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WINLEVI is a prescription medicine used on the skin (topical) to treat acne vulgaris in people 12 years of age and older.
WINLEVI is an FDA-approved topical cream that works differently from other acne topicals. WINLEVI is an androgen inhibitor that targets the acne hormones in the skin, decreasing sebum production and reducing inflammation, which can help treat your acne.
WINLEVI can be used by FEMALES and MALES, ages 12 and older, with acne.
WINLEVI works by targeting acne hormones in the skin, which reduces sebum (oily wax in the skin) production and inflammation to help treat acne.
Acne hormones control the amount of sebum produced in tiny glands near the surface of your skin, which leads to acne. WINLEVI is an FDA-approved prescription cream that targets these acne hormones in your skin.
The exact way WINLEVI works on acne is unknown.
Sebum is an oily wax in your skin that acts as “food” for acne-causing bacteria.
Acne hormones called androgens are responsible for making this sebum in glands near the skin’s surface, called sebaceous glands. Androgen hormones also affect how much sebum is made. Excess sebum can lead to oily skin and acne.
The active ingredient is clascoterone, an androgen receptor inhibitor that targets acne hormones in your skin.
The exact way WINLEVI works on acne is unknown.
WINLEVI is a cream, and the color is white to almost white.
WINLEVI should be applied 2 times daily using about a fingertip amount (approximately one gram). Watch the video
WINLEVI is an FDA-approved topical cream for twice-daily use. It will be most effective when used as prescribed.
Apply WINLEVI twice a day, in the morning and the evening.
Before using WINLEVI, gently wash and dry the affected area.
WINLEVI should be applied to the entire affected area (face, chest, shoulders, and/or back).
Avoid using WINLEVI cream on skin areas with cuts, abrasions, eczema, or on sunburned skin. Avoid getting WINLEVI cream into your eyes, lips, mouth, corners of the nose, or mucous membranes.
WINLEVI should be stored at room temperature, between 68° F and 77° F. It may be stored in your bathroom to remind you to use it during your skincare routine.
You should pick up your WINLEVI prescription from the pharmacy or ensure it is hand-delivered to you. WINLEVI should not be left in hot temperatures for any period of time, including in a mailbox, on the doorstep, or in a vehicle.
WINLEVI was studied in 1421 FEMALES and MALES ages 12 and older with acne vulgaris. About half of the patients used WINLEVI twice daily, and the other half used a cream with no active ingredient twice daily. Patients were treated for 12 weeks during the study, which looked at the safety and effectiveness of WINLEVI.
In clinical studies with WINLEVI, a noticeable reduction in acne was seen as early as week 4. After 12 weeks of use, WINLEVI demonstrated a reduction in pimples, whiteheads, and blackheads, and patients had clear or almost clear skin.
The most common reactions were mild skin redness, peeling or dryness, and itching where WINLEVI was applied. These are not all of the possible side effects of WINLEVI.
In clinical studies, the side effects were generally mild to moderate.
The WINLEVI Co-Pay Program provides savings to eligible patients. When WINLEVI is covered or prior authorization is approved, patients may pay as little as $20. When WINLEVI is not covered under insurance, patients may pay as little as $90.
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