Description
Prademagene zamikeracel topical is used to treat wounds in patients with recessive dystrophic epidermolysis bullosa (RDEB).
This medicine is to be given only by or under the direct supervision of your doctor.
This product is available in the following dosage forms:
- Sheet
Before Using
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:
Allergies
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Pediatric
Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of prademagene zamikeracel topical in children.
Geriatric
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of prademagene zamikeracel topical in the elderly.
Breastfeeding
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
Drug Interactions
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.
Other Interactions
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.
Proper Use
A doctor will apply this medicine to your wound during surgery.
Do not touch the treated area for 5 to 10 days. Keep the dressing dry and do not submerge the treated area in water. The dressing should fall off within 2 to 3 weeks after this medicine is applied.
Precautions
It is very important that your doctor check your progress closely to make sure that this medicine is working properly. Blood tests may be needed to check for unwanted effects.
This medicine may cause serious allergic reactions to certain medicines (eg, amikacin, vancomycin), including anaphylaxis, which can be life-threatening and require immediate medical attention. Check with your doctor right away if you have chest tightness, cough, difficulty swallowing, dizziness, fast heartbeat, hives, itching, skin rash, puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue, runny nose, or unusual tiredness or weakness.
This medicine may increase your risk for cancer. Talk to your doctor about this risk.
This medicine is made from human and bovine-derived products, which may transmit infections, although the risk is low because these products are tested before use. Talk with your doctor if you are concerned.
Side Effects
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor or nurse immediately if any of the following side effects occur:
More common
- Pain and itching at the application site
Incidence not known
- Chest tightness
- cough
- difficulty swallowing
- dizziness
- fast heartbeat
- hives, itching, skin rash
- puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
- runny nose
- unusual tiredness or weakness
- watery eyes
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
DRG-80007471
