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Dear Doctor Letter (Rote-Hand-Brief) on radium-223-dichloride (Xofigo): new restrictions due to increased risk of fractures and possible increased risk of death
2018.08.06
Active substance: Radium-223-dichlorid
The use of Xofigo is associated with an increased risk of fractures. A possible increased risk of death was also observed in a clinical trial investigating radium-223 dichloride (Xofigo) in combination with abiraterone acetate and prednisone/prednisolone in patients with asymptomatic or mildly symptomatic castration resistant prostate cancer.
For details on the procedure please click on the following link to the homepage of the European Medicines Agency (EMA):
Download DHPC / Information letter , Download_VeroeffentlichtAm_EN