Birch Triterpenes

The mechanism of action of FILSUVEZ in the treatment of wounds associated with epidermolysis bullosa is unknown.

• 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. 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.

• None.contraindicated

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. Apply a 1 mm layer of FILSUVEZ to the affected wound surface and cover with wound dressing or apply FILSUVEZ directly to dressing so that the topical gel is in direct contact with the wound. Do not rub in the topical gel. ( 2 ) Apply FILSUVEZ at wound dressing changes until the wound is healed. ( 2 ) Each tube of FILSUVEZ is for one-time use only. ( 2 ) For topical use; not for oral, intravaginal, intra-anal, or ophthalmic use. ( 2 )

Hypersensitivity Reactions : If signs or symptoms of hypersensitivity occur, discontinue use immediately and initiate appropriate therapy. ( 5.1 ) 5.1 Hypersensitivity Reactions 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, discontinue FILSUVEZ immediately and initiate appropriate therapy.

The following clinically significant adverse reactions are discussed elsewhere in the labeling: Hypersensitivity Reactions [see Warnings and Precautions (5.1) ] The most common (incidence ≥2%) adverse reactions are application site reactions. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Chiesi USA Inc. at 1-888-661-9260 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical 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 [see Clinical Studies (14) ] . 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.

8.1 Pregnancy Risk Summary There are no available data with use of FILSUVEZ in pregnant women to evaluate for drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. In an animal reproduction study, oral administration of birch triterpenes to pregnant rats during the period of organogenesis had no effects on reproductive or fetal parameters (see Data ) . Systemic absorption of FILSUVEZ in humans is low following topical administration of FILSUVEZ, and maternal use is not expected to result in fetal exposure to the drug [see Pharmacokinetics (12.3) ] . The background risk of major birth defects and miscarriage for the indicated population is unknown . In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Data Animal Data In an embryofetal development study, birch triterpenes were orally administered to pregnant rats at doses of 10, 30, or 100 mg/kg/day during the period of organogenesis. Birch triterpenes did not cause maternal toxicity or fetal malformations at doses up to 100 mg/kg/day. In a prenatal and postnatal development study, birch triterpenes were orally administered to pregnant rats at doses of 10, 30, or 100 mg/kg/day from gestation day 5 through lactation day 20.

Metabolism

Absorption Systemic exposure to betulin was assessed in the 66 evaluable subjects aged ≥13 months to ≤52 years with dystrophic and junctional EB in the clinical trial EASE using venous blood sampling and validated liquid chromatography with tandem mass spectrometry assay.

• Dec 18, 2023NDANDA215064Chiesi

1. 1Wound Complication3017%
2. 2Wound1911%
3. 3Drug Ineffective179.8%
4. 4Product Dose Omission Issue126.9%
5. 5Wound Infection126.9%
6. 6Ill-defined Disorder116.4%
7. 7Wrong Technique In Product Usage Process116.4%
8. 8Blister105.8%
9. 9Product Administration Interrupted105.8%
10. 10Pruritus105.8%
11. 11Product Use Issue95.2%
12. 12Wound Secretion95.2%
13. 13Death84.6%
14. 14Impaired Healing84.6%
15. 15Off Label Use84.6%

Recent PubMed references pinned to Birch Triterpenes as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

• Betulinic acid is associated with miR-21 modulation, apoptosis and redox changes in breast cancer cells: an in vitro and in silico study.
  Scientific reports · 2026 · Mahmoud MA, Abdo H, Mekky M, et al.
  PMID 42143107DOI 10.1038/s41598-026-51156-z
• Betulin inhibits inflammatory factors synthesis in osteoarthritis synovial fibroblasts by suppressing the PI3K, Akt, and mTOR pathways and activating miR-5006-5p.
  International journal of medical sciences · 2026 · Lee KT, Tsai CH, Wang YH, et al.
  PMID 41938515DOI 10.7150/ijms.130493
• Analysis of BpbHLH Gene Family Responsive to MeJA Signalling in Betula platyphylla Suk. and Functional Mechanisms of BpbHLH42/44 in Genetic Improvement and Triterpenoid Biosynthesis.
  Plant biotechnology journal · 2026 · Li Y, Xu L, Cui J, et al.
  PMID 41841639DOI 10.1111/pbi.70626
• Targeted delivery to joints of the rheumatoid arthritis drug betulin using folic acid-coated nanoparticles based on human serum albumin.
  International journal of biological macromolecules · 2026 · Yang L, Lin Y, Zhang L, et al.
  PMID 41519331DOI 10.1016/j.ijbiomac.2026.150150
• Ultrasound-assisted extraction of bioactive birch (Betula sp.) bark triterpenoids using hydrophobic natural deep eutectic solvents.
  Analytical and bioanalytical chemistry · 2026 · Luque-Jurado I, Rivas S, Lebrón-Aguilar R, et al.
  PMID 41307682DOI 10.1007/s00216-025-06174-7
• Betulin, an active component from Chinese herb birch bark, suppresses tumor angiogenesis and tumor growth by inhibiting the PAX2/VEGF-A/VEGR2 signaling pathway in non-small cell lung cancer.
  Phytomedicine : international journal of phytotherapy and phytopharmacology · 2025 · Li Z, Huang M, Wang J, et al.
  PMID 41166909DOI 10.1016/j.phymed.2025.157445
• In Vitro Evaluation of the Antimicrobial Effect of Betulin on the Rumen Microbiome.
  Animal science journal = Nihon chikusan Gakkaiho · 2025 · Adachi M, Ito K, Scheftgen AJ, et al.
  PMID 41062920DOI 10.1111/asj.70119
• The chemosensitizing activity of betulinic acid in suppressing macrophage polarization through GSK-3β/β-catenin/CXCL1 signaling in breast cancer.
  Phytomedicine : international journal of phytotherapy and phytopharmacology · 2025 · Xu Z, Si J, Liang A, et al.
  PMID 41056857DOI 10.1016/j.phymed.2025.157304

Frequently asked questions

How does Birch Triterpenes work?

The mechanism of action of FILSUVEZ in the treatment of wounds associated with epidermolysis bullosa is unknown.

What is Birch Triterpenes used for?

According to FDA labeling, Birch Triterpenes carries indications including: 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. 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.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Birch Triterpenes?

Birch Triterpenes is classified as Unknown Cellular or Molecular Interaction.

What are the brand names for Birch Triterpenes?

Birch Triterpenes is marketed under brand names including Filsuvez.

What are the contraindications for Birch Triterpenes?

Birch Triterpenes labeling lists contraindications including: None.. Always consult the full prescribing information and a clinician.