Winlevi 1 % topical cream

Generic name:
Clascoterone - topical

Pronunciation
(klas-KOE-ter-one)

Brand name(s)
Winlevi

This medication is used to treat acne. It helps to decrease the number of acne lesions.

Read the Patient Information Leaflet if available from your pharmacist before you start using clascoterone and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

Use this medication only on the skin. Before applying the medication, clean and dry the affected area. Apply a thin film of the medication to the affected area as directed by your doctor, usually twice a day (once in the morning and once in the evening). Do not apply this medication on any cuts, wounds, sunburned skin, or skin with eczema. Wash your hands after use.

Avoid getting this medication in your eyes, nose, mouth, or vagina. If you get this medication in those areas, rinse with plenty of water.

Do not use this drug more often or for longer than prescribed. Your condition will not improve any faster, and your risk of side effects will increase. Do not cover, bandage or wrap the area unless directed to do so by your doctor.

Avoid using this product along with other skin products that may irritate or dry the skin (such as medicated soaps/cleansers, products that contain alcohol).

Tell your doctor if your condition does not get better or if it gets worse.

Redness, itching, peeling, or dryness of the skin may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Rarely, it is possible this medication may be absorbed from the skin into the bloodstream. This can lead to side effects of too little corticosteroid and androgen hormones. These side effects are more likely in children, and in people who use this medication for a long time or over large areas of the skin. Tell your doctor right away if you have any serious side effects, including:

• unusual/extreme tiredness
• weight loss

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including:

• rash
• itching/swelling (especially of the face/tongue/throat)
• severe dizziness
• trouble breathing

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Before using clascoterone, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is unknown if this drug passes into breast milk. Consult your doctor before breastfeeding.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

This medicine may be harmful if swallowed. If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call 1-800-222-1222. Canada residents can call 1-844-764-7669.

Do not share this medication with others.

If you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Use your next dose at the regular time. Do not double the dose to catch up.

Store at room temperature. Do not freeze. Different brands of this medication have different storage needs. Check the product package for instructions on how to store your brand, or ask your pharmacist. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.