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INDICATION AND IMPORTANT SAFETY INFORMATION

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DOSING

AND SAFETY
Hypothetical Male WINLEVI® (clascoterone cream 1%) Patient
Hypothetical Female WINLEVI® (clascoterone cream 1%) Patient Applying Treatment

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.1*

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

DOSING SAFETY
A UNIQUE WAY TO TOPICALLY TREAT ACNE •

START & END THEIR DAY

The WINLEVI® Way

Twice daily for FEMALE and MALE patients 12 years and older.1
Why twice daily?
In clinical trials, 12-week treatment success was based on twice-daily dosing with WINLEVI.1
Instruct patients to:
  • Gently cleanse and dry the affected area.
  • Apply a fingertip amount (approximately one gram) of WINLEVI in a thin, even layer to the affected area (entire face, chest, or back) twice daily— once in the morning and once in the evening.1

Not actual patient.

SAFETY

THE WINLEVI WAY
SAFETY PROFILE IN 2 PHASE 3 PIVOTAL STUDIES OVER 12 WEEKS1
Applying WINLEVI® (clascoterone cream 1%) to Finger
WINLEVI is rapidly metabolized in the skin, limiting systemic absorption.2,3
  • 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.1
Hypothetical Male WINLEVI® (clascoterone cream 1%) Patient
No systemic side effects related to androgen inhibition were observed in 2 phase 3 pivotal trials.4
  • 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 14.5
  • All subjects returned to normal HPA axis function at follow-up 4 weeks after stopping treatment.5
  • 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.5
Hypothetical Female WINLEVI® (clascoterone cream 1%) Patient
The most frequent LSRs were erythema/reddening, pruritus, and scaling/dryness.1,4
  • Other LSRs occurring in less than 5% of patients included: edema, skin atrophy, stinging/burning, striae rubrae, and telangiectasia, which occurred in 3% of subjects treated with vehicle.

Not actual patients.

Winlevi safety profile at 12 weeks1,4

LOCAL SKIN REACTIONS (LSRS) IN ≥1% OF PATIENTS COMPARED TO VEHICLE

(LSRs) in ≥1% of Patients Compared to Vehicle Chart

Other LSRs occurring in less than 5% of patients included edema, skin atrophy, stinging/burning, striae rubrae, and telangiectasia, which occurred in a similar percentage of subjects treated with vehicle.

aThe denominators for calculating the percentages were the 674 of 709 subjects treated with WINLEVI cream and 656 of 712 subjects treated with vehicle in these trials who had local skin reaction results reported after Day 1.1

Winlevi safety profile at 12 weeks4,6

Prevalence of TEAEs by Severity in WINLEVI® (clascoterone cream 1%)

Long-term safety profile of WINLEVI

In a phase 3, open-label, long-term, 9-month extension study6,7

  • Treatment-emergent adverse events (TEAEs) occurred in 18.1% of patients overall over 9 months, and occurred in a similar percentage of patients originally assigned WINLEVI vs vehicle6,7
    • Of patients receiving WINLEVI in the 12-week pivotal study, TEAEs occurred in 18.3% (58/317)6,7
    • Of patients receiving vehicle in 12-week pivotal study, TEAEs occurred in 17.9% (52/290)6,7
  • Most common TEAEs in the safety population included nasopharyngitis, upper respiratory tract infection, viral respiratory tract infection, sinusitis, and application-site acne6,7
  • Most common local skin reactions (LSRs) included erythema, scaling/dryness, and pruritus7
  • No systemic adverse events related to androgen inhibition or HPA axis suppression6,7*

*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.5 Attempt to withdraw use if HPA axis suppression develops.1

LONG-TERM STUDY DESIGN: Patients who had completed one of the WINLEVI 12-week randomized, placebo-controlled phase 3 pivotal trials for facial acne were eligible to continue with WINLEVI in the open-label, single arm, long-term extension study.‡ Study subjects (n=607) applied WINLEVI 2X daily for up to 9 months on the face, trunk, or both. Mean overall daily WINLEVI exposure: 2.3 g (range, 0.2 g to 13 g).6,7

‡Patients off treatment for more than 3 days were not eligible.

WINLEVI® (clascoterone cream 1%) Tube and Packaging

JAAD

Journal of the American Academy of Dermatology

Read more about the long-term safety profile of WINLEVI