WINLEVI (clascoterone) cream 1% is an androgen receptor inhibitor indicated for the topical treatment of acne vulgaris in patients 12 years of age and older.
IMPORTANT SAFETY INFORMATION
WARNINGS AND PRECAUTIONS
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.
Hypothalamic-pituitary-adrenal (HPA) axis suppression may occur during or after treatment with WINLEVI. In the PK trial, HPA axis suppression was observed in 5% of adult subjects and 9% of adolescent subjects at Day 14. 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 use of occlusive dressings.Attempt to withdraw use if HPA axis suppression develops.
Pediatric patients may be more susceptible to systemic toxicity.
Hyperkalemia: Elevated potassium levels were observed in some subjects during the clinical trials. Shifts from normal to elevated potassium levels were observed in 5% of WINLEVI-treated subjects and 4% of vehicle-treated subjects.
Most common adverse reactions occurring in 7% to 12% of patients are erythema/reddening, pruritus and scaling/dryness. Additionally, edema, stinging, and burning occurred in >3% of patients and were reported in a similar percentage of subjects treated with vehicle.
To report SUSPECTED ADVERSE REACTIONS, contact Sun Pharmaceutical Industries, Inc. at 1-800-818-4555 or FDA at 1-800-FDA-1088 or http://www.fda.gov/medwatch.
For more details, please see full Prescribing Information and the Patient Information.
REFERENCES: 1. Ceruti JM, Leiros GJ, Balana ME. Androgens and androgen receptor action in skin and hair follicles. Mol Cell Endocrinol. 2018;465:122-133.
2. Tuchayi SM, Makrantonaki E, Ganceviciene R, Dessinioti C, Feldman SR, Zouboulis CC. Acne vulgaris. Nature Rev Dis Primers. 2015;1:15029. doi: 10.1038/nrdp.2015.29.
3. Cong TX, Hao D, Wen X, Li XH, He G, Jiang X. From pathogenesis of acne vulgaris to anti-acne agents. Arch Dermatol Res. 2019;311(5):337-349.
4. Del Rosso JQ, Kircik LH, Stein Gold L, et al. Androgens, androgen receptors, and the skin: from the laboratory to the clinic with emphasis on clinical and therapeutic implications. J Drugs Dermatol. 2020;19(3):30-35.
5. 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.
6. Rosette C, Agan FJ, Mazzetti A, Moro L, Gerloni M. Cortexolone 17α-propionate (clascoterone) is a novel androgen receptor antagonist that inhibits production of lipids and inflammatory cytokines from sebocytes in vitro. J Drugs Dermatol. 2019;18(5):217-223.
7. Makrantonaki E, Ganceviciene R, Zouboulis C. An update on the role of the sebaceous gland in the pathogenesis of acne. Dermatoendocrinol. 2011;3(1):41-49.
8. Elsaie ML. Hormonal treatment of acne vulgaris: an update. Clin Cosmet Investig Dermatol. 2016;9:241-248.
9. Lai JJ, Chang P, Lai KP, Chen L, Chang C. The role of androgen and androgen receptor in skin-related disorders. Arch Dermatol Res. 2012;304(7):499-510.
10. Rao A, Douglas SC, Hall JM. Endocrine disrupting chemicals, hormone receptors, and acne vulgaris: a connecting hypothesis. Cells. 2021;10(6):1439.
11. Ryan-Kewley AE, Williams DR, Hepburn N, Dixon RA. Non-antibiotic isotretinoin treatment differentially controls Propionibacterium acnes on skin of acne patients. Front Microbiol. 2017;8(1381):1-11.
12. Mazzetti A, Moro L, Gerloni M, Cartwright M. A phase 2b, randomized, double-blind vehicle controlled, dose escalation study evaluating clascoterone 0.1%, 0.5%, and 1% topical cream in subjects with facial acne. J Drugs Dermatol. 2019;18(6):570-575.
13. Winlevi [prescribing information]. Cranbury, NJ: Sun Pharmaceutical Industries, Inc.; September 2021.
14. US Food and Drug Administration. Novel drug approvals for 2020. https://www.fda.gov/drugs/new-drugs-fda-cders-new-molecular-entities-and-new-therapeutic-biological-products/novel-drug-approvals-2020. Updated January 13, 2021. Accessed September 1, 2022.
15. Leyden JJ, Del Rosso JQ, Baum EW. The use of isotretinoin in the treatment of acne vulgaris: clinical considerations and future directions. J Clin Aesthet Dermatol. 2014;7(2 suppl):S3-S21.