Winlevi (clascoterone)

No dosing information is available for this tab.

Clascoterone is applied topically to the skin as a 1% cream. To apply, first cleanse the affected areaand let skin dry. Apply a thin, uniform layer of clascoterone cream to the affected area. Avoid accidental transfer of the cream into the eyes, mouth, or other mucous membranes; if accidental contact with these areas occurs, rinse thoroughly with water. The cream should not be applied to the eye and should not be administered orally or intravaginally.

Prior to dispensing, store clascoterone cream in a refrigeratorbetween 2-8degreesC; do not freeze. Upon dispensing, instruct the patient to store at room temperature between 20-25degreesC. Discard the unused product within 180 days of dispensing or 1 month after first opening, whichever is sooner.

No dosing information is available for this tab.

No clinical studies have been conducted to evaluate the drug interaction potential of topical clascoterone. In vitro studies indicate that clascoterone inhibits cytochrome P450 (CYP) isoenzymes 1A2, 2B6, 2C8, 2C9,2C19,2D6, 2E1, and 3A4; however, this is not expected to have a meaningful effect on the pharmacokinetics of drugs metabolized by these isoenzymes. In vitro data indicate that clascoterone does not induce CYP 1A2, 2B6, or 3A4.

There are no contraindication interactions for this drug.

There are no severe interactions for this drug.

There are no moderate interactions for this drug.

*None.

• Hypothalamic-pituitary insufficiency

There are no severe contraindications for this drug.

• Hyperkalemia

Adverse effects occurring in 7-12% of patients receiving topical clascoterone include erythema/redness, pruritis, and scaling/dryness.

Rare or Very Rare

• Hyperkalemia
• Hypothalamic-pituitary insufficiency
• Polycystic ovarian syndrome

More Frequent

• Dry skin
• Erythema
• Pruritus of skin
• Skin scaling

Less Frequent

• Localized edema
• Skin atrophy
• Skin striae
• Stinging of skin
• Telangiectasia

Rare or Very Rare

• Amenorrhea

No enhanced messaging available.

Safety and effectiveness of topical clascoterone for the treatment of acne vulgaris have been established in pediatric patients aged 12-18 years. Safety and effectiveness of topical clascoterone for the treatment of acne vulgaris has not been established for patients <12 years of age.

Data are inadequate to assess whether use of topical clascoterone during pregnancy is associated with major birth defects, miscarriage, or other adverse maternal or fetal outcomes. In animal studies, adverse developmental effects were observed following administration of subcutaneous clascoterone to pregnant rats and rabbits during the period of organogenesis at maternally toxic dosages producing exposures greater than those achieved with the maximum recommended human dose.

There are no data regarding the presence of clascoterone or its metabolite in human milk, the effects on the breast-fed infant, or the effects on milk production. Consider the developmental and health benefits of breast-feeding along with the mother's clinical need for clascoterone and any potential adverse effects on the breastfed child from clascoterone or from the underlying maternal condition.

The manufacturer makes no specific dosage recommendations for geriatric patients.

Clinical studies of topical clascoterone did not include sufficient numbers of subjects aged>=65 years to determine whether they respond differently from younger subjects.