Clascoterone Topical

Clascoterone Topical is a prescription medication used topically to treat acne vulgaris in people 12 years of age and older.

• Clascoterone Topical is available under the following different brand names: Winlevi

Common side effects of Clascoterone Topical include:

• Skin reddening,
• Itching,
• Scaling/dryness,
• Swelling,
• Stinging, and
• Burning

Serious side effects of Clascoterone Topical include:

• High blood potassium--nausea, weakness, tingly feeling, chest pain, irregular heartbeats, loss of movement; or
• Decreased adrenal gland hormones--nausea, vomiting, stomach pain, loss of appetite, feeling tired or light-headed, muscle or joint pain, skin discoloration, craving salty foods.

Rare side effects of Clascoterone Topical include:

• none 

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors;
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheadedness, or passing out.

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult and pediatric dosage

Topical cream

• 1%

Acne Vulgaris

Adult dosage

• Apply a thin layer topically to the affected area two times a day

Pediatric dosage

• Indicated for acne vulgaris in patients aged above 12 years
• Children below 12 years: Safety and efficacy not established
• Children above 12 years: Apply a thin layer topically to the affected area two times a day

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Clascoterone Topical has no noted severe interactions with any other drugs.
• Clascoterone Topical has no noted serious interactions with any other drugs.
• Clascoterone Topical has no noted moderate interactions with any other drugs.
• Clascoterone Topical has no noted minor interactions with any other drugs.

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all your products. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your healthcare professional or doctor for additional medical advice, or if you have health questions or concerns.

Contraindications

• None 

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Clascoterone Topical?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Clascoterone Topical?”

Cautions

• May induce local irritation (. g, erythema, redness, pruritus, scaling, dryness); limit concomitant use with other potentially irritating topical products that have a strong drying effect or have high concentrations of alcohol, astringents, spices, or lime
• HPA axis suppression
  • Hypothalamic-pituitary-adrenal (HPA) axis suppression observed in clinical trials; may occur during or after treatment
  • Conditions that increase systemic absorption include use over large surface areas, prolonged use, and occlusive dressings
  • If HPA axis suppression develops, attempt to withdraw the drug
  • Pediatric patients may be more susceptible to systemic toxicity.

Pregnancy and Lactation

• No data are available on use in pregnant females to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes
• Lactation
  • Data are not available regarding the presence of clascoterone or metabolite in human milk, its effects on breastfed infants, and its effects on milk production.