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Clascoterone: Drug information

Clascoterone: Drug information
(For additional information see "Clascoterone: Pediatric drug information" and see "Clascoterone: Patient drug information")

For abbreviations, symbols, and age group definitions used in Lexicomp (show table)
Brand Names: US
  • Winlevi
Brand Names: Canada
  • Winlevi
Pharmacologic Category
  • Androgen Receptor Inhibitor
Dosing: Adult
Acne vulgaris

Acne vulgaris (alternative agent):

Note: Reserve for patients in whom initial topical therapies fail; for moderate to severe acne, may be used as part of an appropriate combination regimen (Ref).

Topical: Apply thin layer to affected areas of skin twice daily (Ref).

Dosing: Kidney Impairment: Adult

There are no dosage adjustments provided in the manufacturer's labeling.

Dosing: Hepatic Impairment: Adult

There are no dosage adjustments provided in the manufacturer's labeling.

Dosing: Pediatric

(For additional information see "Clascoterone: Pediatric drug information")

Acne vulgaris

Acne vulgaris: Children ≥12 years and Adolescents: Topical: Apply thin layer to the affected area twice daily, in the morning and the evening.

Dosing: Kidney Impairment: Pediatric

There are no dosage adjustments provided in the manufacturer's labeling.

Dosing: Hepatic Impairment: Pediatric

There are no dosage adjustments provided in the manufacturer's labeling.

Adverse Reactions (Significant): Considerations
Adrenal suppression

Reversible hypothalamic-pituitary-adrenal axis suppression (HPA-axis suppression) has been observed with clascoterone therapy.

Mechanism: Dose-related; related to the pharmacologic action (androgen receptor inhibitor).

Onset: Varied; in a pharmacokinetic trial, laboratory evidence of HPA-axis suppression was observed 2 weeks after initiation of therapy and in these subjects returned to normal 4 weeks after therapy discontinuation (Ref).

Risk factors:

• Children and adolescents (may be more susceptible)

• Application to large surface areas

• Prolonged use

• Use of occlusive dressings

Adverse Reactions

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.

>10%: Dermatologic: Exfoliation of skin, xeroderma

1% to 10%: Dermatologic: Atrophic striae (3%)

Frequency not defined:

Endocrine & metabolic: Amenorrhea, HPA-axis suppression (Mazzetti 2019), hyperkalemia

Genitourinary: Polycystic ovary syndrome

Contraindications

There are no contraindications listed in the manufacturer's labeling.

Warnings/Precautions

Concerns related to adverse effects:

• Local effects: Local adverse reactions may occur (eg, erythema, redness, pruritus, dryness, scaling) during treatment. Use with concomitant topical products (eg, medicated or abrasive soaps and cleansers, soaps and cosmetics with a strong drying effect, products with high concentrations of alcohol, astringents, spices, or limes) should be limited.

• Systemic effects: Absorption is increased by the use of occlusive dressings, application to large surface areas, or prolonged use.

Special populations:

• Pediatric: Children may absorb proportionally larger amounts after topical application and may be more prone to systemic effects. Prolonged use may affect growth velocity; growth should be routinely monitored in pediatric patients.

Other warnings/precautions:

• Appropriate use: For external use only; not for oral, ophthalmic, or intravaginal use. Avoid contact with eyes, mouth, and other mucous membranes. Not for use on eczematous, abraded, broken, or sunburned skin.

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Cream, External:

Winlevi: 1% (60 g) [contains cetyl alcohol, edetate (edta) disodium, polysorbate 80, propylene glycol]

Generic Equivalent Available: US

No

Pricing: US

Cream (Winlevi External)

1% (per gram): $11.66

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Dosage Forms: Canada

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Cream, External:

Winlevi: 1% (2 g, 10 g, 30 g, 60 g) [contains cetyl alcohol, edetate (edta) disodium, polysorbate 80, propylene glycol]

Administration: Adult

Topical: Clean and dry skin before applying. For topical external use only; not for oral, ophthalmic, or intravaginal use. Avoid contact with eyes, mouth, or other mucous membranes; rinse thoroughly if accidental contact with these areas occurs. Avoid use on cuts, abrasions, and eczematous or sunburned skin.

Administration: Pediatric

Topical: For topical use only; not for oral, ophthalmic, or intravaginal use. Gently wash and dry the affected area, then apply a thin, uniform layer. Avoid eyes, mouth, or other mucous membranes; rinse thoroughly with water if contact occurs. Do not apply to eczematous, abraded, broken, or sunburned skin.

Use: Labeled Indications

Acne vulgaris: Treatment of acne vulgaris in patients ≥12 years of age.

Metabolism/Transport Effects

None known.

Drug Interactions

There are no known significant interactions.

Pregnancy Considerations

Adverse events were observed in some animal reproduction studies following subcutaneous administration. Information related to topical clascoterone exposure in pregnancy is limited. Pregnant patients were excluded from the initial clinical studies and patients were removed from the trial once pregnancy was confirmed (Eichenfield 2020; Hebert 2020).

Breastfeeding Considerations

It is not known if clascoterone is present in breast milk. According to the manufacturer, the decision to breastfeed during therapy should consider the risk of infant exposure, the benefits of breastfeeding to the infant, and the benefits of treatment to the mother.

Monitoring Parameters

Skin irritation.

Mechanism of Action

Clascoterone is an androgen receptor inhibitor that decreases sebum production and inflammation.

Pharmacokinetics (Adult Data Unless Noted)

Protein binding: 84% to 89%.

Brand Names: International
International Brand Names by Country
For country code abbreviations (show table)

  • (BD) Bangladesh: Clascon;
  • (PR) Puerto Rico: Winlevi
  1. Eichenfield L, Hebert A, Gold LS, et al. Open-label, long-term extension study to evaluate the safety of clascoterone (CB-03-01) cream, 1% twice daily, in patients with acne vulgaris. J Am Acad Dermatol. 2020;83(2):477-485. doi:10.1016/j.jaad.2020.04.087 [PubMed 32348828]
  2. Graber E. Acne vulgaris: Management of moderate to severe acne in adolescents and adults. Post TW, ed. UpToDate. Waltham, MA: UpToDate Inc. http://www.uptodate.com. Accessed February 3, 2022a.
  3. Graber E. Acne vulgaris: overview of management. Post TW, ed. UpToDate. Waltham, MA: UpToDate Inc. http://www.uptodate.com. Accessed February 3, 2022b.
  4. Hebert A, Thiboutot D, Stein Gold L, et al. Efficacy and safety of topical clascoterone cream, 1%, for treatment in patients with facial acne: two phase 3 randomized clinical trials. JAMA Dermatol. 2020;156(6):621-630. doi:10.1001/jamadermatol.2020.0465 [PubMed 32320027]
  5. Mazzetti A, Moro L, Gerloni M, Cartwright M. Pharmacokinetic profile, safety, and tolerability of clascoterone (cortexolone 17-alpha propionate, CB-03-01) topical cream, 1% in subjects with acne vulgaris: an open-label phase 2a study. J Drugs Dermatol. 2019;18(6):563. [PubMed 31251549]
  6. Winlevi (clascoterone) [prescribing information]. Cranbury, NJ: Sun Pharmaceutical Industries Inc; December 2022.
  7. Zaenglein AL, Pathy AL, Schlosser BJ, et al. Guidelines of care for the management of acne vulgaris. J Am Acad Dermatol. 2016;74(5):945-973.e33. http://www.jaad.org/article/S0190-9622(15)02614-6/pdf. Accessed March 3, 2022. [PubMed 26897386]
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