Clascoterone (Topical) (Monograph)

Brand name: Winlevi
Drug class: Skin and Mucous Membrane Agents, Miscellaneous

Medically reviewed by Drugs.com on Sep 24, 2023. Written by ASHP.

Introduction

Androgen receptor inhibitor; skin or mucous membrane agent.

Uses for Clascoterone (Topical)

Acne Vulgaris

Topical treatment of acne vulgaris in patients ≥12 years of age.

Recent consensus recommendations suggest that clascoterone may be a suitable treatment option for select patients, including those with moderate to severe acne who prefer not to take antibiotics, transmasculine patients for whom systemic androgen therapies could impact gender-affirming care, gender minority patients, other patients receiving androgen therapy, patients between 29–40 years of age with acne (regardless of gender), patients who are not appropriate candidates for treatment with isotretinoin, and those who prefer non-oral medications.

Clascoterone (Topical) Dosage and Administration

General

Patient Monitoring

• Monitor patients (especially pediatric patients) for symptoms of hypothalamic-pituitary-adrenal (HPA) axis suppression.

Administration

Apply topically as a 1% cream.

Cleanse area, let skin dry, then apply a thin, uniform layer to affected area.

Avoid accidental transfer to eyes, mouth, or other mucous membranes; if accidental contact occurs, rinse thoroughly with water.

Do not apply to the eye or administer orally or intravaginally.

Dosage

Pediatric Patients

Acne Vulgaris

Topical

Pediatric patients ≥12 years of age: Apply thin layer to affected area(s) twice daily.

Adults

Acne Vulgaris

Topical

Apply thin layer to affected area(s) twice daily.

Special Populations

Hepatic Impairment

No specific dosage recommendations.

Renal Impairment

No specific dosage recommendations.

Geriatric Use

No specific dosage recommendations.

Cautions for Clascoterone (Topical)

Contraindications

None.

Warnings/Precautions

Local Skin Reactions

Can cause local skin irritation. Limit concomitant use with other products that can irritate skin. Do not apply to cuts, abrasions, eczematous, or sunburned skin.

Hypothalamic-pituitary-adrenal (HPA) Axis Suppression

Suppression of the HPA axis has occurred. In the pharmacokinetic trial, normal HPA axis function returned within 4 weeks of discontinuation. Systemic absorption may be augmented with application over large surface areas, prolonged use, and use with occlusive dressings. Pediatric patients may be more susceptible to systemic toxicity. If HPA axis suppression develops during treatment, attempt to withdraw the drug.

Specific Populations

Pregnancy

Data inadequate to assess whether use of topical clascoterone during pregnancy is associated with major birth defects, miscarriage, or other adverse maternal or fetal outcomes. Adverse developmental effects observed in animal reproduction studies.

Lactation

Not known whether distributes into human milk, affects nursing infants, or affects milk production. Consider the developmental and health benefits of breast-feeding along with the mother's clinical need for the drug and any potential adverse effects on the breastfed child from clascoterone or from the underlying maternal condition.

Pediatric Use

Safety and efficacy established in pediatric patients ≥12 years of age. Safety and efficacy not established in pediatric patients <12 years of age.

Geriatric Use

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

Common Adverse Effects

Adverse effects occurring in 7–12% of patients: erythema/redness, pruritis, scaling/dryness.

Drug Interactions

No clinical studies have been conducted to evaluate drug interaction potential.

In vitro, inhibits CYP1A2, 2B6, 2C8, 2C9, 2C19, 2D6, 2E1, 3A4; not expected to have a meaningful effect on pharmacokinetics.

In vitro, does not induce CYP1A2, 2B6, or 3A4.

Clascoterone (Topical) Pharmacokinetics

Distribution

Extent

Not known whether distributed into human milk.

Plasma Protein Binding

84–89%.

Elimination

Elimination Route

Excretion not fully characterized in humans.

Stability

Storage

Topical

Cream

Prior to dispensing, store at 2–8ºC; do not freeze.

While in use, store at 20–25ºC; do not freeze. Discard unused product 180 days after date of dispensing or 1 month after first opening, whichever is sooner.

Actions

• Androgen receptor inhibitor; exact mechanism for treatment of acne vulgaris unknown.

• Androgens stimulate production of sebum; increased sebum production can cause accumulation of skin cells within hair follicles. This creates an anaerobic environment, which is ideal for proliferation of Cutibacterium acnes. Androgens can also stimulate inflammatory cytokines.

Advice to Patients

• Avoid applying topical clascoterone to damaged skin (such as cuts, abrasions), eczematous areas, and sunburned skin.

• Avoid concomitant use of other potentially irritating topical products (medicated or not).

• Advise patients to inform their clinician of existing or contemplated concomitant therapy, including prescription and OTC drugs and dietary or herbal supplements, as well as any concomitant illnesses.

• Advise women to inform their clinician if they are or plan to become pregnant or plan to breast-feed.

• Inform patients of other important precautionary information.

Additional Information

The American Society of Health-System Pharmacists, Inc. represents that the information provided in the accompanying monograph was formulated with a reasonable standard of care, and in conformity with professional standards in the field. Readers are advised that decisions regarding use of drugs are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and that the information contained in the monograph is provided for informational purposes only. The manufacturer’s labeling should be consulted for more detailed information. The American Society of Health-System Pharmacists, Inc. does not endorse or recommend the use of any drug. The information contained in the monograph is not a substitute for medical care.

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.

Reload page with references included

Frequently asked questions

• Does Winlevi need to be refrigerated?
• How long does Winlevi take to work for acne?

Medical Disclaimer