NPRA

Xofigo® (radium-223 dichloride): Important Safety Information Update Regarding Increased Incidence of Deaths and Fractures in a Randomized Clinical Trial with Xofigo® used in Combination with Abiraterone Acetate and Prednisolone/ Prednisone

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Date: 8 December 2017

Description:

Preliminary data from a randomised clinical trial showed an increased incidence of fractures (24% vs. 7%) and deaths (27% vs. 20%) in patients with chemotherapy-naïve metastatic castration-resistant prostate cancer (CRPC) receiving Xofigo^® in combination with abiraterone acetate and prednisolone/ prednisone.

Further analysis of these results is being carried out, and the measures outlined below should be followed until more information is available:

Do not treat patients with metastatic CRPC with Xofigo^® in combination with abiraterone acetate and prednisolone/ prednisone.
Continued monitoring for fractures should be considered for patient who were previously treated with Xofigo^® in combination with abiraterone acetate and prednisolone/ prednisone.

A Direct Healthcare Professional Communication (DHPC) has been issued by Bayer Co. (Malaysia) Sdn. Bhd. in agreement with NPRA to highlight this safety issue. Please refer to this DHPC for further information.