Important Safety Information - Winlevi

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.