Filsuvez (birch bark extract)

It isessential that the manufacturer's labeling be consulted for more detailed information on dosage and administration of this drug. Dosage summary:

No dosing information is available for this tab.

No dosing information is available for this tab.

No dosing information is available for this tab.

There is no enhanced messaging for this drug.

There are no contraindication interactions for this drug.

There are no severe interactions for this drug.

There are no moderate interactions for this drug.

None

There are no contraindication contraindications for this drug.

There are no severe contraindications for this drug.

• No disease contraindications

The most common (incidence >=2%) adverse reactions are application site reactions.

There are no severe adverse reactions for this drug.

More Frequent

• Acute pain at drug application site
• Application site rash

Less Frequent

• Squamous cell carcinoma of skin

No enhanced messaging available.

The safety and effectiveness of birch triterpenes for the treatment of wounds associated with dystrophic and junctional epidermolysis bullosa have been established in pediatric patients 6 months of age and older. Use of birch triterpenes in this age group is supported by evidence from a single randomized, placebo-controlled trial in 156 subjects 6 months to 17 years of age.

The safety and effectiveness of birch triterpenes have not been established in pediatric patients younger than 6 months of age.

There are no available data with use of birch triterpenes in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. In an animal reproduction study, oral administration of birch triterpenes to pregnant rats during the period of organogenesis had no effects on reproductive or fetal parameters.

Systemic absorption of birch triterpenes in humans is low following topical administration of birch triterpenes, and maternal use is not expected to result in fetal exposure to the drug .

The background risk of major birth defects and miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.

There are no data on the presence of birch triterpenes or metabolites in human milk, the effects on the breastfed infant, or the effects on milk production.

No effects on the breastfed infant are anticipated since the systemic exposure of the breastfeeding woman to birch triterpenes would be low. Therefore, the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for birch triterpenes and any potential adverse effects on the breastfed infant from the drug or underlying maternal condition.

Clinical studies of birch triterpenes did not include sufficient numbers of epidermolysis bullosa subjects 65 years of age and older to determine whether they respond differently from younger subjects.