Winlevi Cream: Uses, Dosage, Side Effects, Precautions and Alternates

Quick overview

Winlevi Cream contains clascoterone, a topical acne agent that works as an androgen receptor inhibitor. It is a prescription cream used on the skin to treat acne vulgaris (pimples, blackheads, and whiteheads) in adolescents 12 years and older and in adults. It may reduce oil production and inflammation in the skin, with a reduction in acne possible as early as 4 weeks and fuller effects around 3 months.

What is Winlevi Cream

Winlevi is a prescription cream that contains clascoterone. It is used on the skin to treat acne vulgaris, a common skin condition that causes pimples, blackheads, and whiteheads.

Winlevi Cream uses

• Treats acne vulgaris (pimples, blackheads, and whiteheads) on the face in adolescents 12 years and older
• Treats acne vulgaris on the face, chest, and/or back in adults

Benefits of Winlevi Cream

• Leads to fewer pimples, whiteheads, and blackheads
• Moisturizes skin instead of drying it out like some other acne medicines
• May show a reduction in acne as early as 4 weeks, with fuller effect around 3 months

How Winlevi Cream works

Winlevi blocks receptors in the skin that normally respond to hormones called androgens. This reduces oil (sebum) production and inflammation in the skin, which are both causes of acne.

Winlevi Cream dosage

Gently wash and dry the affected skin area before applying the cream. Apply a thin, even layer to the affected area twice a day, once in the morning and once in the evening, waiting at least eight hours between applications. Massage the cream in gently and avoid the eyes, eyelids, lips, and nostrils. Wash your hands after applying the cream. Do not cover the treated area with bandages or dressings.

If using other skin products such as moisturizers or sunscreen, apply them at least 2 hours before or after Winlevi. Avoid skin products that can dry or irritate the skin, such as medicated or abrasive soaps, strong drying cosmetics, products with high alcohol content, or astringents.

Adolescents should apply the cream to the face only, while adults may use it on the face, chest, and/or back. Do not apply extra cream to make up for a missed dose. Your doctor will let you know how long to use this medicine, often with check-ins every three months to see how your skin is responding.

Available forms and strengths

• Cream 1%

Side effects of Winlevi Cream

Common

• Redness of the skin
• Scaling or dryness
• Itching
• Stinging or burning
• Swelling (edema)

Serious

• Local skin irritation such as itching, burning, redness, or peeling
• Adrenal gland problems (the gland may not make enough of certain hormones), sometimes called adrenal insufficiency or HPA axis suppression
• Elevated potassium levels seen in some people during studies

Warnings and precautions

• Winlevi can cause local skin irritation such as itching, burning, redness, or peeling.
• Winlevi can affect the adrenal gland, causing it to make less of certain hormones. Your doctor may stop treatment if this happens.
• Do not use Winlevi on skin with cuts, abrasions, eczema, or sunburn.
• Keep Winlevi away from your eyes, mouth, and vagina; it is for use on the skin only.
• Do not give this medicine to other people, even if they have similar symptoms, since it may harm them.
• Children may be more likely than adults to experience whole-body (systemic) side effects from this medicine.
• For external use only. Do not use in the eyes, mouth, vagina, or on other mucous membranes. If contact occurs, rinse thoroughly with water.
• Avoid damaged skin, including cuts, abrasions, eczema, or sunburned areas.
• Avoid or limit other irritating topical products, such as abrasive cleansers, strongly drying soaps/cosmetics, high-alcohol products, and astringents.
• Large treatment areas, prolonged use, and occlusive dressings may increase systemic absorption.
• Safety and effectiveness are not established below 12 years of age.
• Avoid using skin products that contain high amounts of alcohol, since they may dry out or irritate skin treated with Winlevi.
• Winlevi is not expected to affect your ability to drive or use machines.
• Winlevi should not be used during pregnancy. It is not known if this medicine will harm an unborn baby, though animal studies suggest it could cause harm. Tell your healthcare professional if you are pregnant or planning pregnancy.
• It is not known if Winlevi passes into breast milk, so talk to your healthcare provider about the safest way to feed your baby while using this medicine.

Storage

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

When to see a doctor

• Contact your doctor if you notice symptoms that could mean your adrenal gland isn't working properly, such as feeling very tired, losing weight without trying, having a poor appetite, low blood pressure, nausea, diarrhea, vomiting, stomach pain, or low blood sugar.
• If cream accidentally gets in your eyes, mouth, or other mucous membranes, rinse the area thoroughly with water.
• If your acne comes back or gets worse shortly after stopping treatment, contact your doctor before restarting the cream, as this could be a rebound reaction.
• Tell your doctor about any side effects you experience, including ones not listed in the product information.

Alternatives

• Adapalene
• Benzoyl peroxide
• Azelaic acid