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. 

 
 
Healthcare professional, Therapeutic Products
Published:

Dear Healthcare Professional Letters

12 Dec 2019

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

Step 1: On the top navigation ribbon of webpage, select 'For Healthcare Professionals' followed by 'Health Professionals Portal' and click on the choice of profession. User will be redirected to the specific HPP webpage for the selected profession.

Step 2: Click on the Restricted Content icon on the left panel of webpage and login via SingPass.

Step 3: Click on the MOH Alert icon under ‘Applications’ section

Step 4: Click on the Drug Alert tab to view the DHCPLs.