information and recommendations relating to the risk of meningioma

Thursday 21st November 2024 01:45 PM

En agreement with the European Medicines Agency (EMA) and the National Agency for the Safety of Medicines and Health Products (ANSM), the Pfizer laboratory recalls the increased risk of meningioma associated with medroxyprogesterone acetate, mainly during prolonged exposure, and specifies the recommendations applicable in the event of treatment with DEPO-PRODASONE 500 mg suspension for injection [1, 2].

A necessary adjustment for DEPO-PRODASONE

In France, two specialties of medroxyprogesterone acetate in high doses in the form of injectable suspensions are available:

in contraception : DEPO PROVERA 150 mg/3 mL intramuscular suspension, specialty for which measures to minimize the risk of meningioma and monitor patients in the event of prolonged use were issued in 2023 (cf. in the articles du July 27, 2023 and December 21, 2023), following the publication of an EPI-Phare study [3]. According to this study carried out in the French population and published in June 2023, there is an increased risk of developing a meningioma with prolonged use (3 years or more) of medroxyprogesterone acetate dosed at 150 mg/3 mL compared to a control group (cf. our article of June 29, 2023);
en oncologie : DEPO-PRODASONE 500 mg suspension injectable (cf. Boxed), specialty for which no recommendation relating to the risk of meningioma had been formulated until now.

**Box – Therapeutic indication of DEPO-PRODASONE**
Hormonal treatment of certain hormone-dependent cancers: metastatic breast cancer, after failure of selective estrogen receptor activation modulators (MoSARE or SERM), aromatase inhibitors and/or fulvestrant. recurrent or metastatic endometrioid type endometrial cancer.

Recommendations for DEPO-PRODASONE

Concerning the specialty DEPO-PRODASONE used in oncology, the following recommendations relating to the risk of meningioma apply:

If a meningioma is diagnosed, the need for continued treatment should be carefully reassessedon a case-by-case basis, taking into account individual benefits and risks. This recommendation is different from that applicable to DEPO PROVERA, the use of which is contraindicated in cases of meningioma. or history of meningioma ;
Patients must be monitored for signs and symptoms of meningioma in accordance with clinical practice: vision problems or hearing (hearing loss, ringing in the ears), loss of smell, headaches that get worse over time, memory problems, seizures or weakness in the extremities;
The MRI follow-up is not obligatory for DEPO-PRODASONE. For DEPO PROVERA, this regular monitoring by brain MRI has been necessary since July 2024 [4] for women whose treatment is continued beyond one year.

The information documents for DEPO-PRODASONE 500 mg (summary of product characteristics and leaflet) will be mis updated to reflect the risk of meningioma (addition of a warning and adverse effect).