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WINLEVI® (clascoterone) cream 1% is a prescription medicine used on the skin (topical) to treat acne vulgaris in people 12 years of age and older.

WINLEVI and dr. sandra lee, aka dr. pimple popper

WINLEVI is proud to partner with Dr. Lee, one of the world’s foremost authorities on skin care, dermatology, and acne. She brings her 25 years of dermatology and cosmetic surgery experience to help answer questions about how WINLEVI works, why you get acne in the first place, and when it’s time to talk to your dermatology professional.

Watch Dr. Lee explain how WINLEVI is different

You’ve got questions, we’ve got answers

WINLEVI Basics

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.

Formulation

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.

Application

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.

Where to Keep WINLEVI

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.

Results

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.

Side Effects

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.

Savings and Support

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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Important Patient Information

Before using WINLEVI cream, tell your healthcare provider about all of your medical conditions, particularly if you:

  • have skin problems, including eczema, cuts or sunburn.
  • are pregnant or plan to become pregnant. It is not known if WINLEVI cream will harm your unborn baby

Important Safety Information

Indication

What is WINLEVI® cream?

WINLEVI (clascoterone) cream 1% is a prescription medicine used on the skin (topical) to treat acne vulgaris in people 12 years of age and older.

It is not known if WINLEVI cream is safe and effective in children under 12 years of age.

Important Patient Information

Before using WINLEVI cream, tell your healthcare provider about all of your medical conditions, particularly if you:

  • have skin problems, including eczema, cuts or sunburn
  • are pregnant or plan to become pregnant. It is not known if WINLEVI cream will harm your unborn baby
  • are breastfeeding or plan to breastfeed. It is not known if WINLEVI cream passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby during treatment with WINLEVI cream

WINLEVI cream is for use on the skin only (topical). Do not use WINLEVI cream in or on your eyes, mouth, or vagina. Do not use WINLEVI cream for a condition for which it was not prescribed. Do not give WINLEVI cream to other people, even if they have the same symptoms you have. It may harm them.

What are the possible side effects of WINLEVI cream?

WINLEVI cream can cause serious side effects, including:

  • local skin reactions. WINLEVI cream may cause local skin irritation including itching, burning, skin redness or peeling.
  • symptoms of a disorder where the adrenal gland does not make enough of certain hormones (adrenal insufficiency) during treatment with WINLEVI. Your healthcare provider may stop your treatment with WINLEVI if you develop any adrenal problems.

The most common side effects of WINLEVI cream include reddening, scaling or dryness, and itching of the skin being treated.
These are not all of the possible side effects of WINLEVI cream.

Tell your healthcare provider about the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Call your healthcare provider for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or to Sun Pharmaceutical Industries, Inc. by calling 1-800-818-4555.

Please see full Prescribing Information and the Patient Information.