In accordance with the European Medicines Agency (EMA) and the National Agency for the Safety of Medicines and Health Products (ANSM), laboratories marketing drugs containing cyproterone (ACP) acetate (ACP) wish to inform you of the following elements

Summary as a case of meningiomas (simple and multiple) were reported when using ACP (Androcur), mainly at 25 mg/day and more doses.  The risk of meningioma increases with the increase in cumulative doses.

The use of ACP (Androcur) is contraindicated in patients with meningioma or a history of meningioma.  Patients treated with ACP (Androcur) must be monitored for monitoring and detection of meningiomas in accordance with clinical practice1. replica meningioma is diagnosed in a patient treated with ACP (Androcur) Decree permanently. ÉADAIX MAJOR HIRSUTISMES OF NON-TUMORAL ORIGIN (idiopathic, polycystic ovary syndrome), when they seriously sound about psycho-affective and social life, ACP (ANDROCUR) at 50 mg is indicated when the use of ACP (Androcur) drugs at lower dose or other treatment options has not obtained results Satisfactory.  For the reduction of sexual impulses in paraphilies in combination with psychotherapeutic management, ACP (Androcur) at 100 mg can be used when other treatments are deemed inappropriate.  The use of ACP (Androcur) for the following indication remains unchanged: anti-androgenic palliative treatment of prostate cancer. And recommendations on monitoring users of cyproterone acetate (50 and 100mg) issued by ANSM in 2018 and 2019 remain unchanged.

As a reminder, an information certificate must be signed each year by the patient and his prescribing doctor and be given to the pharmacist for any issuance of these drugs.

Additional information in women, the therapeutic indications of ACP (Androcur) in monotherapy at the 50mg dose include major female hirsutisms of non-tumor origin (idiopathic, polycystic ovary syndrome), when they seriously sound on psycho-affective and social life . In men, therapeutic indications

Include, in a dose of 50mg and 100mg, the anti-Androgenic palliative treatment of prostate cancer, and in a dose of 100 mg, the reduction of sexual impulses in paraphilies in association with psychotherapeutic management. Meningioma is a rare tumor that forms from the meninges . The clinical signs and symptoms of meningioma can be non -specific and include vision disorders, hearing loss or tinnitus, loss of smell, headache that worsen over time, memory loss, convulsive crises and weakness in the extremities. was initially described in 2008 and the summary of the characteristics of the product (RCP) of the specialties containing ACP (Androcur) dosed at 10mg or more has been updated to include a contraindication in the case of meningiom or a history of meningioma, as well as a warning concerning this risk.

Recently, the results of a French epidemiological study of cohort showed an association between ACP (Androcur) and the risk of meningioma, dependent on the cumulative dose.
This study relied on the data from the National Health Insurance Fund (CNAM) and included a population of 25,3777 Female treated by ACP (Androcur) tablets in a dose of 50mg or 1200mg. The incidence of meningiomas treated with surgery or radiotherapy was compared between women exposed to ACP (Androcur) in high doses (cumulative dose ≥3g) and women weakly exposed to ACP (cumulative dose <3g). A relationship between the cumulative dose and the risk of meningioma has been highlighted: cumulative dose of ACPT to incidence (in patient-years) HRAAJUSTED (95%CI) B Low exposed (<3 g) 4.5/100,000 ref.exposed to ≥3 g23.8/100,0006.6 [4.0-11.1] 12 to 36 G26/100 000 6.4 [3.6-11.5] 36 to 60 G54.4/100,000 11.3 [5.8-22.2] More than 60 G129.1/100,000 21.7 [10.8-43.5] Ahazard ratio adjusted as age as a variable dependent on time and estrogens to inclusion.

A cumulative dose of 12 g can correspond, for example, to 1 year of treatment to 50 mg/day for 20 days each month.
Given this data, the ACP (Androcur) processing at 50 mg or 100 mg must be limited to the situations in which other treatments or interventions are not available or considered inappropriate regardless of the indications , with the exception of the palliative anti-Androgenic treatment of prostate cancer. In addition, the lowest possible effective dose should be used. Informations of drugs containing cyproterone acetate in association with ethinylestradiol or estradiol valley

ACP (2mg) in combination with ethinylestradiol (EE) is indicated in the following cases: treatment of moderate to severe acne linked to a sensitivity to androgens (associated or not with seborrhea) and/or treatment of hirsutism, in women of child procurement. For acne treatment, ACP/EE should only be used after failure of topical treatment or systemic antibiotic treatments.

ACP (1MG) in combination with the estradiol valley (VE) is indicated in the following cases: Hormone substitute treatment (HRT) symptoms of estrogen deficit in menopausal women Set prevention of post-menopausal osteoporosis in women with an increased risk of osteoporotic fracture and presenting intolerance or Treatments indicated in the prevention of osteoporosis. No new safety problem has not been identified concerning the risk of meningioma associated with products containing ACP/EE or ACP/VE at low dose. 3Weill A and Coll. (June 2019).

Prolonged exposure to high doses of cyproterone acetate and risk of meningioma in women. Paris: ANSM.

Declaration of adverse effects immediately declare any adverse effect suspected of being due to medication with your regional pharmacovigilance center or on www.signally-sante.gouv.fr .

ACP (Androcur) - Letter to healthcare professionals of April 16, 2020 - ANSM

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