Winlevi (Clascoterone) – Topical

What Is Winlevi?

Winlevi (clascoterone) is a topical prescription product used for a common skin condition called acne vulgaris (acne). Winlevi is an androgen (hormone) receptor inhibitor.

It’s thought to work by inhibiting the effects of androgen receptors (binding sites) in sebaceous (oil) glands, which are located in skin pores. By blocking these hormone binding sites, Winlevi may help with lessening oil production and inflammation (your body’s response to an offending agent, which causes swelling, pain, and redness).

Winlevi is available as a topical cream.

Drug Facts

Generic Name: Clascoterone

Brand Name: Winlevi

Drug Availability: Prescription

Administration Route: Topical

Therapeutic Classification: Anti-acne

Available Generically: No

Controlled Substance: N/A

Active Ingredient: Clascoterone

Dosage Form: Cream

What Is Winlevi Used For?

The Food and Drug Administration (FDA) approved Winlevi as a treatment option for acne vulgaris (acne) in people aged 12 years and older.

In the United States, acne is a common skin condition that affects millions of teenagers and young adults on a yearly basis. Acne is the result of skin pores that are clogged with oil and dead skin cells. Bacteria might also grow in these pores.

How to Use Winlevi

Carefully read the Winlevi label and packaging instructions before use. If you have any questions, talk with your healthcare provider or pharmacist. The following, however, are general directions to use Winlevi:

  1. Before using Winlevi, wash your hands. 
  2. Next, gently wash and clean affected skin areas. If you prefer, you can wear gloves before cleaning your skin and using the Winlevi cream.
  3. After your skin is dry, apply a thin, even layer (1 gram) of Winlevi cream to the affected areas. 
  4. Don’t use Winlevi on eczema or sunburned skin. Also, avoid applying the cream on skin with cuts and scrapes. 
  5. Rewash your hands after using the topical medication.
  6. Since Winlevi typically is used twice daily, repeat steps 1–5 in the evening.
  7. Don’t tightly cover or wrap applied skin areas.

This is a topical medication meant to be applied to the skin. Avoid getting Winlevi into the eyes, nose, lips, or vagina. If contact with mucous membranes happens, rinse well with water.

How to Store Winlevi

With Winlevi being a noncontrolled medication, your healthcare provider can approve up to one year’s worth of refills from the original written date on the prescription.

After receiving Winlevi from the pharmacy, store the medication at room temperature (between 68 degrees and 77 degrees Fahrenheit). Make sure to not freeze the product.

Also, keep in mind that Winlevi has one of the following two expiration dates, and you should go by whichever one is sooner:

  • 180 days (six months) from the date that you picked up Winlevi from the pharmacy
  • One month from the date that you open the tube of Winlevi cream

When traveling, be familiar with your final destination’s regulations before taking your trip. In general, however, keep Winlevi in its original container or packaging, with the pharmacy label containing your name attached. Also, make a copy of your Winlevi prescription.

How Long Does Winlevi Take to Work?

You might notice an improvement in your acne symptoms within 12 weeks (three months). Talk with your healthcare provider if you don’t see any difference in symptoms by 12 weeks of therapy.

What Are the Side Effects of Winlevi?

Although Winlevi is a topical medication, side effects are possible.

This is not a complete list of side effects and others may occur. A medical professional can advise you on side effects. If you experience other effects, contact your pharmacist or a medical professional. You may report side effects to the FDA at www.fda.gov/medwatch or 800-FDA-1088.

Common Side Effects

Most of Winlevi’s common side effects occur at the application site—the affected skin areas where the cream was applied.

  • Burning or stinging sensation
  • Dry and scaly skin
  • Itchiness
  • Redness
  • Swelling

While the above side effects are common with Winlevi, they can become excessive and serious. To limit the severity of these side effects, don’t apply Winlevi to eczema or sunburned skin. Also, avoid using the topical medication on skin with cuts and scrapes.

Additionally, don’t use Winlevi in combination with harsh or medicated skin products with a lot of alcohol, astringents, spices, lime, and strong drying effects.

Contact your healthcare provider about any concerning side effects.

