CYPROTERONE. Androcur is a drug prescribed in case of hair disorder, acne in women or prostate cancer in men. At high doses and over a long period, it can increase the risk of meningioma, a tumor of the meninges.
Androcur® (cyproterone acetate) is a hormonal treatment indicated in women in case hirsutism (hair disorder and excess sebum like acne) and at the man in certain forms of Prostate cancer. However, since 2009, Androcur® has been subject to particular surveillance following the signal issued by France at the European level on the risk of the appearance of meningioma, a tumour, usually benign, that develops from the membranes that surround the brain and spinal cord (the brains), recalls a press release from the ANSM of December 1, 2022. This risk is in the leaflet of the drug and its generics since 2011. In 2018, the risk of meningiomas linked to prolonged use of cyproterone acetate at high doses (≥ 25 mg/day) was quantified for the first time by Health Insurance. This study showed that the risk is multiplied by 7 for women treated with high doses over a long period of time (more than 6 months) and by 20 After 5 years of treatment. In the light of these results, the ANSM set up a temporary specialized scientific committee (CSST) For review and modify the conditions of use and prescription of these drugs in order to limit the risk of meningioma. Since then, it has been observed a very strong decrease in the use of Androcur and its generics in all exposed people, particularly women. We have also observed a clear improvement in imaging monitoring as well as a reduction in the number of surgical removals of meningiomas, according to a study conducted by Gis Epi-Phare of the ANSM.
What is Androcur?
Androcur® is a hormonal treatment which contains a derivative of progesterone: cyproterone acetate. It has an antihormonal action, opposing the action of androgen hormones, mainly testosterone. It has a contraceptive effect.
What are the indications for Androcur in women?
According to the Medicines Agency, the indications depend on the dosage of cyproterone.
► 50 mg tablets are indicated for womenin the treatment of certain hormonal diseases manifested by an increase in the hair system (hirsutism).
What are the indications for Androcur in men?
► 50 mg tablets are indicated for men in certain forms of prostate cancer. Its action slows down the growth of prostate cells.
► 100 mg tablets have indications in the treatment of paraphilia (paraphilias consist of sexual arousal by atypical objects, situations, and/or objectives) in association with psychotherapeutic treatment.
Prescription in transgender people: in which cases?
In its original indications, Androcur® could also be prescribed to people transgender, in order to decrease male hormones as part of their transition course. However, in 2020, at the request of France, the European Medicines Agency (EMA) decided to restrict the conditions of use of Androcur®. Without prohibiting its use, the agency no longer recommends its prescription in transgender people.
What is the risk of meningioma with Androcur?
Cyproterone acetate, the active substance of Androcur® is monitored since 2009 at European level (European Medicines Agency following a report issued by France) because of the risk of developing meningioma during its use. A meningioma is a tumor, most often benign, which develops from the membranes that envelop the brain and spinal cord. It can result in various symptoms such as frequent headaches, vision, language, memory and hearing problems, nausea, dizziness, convulsions, loss of smell, weakness, paralysis. This signal led to include this risk in the drug leaflet since 2011. To clarify the relationship between taking the drug and the risk of meningioma, the Health Insurance conducted a pharmaco-epidemiological study in 2028, the results of which showed that:
► The risk of meningioma is increased by 7 for women treated with high doses (≥ 25 mg/day) over a long period of time (more than 6 months)
►The risk of meningioma is increased per 20 After 5 years of treatment.
► The risk of meningioma intensifies therefore as the dose and duration of treatment with cyproterone acetate increase.
Following these results, the conditions for dispensing the drug were reviewed. A study carried out by GIS EPI-PHARE using the National Health Data System (SNDS) covering the period 2010-2021 highlighted a very strong decrease in the use of Androcur and its generics in all exposed people, particularly women. At the end of 2021, the number of people treated with high-dose cyproterone acetate decreased significantly compared to August 2018, with a more marked drop for women (-88%) than for men (-69%) and for women. transgender women (-50%). Furthermore, the study reveals a very sharp decrease in the number of meningioma operations associated with cyproterone acetate (-93%), particularly in women (7 women operated on in 2021 compared to 95 in 2017). Please note that given the therapeutic benefit of these drugs, their marketing in France is not called into question.
What if you take Androcur?
According to the ANSM procedure:
► Your treatment needs to be reassessed at least once a yearwhether you have been taking it for a short time or for several years.
► In addition, periodic monitoring by brain imaging (MRI) is to be carried out according to the following schedule: an MRI at the start of treatment, to be repeated within 5 years, then every 2 years as long as the MRI is normal and the treatment is continued. If your doctor has not yet ordered a brain imaging (MRI) test, ask him or her to order one for you.
► If the MRI reveals the presence of a meningioma, the doctor will ask you to permanently stop your treatment because it is contraindicated in cases of meningioma (and in cases of a history of meningioma). Your doctor will refer you to a neurosurgeon who will assess the treatment to be adopted according to your individual situation.
► Beyond one year of treatment, your doctor must give you each year an information certificate which you must complete and sign together. To obtain your medication, this annual certificate (or a copy) must always be presented to the pharmacy in addition to your prescription.
► Do not stop your treatment without talking to your doctor. The latter is in fact best able to judge your care and the relevance of stopping treatment by taking into account your personal medical situation as a whole (individual benefit/risk).
► If you think you have experienced a side effect in connection with your treatment, we invite you to declare it directly on the portal for reporting adverse events : https://signalement.social-sante.gouv.fr
This declaration can also be made by your doctor or any other health professional or by a patient or user association.
What are the side effects of Androcur?
► In women:
- breast tension
- change in libido
- menstrual disorders (slight bleeding between periods, cessation of periods, etc.).
► In humans:
- decrease in sperm production usually reversible upon discontinuation of treatment, which may result in temporary infertility
- gynecomastia
- incapacity
- low libido
- sweats
- hot flashes
- anemia
- bone loss with prolonged treatment.
► In women as in men:
- weight change
- shortness of breath
- heavy legs
- migraine
- headache
- rash
- fatigue
- hustle
- depressed state.
► Rarely:
- hepatitis
- thromboembolic accident
- meningioma
What are the contraindications of Androcur?
Androcur® should not be used in the following cases:
- severe liver disease, some rare diseases that cause excess bilirubin in the blood
- tuberculosis or deterioration in general condition related to a serious illness
- thromboembolic accident (phlebitis, pulmonary embolism, myocardial infarction, etc.) old or occurring during treatment
- severe depression
- sickle cell anemia
- presence of an old or recent meningioma (brain tumor)
- history of herpes gestationis, jaundice or prolonged itching during pregnancy (50 mg tablet).
Is Androcur available with or without a prescription?
Androcur® is only available on medical prescription from list I, which can only be obtained upon presentation of a prescription written by a doctor, dental surgeon or midwife. Medicines on list I (red box on the box) can only be dispensed for the duration of treatment mentioned on the prescription, we can read on the Ministry of Health website.
What is the price of Androcur? What reimbursement?
ANDROCUR® 50 mg (scored tablet (white); box of 20) is sold at the price of 8.48 euros and is refundable at 30%.
Sources: Androcur (cyproterone acetate): the measures taken since 2018 have led to a clear reduction in the risk of meningioma, ANSM, December 1, 2022 / Androcur (cyproterone acetate) and generics: risk of meningioma during prolonged use, ANSM, 27 August 2018 / Froelich, S. et al. Does cyproterone acetate promote multiple meningiomas? Endocrine abstracts 16, P158 (2008)