Clascoterone

Class: Skin and Mucous Membrane Agents, Miscellaneous
Chemical Name: [(8R,9S,10R,13S,14S,17R)-17-(2-hydroxyacetyl)-10,13-dimethyl-3-oxo-2,6,7,8,9,11,12,14,15,16-decahydro-1H-cyclopenta[a]phenanthren-17-yl] propanoate
Molecular Formula: C₂₄H₃₄O₅
CAS Number: 19608-29-8
Brands: Winlevi

Medically reviewed by Drugs.com on Oct 18, 2021. Written by ASHP.

Introduction

Clascoterone, an androgen receptor inhibitor, is a skin or mucous membrane agent.

Uses for Clascoterone

Clascoterone has the following uses:

Clascoterone cream is indicated for the topical treatment of acne vulgaris in patients 12 years of age and older.

Clascoterone Dosage and Administration

General

Clascoterone is available in the following dosage form(s) and strength(s):

Cream, 1%.

Dosage

It isessentialthat the manufacturer's labeling be consulted for more detailed information on dosage and administration of this drug. Dosage summary:

Pediatric Patients

Dosage and Administration

• Adolescents ≥12 years of age: Apply a thin layer (approximately 1 gram) to affected area twice daily (morning and evening). Avoid contact with eyes, mouth, and mucous membranes.

• For topical use only. Not for ophthalmic, oral or vaginal use.

Adults

Dosage and Administration

• Apply a thin layer (approximately 1 gram) to affected area twice daily (morning and evening). Avoid contact with eyes, mouth, and mucous membranes.

• For topical use only. Not for ophthalmic, oral or vaginal use.

Cautions for Clascoterone

Contraindications

None.

Warnings/Precautions

Local Skin Reactions

Clascoterone 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. Conditions which augment systemic absorption include use over large surface areas, prolonged use, and the us...