WINLEVI Cream Ref.[116166] Active ingredients: Clascoterone

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

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.

In adolescents, the physician may decide to conduct the first evaluation visit earlier than three months, depending on the patient's adherence to treatment and/or safety considerations (see sections 4.4 and 4.8).

Renal or hepatic impairment

No studies have been conducted in patients with renal or hepatic impairment. Given the very low systemic absorption, no dose adjustment or special considerations are anticipated for these patients (see section 5.2).

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. Currently available data are described in section 5.1 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. The cream must be applied without using occlusive dressing to avoid an increased risk for systemic undesirable effects (see section 4.4).

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. This is also applicable to the use of sunscreen or emollients.

The patient should be instructed to apply a thin, uniform layer of Winlevi to the affected area, massaging gently, avoiding the eyes, eyelids, lips and nostrils, and then wash hands after application. The cream must be applied to the entire affected area and not to the acne lesions only.

There is no specific treatment for an overdose with Winlevi.

In the dedicated phase 2 clinical study, a mean daily amount of 11.3 g and 9.3 g clascoterone cream 10 mg/g was administered for 2 weeks to 20 adult and 22 adolescent patients, respectively, resulting in laboratory-based HPA axis suppression in 5% of adults and 9% of adolescents respectively.

In the event of overdose, Winlevi should be discontinued and the patient monitored for potential occurrence of HPA axis suppression signs and symptoms.

3 years.

Discard the unused product 1 month after first opening.

Prior to dispensing: store in a refrigerator (2°C-8°C).

Once dispensed to patient: before opening, store in a refrigerator (2°C–8°C). After the first opening, do not store above 25°C.

Do not freeze.

Epoxy-lined aluminium tube with a polypropylene screw cap.

Pack sizes: tubes of 10 g, 30 g or 60 g.

Not all pack sizes may be marketed.

This medicinal product may pose a risk to the environment (see section 5.3).

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.