Clascoterone

Local Irritation: Pruritus, burning, skin redness or peeling may be experienced with WINLEVI cream. If these effects occur, discontinue or reduce the frequency of application of WINLEVI cream. ( 5.1 ) Hypothalamic-pituitary-adrenal (HPA) axis suppression may occur during or after treatment with clascoterone. ( 5.2 ) Attempt to withdraw use if HPA axis suppression develops. ( 5.2 ) Pediatric patients may be more susceptible to systemic toxicity. ( 5.2 , 8.4 ) Hyperkalemia: Elevated potassium levels were observed in some subjects during the clinical trials. ( 12.2 )

Local Skin Reactions WINLEVI cream may induce local irritation (erythema/redness, pruritus, scaling/ dryness). Concomitant use with other potentially irritating topical products (medicated or abrasive soaps and cleansers, soaps and cosmetics that have a strong drying effect and products with high concentrations of alcohol, astringents, spices or lime) should be limited. The product should not be applied to cuts, abrasions, eczematous or sunburned skin.

Hypothalamic-pituitary-adrenal (HPA) Axis Suppression Hypothalamic-pituitary-adrenal (HPA) axis suppression was observed and may occur during or after treatment with clascoterone. In the PK trial, all subjects returned to normal HPA axis function at follow-up 4 weeks after stopping treatment [see Clinical Pharmacology (12.2) ]. Conditions which augment systemic absorption include use over large surface areas, prolonged use, and the use of occlusive dressings. If HPA axis suppression develops, an attempt should be made to withdraw the drug. Pediatric patients may be more susceptible to systemic toxicity.