Filsuvez

Pronunciation: fill-sue-vez
Generic name: birch triterpenes
Dosage form: topical gel
Drug class: Herbal products

Medically reviewed by Carmen Pope, BPharm. Last updated on Dec 20, 2023.

What is Filsuvez?

Filsuvez (birch triterpenes) is a topical, home-administered birch bark extract gel that may be used to treat partial thickness wounds associated with dystrophic and junctional epidermolysis bullosa in adults and children aged 6 months of age and older.

How Filsuvez works for the treatment of wounds associated with epidermolysis bullosa is unknown. In a double-blind, randomized, vehicle-controlled, phase III EASE trial in patients with EB, birch bark extract significantly increased the number of patients reporting complete target wound closure within 45 days, and was well tolerated.

Epidermolysis bullosa EB is a rare, chronic, debilitating inherited skin disease that causes a person’s skin and mucous membranes to be so fragile they can be injured and blister just from touch or even spontaneously. It can affect infants, children, and adults; is intensely painful; and can affect mobility. Symptoms include slow-healing wounds at risk of infection and painful dressing changes. Junctional EB is the major form of EB, and there are many types, all of which cause widespread blistering. Dystrophic EB can be dominant or recessive and is caused by a mutation in the collagen 7 gene.

Filsuvez was FDA approved on December 19, 2023.

Warnings

Local hypersensitivity and skin reactions have been reported in patients treated with Filsuvez including urticaria and dermatitis. If signs and symptoms of local or systemic hypersensitivity occur, such as red itchy bumps (hives), skin rash, redness, or itching, discontinue Filsuvez immediately and call your healthcare provider. Do not use Filsuvez if you are allergic to any of its ingredients.

It is unknown if Filsuvez is safe and effective in children younger than 6 months of age.

Before taking

Before using Filsuvez, tell your healthcare provider about all of your medical conditions, including if you:

• are pregnant or plan to become pregnant
• are breastfeeding or plan to breastfeed.

Pregnancy and breastfeeding

It is not known if Filsuvez will harm your unborn baby.

It is not known if Filsuvez passes into your breast milk.

How should I use Filsuvez?

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

• The tube 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.
• Wash hands before applying or wear gloves.
• Clean wounds before applying as instructed by your healthcare provider.

Apply a 1 mm layer to the affected wound surface area or directly to the dressing at each dressing change. Do not rub in the gel. Keep applying until the wound is healed. Wash hands after applying.

• 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 draining yellow or greenish fluid (pus).

Do not use it near the eyes, or other mucous membrane areas such as the 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.

Check the expiration date on the tube. Do not use it if the expiration date has passed. Call your pharmacist or healthcare provider for instructions.

What are the side effects of Filsuvez?

Filsuvez may cause serious side effects including:

• Allergic reactions and skin reactions. Symptoms may include 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.

The most common side effect of Filsuvez affecting 2% or more people are application site reactions, such as pain and itchy skin.

These are not all the possible side effects. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088 or to Amryt Pharmaceuticals DAC at 1-855-303-2347.

Related/similar drugs

What other drugs will affect Filsuvez?

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Storage

Store at room temperature between 68°F to 77°F (20°C to 25°C). Do not freeze.

Filsuvez is for one-time use only. Throw away (dispose of) any remaining liquid and the tube right away after use in household trash or through a drug take-back option, if available. Go to www.fda.gov/drugdisposal for more information on drug disposal.

Keep Filsuvez and all medicines out of the reach of children.

Ingredients

Active: birch triterpenes

Inactive: refined sunflower oil

Supplied as a topical gel containing 10% birch triterpenes w/w supplied in three 25 mL sterile tubes.

Manufacturer

Chiesi Global Rare Diseases.

Amryt Pharmaceuticals.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Medical Disclaimer