Severe Side Effects

Other severe side effects may include high potassium amounts in the body. Symptoms of high potassium may include:

  • Breathing difficulties
  • Chest pain
  • Fast heartbeat 
  • Nausea or vomiting
  • Weak, numb, or tingling muscles

Some people might also experience hypothalamic-pituitary-adrenal (HPA) axis suppression, which is also known as adrenal insufficiency or Addison’s disease. People who experience this condition aren’t making enough of certain hormones—like cortisol.

Adrenal insufficiency can cause worrisome changes in:

  • Appetite
  • Blood pressure
  • Blood sugar
  • Energy
  • Mood
  • Weight

Get medical help if you suspect that you’re experiencing these serious side effects.

Long-Term Side Effects

Possible long-term side effects of Winlevi may include:

Some people might also experience polycystic ovaries. People with this condition have cysts (pockets of liquid) in their ovaries that can lead to several symptoms. Some symptoms may include:

  • Excessive hair growth in undesirable areas
  • Irregular menstrual periods
  • Thick skin patches
  • Weight pain

If you suspect that you’re experiencing these long-term side effects during or after Winlevi use, immediately get medical help or contact your healthcare provider.

Report Side Effects

Winlevi may cause other side effects. Call your healthcare provider if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your provider may send a report to the FDA's MedWatch Adverse Event Reporting Program or by phone (800-332-1088).

Dosage: How Much Windevi Should I Take?

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The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

  • For topical dosage form (cream):
    • For acne:
      • Adults and children 12 years of age and older—Apply a thin layer to the affected area(s) of the skin 2 times a day, in the morning and the evening.
      • Children younger than 12 years of age—Use and dose must be determined by your doctor.

Modifications

While the FDA approved Winlevi for children between the ages of 12 and 18 years old, the manufacturer states that children might be at a higher risk of developing adrenal insufficiency with Winlevi.

As a result, the healthcare provider may want to closely monitor and follow up about symptoms and side effects.

There is no safety and effectiveness data on Winlevi in pregnant people, but some animal studies suggest potential negative effects on the fetus with Winlevi—when injected under the mother’s skin.  As for people with nursing infants, there is also no safety and effectiveness data on Winlevi in nursing babies.

Before using Winlevi, talk with your healthcare provider to weigh the benefits and risks of using this topical medication while pregnant or nursing.

Avoid applying Winlevi to skin areas that have:

  • Eczema
  • Scrapes and cuts
  • Sunburn

Missed Dose

When using Winlevi, follow your healthcare provider’s directions.

In general, try to use Winlevi as soon as you remember that you missed a dose. However, if it’s close to your next dosing time, then skip the missed dose and apply Winlevi at this next scheduled time. Don’t try to use more cream to make up for the missed dose.

Overdose: What Happens If I Use Too Much Winlevi?

Use Winlevi cream only as prescribed by your healthcare provider.

If you use too much Winlevi cream, there is likely a higher chance of serious and long-term side effects—like adrenal insufficiency. Try to use a thin layer of medicated cream only on affected skin areas for as long as your provider recommends.

If you’re experiencing worrisome side effects, get medical help right away.

What Happens If I Overdose on Winlevi?

If you think you or someone else may have overdosed on Winlevi, call a healthcare provider or the Poison Control Center (800-222-1222).

If someone collapses or isn't breathing after taking Winlevi, call 911 immediately.

Precautions

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It is important that your doctor check your or your child's progress at regular visits. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to use it. Blood tests may be needed to check for unwanted effects.

If your condition does not improve or if it become worse, check with your doctor.

Skin reactions including local skin irritation including itching, burning, skin redness or peeling, dryness, scaling, or stinging can occur when you use this medicine.

This medicine may cause adrenal or pituitary gland problems. Check with your doctor right away if you have darkening of the skin, diarrhea, dizziness, fainting, loss of appetite, mental depression, nausea, skin rash, unusual tiredness or weakness, or vomiting.

Unless your doctor tells you otherwise, you should avoid skin products that can dry or irritate the skin. Some examples are:

  • Skin products that cause sensitivity to the sun, such as those containing spices or limes.
  • Skin products containing a large amount of alcohol, such as astringents, shaving creams, or after-shave lotions.
  • Skin products that are too drying or abrasive, such as some cosmetics, soaps, or skin cleansers.

What Are Reasons I Shouldn’t Use Winlevi?

