Uses

What is Winlevi used for?

Winlevi (clascoterone) is commonly used to treat acne vulgaris on your skin.

Winlevi may also be used for other conditions as determined by your healthcare provider.

How does Winlevi work (mechanism of action)?

Winlevi belongs to a group of medicines called androgen receptor inhibitors. It is unknown how Winlevi works to treat acne vulgaris, but it may reduce oil production and have anti-inflammatory effects.

How is Winlevi supplied (dosage forms)?

Winlevi is available in a 1% topical cream that is applied to the skin.

How should I store Winlevi?

Winlevi should be stored at room temperature, between 68 F to 77 F (20 C to 25 C). Throw away any unused product 180 days after it is dispensed from the pharmacy or one month after first opening the container (whichever is sooner). Do not freeze.

Side Effects

What are the most common side effects of Winlevi?

The most common side effects of Winlevi are listed below. Tell your healthcare provider if you have any of these side effects that bother you.

  • Skin reddening
  • Itching
  • Scaling or dryness of skin

There may be other side effects of Winlevi that are not listed here. Contact your healthcare provider if you think you are having a side effect of a medicine. In the U.S., you can report side effects to the FDA at www.fda.gov/medwatch or by calling 800-FDA-1088. In Canada, you can report side effects to Health Canada at www.health.gc.ca/medeffect or by calling 866-234-2345.

What are the serious side effects of Winlevi?

While less common, the most serious side effects of Winlevi are described below, along with what to do if they happen.

Severe Allergic Reactions. Winlevi may cause allergic reactions, which can be serious. Stop using Winlevi and get help right away if you have any of the following symptoms of a serious allergic reaction.

  • Breathing problems or wheezing
  • Racing heart
  • Fever or general ill feeling
  • Swollen lymph nodes
  • Swelling of the face, lips, mouth, tongue, or throat
  • Trouble swallowing or throat tightness
  • Itching, skin rash, or pale red bumps on the skin called hives
  • Nausea or vomiting
  • Dizziness, feeling lightheaded, or fainting
  • Stomach cramps
  • Joint pain

Reduced Adrenal Function. Winlevi can cause your body’s adrenal glands to stop making as much cortisol (the stress hormone). This is known as adrenal insufficiency and can happen during or after treatment with Winlevi. Adrenal insufficiency can get worse if your body is under stress because of fever, surgery, or trauma. Tell your healthcare provider if you have any of the following symptoms of adrenal insufficiency.

  • Nausea and vomiting
  • Weakness, tiredness, or lack of energy
  • Low blood pressure

Warnings & Precautions

Who should not use Winlevi?

Allergies to Ingredients. People who are allergic to any of the following should not use Winlevi.

  • Clascoterone
  • Winlevi
  • Any of the ingredients in the specific product dispensed

Your pharmacist can tell you all of the ingredients in Winlevi.

What should I know about Winlevi before using it?

Do not use Winlevi unless it has been prescribed to you by a healthcare provider. Use it as prescribed.

Do not share Winlevi with other people, even if they have the same condition as you. It may harm them.

Keep Winlevi out of the reach of children.

Winlevi is for use on the skin only. It should not be used on other areas of the body such as your eyes, mouth, or vagina. If any of these areas come in contact with Winlevi, rinse the area well with water.

Do not use Winlevi on cuts, damaged or sunburned skin, or skin areas affected by eczema.

If possible, avoid or limit using Winlevi with other products that can irritate your skin, such as the following.

  • Medicated or abrasive skin cleansers or soaps
  • Soaps or other products that cause skin dryness
  • Products containing high amounts of alcohol
  • Products that cause skin contraction (astringents)
  • Other irritants, such as spices or lime

Wash your hands after applying Winlevi.

What should I tell my healthcare provider before using Winlevi?

Tell your healthcare provider about all of your health conditions and any prescription or over-the-counter (OTC) medicines, skin products, vitamins/minerals, herbal products, and other supplements you are using. This will help them determine if Winlevi is right for you.

In particular, make sure that you discuss any of the following.

Skin Problems. Winlevi may cause skin reactions where it is applied. It should not be applied to skin areas with cuts, damaged or sunburned skin, or skin areas affected by eczema. Tell your healthcare provider if you have any of these skin problems.

Pregnancy. It is not known if or how Winlevi could affect pregnancy or harm an unborn baby. Tell your healthcare provider if you are or plan to become pregnant.

Breastfeeding. It is not known if Winlevi passes into breast milk. Tell your healthcare provider if you are breastfeeding or plan to breastfeed. Your healthcare provider will advise you if you should use Winlevi while breastfeeding.

How can I get more information about Winlevi?

For more information about Winlevi, you can visit the manufacturer’s website at www.winlevi.com or call them at 800-818-4555.

Interactions

Does Winlevi interact with foods or drinks?

There are no known interactions between Winlevi and foods or drinks.

It is unknown if drinking alcohol will affect Winlevi.

Does Winlevi interact with other medicines (drug interactions)?

There are no known interactions between Winlevi and other medicines. Always tell your healthcare provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using.

Does Winlevi (clascoterone) interact with other drugs you are taking?
Enter your medication into the WebMD interaction checker

Overdose/Missed Dose

What should I do if I accidentally use too much Winlevi?

If you or someone else has used too much Winlevi, get medical help right away, call 911, or contact a Poison Control center at 800-222-1222.

What should I do if I miss a dose of Winlevi?

If you miss your scheduled dose of Winlevi, apply it as soon as you remember. If it is almost time for your next scheduled dose, skip the missed dose and follow the original schedule. Do not apply Winlevi more often than prescribed.