Agenzia Italiana del Farmaco
Direct communication with healthcare professionals on Medrossiprogesterone acetato - Direct communication with healthcare professionals on Medrossiprogesterone acetato
Direct communication with healthcare professionals on Medrossiprogesterone acetato
Medroxyprogesterone acetate: Risk of meningioma and measures to minimise this risk.
Summary
- There is an increased risk of developing meningioma with high doses of medroxyprogesterone acetate (all injectable and ≥100 mg oral formulations), primarily after prolonged use (several years).
- For contraception or non-oncological indications:
- Medicines containing high doses medroxyprogesterone acetate are contraindicated in patients with meningioma or a history of meningioma.
- If meningioma is diagnosed in a patient treated with high doses medroxyprogesterone acetate, treatment must be stopped.
- For oncological indications:
- If a meningioma is diagnosed in a patient treated with high doses medroxyprogesterone acetate, the need to continue the treatment should be carefully reconsidered, on a case-by-case basis taking into account individual benefits and risks.
- Patients treated with high doses medroxyprogesterone acetate should be monitored for signs and symptoms of meningioma in accordance with clinical practice.
Published on: 10 October 2024
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