Xofigo® (radium-223 dichloride)- Important safety information update regarding increased incidence of deaths and fractures in a randomised clinical trial used in combination with abiraterone acetate and prednisolone/prednisone

Bayer would like to inform healthcare professionals that an increased incidence of deaths and fractures has been identified in a randomised clinical trial in patients with chemotherapy-naïve metastatic castration-resistant prostate cancer (CRPC) receiving radium-223 dichloride in combination with abiraterone acetate and prednisolone/prednisone (15396/ERA-223 study). The full analysis of the results is not yet completed. Healthcare professionals are advised not to treat patients with metastatic CRPC with radium-223 dichloride in combination with abiraterone acetate and prednisolone/prednisone and to consider continued monitoring previously treated patients for fractures. Please refer to the letter for details. 

Only abstracts of the Dear Healthcare Professional Letters (DHCPL) are provided on this website. Details of these letters can be found in the MOH Alert System, which is accessible via the Health Professionals Portal (HPP), a one-stop portal for all healthcare professionals in Singapore. Dentists, medical doctors and pharmacists may access HPP at https://hpp.moh.gov.sg and follow the procedures below to access the MOH Alert system.

Step 1: Select your profession under ‘For Healthcare Professionals’.

Step 2: Click on ‘Useful links’.

Step 3: Click on ‘MOH Alert’ and log in via Singpass.

Step 4: Click on ‘Drug Alerts’ or ‘Med Device Alerts’ to view the DHCPLs.