INDICATION & IMPORTANT SAFETY INFORMATION

Indication

FILSUVEZ is indicated for the treatment of wounds associated with dystrophic and junctional epidermolysis bullosa (EB) in adult and pediatric patients 6 months of age and older.

Important Safety Information

Warnings & Precautions

Local hypersensitivity and skin reactions have been reported in patients treated with FILSUVEZ, including urticaria and dermatitis. If signs or symptoms of hypersensitivity occur, discontinue use immediately and initiate appropriate therapy.

Adverse Reactions

The most commonly reported adverse reaction in clinical trials was pruritus and pain at the wound application site (7.3%).

Patient Counseling Information

Please refer to Prescribing Information for administration instructions.

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.

Please see full Prescribing Information.

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FILSUVEZ is a registered trademark owned by the Chiesi Group.
PP-RA-00961 V1.0