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Xofigo (Radium-223 Dichloride) – Contraindicated in Combination with Abiraterone Acetate (Zytiga) and Prednisone/Prednisolone

The European Medicines Agency’s (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) has recommended a contraindication regarding use of Xofigo in combination with abiraterone acetate (Zytiga) and prednisone/prednisolone. This recommendation follows the review of preliminary data from an ongoing clinical trial which shows an increased risk of death and fractures. Pending conclusion of the review and to allow a thorough assessment of the available data, this contraindication is being introduced to protect public health. Xofigo is currently approved for the treatment of men with castration-resistant prostate cancer, symptomatic bone metastases and no known visceral metastatic disease.   Information about this review and…