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).

©2026 Chiesi USA, Inc. All rights reserved.
FILSUVEZ is a registered trademark owned by the
Chiesi Group.
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