The Winlevi Way

Hypothetical WINLEVI® (clascoterone cream 1%) Patients

Models shown are not actual patients.
*The exact mechanism of WINLEVI in acne vulgaris is unknown.¹

A first-in-class mechanism to target androgen receptors in acne vulgaris^1,2*

Female & Male

12+

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.

WINLEVI® (clascoterone cream 1%) Co-Pay Card

Discover savings for eligible commercially insured patients

Learn More

A different way to treat acne •

FDA-approved WINLEVI is the first novel topical mechanism for acne in 40 years^2-4*

Targeting the effects of hormones in the skin

As you know, androgen hormones can cause acne in both females AND males by stimulating sebum production and inflammation.⁵ First-in-class WINLEVI (clascoterone) cream 1% is an FDA-approved novel topical androgen receptor inhibitor appropriate for use in both female AND male patients.^1-4

WINLEVI is not like other acne treatments. Topical WINLEVI treats acne differently. And that could make a real difference to your patients.

Models shown are not actual patients.

Inhibits effects of androgen hormones on cells in sebaceous glands^1,3,6

Significantly reduces inflammatory and noninflammatory lesions^1,3

7% to 12% of patients experienced erythema/reddening, pruritus and scaling/dryness^1,3†

No systemic side effects related to androgen inhibition^3‡

Approved for female AND male patients aged 12 and up^1,3

*The exact mechanism of WINLEVI in acne vulgaris is unknown.¹

^†Additionally, edema, stinging, and burning occurred in >3% of patients and were reported in a similar percentage of subjects treated with vehicle.

^‡In a maximum-use PK study in 42 patients, hypothalamic-pituitary-adrenal (HPA) axis suppression was observed in 5% (1/20) of adults (6 g BID) and 9% (2/22) of adolescents (4 g BID) at Day 14. All patients returned to normal HPA axis function at follow-up 4 weeks after the end of treatment.⁷ Attempt to withdraw use if HPA axis suppression develops.¹

Learn More

See the results

Models shown are not actual patients.

Sign up for updates

For future updates and helpful information regarding prescribing WINLEVI, sign up to receive email communications.

IMPORTANT SAFETY INFORMATION

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.

The Winlevi Way

FDA-approved WINLEVI is the first novel topical mechanism for acne in 40 years2-4*

Sign up for updates

INDICATION

IMPORTANT SAFETY INFORMATION

FDA-approved WINLEVI is the first novel topical mechanism for acne in 40 years^2-4*