Winlevi

Treatment should be initiated and supervised by a physician experienced in the diagnosis and treatment of acne vulgaris. Posology A thin uniform layer of cream should be applied to the affected area twice a day, in the morning and the evening, with at least eight hours between applications.

Two (2) fingertip units of cream (corresponding to approximately 1 g of cream) will cover an area of about 28 x 22 cm (approximately 600 cm2 of skin, corresponding to the average surface area of the face). Adults 3 Total daily dose should not exceed ten (10) fingertip units (corresponding to approximately 5 g of 10 mg/g clascoterone cream).

The cream can be applied on the face, chest and/or back. Adolescents (from 12 to < 18 years of age) Total daily dose should not exceed four (4) fingertip units (corresponding to approximately 2 g of 10 mg/g clascoterone cream). The cream must be applied on the face only.

No more than 60 g a month should be used (corresponding to one 60 g tube or two 30 g tubes). For adults and adolescents, to achieve the therapeutic effect, it is recommended to treat for three months. After three months of treatment, it is recommended that the physician evaluates the continued improvement of the patient.

Thereafter, regular assessment every three months of the skin and of the status of the patient should determine if continued use of the product is needed taking into account the status of the disease and the safety profile of the treatment.

8). Renal or hepatic impairment No studies have been conducted in patients with renal or hepatic impairment. 2). Elderly There are no clinical data in patients aged 65 years or older. Winlevi is not recommended for use in patients aged 65 years or older.

Paediatric population Children from 9 to < 12 years The safety and efficacy of Winlevi in children aged 9 to < 12 years old has not been established. 1 but no recommendation on a posology can be made. Children below 9 years of age There is no relevant use of Winlevi in children aged less than 9 years for the treatment of acne vulgaris.

Method of administration Winlevi is for cutaneous use only. The affected areas should be clean and dry before application. Winlevi should not be applied to cuts, abrasions, eczematous or sunburned skin. 4). Other cutaneous medicinal products used to treat other conditions on the same skin areas should be applied with a minimum of two (2) hours before or after the application of Winlevi.

0%). These reactions were usually self-limiting and resolved during use of this medicinal product. Tabulated list of adverse reactions Adverse reactions reported with cutaneous clascoterone in both adult and adolescent (from 12 to < 18 years of age) patients, including clinical trials and post-marketing experience, are presented in Table 1 below, according to the MedDRA system organ classification.

The frequency of adverse reactions is defined as follows: very common ≥ 1/10; common ≥ 1/100 and to < 1/10; uncommon ≥ 1/1 000 and to < 1/100; rare ≥ 1/10 000 and to < 1/1 000; very rare < 1/10 000; not known (cannot be estimated from the available data).

7 Table 1: Adverse reactions in adult and adolescent (from 12 to < 18 years of age) patients System Organ Class Adverse reaction Frequency Infections and infestations Application site folliculitis Rare Immune system disorders Hypersensitivity Rare Nervous system disorders Headache Rare Respiratory, thoracic and mediastinal disorders Oropharyngeal pain Rare Skin and subcutaneous tissue disorders Acne Dermatitis contact Rare General disorders and administration site conditions Application site pain Application site dryness Application site erythema Application site hypertrichosis Common Investigations Adrenocorticotropic hormone (ACTH) stimulation test abnormal* Common * assessed in the dedicated phase 2 study at supratherapeutic dosages, see section below.

3 g (adolescents). No clinical signs or symptoms of adrenal suppression were observed. 4). 4). 9%). Frequency, type and severity of adverse reactions through week 12 were similar to those in adults as presented in Table 1, which covers both populations.

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. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.

1); no other clinical signs, symptoms or related endocrine adverse reactions were associated with such laboratory results. 8). g. 2). 8). Patients should be instructed to inform their physician if they develop any symptoms of HPA-axis suppression.

If adrenal insufficiency is suspected, morning serum cortisol levels could be measured and the patient may be referred for endocrinological evaluation; treatment should be interrupted if HPA axis suppression is confirmed. Adolescents (from 12 to < 18 years of age) The paediatric population may be at increased risk of HPA axis suppression.

1). 2). 8). 2). Local irritation could be increased in case of concomitant use of cutaneous anti-acneic medicinal products. e. 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 used with caution, applied with a minimum of two (2) hours before or after the application of this medicinal product.

g. rosacea or perioral dermatitis, should be avoided. The concomitant application of astringent cleansing cosmetic products and drying or irritating agents (such as perfumed or alcohol-containing products) should be avoided. 5 In patients, whose skin has been subjected to procedures such as depilation, chemical peels, dermabrasion or laser resurfacing, the skin should be allowed to recover before application is considered.

Concomitant use with photodynamic therapy is not recommended. Treatment with this medicinal product should be discontinued prior to initiating photodynamic therapy. Accidental exposure to mucous membranes Accidental transfer of cream into eyes, mouth or other mucous membranes should be avoided.

If contact with mucous membranes occurs, the area should be rinsed thoroughly with water. , an exacerbation of acne vulgaris) following treatment withdrawal was not assessed during the clinical studies. , topical corticosteroids) and cannot be excluded for this medicinal product.

1. 6).