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.
PP-RA-01829 V1.0