Birch Triterpenes (burch try-TER-peens)

Treats wounds in patients with dystrophic and junctional epidermolysis bullosa (EB).

Brand Name(s):

Filsuvez

When This Medicine Should Not Be Used:

How to Use This Medicine:

Gel/Jelly

• Your doctor will tell you how much medicine to use. Do not use more than directed.
• Use this medicine only on your skin. Rinse it off right away if it gets on a cut or scrape. Do not get the medicine in your eyes, nose, or mouth.
• Wash your hands with soap and water before and after you use this medicine. You may also wear gloves.
• Apply a thin layer of the medicine to the affected area. Rub it in gently.
• Read and follow the patient instructions that come with this medicine. Talk to your doctor or pharmacist if you have any questions.
• Clean the wound as instructed by your provider before applying the medicine. Apply this medicine at each dressing change until the wound is healed.
• You can apply this medicine directly to the wound, or to the non-adhesive dressing surface that will be in contact with the wound. Do not rub in the medicine.
• Missed dose: Apply a dose as soon as you can. If it is almost time for your next dose, wait until then and apply a regular dose. Do not apply extra medicine to make up for a missed dose.
• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

Warnings While Using This Medicine:

• Tell your doctor if you are pregnant or breastfeeding.
• Your doctor will check your progress and the effects of this medicine at regular visits. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Severe itching, burning, pain, redness, stinging, swelling, or skin irritation where the medicine is applied

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088