The most common side effect of FILSUVEZ is application site reactions, such as pain and itchy skin¹

Adverse Event

FILSUVEZ
(n=109) n (%)

Placebo
(n=114) n (%)

All patients
(N=223) N (%)

Application Site Reaction*

8 (7.3)

7 (6.1)

15 (6.7)

The incidence of application site reactions with FILSUVEZ was comparable to placebo gel¹
Local hypersensitivity and skin reactions have been reported in patients treated with FILSUVEZ, including urticaria and dermatitis¹
Long-term treatment with FILSUVEZ was well tolerated, with no new safety signals identified at the end of the 2-year extension period²
Patients using FILSUVEZ experienced a low incidence of wound infections, which were typically mild to moderate through the long-term analysis²

A consistent wound cleansing routine reduces the risk of infection and aids in the wound healing process¹

*Includes application site pruritus, administration site pain, and administration site pruritus.¹

See the before and after images of wounds treated with FILSUVEZ²

Images

This image depicts the wound of a real patient with recessive dystrophic EB before and after treatment with FILSUVEZ in the EASE trial. Image used with permission.

Review dosing guidance and application instructions for FILSUVEZ

Dosing

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.

FILSUVEZ has a well-established safety profile¹

The most common side effect of FILSUVEZ is application site reactions, such as pain and itchy skin¹

See the before and after images of wounds treated with FILSUVEZ²

Important Safety Information & Indication

Important Safety Information & Indication

Important Safety Information

Indication

FILSUVEZ has a well-established safety profile1

The most common side effect of FILSUVEZ is application site reactions, such as pain and itchy skin1

See the before and after images of wounds treated with FILSUVEZ2

Important Safety Information & Indication

Important Safety Information & Indication

Important Safety Information

Indication

FILSUVEZ has a well-established safety profile¹

The most common side effect of FILSUVEZ is application site reactions, such as pain and itchy skin¹

See the before and after images of wounds treated with FILSUVEZ²