Birch triterpenes
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Rafael Garcia
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Overview
Birch triterpenes is {{{aOrAn}}} {{{drugClass}}} that is FDA approved for the {{{indicationType}}} of FILSUVEZ (birch triterpenes) topical gel is used to treat wounds associated with dystrophic and junctional epidermolysis bullosa.. Common adverse reactions include The most common (incidence ≥2%) adverse reactions are application site reactions..
Adult Indications and Dosage
FDA-Labeled Indications and Dosage (Adult)
FILSUVEZ topical gel is indicated for the treatment of wounds associated with dystrophic and junctional epidermolysis bullosa.
Apply a 1 mm layer of FILSUVEZ to the affected wound surface and cover with wound dressing or apply FILSUVEZ directly to dressing so that the topical gel is in direct contact with the wound. Do not rub in the topical gel.
Off-Label Use and Dosage (Adult)
Pediatric Indications and Dosage
FDA-Labeled Indications and Dosage (Pediatric)
FILSUVEZ topical gel is indicated for the treatment of wounds associated with dystrophic and junctional epidermolysis bullosa.
Apply a 1 mm layer of FILSUVEZ to the affected wound surface and cover with wound dressing or apply FILSUVEZ directly to dressing so that the topical gel is in direct contact with the wound. Do not rub in the topical gel.
Off-Label Use and Dosage (Pediatric)
Contraindications
None.
Warnings
Hypersensitivity Reactions: If signs or symptoms of hypersensitivity occur, discontinue use immediately and initiate appropriate therapy.
Adverse Reactions
Clinical Trials Experience
The most common (incidence ≥2%) adverse reactions are application site reactions.
Postmarketing Experience
There is limited information regarding Birch triterpenes Postmarketing Experience in the drug label.
Drug Interactions
There is limited information regarding Birch triterpenes Drug Interactions in the drug label.
Use in Specific Populations
Pregnancy
Pregnancy Category (FDA):
There is no FDA guidance on usage of Birch triterpenes in women who are pregnant.
Pregnancy Category (AUS):
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Birch triterpenes in women who are pregnant.
Labor and Delivery
There is no FDA guidance on use of Birch triterpenes during labor and delivery.
Nursing Mothers
There is no FDA guidance on the use of Birch triterpenes in women who are nursing.
Pediatric Use
There is no FDA guidance on the use of Birch triterpenes in pediatric settings.
Geriatic Use
There is no FDA guidance on the use of Birch triterpenes in geriatric settings.
Gender
There is no FDA guidance on the use of Birch triterpenes with respect to specific gender populations.
Race
There is no FDA guidance on the use of Birch triterpenes with respect to specific racial populations.
Renal Impairment
There is no FDA guidance on the use of Birch triterpenes in patients with renal impairment.
Hepatic Impairment
There is no FDA guidance on the use of Birch triterpenes in patients with hepatic impairment.
Females of Reproductive Potential and Males
There is no FDA guidance on the use of Birch triterpenes in women of reproductive potentials and males.
Immunocompromised Patients
There is no FDA guidance one the use of Birch triterpenes in patients who are immunocompromised.
Administration and Monitoring
Administration
Apply FILSUVEZ at wound dressing changes until the wound is healed. Each tube of FILSUVEZ is for one-time use only. For topical use; not for oral, intravaginal, intra-anal, or ophthalmic use.
Monitoring
There is limited information regarding Birch triterpenes Monitoring in the drug label.
IV Compatibility
There is limited information regarding the compatibility of Birch triterpenes and IV administrations.
Overdosage
There is limited information regarding Birch triterpenes overdosage. If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.
Pharmacology
There is limited information regarding Birch triterpenes Pharmacology in the drug label.
Mechanism of Action
The mechanism of action of FILSUVEZ in the treatment of wounds associated with epidermolysis bullosa is unknown.
Structure
There is limited information regarding Birch triterpenes Structure in the drug label.
Pharmacodynamics
There is limited information regarding Birch triterpenes Pharmacodynamics in the drug label.
Pharmacokinetics
There is limited information regarding Birch triterpenes Pharmacokinetics in the drug label.
Nonclinical Toxicology
There is limited information regarding Birch triterpenes Nonclinical Toxicology in the drug label.
Clinical Studies
There is limited information regarding Birch triterpenes Clinical Studies in the drug label.
How Supplied
There is limited information regarding Birch triterpenes How Supplied in the drug label.
Storage
There is limited information regarding Birch triterpenes Storage in the drug label.
Images
Drug Images
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Package and Label Display Panel
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Patient Counseling Information
There is limited information regarding Birch triterpenes Patient Counseling Information in the drug label.
Precautions with Alcohol
Alcohol-Birch triterpenes interaction has not been established. Talk to your doctor regarding the effects of taking alcohol with this medication.
Brand Names
There is limited information regarding Birch triterpenes Brand Names in the drug label.
Look-Alike Drug Names
There is limited information regarding Birch triterpenes Look-Alike Drug Names in the drug label.
Drug Shortage Status
Price
References
The contents of this FDA label are provided by the National Library of Medicine.