Winlevi Special Precautions

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 Pharmacology: Pharmacodynamics under Actions]. 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.
Use in Children: Safety and effectiveness of WINLEVI cream for the topical treatment of acne vulgaris have been established in 641 pediatric patients, aged 12 to 18 years in two identical multicenter, randomized, double-blind, vehicle-controlled, 12-week trials and 2 open-label pharmacokinetic studies [see Pharmacology: Pharmacodynamics: Clinical Studies under Actions].
Safety and effectiveness of WINLEVI cream for the topical treatment of acne vulgaris has not been established in pediatric patients under 12 years of age.
Hypothalamic-pituitary-adrenal (HPA) axis suppression was observed in 2/22 (9%) adolescent subjects. All subjects returned to normal HPA axis function at follow-up 4 weeks after stopping the treatment [see Pharmacology: Pharmacodynamics under Actions]. Children may be more susceptible to systemic toxicity when treated with clascoterone. [see Pharmacology: Pharmacodynamics under Actions].
Use in the Elderly: Clinical studies of WINLEVI cream did not include sufficient numbers of subjects aged 65 years of age and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.