Clascoterone (Winlevi®)

Clascoterone is available as a prescription topical treatment. It is available in cream form.

• Available forms:
  
  
  • Topical treatment: 
    
    
    • Cream
      Available as prescription
      Generic not available (US)
    • Brand names (US):
      • Winlevi®
• Available in these doses: 
  
  
  • Cream: 1%

• Dosing information:
  
  
  • Clascoterone is used twice per day, once in the morning and once in the evening

• Who is it for? 
  
  
  • Gender:
    • Males and females
  • Severity of acne:
    • Moderate-to-severe acne
  • Age:
    • Children of 12 years and older, adolescents, and adults

How to use it:

Clascoterone is a topical treatment and is available as a cream. 

Clascoterone is usually applied twice a day, around the same time every day, once in the morning and once in the evening. 

Wash your hands with soap and water before using the medication.

Before applying clascoterone, wash the acne-affected skin with water and a mild cleanser. Pat the skin dry with a soft towel. 

Apply a pea-sized amount of clascoterone and spread evenly on the acne-affected skin, leaving a thin film of cream.

Wash your hands after application of the medication.

Clascoterone should only be applied to intact skin. Do not use clascoterone on damaged skin areas with cuts, abrasions, eczema, or on sunburned skin.

Your physician will specify how much of the medication you need to apply and how often. Do not apply more clascoterone or apply clascoterone more frequently because this will not improve the results and may cause skin irritation.  

It may take some time before the effects of clascoterone are seen on acne. You may start to see some improvement in acne after 4 weeks. Clascoterone needs to be used for 3 months in order to determine whether it is effectively treating your acne. If your symptoms get worse or do not improve after 3 months, contact your physician. 

The dosing for children of 12 years and older and adolescents is the same as the dosing for adults. Clascoterone is not recommended in children younger than 12 years. 

Do not get clascoterone in your eyes, nose, or mouth. If it does get into your eyes, wash your eyes with a generous amount of water and seek medical attention if there is any irritation. 

Follow the instructions on your prescription carefully and apply clascoterone exactly as prescribed by your physician. Do not change the dose or the frequency of your medication, unless your physician advises you to do so. If you have any questions about the medication or the prescription, ask your physician or pharmacist.

Be aware of: 

• Before using clascoterone, let your physician or pharmacist know if you are allergic to clascoterone or any of the other ingredients in the cream.
• Before using clascoterone, tell your physician if you have any disease related to the production of adrenal hormones, kidney problems, or other conditions that increase the potassium levels in your blood. If you do suffer from any of these conditions, your physician may advise you not to use clascoterone.
• Clascoterone may increase the potassium levels in your blood. Avoid taking potassium-containing salt substitutes. Talk with your physician about your diet and the amount of potassium-rich foods (such as bananas, prunes, raisins, and orange juice) that you eat. 
• If you are using clascoterone and are pregnant or want to become pregnant, talk to your physician about clascoterone use during pregnancy.
• If you are using clascoterone and are considering breastfeeding, talk to your physician about clascoterone use during breastfeeding.
• Clascoterone may cause imbalances in your electrolyte levels.
• If you are becoming sick while you are using clascoterone, especially if you have severe nausea, continuous vomiting, or diarrhea, consult your physician. These conditions cause an increased loss of fluid and salt that may lead to low blood pressure, which may be worse when using clascoterone.

Drug interactions:

Although no significant interactions were detected between clascoterone and other medications, inform your physician or pharmacist about all the prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take before starting clascoterone. Also inform your physician or pharmacist of the skin products you use including soaps, cleansers, moisturizers, and cosmetics.

What if I overdose? 

In case of overdose, contact an emergency facility or call the American Association of Poison Control Centers at 1 (800) 222-1222 (available 24/7).

If immediate assistance is necessary because the victim has collapsed, had a seizure, has trouble breathing, or cannot be awakened, call 911 at once.

Information can also be found online at https://www.poisonhelp.org/help

What if I miss a dose?

As soon as you recall that you have missed a dose, apply the missed dose. However, skip the missed dose if it is almost time for your next dose and continue with your prescribed dosing schedule. Do not take a double dose to make up for the missed dose. 

Storage:

Store your medication in the container that the pharmacist provided and keep it out of reach and out of sight of children. Many containers can be opened by children. Keep the container tightly closed. Always lock safety caps and immediately place the medication in a safe location that is up and away from the sight of young children, to prevent poisoning (www.upandaway.org).

Store the medication at room temperature. Keep the medication away from excessive heat and moisture – do not store in the bathroom. Do not freeze clascoterone.

Disposal:

Do not keep outdated medication and medication that you no longer use. Unneeded medications should be disposed of in a way that pets, children, and other people cannot consume them. Do not flush the medication down the toilet. Contact your pharmacist to learn about the availability of a medicine take-back program in your neighborhood, or get in touch with your local garbage/recycling department to ensure safe disposal. If you do not have access to a take-back program, you can find more information on safe disposal of medication on the FDA website: (https://www.fda.gov/Drugs/ResourcesForYou/Consumers/BuyingUsingMedicineSafely/EnsuringSafeUseofMedicine/SafeDisposalofMedicines/ucm186187.htm)