Prademagene zamikeracel

Prademagene zamikeracel is a prescription medication indicated for the treatment of wounds in adult and pediatric patients with recessive dystrophic epidermolysis bullosa (RDEB). 

Prademagene zamikeracel is available under the following different brand names: Zevaskyn.

Common side effects of Prademagene zamikeracel include:

• procedural pain
• pruritus

Serious side effects of Prademagene zamikeracel include:

• not available

Rare side effects of Prademagene zamikeracel include:

• none 

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, coordination loss, unsteady, very stiff muscles, high fever, profuse sweating, or tremors.
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights.
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheadedness, or passing out.

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult and pediatric dosage

Topical cellular sheet

• 41.25 cm2 (5.5 cm x 7.5 cm) sheet containing functional copies of COL7A1 gene
• Single dose consists of up to 12 sheets

Epidermolysis Bullosa

Adult and pediatric dosage

• For autologous topical application on wounds only
• Recommended dose based on wound surface area
• Each topical sheet covers an area of 41.25 cm2

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

Tell your doctor or pharmacist about all the products you use. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Visit the RxList Drug Interaction Checker for any drug interactions. Check with your healthcare professional or doctor for additional medical advice, health questions, or concerns.

Contraindications

• None

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Prademagene zamikeracel?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Prademagene zamikeracel?”

Cautions

Hypersensitivity reactions

• Severe hypersensitivity reactions (e.g., anaphylaxis) to vancomycin, amikacin, or product excipients may occur with application
• Monitor for signs and symptoms of hypersensitivity reactions (e.g., itching, swelling, hives, difficulty breathing, runny nose, watery eyes, nausea); treat according to standard clinical practice

Retroviral vector (RVV)-mediated insertional oncogenesis

• RVV-mediated insertional oncogenesis may occur after treatment
• Lifelong monitoring for the development of malignancies is recommended
• If a malignancy occurs, contact Abeona Therapeutics Inc. at 1-844-888-2236 to obtain instructions on collecting patient samples for testing

Transmission of infectious agents

• Autologous products are manufactured using human and bovine-derived reagents and carry the risk of transmitting infectious disease or agents
• Reagents are tested for human and animal viruses, bacteria, fungi, and mycoplasma before use; however, these measures do not eliminate the risk of transmitting these or other infectious diseases or agents

Pregnancy and Lactation

• There are no available data regarding use during pregnancy
• No animal reproductive and developmental toxicity studies have been conducted
• Advise females of childbearing potential to use an effective method of contraception to prevent pregnancy at the time of treatment

Lactation

• Data are unavailable regarding the presence of Prademagene zamikeracel in human milk, its effect on breastfed infants, or its effects on milk production
• Animal lactation studies have not been conducted