Version May 2024
Dystrophic and junctional epidermolysis bullosa, wound treatment: Infants ≥6 months, Children, and Adolescents: Topical: Apply a 1 mm layer to the affected wound surface and cover with a sterile nonadhesive wound dressing; alternatively, may apply directly to wound dressing before placing dressing on wound. Use with each wound dressing change until the wound is healed; if wound becomes infected, discontinue until infection is resolved.
There are no dosage adjustments provided in the manufacturer's labeling.
There are no dosage adjustments provided in the manufacturer's labeling.
(For additional information see "Birch triterpenes: Drug information")
Dystrophic epidermolysis bullosa: Topical: Apply a 1-mm layer to the affected wound surface with dressing changes until wound is healed.
Junctional epidermolysis bullosa : Topical: Apply a 1-mm layer to the affected wound surface with dressing changes until wound is healed.
There are no dosage adjustments provided in the manufacturer's labeling; however, dosage adjustment unlikely due to low systemic absorption.
There are no dosage adjustments provided in the manufacturer's labeling; however, dosage adjustment unlikely due to low systemic absorption.
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Adverse reactions reported in adults and pediatrics.
1% to 10%: Local: Application-site reaction (7%; including application-site pain and application-site pruritus)
Frequency not defined:
Dermatologic: Allergic skin reaction
Hematologic & oncologic: Squamous cell carcinoma
Local: Local hypersensitivity reaction
There are no contraindications listed in the manufacturer's labeling.
Concerns related to adverse effects:
• Hypersensitivity: Local hypersensitivity and skin reactions, including dermatitis and urticaria, have been reported.
Filsuvez: FDA approved December 2023; anticipated availability currently unknown.
Topical: Wash hands before and after application, or wear gloves for application. Clean the wound before application. Apply a 1 mm layer to the affected wound surface only, then cover with a sterile nonadhesive wound dressing. Alternatively, may apply directly to wound dressing before affixing dressing to wound. Once sterile tube is opened, use immediately; discard tube and any remaining product after use; each tube is for one-time use only. For topical use only; avoid contact with eyes and mucous membranes (oral, intravaginal, or intra-anal); in case of accidental contact, irrigate the area with water.
Topical: For topical use only; not for ophthalmic use or use on mucous membranes (eg, mouth, vagina, anus). Wash hands before and after applying or wear gloves when applying. Once tube is opened, apply immediately; each tube is for one use only; discard any unused portion. Apply to clean, affected wound surface only; cover the entire wound surface with a 1-mm layer of gel but do not rub in. Cover wound with a sterile, nonadhesive wound dressing. Alternatively, may apply a generous layer of gel directly to the sterile, nonadhesive dressing; ensure the entire nonadhesive dressing is covered and then apply the dressing so that the gel is in direct contact with the wound. If treatment wound becomes infected, discontinue use until infection has resolved.
Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F); do not freeze. Each tube is for single use only; use immediately upon opening; discard any unused portion.
Treatment of wounds associated with dystrophic and junctional epidermolysis bullosa (FDA approved in ages ≥6 months and adults).
None known.
There are no known significant interactions.
Topical maternal use during pregnancy is not expected to provide clinically relevant fetal exposure.
Monitor for local hypersensitivity reaction.
Although the precise mechanism is unknown, birch triterpenes has been shown to accelerate the re-epithelialization of wounds via modulation of inflammatory mediators, keratinocyte migration, and differentiation stimulation (Ref).
Protein binding: >99.9%.
Metabolism: Primarily hepatic, via CYP3A.
آیا می خواهید مدیلیب را به صفحه اصلی خود اضافه کنید؟
