Safety

WINLEVI® IS GENERALLY WELL TOLERATED2,3,16,17

  • Systemic side effects were noted in the phase Ill trials 25 and 26.2
  • Contraindications: Hypersensitivity to the active substance or to any of the excipients.2

WINLEVI® IS GENERALLY WELL TOLERATED2,3,16,17

  • Systemic side effects were noted in the phase Ill trials 25 and 26.2
  • Contraindications: Hypersensitivity to the active substance or to any of the excipients.2

SPECIAL WARNINGS AND PRECAUTIONS FOR USE2

  • WINLEVI® is for external use only. Not for ophthalmic, oral or vaginal use.
  • WINLEVI® should not be applied to cuts, abrasions, eczematous or sunburned skin.
  • Accidental transfer of cream into eyes, mouth or other mucous membranes should be avoided. If contact with mucous membranes occurs, rinse thoroughly with water.
  • Local Skin Reactions: Clascoterone may induce local irritation (oedema, erythema/redness, pruritus, scaling/ dryness, skin atrophy, stinging/burning, striae rubrae, telangiectasia).
  • 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.
  • Hypothalamic-pituitary-adrenal (HPA) Axis Suppression:
    • HPA axis suppression was observed and may occur during or after treatment with clascoterone. All Phase 2 maximum use clinical-trial subjects with HPA-axis suppression returned to normal HPA axis function 4 weeks after stopping treatment. Conditions, which augment systemic absorption, include use over large surfaces areas, prolonged use and the use of occlusive dressings.
    • If HPA axis suppression develops, consider withdrawing the medicinal product. HPA axis suppression was observed in 1/20 (5%) of adult subjects and in 2/22 (9%) of adolescent subjects. Paediatric patients may be more susceptible to systemic toxicity.
  • Hyperkalaemia: Elevated potassium levels were observed in some subjects treated with WINLEVI® or with the vehicle during the clinical trials.
  • Excipients
    • Cetyl alcohol: 25 mg cetyl alcohol in each gram. Cetyl alcohol may cause local skin reactions (e.g. contact dermatitis).
    • Propylene glycol: Contains 250 mg propylene glycol in each gram. Propylene glycol may cause skin irritation.

SAFETY PROFILE OPEN LABEL EXTENSION STUDY3

Study design

a Number of ITT patients ≥ 12 years of age enrolled in Study 25.
b Number of ITT patients ≥ 12 years of age enrolled in Study 26.
c Number of ITT patients ≥ 12 years of age enrolled in the long-term extension study (Study 27).
d Patients who achieved IGA score of ≤1 could stop treatment and resume if/when acne worsened.
e Total clascoterone treatment duration was up to 12 months for patients treated with clascoterone for 3 months in the pivotal studies.

BID, twice daily.

(adapted from Eichenfield et al. 20243)

Study results:

  • Consistent with previous studies erythema/reddening was the most common local skin reaction.20
  • No systemic side effects were noted.20
  • There was a low frequency of TEAEs.20
  • Long-term safety of clascoterone cream 1% and vehicle-treated individuals from the phase Ill trials were enrolled in an open-label, single-arm, 9-month extension study.20
  • Safety results consistent with phase Ill trials20
  • Safety data included face and trunk events.20

TEAE, treatment emergent adverse event.

(adapted from Eichenfield et al. 202020)

SAFETY DATA2

FROM CLINICAL STUDIES, THE MOST FREQUENTLY OBSERVED SIDE EFFECTS INCLUDED ERYTHEMA/ REDNESS, SCALING/DRYNESS.2

ADVERSE REACTIONS2,a

INCIDENCE OF NEW OR WORSENING LOCAL SKIN REACTIONS REPORTED BY ≥ 1% OF SUBJECTS TREATED WITH CLASCOTERONE AFTER DAY 1 IN 12-WEEK CONTROLLED CLINICAL TRIALS2

a Frequencies have been evaluated according to the following convention: very common (≥ 1/10), common (z 1/100 to <1/10), uncommon (2 1/10,000 to <1/1,000), very rare (<1/10,000) and not known (cannot be estimated from the available data).
b The denominators for calculating the percentages were the 674 of 709 subjects treated with clascoterone and 656 of 712 subjects treated with vehicle in these trials who had local skin reaction results reported after day 1.

LESS COMMON CLINICAL TRIAL ADVERSE REACTIONS

The following adverse reactions associated with the use of WINLEVI® were identified in clinical trials and the long-term safety study. The events are categorized by body system.

Reproductive system and breast disorders:
polycystic ovaries

Skin and subcutaneous tissue disorders:
hair colour changes

LESS COMMON CLINICAL TRIAL ADVERSE REACTIONS - PAEDIATRICS

In clinical trials, the types of adverse reactions seen with WINLEVI® were comparable in adult and paediatric patients.

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Indication

WINLEVI® (clascoterone) 10 mg/g cream is indicated for the topical treatment of acne vulgaris in patients 12 years of age and older.2

Adverse event reporting

Adverse events should be reported. Reporting forms and information can be found at yellowcard.mhra.gov.uk. Adverse events should also be reported to Glenmark Pharmaceuticals Europe Ltd medical_information@glenmarkpharma.com or call 0800 458 0383.

References

  1. Rosette C, et al. J Drugs Dermatol. 2019;18(5):412-418.
  2. WINLEVI® SPC.
  3. Eichenfield LF, et al. J Drugs Dermatol. 2024;23(1):1278-1283.
  4. Purdy S, DeBerker D. BMJ Clin Evid. 2008;1714.
  5. Zouboulis CC, Bettoli V. Br J Dermatol. 2015;Suppl 1:27-36.
  6. ONS. Estimates of the population for the UK, England, Wales, Scotland and Northern Ireland. Accessed 27 June 2024. https://www.ons.gov.uk/peoplepopulationandcommunity/populationandmigration/populationestimates/datasets/populationestimatesforukenglandandwalesscotlandandnorthernireland.
  7. Primary Care Dermatology Society. Acne: acne vulgaris. Accessed 27 June 2024. https://www.pcds.org.uk/clinical-guidance/acne-vulgaris.
  8. Dawson AL, et al. BMJ. 2013;346:f2634.
  9. Layton AM, Thiboutot D, Tan J. Br J Dermatol. 2021;184(2):219-225.
  10. Morshed ASM, et al. Sci Rep. 2023; 13: 21084.
  11. Baldwin, H et al. J Drugs Dermatol. 2023;22(6):582-587.
  12. Del Rosso JQ, Kircik L. J Dermatolog Treat. 2024;35(1):2298878.
  13. Kurokawa I, et al. Dermatol Ther (Heidelb). 2021;11(4):1129-1139.
  14. Tuchayi S, et al. Acne vulgaris. Nat Rev Dis Primers. 2015; 1:15029.
  15. Kim HJ, et al. Int J Mol Sci. 2024;25(10):5302.
  16. Hebert A, et al. J Drugs Dermatol. 2023;22(2):174-181.
  17. Hebert A, et al. JAMA Dermatol. 2020;156(6):621-630.
  18. Abelson MB, Fink K. (2003). Controlling for the Placebo Effect. Review of Ophthalmology. Accessed October 2024.
  19. Hebert A, et al. JAMA Dermatology. 2020;156(6):621-630 (Supplement 1).
  20. Eichenfield L, et al. J Am Acad Dermatol. 2020;83(2):477-485.
  21. Mazzetti A, et al. J Drugs Dermatol. 2019;18(6):563.
  22. NICE Clinical Knowledge Summary. Acne vulgaris.

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