Why is this medicine prescribed?
Prademagene zamikeracel topical is used to treat skin wounds in people with a certain type of dystrophic epidermolysis bullosa (an inherited disorder that causes the skin to be fragile leading to blisters, wounds, skin infections, and scarring). Prademagene zamikeracel is in a class of medications called gene therapy. It works by replacing a gene that promotes wound healing and strengthens and stabilizes skin.
Are there other uses for this medicine?
This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.
How should this medicine be used?
Prademagene zamikeracel comes as a sheet made from your own skin cells to be surgically applied to skin wounds by a doctor in a hospital or medical facility. Prademagene zamikeracel topical sheets are applied to wounds in a single surgical procedure and may be applied to more than one wound site.
Before you receive prademagene zamikeracel topical sheets, a sample of your skin cells will be taken from your skin. The sample will be sent to the manufacturer to prepare prademagene zamikeracel topical sheets. Because this medication is made from your own cells, it must be given only to you.
Avoid contact with treated wounds and wound dressings or bandages for about 5 to 10 days after surgical treatment with prademagene zamikeracel. Keep wound dressings and bandages dry; do not soak or submerge them in water until the they fall off the treatment sites (usually within 2 to 3 weeks after surgery). Ask your doctor if you have any questions about wound dressings or bandages.
Prademagene zamikeracel may cause pain and itching at treatment sites. Do not touch or scratch treated wounds or wound dressings or bandages. Tell your doctor or nurse immediately if you experience any of the following symptoms: fever or worsening drainage, pain, or swelling at the treatment sites.
Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient.
What special precautions should I follow?
Before receiving prademagene zamikeracel topical,
- tell your doctor or pharmacist if you are allergic to this medication, any part of this medication, or any other medications, foods or substances. Tell your doctor or pharmacist about the allergy and what symptoms you had.
- tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take.
- tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. You should not become pregnant while you are receiving prademagene zamikeracel. If you become pregnant while receiving prademagene zamikeracel, call your doctor.
What special dietary instructions should I follow?
Unless your doctor tells you otherwise, continue your normal diet.
What side effects can this medicine cause?
Prademagene zamikeracel topical may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:
- pain or itching at the treatment site(s)
Some side effects can be serious. If you experience any of these symptoms or those listed in the HOW section, call your doctor immediately or get emergency medical treatment:
- rash; itching; hives; swelling of your face, mouth, tongue, or throat; chest pain; runny nose; watery eyes; nausea; fast heartbeat; or difficulty swallowing or breathing
Prademagene zamikeracel may increase the risk that you will develop cancer. Your doctor will monitor you regularly after your treatment with prademagene zamikeracel. Talk to your doctor about the risks of taking this medication.
Prademagene zamikeracel topical may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.
If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online ( https://www.fda.gov/Safety/MedWatch ) or by phone (
1-800-332-1088).What other information should I know?
Keep all appointments with your doctor.
Keep a written list of all of the prescription and nonprescription (over-the-counter) medicines, vitamins, minerals, and dietary supplements you are taking. Bring this list with you each time you visit a doctor or if you are admitted to the hospital. You should carry the list with you in case of emergencies.