Winlevi

Generic name: Clascoterone
Dosage form: cream 1%
Drug class: Topical acne agents

Usage of 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.

The active ingredient clascoterone is also known as cortexolone 17α-propionate.

Winlevi side effects

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.

Before taking Winlevi

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.

Relate drugs

How to use Winlevi

Winlevi is applied twice a day to the affected area.

Warnings

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.

What other drugs will affect Winlevi

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.

Disclaimer

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