Filsuvez® (birch triterpenes) topical gel

INDICATION & IMPORTANT SAFETY INFORMATION

What is FILSUVEZ (birch triterpenes) topical gel for?

FILSUVEZ is a prescription medicine used on the skin
to treat wounds that may happen with dystrophic and junctional epidermolysis bullosa (EB) in adults and children 6 months of age and older.

It is not known if FILSUVEZ is safe and effective in children younger than 6 months of age.

What is the most important safety information I should know?

FILSUVEZ may cause a serious side effect of allergic reactions.

Allergic reactions and skin reactions to FILSUVEZ
may include the following symptoms: red itchy bumps (hives), skin rash, redness
or itching. If you get any
of these symptoms, stop using FILSUVEZ right away and call your healthcare provider.

What are the possible side effects of FILSUVEZ?

The most common side effect of FILSUVEZ is application site reactions, such as pain and itchy skin.

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

How should I use FILSUVEZ?

See the detailed “Instructions for Use” that comes with FILSUVEZ for information on how to apply FILSUVEZ.

Use FILSUVEZ exactly as your healthcare provider tells you to use it.

The tube of FILSUVEZ is for one-time use only. After
the tube has been opened, apply the gel right away. Throw away any remaining gel and the tube after use.

Do not use around or get FILSUVEZ in the eyes, or mucous membrane areas, examples are mouth, vagina or anus.

If you get FILSUVEZ in your eyes or mucous membrane area, rinse with clean water right away. Contact your healthcare provider if you have any discomfort.

If the wounds you are
treating with FILSUVEZ
become infected, stop
treatment and contact your
healthcare provider. Signs
or symptoms of infection
may include the wound
becoming red, warm,
swollen, painful or drains
yellow or greenish fluid
(pus).