It is also not recommended in combination with systemic cancer therapies other than LHRH analogues. Xofigo is not recommended in patients with a low level of osteoblastic bone metastases and in patients with only asymptomatic bone metastases. Subsequent systemic cancer treatment should not be initiated for at least 30 days after the last administration of Xofigo. In addition, Xofigo should not be started in the first 5 days following the last dose of abiraterone and prednisone/prednisolone. Xofigo is contraindicated in combination with abiraterone acetate and prednisone/prednisolone. Xofigo should only be used as monotherapy or in combination with an LHRH analogue for the treatment of adult patients with metastatic castration-resistant prostate cancer (mCRPC), symptomatic bone metastases and no known visceral metastases, who are in progression after at least two prior lines of systemic therapy for mCRPC (other than LHRH analogues), or ineligible for any available systemic mCRPC treatment. A possible increased risk of death was also observed in a clinical trial investigating Xofigo in combination with abiraterone acetate and prednisone/prednisolone in patients with asymptomatic or mildly symptomatic castration-resistant prostate cancer. The use of Xofigo is associated with an increased risk of fractures. The PRAC’s recommendations have now been endorsed by EMA’s Committee for Medicinal Products for Human Use (CHMP) and will be sent to the European Commission for a final legal decision. The company that markets Xofigo will have to conduct studies to further characterise these events and clarify the mechanisms behind them. However, the reasons for a possible earlier death seen in this study are not fully understood. It is thought that Xofigo, which is taken up by the bone, accumulates at sites where the bone is already damaged, for example by osteoporosis or micro-fractures, increasing the risk of fracture. In addition, 29% of patients who received the Xofigo combination had fractures, compared with 11% of patients given the placebo combination. In the study, patients given the combination with Xofigo died on average 2.6 months earlier than those given the combination with placebo. In addition, the combination used in this study is now contraindicated. The study included patients with no or only mild symptoms, whereas Xofigo is only authorised in patients with symptoms. The review of Xofigo was carried out by EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) after data from a clinical study suggested that patients given Xofigo in combination with Zytiga and prednisone/prednisolone could be at risk of dying earlier and had more fractures than patients given placebo with Zytiga and prednisone/prednisolone. The medicine should also not be used in patients who have no symptoms, in line with the current indication in addition, the use of Xofigo is not recommended in patients with a low number of osteoblastic bone metastases. Xofigo should not be used with other systemic cancer therapies, except for treatments to maintain reduced levels of male hormones (hormone therapy). Xofigo must also not be used with the medicines abiraterone acetate (Zytiga) and the corticosteroid prednisone or prednisolone. The European Medicines Agency (EMA) has concluded its review of the cancer medicine radium-223 dichloride (Xofigo) and has recommended restricting its use to patients who have had two previous treatments for metastatic prostate cancer to the bone or who cannot receive other treatments.
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