Does Winlevi need to be refrigerated?

No, Winlevi does not need to be refrigerated after you pick up your prescription. It can be stored at room temperature between 68°F and 77°F (20°C to 25°C). Do not freeze this medicine.

How long does Winlevi last?

Throw away (discard) the unused portion 180 days after the date of dispensing OR 1 month after first opening, whichever is sooner.

• Thirty days (one month) after first opening the tube, throw away the product, even if there is unused medicine in the tube.
• If you have not opened the tube after picking it up from the pharmacy, you do not need to discard the unopened product for 180 days (6 months).

Before dispensing the product, your pharmacist will keep the medicine in the refrigerator, but you can keep it at room temperature once you pick it up.

What is Winlevi?

Winlevi (clascoterone) cream 1% is a prescription topical medicine approved in August 2020 by the FDA to treat acne vulgaris in patients 12 years and older. It can be used on the face, chest, shoulders, and/or back and is applied twice daily.

Winlevi is a first-in-class topical androgen receptor inhibitor and was the first medicine for over 40 years with a new way of working in acne treatment. It targets acne hormones in the skin, decreasing sebum (the oily wax substance in skin glands) and inflammation to help treat acne.

It is manufactured by Sun Pharmaceuticals.

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How does it work?

Hormones that can aggravate acne (called androgens) are responsible for making sebum in the sebaceous glands near the skin’s surface.

Clascoterone, the active ingredient in Winlevi, is an androgen receptor inhibitor. Laboratory studies suggest that it competes with androgens, specifically dihydrotestosterone (DHT), for binding to the androgen receptors within the sebaceous gland and hair follicles.

Due to this action, Winlevi is thought to help limit increased sebum production and inflammation in both males and females. The exact mechanism of action of clascoterone is not fully known.

This is not all the information or side effects you need to know about Winlevi (clascoterone) for safe and effective use and does not take the place of your doctor’s directions. Review the full product information and discuss this information and any questions you have with your doctor or other health care provider.