WINLEVI (clascoterone) cream for Acne Vulgaris

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

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

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

• have skin problems, including cuts, eczema, or sunburn.

• are pregnant or planning to become pregnant. It is not known if WINLEVI cream can harm your unborn baby.

• are breastfeeding or plan to breastfeed. It is not known if WINLEVI cream can pass into your breast milk. Talk to your doctor about the best way to feed your baby during treatment with WINLEVI cream

• Use WINLEVI cream exactly as your doctor tells you.

• Before applying the cream, gently wash and dry the affected areas, and then

• Apply a thin even layer of the cream to the affected areas 2 times (morning and night) each day

• wash your hands after applying the cream.

• Avoid using WINLEVI cream on the areas of your skin where there are cuts, abrasions, sunburned skin, or eczema.

• WINLEVI cream should be used on the skin only. Do not use WINLEVI cream in or on your eyes, mouth, or vagina, lips, or mucous membranes.

• Avoid using skin products that may irritate or dry your skin such as:
  • medicated soaps and cleansers
  • cleansers, soaps, and cosmetics that have a strong drying effect
  • products that contain high amounts of alcohol
  • spices, astringents, or lime

The most common side effects of WINLEVI cream include:

reddening, scaling or dryness, and itching of the skin being treated.

WINLEVI cream can cause serious side effects, including:

• local skin reactions: WINLEVI cream may cause local skin irritation including skin redness, itching, burning, or peeling.

• Hypothalamic-pituitary-adrenal (HPA) axis suppression: a disorder where the adrenal gland does not make enough of certain hormones (adrenal insufficiency) during treatment with WINLEVI. Your doctor may stop your treatment with WINLEVI if you develop any adrenal problems.

• Hyperkalemia (increase in potassium): increase in potassium levels was observed in clinical trials.

• Systemic poisoning in pediatric patients: pediatric patients may be more susceptible to systemic poisoning.

• Polycystic Ovarian Syndrome: a disease with cysts in the ovaries

Store WINLEVI cream at room temperature between 68° C to 77° C. Do not freeze.

Active ingredients: clascoterone

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

It can take up to 3 months for your skin to completely improve.

Yes, WINLEVI cream can cause purging. There will be redness, dryness or scaling, and itching of the skin when using the cream.

No, WINLEVI cream cannot be used with benzoyl peroxide as it would lead to excessive drying, scaling, itching, and redness.

Yes, WINLEVI can affect your period and lead to the absence of menstrual periods but this is a very rare side effect.

Yes, WINLEVI can be used with tretinoin and is completely safe. You can use WINLEVI in the morning and tretinoin at night.

It is not known whether it is safe to use WINLEVI during pregnancy and breastfeeding. You will have to consult your doctor about this.

Yes, WINLEVI can be used for hormonal acne and is completely safe.