Prademagene zamikeracel

What Prademagene zamikeracel is used for

Quoted from the “Indications and Usage” section of the FDA-approved label.

ZEVASKYN is indicated for the treatment of wounds in adult and pediatric patients with recessive dystrophic epidermolysis bullosa (RDEB). ZEVASKYN is an autologous cell sheet-based gene therapy indicated for the treatment of wounds in adult and pediatric patients with recessive dystrophic epidermolysis bullosa (RDEB).

— FDA label: Zevaskyn, Abeona Therapeutics Inc., effective March 19, 2026. Read the full label on DailyMed →

Label quoted: the one for the most common form (cellular sheet, topical), Zevaskyn, Abeona Therapeutics Inc.; it covers 1 product in the FDA NDC Directory. The side effects, interactions, dosage and pregnancy quotes below come from this same label.

This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.

Boxed warning

A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.

The label quoted above has no boxed warning.

Prademagene zamikeracel side effects

Quoted from the “Adverse Reactions” section of the FDA-approved label. Tell your doctor about any side effect that worries you.

The most common adverse reactions (incidence ≥5%) were procedural pain and pruritus.

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(6) To report SUSPECTED ADVERSE REACTIONS, contact Abeona Therapeutics Inc at 1-844-888-2236 or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a product cannot be directly compared to the rates in the clinical trials of another product and may not reflect the rates observed in practice. The safety data described in this section reflects exposure of 11 patients to ZEVASKYN in the VIITAL study [see Clinical Studies (14)]. The median number of sheets patients received was 6 (range 3-6), and the total exposure time was 6 months following ZEVASKYN application. The most common adverse reactions occurring in ≥5% of patients were procedural pain (n=3; 27%) and pruritus (n=1; 9%).

— FDA label: Zevaskyn, Abeona Therapeutics Inc., effective March 19, 2026. Read the full label on DailyMed →

Prademagene zamikeracel dosage

Quoted from the “Dosage and Administration” section of the FDA-approved label. Your own dose is the one your doctor prescribes: do not change it on your own.

For autologous topical application on wounds only The recommended dose of ZEVASKYN is based on the surface area of the wound(s). One sheet of ZEVASKYN covers an area of 41.25 cm 2. (2.1) Up to twelve ZEVASKYN sheets may be manufactured from the patient biopsies and supplied for potential use. (2.1) Verify the patient’s identity prior to ZEVASKYN application. (2.2) See full prescribing information for ZEVASKYN preparation, and administration instructions.

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(2.2, 2.3) Figure 1 2.1 Recommended Dose For autologous topical application on wounds only. The recommended dose of ZEVASKYN is based on the surface area of the wound(s). One sheet of ZEVASKYN covers an area of 41.25 cm 2. Up to twelve ZEVASKYN sheets may be manufactured from the patient biopsies and supplied for potential use. 2.2 Receipt and Preparation Receipt of ZEVASKYN ZEVASKYN is shipped directly to the qualified treatment center sealed in transport packaging. If the patient is expected to be ready for same-day application, transport the packaging to the operating room. Hold at room temperature (15-25°C) until preparation to maintain cell viability. If the patient is not expected to be ready for same-day application, store the packaging containing ZEVASKYN in a secure onsite location at room temperature (15-25°C) until preparation to maintain cell viability. Preparation ZEVASKYN is to be prepared by the manufacturer in an appropriate healthcare setting for surgical application by a qualified healthcare provider. Manufacturer will conduct Quality Control (QC) testing to release the product immediately prior to surgery in the operating room. Verify patient’s identity during preparation. Hold ZEVASKYN at room temperature (15-25°C) until application. Apply all selected sheets in a single surgical session. 2.3 Administration Below is the list of standard surgical supplies needed for ZEVASKYN administration and not provided by the manufacturer: scalpel scissors forceps resorbable sutures non-adhesive dressings topical antibiotic ointment 1. Verify patient’s identity prior to ZEVASKYN application. Do not apply ZEVASKYN if the information on the patient-specific label(s) does not match the intended patient. 2. Prepare wound by debridement under general or other appropriate anesthesia to accommodate ZEVASKYN sheet(s). 3. Before surgical application, pick up ZEVASKYN sheet with forceps by grasping the titanium ligating clips (Figure 1). Handle ZEVASKYN sheets only with forceps and only by the titanium ligating clips. Figure 1. ZEVASKYN sheets removed with forceps for application 4. Do not trim ZEVASKYN sheets. 5. Apply unaltered ZEVASKYN sheets onto the wound bed only (nylon suture on the ZEVASKYN sheet facing away from wound) by affixing via resorbable sutures. Do not suture ZEVASKYN onto healthy intact skin. Do not overlap ZEVASKYN sheets on wounds. 6. Apply all selected sheets in a single surgical session. 7. Cover area of application of ZEVASKYN sheets with non-adhesive dressings and topical antibiotic ointment. After ZEVASKYN application 8. Instruct patient to leave the treated area undisturbed for 5-10 days at the discretion of the physician based on individual needs for immobilization of treated areas and post-surgical recovery. 9.

— FDA label: Zevaskyn, Abeona Therapeutics Inc., effective March 19, 2026. This is part of the section. Read the full label on DailyMed →

Prademagene zamikeracel in pregnancy

Quoted from the pregnancy part of the FDA-approved label. Ask your doctor before you take any medicine while pregnant or planning a pregnancy.

Risk Summary There are no available data with ZEVASKYN use in pregnant women. No animal reproductive and developmental toxicity studies have been conducted with ZEVASKYN. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively.

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Clinical Considerations Women of childbearing potential should be advised to use an effective method of contraception to prevent pregnancy at the time of treatment with ZEVASKYN.

— FDA label: Zevaskyn, Abeona Therapeutics Inc., effective March 19, 2026. Read the full label on DailyMed →

Forms and how it is given

Companies that list this medicine

Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.

• Abeona Therapeutics Inc.1 product

FDA approval history

• BLA: Biologics License Application: how a biologic medicine (made from living cells) is approved.

Shortage status

The FDA drug shortage list does not show these products.

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Recalls

No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.

Official identifiers

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Sources

1. FDA-approved label on DailyMed (National Library of Medicine) — Zevaskyn, Abeona Therapeutics Inc., effective March 19, 2026; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
2. NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
3. Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
4. Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
5. Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026

openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →

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