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What is Winlevi, and how does it work?
Winlevi cream 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.
What is the dosage for Winlevi?
Cleanse the affected area gently. After the skin is dry, apply a thin uniform layer of Winlevi cream twice per day, in the morning and the evening, to the affected area. Avoid accidental transfer of Winlevi cream into eyes, mouth or other mucous membranes. If contact with mucous membranes occurs, rinse thoroughly with water.
Winlevi cream is for topical use only. Winlevi cream is not for ophthalmic, oral or vaginal use.
What are the side effects of Winlevi?
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.
Call your healthcare provider for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Is Winlevi safe to use while pregnant or breastfeeding?
- There are no available data on Winlevi cream use in pregnant women to evaluate for a drugassociated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes.
- There are no data regarding the presence of clascoterone or metabolite in human milk, the effects on the breastfed infant or the effects on milk production.
- The lack of clinical data during lactation precludes a clear determination of the risk of clascoterone to an infant during lactation; therefore, the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for clascoterone and any potential adverse effects on the breastfed child from clascoterone or from the underlying maternal condition.
Winlevi cream is a prescription medicine used on the skin (topical) to treat acne vulgaris in people 12 years of age and older. The most common side effects of Winlevi cream include reddening, scaling or dryness, and itching of the skin being treated. Serious side effects include local skin reactions and adrenal insufficiency.
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