Winlevi
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.
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.
Drug facts
More on Winlevi (clascoterone) essentials
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
- Stinging or burning
- Swelling
- Stretch marks
- Spider veins
- Thinning of skin
- No menstrual cycles
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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Pros and cons of Winlevi (clascoterone)
Pros
- Applied to the skin
- Only acne medication that's thought to work by blocking hormones can that cause acne
- Safe to use in young adults and children 12 years or older, who are most commonly affected by acne
Cons
- Need to apply twice daily
- Can cause skin irritation, burning, and peeling
- Unclear if it's safe to use during pregnancy and breastfeeding
Pharmacist tips for Winlevi (clascoterone)
- 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).
Common questions about Winlevi (clascoterone)
Winlevi (clascoterone) is neither a corticosteroid nor a retinoid. Instead, it's a type of hormonal medication called an androgen receptor inhibitor. Winlevi (clascoterone) is the only medication that controls acne by blocking hormones that makes your skin produce more oil. Ask your dermatology team if you have more questions about how Winlevi (clascoterone) works.
People who took Winlevi (clascoterone) in clinical studies didn't report skin purging, which is a temporary increase in acne that some other acne medications might cause. But people did experience skin irritation, such as redness, dryness, and itching. Talk with your dermatologist if you're concerned about how Winlevi (clascoterone) might affect your skin.
It can take up to 3 months for your skin to improve after starting Winlevi (clascoterone). If you don't notice your skin getting better after 3 months, discuss with a dermatologist whether you should continue using Winlevi (clascoterone) or consider other treatment options.
Clinical studies looked at how well Winlevi (clascoterone) worked for people who had moderate-to-severe acne after 3 months of treatment. Results showed that about 20% of people who used Winlevi (clascoterone) experienced clear to almost clear skin, compared to about 8% of people who used placebo cream. Ask your healthcare team if you have more questions about what results you might expect after starting Winlevi (clascoterone).
You can store Winlevi (clascoterone) at room temperature, between 68°F and 77°F. When you pick up Winlevi (clascoterone) from your local pharmacy, it might feel cold because it's typically stored in the refrigerator at your pharmacy. Once you open the tube and start using it, you can store it at room temperature. Keep in mind that Winlevi (clascoterone) is only good for 6 months after you bring it home from the pharmacy, or 1 month after you open the tube (whichever comes first). Don't continue to use the medication past this time.
Winlevi (clascoterone) is a topical cream that's FDA-approved to treat acne in people ages 12 years and older. Spironolactone (Aldactone) is an oral blood pressure medication that's sometimes prescribed by dermatologists off-label to treat acne based on guidelines by the American Academy of Dermatology. Both medications treat acne by lowering the amount of androgen hormones in the body, but they do so in different ways. Winlevi (clascoterone) is applied to the skin twice daily; you might expect to see an improvement in your skin after 3 months. Spironolactone (Aldactone) is taken by mouth, typically once daily); you might see your acne getting better after a few weeks of treatment. Talk with your dermatology team if you have more questions about Winlevi (clascoterone) and spironolactone (Aldactone).
Ask your dermatologist if you can use Winlevi (clascoterone) and tretinoin (Retin-A) together. These 2 medications work differently to treat acne and aren't known to directly interact with each other. But because both medications can cause similar skin-related side effects, such as dryness and redness, taking them together can worsen skin irritation.
More research is needed to understand how Winlevi (clascoterone) might affect human pregnancy. Limited animal studies suggest it might cause harm, but it's unclear whether this medication might affect humans in the same way. If you're pregnant or planning to become pregnant, discuss the risks and benefits of using Winlevi (clascoterone) with your dermatologist. Also, ask them about options for treating acne during pregnancy.
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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.
Winlevi (clascoterone) dosage
Tube of cream| Dosage | Quantity | Price as low as | Price per unit |
|---|---|---|---|
| 60g of 1% | 1 tube | $498.41 | $498.41 |
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.
How much does Winlevi (clascoterone) cost?
$498.41
What are alternatives to Winlevi (clascoterone)?
