Winlevi

Winlevi cream is a prescription medication for acne vulgaris treatment. It contains clascoterone, an androgen receptor inhibitor. Winlevi cream works by blocking androgen receptors in the sebaceous glands and hair follicles of the skin. By doing so, it is thought to help reduce oil (sebum) production and inflammation, which improves acne.

Winlevi was FDA-approved on August 26, 2020, for topical treatment of acne vulgaris in patients 12 years of age and older.

• Use Winlevi cream exactly as your healthcare provider tells you to use it.
• Before applying the cream, gently wash and dry the affected skin area.
• After the skin is dry, apply a thin, even layer of Winlevi cream to the affected areas 2 times each day, in the morning and the evening.
• Wash your hands after applying the cream, so you do NOT get any cream accidentally in your eyes, mouth, or other mucous membranes. If this cream does come into contact with mucous membranes occurs, rinse thoroughly with water.

Winlevi cream is for use on the skin only (topical). Do not use the cream in or on your eyes, mouth, or vagina.

Tell your doctor if you use other medicines or have other medical conditions or allergies.

Before using Winlevi cream, tell your healthcare provider about all of your medical conditions, including if you have any other skin problems including eczema, cuts, or sunburn.

Pregnancy

Tell your healthcare provider if you are pregnant or plan to become pregnant. It is not known if Winlevi cream will harm your unborn baby.

Breastfeeding

Tell your healthcare provider if you 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 can cause serious side effects:

• Local skin reactions including local skin irritation, itching, burning, skin redness, or peeling.
• Hypothalamic-pituitary-adrenal (HPA) axis suppression. This is where the adrenal gland does not make enough of certain hormones (adrenal insufficiency). Your healthcare provider may stop your treatment with Winlevi if you develop any adrenal problems. This is less likely to happen if Winlevi is used on a small surface area, without the use of occlusive dressings, and not for a prolonged period of time.

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. Call your healthcare provider for medical advice about side effects. You may report side effects to FDA at 1-800-FDA1088.

Winlevi is applied twice a day to the affected area.

Do not use 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. If contact with mucous membranes happens, rinse well with water.

Do not use skin products that may dry or irritate your skin, such as:

• medicated or abrasive soaps and cleansers
• soaps, cleansers, and cosmetics that have strong skin-drying effects
• products that contain high amounts of alcohol
• astringents, spices, or lime

Tell your doctor about all your current medicines.

Avoid using skin products that may dry or irritate your skin including medicated or abrasive soaps and cleansers, or any soaps, cleansers, and cosmetics that have strong skin-drying effects, or skin products that contain high amounts of alcohol or astringents.

• Store at room temperature between 68°F and 77°F (20°C to 25°C).
• Do not freeze.
• Throw away (discard) the unused portion 180 days after the date of dispensing or 1 month after the first opening, whichever is sooner.

Before Dispensing: Store the product in a refrigerator between 36°F and 46°F (2°C and 8°C). Do not freeze.

Active ingredient: clascoterone Inactive ingredients: cetyl alcohol, citric acid monohydrate, edetate disodium, mineral oil, mono- and di-glycerides, polysorbate 80, propylene glycol, purified water, and vitamin E.

Manufactured for: Sun Pharmaceutical Industries Limited

Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512