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Clascoterone (On the skin)

Clascoterone (klas-KOE-ter-one)

Treats acne.

Brand Name(s):

Winlevi

When This Medicine Should Not Be Used:

How to Use This Medicine:

Cream

• Your doctor will tell you how much medicine to use. Do not use more than directed.
• This medicine is for use only on the skin. Do not get it into your eyes, nose, or mouth. If you do, rinse the area right away with plenty of water. Do not use on skin areas that have cuts, scrapes, sunburn, or an itchy, scaly, red rash.
• To use: Gently wash and dry the affected skin area. After the skin is dry, apply a thin even layer of the cream to the affected areas.
• Use this medicine only on your skin. Rinse it off right away if it gets on a cut or scrape. Do not get the medicine in your eyes, nose, or mouth.
• Apply a thin layer of the medicine to the affected area. Rub it in gently.
• Wash your hands with soap and water before and after you use this medicine.
• Do not cover the treated area with a bandage unless directed by your doctor.
• Read and follow the patient instructions that come with this medicine. Talk to your doctor or pharmacist if you have any questions.
• Missed dose: Apply a dose as soon as you can. If it is almost time for your next dose, wait until then and apply a regular dose. Do not apply extra medicine to make up for a missed dose.
• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.
• Throw away the unused cream 180 days after the date of dispensing or 1 month after first opening, whichever is sooner.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Do not use any other medicines on the treated skin areas without asking your doctor. Avoid using any skin care products that can dry or irritate your skin. These include harsh skin cleansers, soaps or cosmetics that cause dryness, or products that contain alcohol, astringents, spices, or lime.

Warnings While Using This Medicine:

• Tell your doctor if you are pregnant or breastfeeding, or if you have eczema, other skin problems, or sunburn.
• This medicine may cause the following problems:
  • Skin reactions
  • Adrenal or pituitary gland problems
• Do not use this medicine to treat a skin problem your doctor has not examined.
• Call your doctor if your symptoms do not improve or if they get worse.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Blisters, swelling, rash, or red, scaly, crusty skin
• Color changes on the skin, dark freckles, easy bruising, muscle weakness, round, puffy face
• Severe skin itching, burning, redness, peeling, or pain

If you notice these less serious side effects, talk with your doctor:

• Mild skin itching, peeling, stinging, burning, or dryness

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088

Last Updated: 9/6/2024