Birch Triterpenes (Monograph)

Brand name: Filsuvez
Drug class: Skin and Mucous Membrane Agents, Miscellaneous

Introduction

Birch triterpenes is a botanical drug product composed of a mixture of pentacyclic triterpenes.

Uses for Birch Triterpenes

Birch triterpenes has the following uses:

Birch triterpenes topical gel is indicated for the treatment of wounds associated with dystrophic and junctional epidermolysis bullosa in adults and pediatric patients 6 months of age and older.

Birch Triterpenes Dosage and Administration

General

Birch triterpenes is available in the following dosage form(s) and strength(s):

Topical gel: 10% birch triterpenes w/w supplied in 25 mL sterile tubes

Dosage

It is essential that the manufacturer's labeling be consulted for more detailed information on dosage and administration of this drug. Dosage summary:

Adult and Pediatric Dosage

• Wash hands before and after applying the gel, or wear gloves for application.

• Apply a 1 mm layer of birch triterpenes to the affected wound surface and cover with a sterile, nonadhesive wound dressing. Alternatively, apply the gel directly to the dressing so that it is in direct contact with the wound. Do not rub in the topical gel.

• Apply birch triterpenes at wound dressing changes until the wound is healed.

• Each tube of birch triterpenes is for one-time use only; once tube is opened, use product immediately.

• For topical use; not for oral, intravaginal, intra-anal, or ophthalmic use.

• Avoid contact with eyes and mucous membranes (e.g., mouth, vagina, anus). In case of accidental contact, irrigate area with water.

Cautions for Birch Triterpenes

Contraindications

None

Warnings/Precautions

Hypersensitivity Reactions

Local hypersensitivity and skin reactions have been reported in patients treated with birch triterpenes, including urticaria and dermatitis.

If signs and symptoms of local or systemic hypersensitivity occur, discontinue birch triterpenes immediately and initiate appropriate therapy.

Specific Populations

Pregnancy

There are no available data with use of birch triterpenes in pregnant women to evaluate for a 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.

Systemic absorption of birch triterpenes in humans is low following topical administration of birch triterpenes, and maternal use is not expected to result in fetal exposure to the drug .

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.

Lactation

There are no data on the presence of birch triterpenes or metabolites in human milk, the effects on the breastfed infant, or the effects on milk production.

No effects on the breastfed infant are anticipated since the systemic exposure of the breastfeeding woman to birch triterpenes would be low. Therefore, the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for birch triterpenes and any potential adverse effects on the breastfed infant from the drug or underlying maternal condition.

Pediatric Use

The safety and effectiveness of birch triterpenes for the treatment of wounds associated with dystrophic and junctional epidermolysis bullosa have been established in pediatric patients 6 months of age and older. Use of birch triterpenes in this age group is supported by evidence from a single randomized, placebo-controlled trial in 156 subjects 6 months to 17 years of age.

The safety and effectiveness of birch triterpenes have not been established in pediatric patients younger than 6 months of age.

Geriatric Use

Clinical studies of birch triterpenes did not include sufficient numbers of epidermolysis bullosa subjects 65 years of age and older to determine whether they respond differently from younger subjects.

Common Adverse Effects

The most common (incidence ≥2%) adverse reactions are application site reactions.

Drug Interactions

Specific Drugs

It is essential that the manufacturer's labeling be consulted for more detailed information on interactions with this drug, including possible dosage adjustments. Interaction highlights:

Please see product labeling for drug interaction information.

Actions

Mechanism of Action

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

Advice to Patients

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

• Advise patients to wash hands before and after applying birch triterpenes or wear gloves for application.

• Advise patients to apply a 1 mm layer of birch triterpenes to the affected wound surface. Do not rub in the gel. Cover the wound with a sterile non-adhesive wound dressing. Alternatively, apply a generous layer of birch triterpenes directly to the dressing so that the gel is in direct contact with the wound.

• Advise patients to apply birch triterpenes to cleansed wounds at dressing changes until the wound is healed.

• Advise patients that birch triterpenes is for topical use only. Birch triterpenes is not for ophthalmic use and should not be applied to mucous membranes. In case of accidental contact, irrigate eyes with water.

• Advise patients that the sterile tube of topical gel is for one-time use only. Once the tube is opened, use the product immediately. Discard the tube after use, even if there is some topical gel left.

• Inform patients that local hypersensitivity and skin reactions, including urticaria and dermatitis, have been reported in patients treated with birch triterpenes. If signs and symptoms of local hypersensitivity or skin reactions occur, instruct patients to discontinue birch triterpenes immediately and contact their healthcare provider.

Additional Information

AHFSfirstRelease^™. For additional information until a more detailed monograph is developed and published, the manufacturer's labeling should be consulted. It is essential that the manufacturer's labeling be consulted for more detailed information on usual uses, dosage and administration, cautions, precautions, contraindications, potential drug interactions, laboratory test interferences, and acute toxicity.

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.

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