There are certain situations in which you might not be able to use Winlevi, or may need to stop using it:

  • If you develop adrenal insufficiency, immediately talk with your healthcare provider, who will help you stop the medicated cream.
  • Don’t use Winlevi on skin areas with eczema, sunburn, cuts, and scrapes.

What Other Medications Interact With Winlevi?

There is no information on drug interactions between Winlevi and other medications.

However, combining Winlevi with harsh or medicated skin products that have a lot of alcohol or strong drying effects can cause local skin reactions. Other skin products to avoid include ones that contain limes and spices.

If you have questions or concerns about Winlevi’s drug interactions, talk with your pharmacist or healthcare provider.

What Medications Are Similar?

Although there are many topical and oral (by mouth) treatments for acne available, Winlevi is the only topical product in the androgen receptor medication class.

How Winlevi works is not completely understood, but it is thought to lessen the amount of inflammation in skin pores. While the retinoid medication class works differently than Winlevi, it’s thought also to influence inflammation.

Therefore, the topical retinoids might be the most similar to Winlevi. Some examples of retinoid products are:

  • Differin (Adapalene) 
  • Fabior (tazarotene)
  • Aklief (trifarotene)

Like Winlevi, these three topical retinoids have similar common side effects. However, Fabior isn’t recommended for people who are pregnant.

Compared with Winlevi, experts consider the retinoid medication class as the first-choice for mild acne. As for moderate and severe acne, retinoids are also go-to options in many combination therapies. Differin is available as an over-the-counter (OTC) item that doesn’t require a prescription from a healthcare provider.

Although Winlevi isn’t currently considered a first-choice treatment option for acne, experts' recommendations might change with more experience in using Winlevi.

Since these medications can be harsh or rough on the skin, they’re unlikely to be used together. Combining these products might raise the risk of side effects. Additionally, if necessary, experts recommend combining retinoids with other medications—like a topical antibiotic—or switching between different retinoids. They don’t typically suggest combining multiple retinoids.

If you have any questions about these medicated topicals, speak with your pharmacist or healthcare provider.

Frequently Asked Questions

  • Where is Winlevi available?

    Winlevi is available with a prescription from your healthcare provider. Local retail pharmacies likely carry Winlevi, but the pharmacy staff may need to order the product for you.

  • How much does Winlevi cost?

    Winlevi became available in early November 2021, and there are no generic equivalents yet. Therefore, Winlevi can be expensive without insurance. If you do have insurance, some insurance companies tend to have high copays for prescription skin creams.

    If cost is a concern, Sun Pharmaceuticals does have a co-pay program. For additional questions about the program, call 877-264-2440. Another option is to visit RxAssist.org to look for medication assistance programs.

  • Is it safe to use Winlevi for a long time?

    A study suggests that using Winlevi for nine months is only linked with mild side effects. How long to use Winlevi can vary by person. Talk with your healthcare provider to determine the duration of therapy for you.

  • What if Winlevi doesn’t work for me?

    Many topical acne medications might initially worsen acne before improving symptoms, but people tend to notice symptom improvement within 12 weeks. If you don’t see any benefit by 12 weeks, talk with your healthcare provider to discuss the next steps.

How Can I Stay Healthy While Using Winlevi?

Acne can be a frustrating skin condition. In addition to consistently applying or taking your acne medications as scheduled, try to incorporate some of the following self-care tips into your daily routine:

  • Use moisturizers regularly: Moisturizing can help with dry and irritated skin that may result from your acne medication.
  • Apply sunscreen with a sun protection factor (SPF) of at least 30: Many topical acne medications make your skin more susceptible to sunburn and sun damage. Others, like Winlevi, shouldn’t be used on sunburned skin.
  • Don’t pick or pop pimples: Squeezing a pimple can damage the skin and make existing blemishes worse.
  • Shower right after you sweat to avoid breakouts.

If you have questions about these tips or would like additional suggestions, consider discussing with your healthcare provider.

Medical Disclaimer

Verywell Health's drug information is meant for educational purposes only and is not intended as a replacement for medical advice, diagnosis, or treatment from a healthcare professional. Consult your healthcare provider before taking any new medication(s). IBM Watson Micromedex provides some of the drug content, as indicated on the page.

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12 Sources
Verywell Health uses only high-quality sources, including peer-reviewed studies, to support the facts within our articles. Read our editorial process to learn more about how we fact-check and keep our content accurate, reliable, and trustworthy.
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