Dosing & Uses
Dosage Forms & Strengths
topical gel
- 10% supplied in 25-mL sterile tubes
Epidermolysis Bullosa
Topical gel indicated for treatment of wounds in patients with junctional and dystrophic epidermolysis bullosa (EB)
Apply a 1 mm layer to affected wound surface only
Do not rub in gel; cover wound with a sterile non-adhesive wound dressing
Alternatively, apply gel directly to dressing so topical gel is in direct contact with the wound
Reapply to cleansed wounds with wound dressing changes until wound is healed
If treated wound is infected, discontinue treatment until infection has resolved
Also, see Administration
Dosage Forms & Strengths
topical gel
- 10% supplied in 25-mL sterile tubes
Epidermolysis Bullosa
Topical gel indicated for treatment of wounds in patients aged ≥6 months with junctional and dystrophic epidermolysis bullosa (EB)
<6 months: Safety and efficacy not established
≥6 months
- Apply a 1 mm layer to affected wound surface only
- Do not rub in gel; cover wound with a sterile non-adhesive wound dressing
- Alternatively, apply gel directly to dressing so topical gel is in direct contact with the wound
- Reapply to cleansed wounds with wound dressing changes until wound is healed
- If treated wound is infected, discontinue treatment until infection has resolved
- Also, see Administration
Adverse Effects
1-10%
Application site reactions (7.3%); placebo gel (6.1%)
Warnings
Contraindications
None
Cautions
Hypersensitivity
- Local hypersensitivity and skin reactions reported, including urticaria and dermatitis
- If signs and symptoms of local or systemic hypersensitivity occur, discontinue immediately and initiate appropriate therapy
Pregnancy & Lactation
Pregnancy
Data are unavailable regarding use in pregnant females to evaluate for drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes
Systemic absorption in humans is low following topical administration and maternal use is not expected to result in fetal drug exposure
Animal studies
- Oral administration to pregnant rats during organogenesis had no effects on reproductive or fetal parameters
Lactation
Data are unavailable regarding presence of birch triterpenes or metabolites in human milk, effects on breastfed infants, or effect on milk production
No effects on breastfed infants are anticipated since systemic exposure would be low
Pregnancy Categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk. C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done. D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk. X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist. NA: Information not available.Pharmacology
Mechanism of Action
Extract from birch bark rich in betulin
Mechanism of action in the treatment of wounds associated with epidermolysis bullosa is unknown
Absorption
Peak plasma concentration (betulin), Day 90: 33 ng/mL (adults); 207 ng/mL (children)
Distribution
Protein bound (betulin): >99%
Metabolism
Not fully characterized; in vitro, betulin was mainly metabolized by cytochrome P450 (CYP)3A
Administration
Topical Preparation
Wash hands before and after applying or wear gloves for application
Colorless to slightly yellowish, opalescent, non-aqueous gel
Topical Administration
For topical use only; not for use on mucous membranes (oral, intravaginal, or intra-anal); not for ophthalmic use
Avoid contact of gel with eyes and mucous membranes (eg, mouth, vagina, anus)
Apply a 1 mm layer to affected wound surface only
Do not rub in gel; cover wound with a sterile non-adhesive wound dressing
Alternatively, apply gel directly to dressing so that the topical gel is in direct contact with the wound
Reapply to cleansed wounds with wound dressing changes until wound is healed
If a treated wound becomes infected, discontinue treatment to that wound until infection has resolved
Each tube is for one-time use only
Once tube is opened, use product immediately
Discard after use in household trash or through a drug take back site, if available
In case of accidental contact, irrigate area with water
Storage
Store at 20-25ºC (68-77ºF); excursions permitted to 15-30ºC (59-86ºF)
Do not freeze
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Formulary
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