The review of Xofigo has been initiated at the request of the European Commission, under Article 20 of Regulation (EC) No 726/2004. Xofigo was authorised in the European Union in November 2013. The ongoing study of Xofigo in combination with Zytiga and prednisone/prednisolone included patients with castration-resistant prostate cancer that has spread mainly to the bones, who have no symptoms or only mild symptoms and who have not been treated with chemotherapy. EMA will communicate further at the conclusion of the review. These are temporary measures until the ongoing in-depth review of the benefits and risks of Xofigo is complete. Healthcare professionals are also warned that the safety and efficacy of Xofigo in combination with a class of second generation androgen receptor antagonists, such as Xtandi ( enzalutamide), have not been established. 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%). This card contains all contact information for your nuclear medicine specialist and help other physicians or governmental institutions ask necessary questions (with your permission).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. Show your treament card to all physicians and nurses who are involved in your care. With this information, you can decide which treatment is the most appropriate for you. Please inform your attending physician and other physicians involved in your care that you are receiving treatment with radium-223. The treatment with radium-223 has no negative influence on your daily activities. The only exception is with pregnant women and small children (blue box). No other precautionary measures are required for the contact you have with other people, including your partner. Dry yourself carefully to prevent contamination.īy following the instructions above, you can minimise radiation exposure to other people. If you are incontinent, specifically with stool incontinence, use diapers, pads or incontinence underwear that you can flush in the toilet.All other persons who use the same toilet must also wash their hands after each time and after every time they have contact with the patient's bodily fluids as listed above. Carefully wash your hands with water and soap each time you use the toilet.For the first seven days after the treatment, only use disposable materials that you can flush down the toilet after using to wipe up spots of bodily fluids (blood, vomit, urine and stool).Flush twice after each time you use the toilet.Urinate in a sitting position or use a urinal to prevent splattering.
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