First-in-Class
A novel way to target androgen receptors in acne vulgaris1,2*
First-in-Class
A novel way to target androgen receptors in acne vulgaris1,2*
*The exact mechanism of WINLEVI in acne vulgaris is unknown.1
For your convenience, please download the Authorization and Appeals Kit, as well as individual sample letters you may need for patient access to WINLEVI.
Pass savings along to your patients with the WINLEVI Co-Pay Program
Enrollment is subject to applicable program maximum restrictions, terms and conditions, and eligibility criteria.
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WINLEVI (clascoterone) cream 1% is an androgen receptor inhibitor indicated for the topical treatment of acne vulgaris in patients 12 years of age and older.
CONTRAINDICATIONS
None.
WARNINGS AND PRECAUTIONS
Local Irritation: Pruritus, burning, skin redness or peeling may be experienced with WINLEVI cream. If these effects occur, discontinue or reduce the frequency of application of WINLEVI cream.
Hypothalamic-pituitary-adrenal (HPA) axis suppression may occur during or after treatment with WINLEVI. In the PK trial, HPA axis suppression was observed in 5% of adult subjects and 9% of adolescent subjects at Day 14. All subjects returned to normal HPA axis function at follow-up 4 weeks after stopping treatment. Conditions which augment systemic absorption include use over large surface areas, prolonged use, and the use of occlusive dressings. Attempt to withdraw use if HPA axis suppression develops.
Pediatric patients may be more susceptible to systemic toxicity.
Hyperkalemia: Elevated potassium levels were observed in some subjects during the clinical trials. Shifts from normal to elevated potassium levels were observed in 5% of WINLEVI-treated subjects and 4% of vehicle-treated subjects.
ADVERSE REACTIONS
Most common adverse reactions occurring in 7% to 12% of patients are erythema/reddening, pruritus and scaling/dryness. Additionally, edema, stinging, and burning occurred in >3% of patients and were reported in a similar percentage of subjects treated with vehicle.
To report SUSPECTED ADVERSE REACTIONS, contact Sun Pharmaceutical Industries, Inc. at 1-800-818-4555 or FDA at 1-800-FDA-1088 or http://www.fda.gov/medwatch.
For more details, please see full Prescribing Information and the Patient Information.