Version July 2025
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.
Hypersensitivity: Discontinue use.
Refer to adult dosing.
(For additional information see "Birch triterpenes: Pediatric drug information")
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.
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.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Gel, External:
Filsuvez: 10% (23.4 g)
No
Gel (Filsuvez External)
10% (per gram): $96.00
Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.
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.
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.
Dystrophic and junctional epidermolysis bullosa: Treatment of wounds associated with dystrophic and junctional epidermolysis bullosa in adults and pediatric patients ≥6 months of age.
None known.
There are no known significant interactions.
Topical maternal use during pregnancy is not expected to provide clinically relevant fetal exposure.
It is not known if birch triterpenes are present in breast milk following topical application; however, topical maternal use while breastfeeding is not expected to provide clinically relevant exposure to an infant via breast milk.
According to the manufacturer, the decision to breastfeed during therapy should consider the risk of infant exposure, the benefits of breastfeeding to the infant, and the benefits of treatment to the mother.
Wound healing; hypersensitivity reactions.
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.
