Brand Name
Filsuvez
Generic Name
Triterpenes
View Brand Information FDA approval date: February 14, 2024
Form: Gel
What is Filsuvez (Triterpenes)?
FILSUVEZ is indicated for the treatment of wounds associated with dystrophic and junctional epidermolysis bullosa in adult and pediatric patients 6 months of age and older. FILSUVEZ topical gel is indicated for the treatment of wounds associated with dystrophic and junctional epidermolysis bullosa in adult and pediatric patients 6 months of age and older.
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Brand Information
FILSUVEZ (birch triterpenes)
1INDICATIONS AND USAGE
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.
2DOSAGE AND ADMINISTRATION
- 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.
3DOSAGE FORMS AND STRENGTHS
Topical gel: 10% birch triterpenes w/w in a colorless to slightly yellowish, opalescent, non-aqueous gel supplied in 25 mL sterile tubes.
4CONTRAINDICATIONS
None.
5ADVERSE REACTIONS
The following clinically significant adverse reactions are discussed elsewhere in the labeling:
- Hypersensitivity Reactions
5.1Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
The safety of FILSUVEZ was evaluated in EASE, a randomized, double-blind, multicenter, placebo-controlled trial in 223 adult and pediatric subjects with inherited EB. During the double-blind phase of EASE, subjects received topical treatment with either FILSUVEZ or a placebo gel on partial-thickness wounds every 1 to 4 days for a total of 90 days. Treated wounds were covered with non-adhesive dressings. Following completion of the double-blind phase, all subjects received FILSUVEZ for a total of 24 months during the open-label phase
Table 1 presents adverse reactions that occurred in at least 2% of subjects treated with FILSUVEZ during the 90-day double-blind phase of EASE and at a greater frequency than in the placebo gel group.
Squamous cell carcinoma of the skin (SCC) was reported as an adverse event in the double-blind and open-label periods of EASE. Four subjects with recessive dystrophic EB each reported one SCC: a 20-year-old male on day 1 of the double-blind period; three female subjects ages 22, 46, and 49 years during the open-label period. Two of the four subjects had applied FILSUVEZ to the area which developed the SCC.
6DESCRIPTION
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
The structural formulae of the main triterpene constituents are shown in Figure 1.
Figure 1: Structure of Triterpene Constituents
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.
7CLINICAL STUDIES
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 cm
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.
8HOW SUPPLIED/STORAGE AND HANDLING
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.
9PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (
10INSTRUCTIONS FOR USE FILSUVEZ®[fill-sue-vez] (birch triterpenes) topical gel
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
Option 1: Apply FILSUVEZ directly to wound.
- Apply a 1 mm layer of FILSUVEZ to the wound (See
Option 2: Apply FILSUVEZ directly to sterile, non-adhesive dressing.
- Apply a generous layer of FILSUVEZ directly to the sterile, non-adhesive dressing (see
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
11PRINCIPAL DISPLAY PANEL - 23.4 g Tube Carton
NDC 10122-310-02
Rx Only
Filsuvez
Topical use only.
Net content 23.4 g
Filsuvez
