Healthcare professionals in the EU must not use a combination of Xofigo with the anti-androgen Zytiga and prednisone/prednisolone, and should stop this combination in men currently treated with it and review the treatment for these patients.īoth medicines can continue to be used separately, in line with the recommendations in their product information. Patients have completed the Xofigo part of the study, and the combination is no longer being used all the patients involved are being monitored closely. The ongoing clinical study includes metastatic prostate cancer patients who have not previously received chemotherapy and who have no symptoms or only mild symptoms, such as pain. Xofigo is currently authorised for use in men whose prostate cancer has spread to the bones and is causing symptoms. In view of the seriousness of the events reported, the PRAC has taken action by introducing a contraindication as a temporary measure to protect patients’ safety while an in-depth review of the benefits and risks of Xofigo is ongoing. In this study 34.7% of patients treated with Xofigo, Zytiga and prednisone/prednisolone have died so far, compared with 28.2% of patients given placebo, Zytiga and prednisone/prednisolone.įractures have also occurred more frequently with the Xofigo combination than the placebo combination (26% versus 8.1%). On 9 March 2018, the European Medicines Agency (EMA) has recommended contraindicating the use of the prostate cancer medicine Xofigo (radium-223 dichloride) with Zytiga ( abiraterone acetate) and prednisone/prednisolone, due to an increased risk of death and fractures with this combination.ĮMA’s Pharmacovigilance Risk Assessment Committee (PRAC) has reviewed the preliminary data from an ongoing clinical study in metastatic prostate cancer patients.

Radium prostate cancer