Pronunciation:

ber-EM-a-jeen jep-ER-pa-vek - svdt

Brand Names:

• Vyjuvek

Dosage Forms:

• Gel/Jelly

Classifications:

Therapeutic—

Wound Care Agent

Uses of This Medicine:

Beremagene geperpavec-svdt topical is used to treat wounds in patients with dystrophic epidermolysis bullosa (DEB) with mutation in the collagen type VII alpha 1 chain (COL7A1) gene.

This medicine is to be given only by or under the direct supervision of your doctor.

Before Using This Medicine:

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.

Children—

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of beremagene geperpavec-svdt topical in children.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of beremagene geperpavec-svdt topical in the elderly.

Breast-feeding—

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.

Other medicines—

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 of This Medicine:

A nurse or other trained health professional will give you this medicine in a medical facility. It is applied only on your skin once a week. Do not get the medicine in your eyes, nose, or mouth. Rinse it off right away with clean water for at least 15 minutes if it does get on these areas.

Do not touch or scratch the wound or dressing for at least 24 hours after application.

Missed dose—

Call your doctor or pharmacist for instructions.

Precautions While Using This Medicine:

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.

Using this medicine could harm unborn baby while you are pregnant. Use an effective form of birth control to keep from getting pregnant. Tell your doctor right away if you think you have become pregnant.

Side Effects of This Medicine:

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.

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Chills

cough

runny nose

skin itching, redness, or rash

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.