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Winlevi

clascoterone
Used for Acne

Winlevi (clascoterone) is a topical cream used to treat acne in people ages 12 years and older. It's a type of hormonal medication called an androgen receptor inhibitor. It's thought to lessen acne by lowering the amount of oil produced by your skin. Winlevi (clascoterone) is applied to the skin twice daily. Some common side effects of this medication include dry skin, itching, and redness. Winlevi (clascoterone) is only available as brand-name medication.

Reviewed by:Last reviewed on October 10, 2024
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What is Winlevi (clascoterone)?

What is Winlevi (clascoterone) used for?

How Winlevi (clascoterone) works

Winlevi (clascoterone) is an androgen receptor inhibitor. While the exact way it works is unknown, it's thought to treat acne by blocking hormones in your skin from making too much sebum (an oily, waxy substance). Too much sebum can clog pores and cause redness or swelling, which can lead to acne.

When does Winlevi (clascoterone) start working?Time passed since treatment started:
HOURS
DAYS
WEEKS
Initial effect
MONTHS
Full effect

Drug facts

Common BrandsWinlevi
Drug ClassTopical skin product
Controlled Substance ClassificationNot a controlled medication
Generic StatusNo lower-cost generic available
AvailabilityPrescription only
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Side effects of Winlevi (clascoterone)

The following side effects may get better over time as your body gets used to the medication. Let your healthcare provider know immediately if you continue to experience these symptoms or if they worsen over time.

Common Side Effects

  • Skin redness (12%)
  • Skin peeling or dry skin (11%)
  • Itching (8%)

Less Common Side Effects

Source: DailyMed

The following Winlevi (clascoterone) side effects have also been reported

Side effects that you should report to your care team as soon as possible:

  • Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
  • Burning, itching, crusting, or peeling of treated skin
  • Low adrenal gland function—nausea, vomiting, loss of appetite, unusual weakness or fatigue, dizziness

Side effects that usually do not require medical attention (report to your care team if they continue or are bothersome):

  • Mild skin irritation, redness, or dryness
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Avg retail price
$751.16(Save 32.30%)
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$508.55
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Pros and cons of Winlevi (clascoterone)

Pros

Cons

  • Need to apply twice daily
  • Can cause skin irritation, burning, and peeling
  • Unclear if it's safe to use during pregnancy and breastfeeding
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Pharmacist tips for Winlevi (clascoterone)

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  • Before applying Winlevi (clascoterone), gently wash and dry all areas of your skin that are affected by acne. Apply a small amount of medication (enough to cover the affected area with a thin layer) twice daily, once in the morning and once in the evening.
  • Wash your hands right after applying the medication to avoid skin irritation and getting the medication on your clothes or other parts of your body.
  • Avoid using Winlevi (clascoterone) in or around your eyes, lips, mouth, corners of your nose, or vagina. If the medication accidentally comes into contact with any of these areas, use water to rinse the areas right away.
  • Don't apply Winlevi (clascoterone) to damaged areas of your skin that have cuts or wounds. Also avoid using the cream on sunburned skin or areas affected by skin conditions, such as eczema. These areas might already be sensitive and using Winlevi (clascoterone) can cause further skin irritation.
  • Winlevi (clascoterone) can cause dry skin, so avoid using skin care products and makeup that also causes dryness. Avoid using harsh or medicated soaps or cleansers to wash your face. Also avoid using skin products with high amounts of drying agents, such as alcohol, spices, or lime. Ask your dermatologist if you have questions about which skin care products to use or avoid.
  • Don't put bandages over your skin after you apply Winlevi (clascoterone). This can cause your body to absorb more medication than recommended and put you at higher risk for side effects, such as skin irritations.
  • Write down the date when you picked up Winlevi (clascoterone) from the pharmacy and when you first opened it. Throw away the medication one month after first opening the tube or six months after picking it up from your pharmacy, whichever date comes first. Winlevi (clascoterone) might not work as well if stored for too long. Ask your pharmacist if you have any questions about storage of Winlevi (clascoterone).
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Risks and warnings for Winlevi (clascoterone)

Winlevi (clascoterone) can cause some serious health issues. This risk may be even higher for certain groups. If this worries you, talk to your doctor or pharmacist about other options.

Skin reactions

  • Risk factors: History of skin reactions | Sensitive skin | Using other skin products or medications that irritate or dry your skin | Using Winlevi (clascoterone) on irritated skin

Winlevi (clascoterone) can cause skin irritations, such as redness, itching, peeling, and dryness. The chances are higher if you're also using other products that cause irritation, such as medicated soaps or products with drying agents, like alcohol. Avoid using Winlevi (clascoterone) on skin that might already be irritated, such as areas with cuts, wounds, or burns. If you develop skin irritation that doesn't go away or worsens, let your healthcare team know because you might need to switch to a different medication.

Low hormone levels

  • Risk factors: Using Winlevi (clascoterone) for a long time | Using Winlevi (clascoterone) over large areas of the body | Covering skin with bandages after applying Winlevi (clascoterone) | Children or adolescents

Winlevi (clascoterone) can cause adrenal suppression during or even after treatment. This means it can disrupt your body's ability to make natural hormones. Children and adolescents are at higher risk for this problem. Let your dermatologist know right away you experience symptoms of adrenal suppression, such as extreme tiredness, muscle weakness, and lack of appetite. You might need to stop using Winlevi (clascoterone) temporarily until your hormone levels return to normal range, which typically takes about one month.

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Winlevi (clascoterone) dosage

The average cost for 1 tube of 60g of 1% of Winlevi (clascoterone) is $508.55 with a free GoodRx coupon. This is 32.30% off the average retail price of $751.16.
tube of creamTube of cream
DosageQuantityPrice as low asPrice per unit
60g of 1%1 tube$508.55$508.55

Typical dosage for Winlevi (clascoterone)

  • Adults and children ages 12 years and older: The typical dose is to apply a thin layer of cream to the areas of your skin affected by acne twice daily, in the morning and evening.
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How much does Winlevi (clascoterone) cost?

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What are alternatives to Winlevi (clascoterone)?

There are a number of medications that your doctor can prescribe in place of Winlevi (clascoterone). Compare a few possible alternatives below.
Winlevi (clascoterone)
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News about Winlevi (clascoterone)

References

Best studies we found

Harris, C. (2021). Clascoterone (Winlevi) for the treatment of acne. American Family Physician.

Hebert, A. A., et al. (2023). Efficacy and safety of 1% clascoterone cream in patients aged > 12 years with acne vulgaris. Journal of Drugs in Dermatology.

National Institute of Diabetes and Digestive and Kidney Diseases. (2018). Definition & facts of adrenal insufficiency & Addison's disease.

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