Description

FILSUVEZ® (birch triterpenes) topical gel is a prescription medication designed for the treatment of partial-thickness wounds in individuals aged six months and older with dystrophic and junctional epidermolysis bullosa (EB). EB is a rare genetic disorder characterized by fragile skin that blisters easily. The active components of FILSUVEZ are triterpenes extracted from the bark of Betula pendula Roth and Betula pubescens Ehrh., including betulin, betulinic acid, erythrodiol, lupeol, and oleanolic acid.

Directions

• Wash hands before and after applying FILSUVEZ or wear gloves during application.
• Apply a 1 mm layer of the gel directly to the affected wound surface without rubbing it in.
• Cover the treated area with a sterile, non-adhesive wound dressing. Alternatively, apply the gel directly to the dressing to ensure it contacts the wound.
• Reapply FILSUVEZ during each dressing change on cleansed wounds until complete healing occurs.
• If a treated wound becomes infected, discontinue use until the infection resolves.
• Each tube is intended for single use only; discard after opening.

Ingredients

Each gram of FILSUVEZ topical gel 10% (w/w) contains 100 mg of birch triterpenes in an oil base of refined sunflower oil. The gel is colorless to slightly yellowish and opalescent.

Contraindications

There are no known contraindications for the use of FILSUVEZ.

Cautions

• Avoid contact with eyes and mucous membranes (e.g., mouth, vagina, anus). In case of accidental contact, rinse thoroughly with water.
• FILSUVEZ is intended for topical use only and should not be used on mucous membranes or for ophthalmic purposes.
• If signs of local or systemic hypersensitivity reactions occur, discontinue use immediately and seek appropriate medical therapy.

Side Effects

• Application site reactions (e.g., urticaria, dermatitis)
• Wound complications
• Pruritus (itching)
• Wound infections
• Hypersensitivity reactions

Product Code : 15186