Source: European Medicines Agency (EU) Revision Year: 2026 Publisher: Cassiopea S.p.A., Via C. Colombo, 1, Lainate, 20045, Milan, Italy
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Pregnancy (see section 4.6).
In a dedicated phase 2 clinical study in adults and adolescents from 12 to <18 years of age, signs of HPA-axis suppression were limited to a laboratory-based assessment (adrenocorticotropic hormone [ACTH] stimulated cortisol levels, see section 5.1); no other clinical signs, symptoms or related endocrine adverse reactions were associated with such laboratory results. This laboratory-based evidence of HPA-axis suppression self-resolved without sequelae after treatment discontinuation (see section 4.8).
Conditions which augment systemic absorption (e.g. use over large surfaces, prolonged use, and the use of occlusive dressings), should be avoided (see section 4.2).
Typical symptoms of HPA-axis suppression include fatigue, weight loss, decreased appetite, low blood pressure, hypoglycemia, nausea, diarrhoea, vomiting, or abdominal pain (see section 4.8). 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.
The paediatric population may be at increased risk of HPA axis suppression. In the dedicated phase 2 study assessing the potential of clascoterone cream to cause HPA axis suppression, laboratory-based evidence of HPA axis suppression was more frequently observed in adolescents than in adults (see section 5.1). In order to reduce the systemic absorption, use in adolescents must be limited to the face only (see section 4.2).
This medicinal product may induce local irritation (such as erythema, pruritus, scaling/dryness, stinging/burning), mostly of minimal or mild severity (see section 4.8). Caution should be used when applying to sensitive areas of the skin, such as the neck: if a local skin reaction in a sensitive area occurs, treatment discontinuation should be considered; emollients may also be applied with a minimum of two (2) hours before or after the application of this medicinal product (see section 4.2).
Local irritation could be increased in case of concomitant use of cutaneous anti-acneic medicinal products. Concomitant therapy with other anti-acneic cutaneous treatments and other products (i.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.
Application to abraded, eczematous skin or patients with inflammatory skin conditions that may coexist with acne, e.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.
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 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.
The rebound effect (i.e., an exacerbation of acne vulgaris) following treatment withdrawal was not assessed during the clinical studies. Rebound effect was reported for compounds structurally related to clascoterone (i.e., topical corticosteroids) and cannot be excluded for this medicinal product. Should there be a reoccurrence of acne vulgaris within days to weeks after successful treatment of the condition with this medicinal product, a withdrawal reaction should be suspected. Reapplication should be done with caution and medical advice is recommended in these cases, or other treatment options should be considered.
Women of childbearing potential have to use an effective contraceptive method during treatment and for at least 10 days after the last dose (see section 4.6). The pregnancy status should be verified before initiating treatment with this medicinal product in women of childbearing potential (see section 4.6).
Educational materials regarding these precautions are available for healthcare professionals and patients (or parents/caregivers). A patient card is provided with the package of this medicinal product.
This medicinal product contains 25 mg cetyl alcohol in each gram. Cetyl alcohol may cause local skin reactions (e.g. contact dermatitis).
This medicinal product also contains 250 mg propylene glycol in each gram. Propylene glycol may cause skin irritation.
No interaction clinical studies have been performed. The use of clascoterone cream at the same time as other cutaneous medicinal products has not been evaluated (see section 4.2).
Since the systemic exposure of clascoterone and its main metabolite cortexolone following cutaneous application is negligible, no interaction with systemic treatments is expected; however caution is advised in concomitant use with glucocorticoid medicinal products.
Women of childbearing potential have to use an effective method of contraception during treatment and for at least 10 days after the last dose. No interaction clinical studies have been performed, therefore, an interaction with hormonal contraception cannot be excluded. The pregnancy status should be verified before initiating treatment with clascoterone in women of childbearing potential.
There are no or a limited amount of data from the use of cutaneous clascoterone in pregnant women. Animal studies have shown reproductive toxicity following subcutaneous administration (see section 5.3). Although systemic absorption of cutaneous clascoterone and its main metabolite cortexolone, is negligible, there could be individual factors (e.g. use over large surfaces, prolonged use) that may contribute to an increased systemic exposure. Based on animals studies and its mechanism of action (androgen receptor inhibition), clascoterone can cause fetal harm. This medicinal product is contraindicated during pregnancy (see section 4.3).
The patient must be informed and understand the risks related to the use of this medicinal product during pregnancy.
It is unknown whether clascoterone/metabolites are excreted in human milk. A risk to the newborns/infants cannot be excluded.
Use of this medicinal product is not recommended while breast-feeding or breast-feeding should be discontinued during treatment with this medicinal product.
There are no data on the effect of clascoterone on human fertility. Results from animal studies following subcutaneous administration showed no effect on fertility in male or female rats (see section 5.3).
Winlevi has no or negligible influence on the ability to drive and use machines.
The most frequently occurring adverse reactions are local skin reactions such as erythema (11.5%), scaling/dryness (10.0%), pruritus (7.4%) and stinging/burning (4.0%). These reactions were usually self-limiting and resolved during use of this medicinal product.
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).
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.
Laboratory evidence of hypothalamic-pituitary-adrenal (HPA) axis suppression(i.e., decreased serum cortisol levels at 30 minutes after ACTH stimulation) was observed in the dedicated phase 2 study in 1/20 (5%) of adult and in 2/22 (9%) of adolescent patients under maximal usage conditions to the entire face, shoulders, upper chest and upper back of acne patients, corresponding to mean daily amounts of 11.3 g (adults) and 9.3 g (adolescents). No clinical signs or symptoms of adrenal suppression were observed. Upon discontinuation of treatment the laboratory test results normalised within 4 weeks (see section 4.4).
If HPA axis suppression occurs, treatment interruption should be considered (see section 4.4).
Among the 444 subjects aged 12 to <18 years enrolled in phase 2 and phase 3 vehicle-controlled studies for acne vulgaris and exposed to clascoterone cream, the overall incidence of adverse reactions was 4/444 (0.9%).
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 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.
Not applicable.
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