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WINLEVI is a brand name for Clascoterone. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Winlevi (clascoterone) is indicated for: the topical treatment of acne vulgaris in patients 12 years of age and older. Paediatrics (<12 years): The safety and efficacy of Winlevi have not been established in paediatric patients under 12 years of age.
Verbatim from this product's MHRA label. Tap a section to expand.
Posology A thin uniform layer (approximately 1 g, corresponding to two fingertip units) of cream should be applied to the affected area twice a day, in the morning and the evening. The affected areas should be clean and dry before application.
Do not spot treat for optimal efficacy. Hands should be washed before and after applying Winlevi cream. If patients forget to take a dose of Winlevi, they should be instructed to apply the next dose at the usual time. Patients should be instructed to not apply a double dose to make up for forgotten doses.
A re-evaluation of patient treatment at 12 weeks should be considered if it is necessary to continue or restart treatment after this period and treatment should be continued after medical review and under regular supervision. Paediatric population Use in adolescents (12 – 18 years of age): dose adjustment is not required when Winlevi is administered to adolescents aged 12 – 18 years.
The safety and efficacy of clascoterone in children below 12 years of age have not yet been established. Renal or hepatic impairment No studies have been conducted in patients with renal or hepatic impairment. 2). Elderly Clinical studies of clascoterone did not include sufficient numbers of subjects aged 65 years of age and over to determine whether they respond differently from younger subjects.
Other reported clinical experience has not identified differences in responses between the elderly and younger patients. Method of administration For cutaneous use.
Summary of safety profile A total of 1,757 subjects have been exposed to at least one application of clascoterone across all of the clinical studies. Exposure to clascoterone twice daily was up to 12 months (including treatment period of the parent studies) for 123 subjects.
From clinical studies, the most frequently observed side effects included erythema/redness, scaling/dryness. In maximum-use Phase 2 studies, less common adverse reactions were HPA-axis suppression and hyperkalemia. Tabulated list of adverse reactions Adverse reactions reported with clascoterone, including clinical trials and post- marketing experience, are presented in Table 1 below, according to the MedDRA system organ classification (SOC and Preferred Term Level) and frequency.
Frequencies have been evaluated according to the following convention: very common (≥ 1/10); common (≥ 1/100 to <1/10); uncommon (≥ 1/1,000 to <1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (<1/10,000) and not known (cannot be estimated from the available data).
Table 1 Adverse reactions System organ class Frequency Adverse Drug Reaction Metabolism and nutrition disorders Common hyperkalemia Very common erythema/redness, scaling/drynessSkin and subcutaneous tissue disorders Common pruritus, stinging/burning, oedema, striae rubrae, skin atrophy, telangiectasia Reproductive system and breast disorders Rare polycystic ovaries, amenorrhea Description of selected adverse reactions Local skin reactions In two identical multicentre, randomized, double-blind, vehicle-controlled trials, 1,421 subjects 12 years and older with facial acne vulgaris applied Winlevi or vehicle twice daily for 12 weeks.
Local skin reactions (oedema, erythema/redness, pruritus, scaling/dryness, skin atrophy, stinging/burning, striae rubrae, telangiectasia) were observed during the 12-week treatment and occurred in a similar percentage of subjects treated with vehicle.
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 (edema, 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 Hypothalamic-pituitary-adrenal (HPA) axis suppression was observed and may occur during or after treatment with clascoterone. 1). 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. 1). 1). Excipients Cetyl alcohol This medicinal product contains 25 mg cetyl alcohol in each gram.
g. contact dermatitis). Propylene glycol This medicinal product also contains 250 mg propylene glycol in each gram. Propylene glycol may cause skin irritation.
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Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Local skin reactions reported by ≥ 1% of subjects treated with clascoterone are shown in Table 2. 8%) a 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.
Clinical Trial Adverse Reactions – Paediatrics In the pooled Phase 3 studies, in patients aged 12 to <18 years of age, there were no adverse reactions reported in > 1% of patients. 3% vehicle). 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.
Abnormal Laboratory Findings:
Hematologic, Clinical Chemistry and Other Quantitative Data Clinical Trial Findings Clinical laboratory evaluations were not performed in the Phase 3 studies. In maximum-use Phase 2 studies, the following abnormal laboratory findings were observed: Endocrine and Metabolism: hypothalamic-pituitary-adrenal (HPA) axis suppression, hyperkalemia (observed in subjects aged 9 to <12 years).
Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.