recessive dystrophic epidermolysis bullosa (RDEB), or to find a Qualified Treatment Center, please visit ZEVASKYN.com.
Planning for Your Patient's
Treatment Journey
Advances in cell and gene therapy are making new types of personalized treatment possible for a range of medical conditions, including RDEB. For many patients, engaging in personalized cell sheet-based gene therapy will be a new experience.
Abeona Assist is here to provide clarity around the ZEVASKYN treatment process and support throughout the entire experience for you and your patients.
Here is what you can expect:
Identify a Qualified Treatment Center (QTC)
The EB Physician and care team at the ZEVASKYN QTC trained in the ZEVASKYN treatment process will work with you and your patient to evaluate and determine if ZEVASKYN is a suitable option. Patients begin by scheduling a medical consultation with their QTC of choice. The care team will review the patient’s medical history, evaluate overall health, and answer questions about the treatment.
Please note: ZEVASKYN QTCs are independently owned and operated. Abeona Therapeutics does not oversee any treatment centers or the medical care they provide.
ZEVASKYN Treatment Planning with a QTC Physician
When a decision is made to move forward with ZEVASKYN, patients will work with the QTC to map out the timeline for the ZEVASKYN journey through biopsy, manufacturing, and surgical application. Your patient’s Abeona Assist Navigator can help answer questions about each step. They can also review coverage benefits and the availability of eligible financial assistance or logistical support options for ZEVASKYN treatment.
Biopsy & ZEVASKYN Therapy Manufacturing
An appointment with the QTC is scheduled to evaluate, discuss, and identify the potential wounds to be treated. Another appointment will be scheduled to obtain two 8 mm punch biopsies for the ZEVASKYN autologous cell sheet-based gene therapy manufacturing process. Patient Navigators are available to assist in planning the visit and providing information and resources to help patients prepare for this step.
Once the biopsy is completed, the patient’s cells are sent from the QTC to Abeona Therapeutics where they are genetically modified and grown into credit card sized ZEVASKYN sheets, specifically for your patient. This process is estimated to take ~25 days. During this time, the Patient Navigator will receive notifications regarding the manufacturing progress to assist your patient in coordinating travel and logistics for the upcoming date of ZEVASKYN surgical application.
ZEVASKYN Surgical Application at QTC
Upon the completion of ZEVASKYN manufacturing, patients and caregivers will travel back to the QTC for surgery. Treatment areas are undisturbed for 5-10 days while the patient is immobilized to allow for healing. The patient will be discharged from the ZEVASKYN QTC and follow-up is at the EB physician's discretion.
The Patient Navigator can continue to be a resource, aiding patients with billing questions, providing reimbursement information, and following up with you after you return home from your surgery.
Enroll in Abeona Assist to get connected to a Patient Navigator to walk with you and your patient on their ZEVASKYN journey.
Need help with something else?
We’re here to help.
Call Us at 855-ABEONA-1 (855-223-6621)
Our regular business hours are Monday-Friday 9 AM – 6:30 PM (ET)
You can also email us at MyNavigator@AbeonaAssist.com
Support is available 24/7 outside of normal business hours.
What is ZEVASKYN & Important Safety Information
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.