Treatment of wounds associated with dystrophic and junctional epidermolysis bullosa.
Action⬆⬇
A botanical drug substance composed of a mixture of the following pentacyclic triterpenes: betulin, betulinic acid, lupeol, erythrodiol, and oleanolic acid. Its mechanism of benefit in dystrophic and junctional epidermolysis bullosa is unknown.
Therapeutic effects:
Closure of wounds.
Pharmacokinetics⬆⬇
Absorption: Undergoes minimal systemic absorption following topical administration.
Distribution: Unknown.
Protein Binding: >99.9%.
Metabolism/Excretion: Betulin may be metabolized by the liver via the CYP3A isoenzyme. Excretion pathway unknown.
Half-Life: Unknown.
Time/Action Profile⬆⬇
ROUTE
ONSET
PEAK
DURATION
Topical
unknown
unknown
unknown
Contraind./Precautions⬆⬇
Contraindicated in:
None.
Use Cautiously in:
OB: Safety not established in pregnancy;
Lactation: Safety not established in breastfeeding;
Pedi: Children <6 mo (safety and effectiveness not established).
(Adults and Children ≥6 mo): Apply 1 mm layer to affected wound surface with each wound dressing change. Continue until wound heals.
Availability⬆⬇
Topical gel: 10%
Assessment⬆⬇
Monitor for hypersensitivity reactions.If urticaria, dermatitis, or systemic hypersensitivity symptoms occur,discontinue birch triterpenes immediately and provide appropriate medical care.
Assess for dermatologic changes (scales; red, raised, wart-like sores; ulcerations), especially at application site, periodically throughout therapy.
Lab Test Considerations:
None.
Implementation⬆⬇
Gel is colorless-yellowish and opalescent. Use immediately after opening and then discard the one-time-use tube. Store at room temperature. Do not freeze.
Wash hands before and after applying birch triterpenes, or use gloves. May apply directly to cleansed wound or dressing. Do not rub in gel. Cover wound with sterile nonadhesive dressing. Birch triterpenes is for topical use only; not for ophthalmic use or use on mucous membranes.
Patient/Family Teaching⬆⬇
Explain purpose and side effects of medication to patient. Advise patient to read Patient Information before starting therapy.
Advise patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and to consult health care professional before taking other medications.
Explain that if hives, dermatitis, or other skin changes occur, immediately discontinue therapy and notify health care professional.
Rep: Advise females of reproductive potential to notify health care professional if pregnancy is planned or suspected or if breastfeeding.
Evaluation/Desired Outcomes⬆⬇
Closure of wounds associated with dystrophic and junctional epidermolysis bullosa.
