FILSUVEZ (birch triterpenes)

AbsorptionSystemic exposure to betulin was assessed in the 66 evaluable subjects aged ≥13 months to ≤52 years with dystrophic and junctional EB in the clinical trial EASE using venous blood sampling and validated liquid chromatography with tandem mass spectrometry assay. Following treatment with FILSUVEZ once daily (n=27), every 2 (n=33) or 3 days (n=4) or once weekly (n=2) for 90 days with a mean treatment area of 12% body surface area or affected wound surface area of 0.11 m 2 at baseline, be...

The efficacy of FILSUVEZ for the treatment of partial-thickness wounds associated with inherited EB was evaluated in a randomized, double-blind, placebo-controlled trial in adults and pediatric subjects 6 months of age and older (EASE; NCT03068780) with dystrophic EB (DEB) and junctional EB (JEB). Subjects were randomized 1:1 to receive FILSUVEZ (n=109) or placebo topical gel (n=114) and instructed to apply approximately 1 mm (0.04 inch) of the investigational product to all their wounds at each dressing change (every 1 to 4 days) for 90 days. At randomization, 1 wound was selected by the inve...

The following clinically significant adverse reactions are discussed elsewhere in the labeling: Hypersensitivity Reactions [see Warnings and Precautions (5.1) ] The most common (incidence ≥2%) adverse reactions are application site reactions. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Chiesi USA Inc. at 1-888-661-9260 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction...

None. None ( 4 )

Hypersensitivity Reactions : If signs or symptoms of hypersensitivity occur, discontinue use immediately and initiate appropriate therapy. ( 5.1 ) 5.1 Hypersensitivity Reactions Local hypersensitivity and skin reactions have been reported in patients treated with FILSUVEZ, including urticaria and dermatitis. If signs and symptoms of local or systemic hypersensitivity occur, discontinue FILSUVEZ immediately and initiate appropriate therapy.