Prademagene zamikeracel topical

Prademagene zamikeracel topical (for the skin) is used in adults and children to treat wounds caused by a specific type of dystrophic epidermolysis bullosa.

Your doctor will confirm that you can be treated with prademagene zamikeracel topical.

Prademagene zamikeracel topical may also be used for other reasons not mentioned in this medication guide.

Prademagene zamikeracel topical is applied in a medical setting by specially trained healthcare professionals.

Before treatment, your doctor will take a sample of your skin that is sent to a laboratory where the skin cells will be used to make prademagene zamikeracel topical.

You will not receive the medicine on the same day your skin cell sample is taken. It will take time to process your skin cells and your doctor will determine your treatment schedule.

A second skin sample collection attempt may be needed to make prademagene zamikeracel topical and your treatment plan may be delayed or changed.

It may not be possible to apply the medicine to all wounds with each treatment.

Make sure to follow up with your doctor about caring for dressings on treated wounds. Keep dressings dry and leave the treatment area alone for 5-10 days to allow for healing.

Use only as directed. Inform your doctor if you are using other medicines, have other medical conditions, or have allergies.

This treatment should not be used if you have a certain gene type. Ask your doctor if you have any questions.

Tell your doctor if you have or have ever had:

• an active or recent infection; or
• use other medications.

Using prademagene zamikeracel topical may increase your risk of developing cancer. Ask your doctor about your individual risk and what symptoms to watch for.

Prademagene zamikeracel topical is made using human and cattle products. They may contain viruses or other infectious agents. The products are tested and treated to reduce the risk of contamination, but there is still a small possibility it could transmit disease. Ask your doctor about any possible risk.

It is not known if prademagene zamikeracel topical will harm an unborn baby. Use birth control during treatment with prademagene zamikeracel topical and tell your doctor if you become pregnant.

Ask a doctor if it is safe to breastfeed while using this medicine.

Get emergency medical help if you have signs of an allergic reaction: hives, difficult breathing, swelling of your face, lips, tongue, or throat.

Prademagene zamikeracel topical may cause serious side effects. Call your doctor immediately if you have:

• signs of infection--fever, chills, sore throat, body aches, unusual tiredness, loss of appetite; or
• increased pain, swelling, oozing, or skin changes around the treatment site.

Common side effects of prademagene zamikeracel topical may include:

• procedure pain; or
• itching.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Usual Adult Dose for Epidermolysis Bullosa:

Apply one to twelve sheets topically depending on wound sizeComments:-One sheet of this drug covers an area of 41.25 cm2.-Verify patient's identity during preparation.-Hold this drug at room temperature (15C to 25C) until application.-Apply the appropriate sheets in a single surgical session.-Do not trim the sheets.-Cover area of application with non-adhesive dressings and topical antibiotic ointment.-Advise the patient to leave the treated area undisturbed for 5 to 10 days based on clinical judgement.-Advise patient to keep dressings dry and to not submerge in water until the gauze of the product falls off the treatment site. The backing should fall off within 2 to 3 weeks of application.Use: Treatment of wounds in adult and pediatric patients with recessive dystrophic epidermolysis bullosa (RDEB).

Usual Pediatric Dose for Epidermolysis Bullosa:

Apply one to twelve sheets topically depending on wound sizeComments:-One sheet of this drug covers an area of 41.25 cm2.-Verify patient's identity during preparation.-Hold this drug at room temperature (15C to 25C) until application.-Apply the appropriate sheets in a single surgical session.-Do not trim the sheets.-Cover area of application with non-adhesive dressings and topical antibiotic ointment.-Advise the patient to leave the treated area undisturbed for 5 to 10 days based on clinical judgement.-Advise patient to keep dressings dry and to not submerge in water until the gauze of the product falls off the treatment site. The backing should fall off within 2 to 3 weeks of application.Use: Treatment of wounds in adult and pediatric patients with recessive dystrophic epidermolysis bullosa (RDEB).

Call your doctor for instructions if you miss an appointment to receive prademagene zamikeracel topical.

In a medical setting, an overdose would be treated quickly.

Do not let treated areas come in contact with water until the gauze backing falls off (usually within 2 to 3 weeks after application).

Tell your doctor about all your other medicines, especially:

• antibiotics such as vancomycin or amikacin.

Other drugs may affect prademagene zamikeracel topical, including prescription and over-the-counter medicines, vitamins, and herbal products. Inform your doctor about all other medicines you are using.