FILSUVEZ is indicated for the treatment of wounds associated with dystrophic and junctional epidermolysis bullosa (EB) in adult and pediatric patients 6 months of age and older.

• Wash hands before and after applying FILSUVEZ or wear gloves for application.
• Apply a 1 mm layer of FILSUVEZ to the affected wound surface only. Do not rub in the gel. Cover the wound with a sterile non-adhesive wound dressing. Alternatively, apply FILSUVEZ directly to the dressing so that the topical gel is in direct contact with the wound.
• Apply FILSUVEZ to cleansed wounds with wound dressing changes until the wound is healed.
• If a FILSUVEZ-treated wound becomes infected, discontinue treatment to that wound until the infection has resolved.
• Each tube of FILSUVEZ is for one-time use only. Once the tube is opened, use the product immediately. Discard the tube after use in household trash or through a drug take back site, if available.
• Avoid contact of FILSUVEZ with eyes and mucous membranes (e.g., mouth, vagina, anus). In case of accidental contact, irrigate the area with water.
• FILSUVEZ is for topical use only. Not for use on mucous membranes (oral, intravaginal, or intra-anal). Not for ophthalmic use.

Topical gel: 10% birch triterpenes w/w in a colorless to slightly yellowish, opalescent, non-aqueous gel supplied in 25 mL sterile tubes.

None.

The following clinically significant adverse reactions are discussed elsewhere in the labeling:

• Hypersensitivity Reactions [see Warnings and Precautions (5.1)]

FILSUVEZ (birch triterpenes) topical gel is a sterile botanical drug product for topical use and contains birch triterpenes in an oil base. FILSUVEZ is a colorless to slightly yellowish, opalescent, non-aqueous gel.

Birch triterpenes is a botanical drug substance composed of a mixture of pentacyclic triterpenes. The botanical drug substance is a dry extract, refined, from birch bark from Betula pendula Roth, Betula pubescens Ehrh., as well as hybrids of both species, quantified to 72-88% (w/w) betulin, 2.4-5.7% (w/w) lupeol, 2.6-4.2% (w/w) betulinic acid, 0.5-1.2% (w/w) erythrodiol, 0.3-0.8% (w/w) oleanolic acid.

The structural formulae of the main triterpene constituents are shown in Figure 1.

Figure 1: Structure of Triterpene Constituents

Betulin		Erythrodiol
Betulinic acid		Oleanolic acid
Lupeol

Each gram of FILSUVEZ topical gel 10% (w/w) contains 100 mg of birch triterpenes in an oil base of refined sunflower oil. FILSUVEZ contains no additional excipients.

The efficacy of FILSUVEZ for the treatment of partial-thickness wounds associated with inherited EB was evaluated in a randomized, double-blind, placebo-controlled trial in adults and pediatric subjects 6 months of age and older (EASE; NCT03068780) with dystrophic EB (DEB) and junctional EB (JEB). Subjects were randomized 1:1 to receive FILSUVEZ (n=109) or placebo topical gel (n=114) and instructed to apply approximately 1 mm (0.04 inch) of the investigational product to all their wounds at each dressing change (every 1 to 4 days) for 90 days. At randomization, 1 wound was selected by the investigator as the target wound for the evaluation of the primary efficacy endpoint. The target wound was defined as a partial-thickness wound of 10-50 cm2 in surface area and present for 21 days to 9 months prior to screening.

Of the 223 subjects randomized, the median age was 12 years (range: 6 months to 81 years), 70% were under 18 years of age, and 60% were male and 40% were female. Eighty three (83)% of subjects were White, 5% were Asian, 1% were Black or African American, and 10% were other races or did not have race recorded. For ethnicity, 35% identified as Hispanic or Latino and 65% identified as not Hispanic or Latino. Of these 223 subjects, 195 had DEB, of which 175 subjects had recessive DEB (RDEB) and 20 had dominant DEB (DDEB); in addition, there were 26 subjects with JEB and 2 subjects with EB simplex.

The primary endpoint was the proportion of subjects with first complete closure of the target wound by Day 45 of the 90-day double-blind phase of the study, based on clinical assessment by the investigator. Efficacy results from EASE are presented in Table 2.

