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FOR US HEALTHCARE PROFESSIONALS ONLY
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FILSUVEZ has a well-established safety profile1

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
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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
disease disease
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 & Indication

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.

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 & Indication

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.

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.
References:
1. FILSUVEZ (birch triterpenes) topical gel [prescribing information]. Chiesi USA; 2024.
2. Murrell D, Bodemer C, Bruckner AL, et al; on behalf of the EASE investigators. Long-term safety and efficacy of Oleogel-S10 (birch bark extract) in epidermolysis bullosa: 24-month results from the phase III EASE study. Br J Dermatol. 2025;192(6):1007-1017.

PP-RA-01346 V1.0