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Indications

REMS


Contraind./Precautions

Contraindicated in:

Use Cautiously in:

Adv. Reactions/Side Effects

Derm: pruritus, SQUAMOUS CELL CARCINOMA

Local: application site pain

Misc: hypersensitivity reactions

Interactions

Drug-drug:

Availability

Route/Dosage

US Brand Names

Filsuvez

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.

Classifications

Therapeutic Classification: none assigned

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

ROUTEONSETPEAKDURATION
Topicalunknownunknownunknown

Patient/Family Teaching

Pronunciation

BERCHtri-TER-peens

Code

NDC Code