FILSUVEZ (birch triterpenes) topical gel, 10% (w/w) is a colorless to slightly yellowish, opalescent, non-aqueous gel and is supplied in 25 mL white aluminum tubes containing 23.4 grams of gel per tube (NDC 10122-310-01).

Each sterile tube is for one-time use only. Once opened, the product should be used immediately and discarded after use.

Advise the patient to read the FDA-approved patient labeling (Patient Information and Instructions for Use).

Manufactured by:

Lichtenheldt GmbH
Pharmazeutische Fabrik
Werk 1
Industriestr. 7-11
23812 Wahlstedt
Germany

Chiesi

Important information: FILSUVEZ is for use on the skin (topical use) only. Do not use FILSUVEZ in or around your eyes or mucous membranes (for example, the mouth, vagina, or anus).

This Instructions for Use contains information on how to apply FILSUVEZ. Read this Instructions for Use before you start using FILSUVEZ. Ask your healthcare provider if you have any questions.

Important Information You Need to Know Before Applying Filsuvez

• Use FILSUVEZ exactly as your healthcare provider tells you to use it.
• Apply FILSUVEZ directly to the wound or to the dressing surface that will be in contact with the wound.
• Clean wounds before applying FILSUVEZ as instructed by your healthcare provider.
• Apply FILSUVEZ with a clean or gloved hand.
• Apply FILSUVEZ at each dressing change until the wound is completely healed.
• Do not get FILSUVEZ in or apply around the eyes, or mucous membranes (For example, mouth, vagina, or anus). If you get FILSUVEZ in your eyes or mucous membranes, rinse with clean water right away. Contact your healthcare provider if you have any discomfort.
• Wash hands after applying FILSUVEZ and caring for wounds.
• The tube of FILSUVEZ is for one-time use only. After the tube has been opened, apply the FILSUVEZ gel right away. Throw away any remaining gel and the tube after use.
• Check the expiration date on the FILSUVEZ tube. Do not use FILSUVEZ if the expiration date has passed. Call your pharmacist or healthcare provider for instructions.

Gather your supplies

• a new tube of FILSUVEZ
• gloves (if using)
• sterile, non-adhesive dressing

Applying Filsuvez

• Wash your hands with soap and water or wear gloves.
• Open a new tube of FILSUVEZ. Apply the gel right away.
• You can apply FILSUVEZ in 2 ways, either directly to the wound or to the non-adhesive dressing surface that will be in contact with the wound.

Option 1: Apply FILSUVEZ directly to wound.

• Apply a 1 mm layer of FILSUVEZ to the wound (See Step 1). Cover the entire wound surface with a 1 mm layer of FILSUVEZ (Step 2). Do not rub in the gel. Cover the wound with a sterile, non-adhesive wound dressing (see Step 3).

  Step 1	Step 2	Step 3
  OR

Option 2: Apply FILSUVEZ directly to sterile, non-adhesive dressing.

• Apply a generous layer of FILSUVEZ directly to the sterile, non-adhesive dressing (see Step 1). Cover the entire non-adhesive dressing with FILSUVEZ (Step 2). Cover the wound with the dressing so that the gel is in direct contact with the wound (see Step 3). Secure the non-adhesive wound dressing as directed by your healthcare provider .

  Step 1

  Step 2

  Step 3

How should I store FILSUVEZ?

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

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

How should I throw away (dispose of) FILSUVEZ?

Throw away (dispose of) any remaining FILSUVEZ 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.

Manufactured by: Lichtenheldt GmbH, Pharmazeutische Fabrik, Werk 1, Industriestr. 7-11, 23812 Wahlstedt, Germany

For more information, call 1-888-661-9260 or go to www.filsuvez.com

This Instructions for Use has been approved by the U.S. Food and Drug Administration. Approved: December-2023

7419-01

NDC 10122-310-02

Rx Only

Filsuvez® (birch triterpenes)
topical gel, 10%

Topical use only.

Net content 23.4 g

Filsuvez®
(birch triterpenes) topical gel