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Depending on the results of these tests, Xofigo may be interrupted or stopped, and you may be given an alternative treatment.

Before, during, and after treatment with Xofigo your doctor will carry out tests to check the health status of your bones.

Xofigo is authorised for use only when the spreading cancer is causing symptoms depending on how the cancer has spread to the bone, your doctor will decide whether Xofigo is the right treatment for you.

In addition Xofigo, used on its own or with medicines called ‘luteinising hormone releasing hormone (LHRH) analogues’, will be reserved for patients who have had at least two previous treatments for prostate cancer that has spread to the bone, or who cannot receive other treatments.

Your doctor will not use the combination of Xofigo and the other two medicines for prostate cancer.

Also, having Xofigo together with the cancer medicine Zytiga and a corticosteroid medicine (prednisone or prednisolone) for prostate cancer could possibly increase the risk of death.

The prostate cancer medicine Xofigo can increase the risk of having fractures.

The European Commission issued a final legal decision valid throughout the EU on 28 September 2018. The PRAC’s recommendations were endorsed by EMA’s Committee for Medicinal Products for Human Use ( CHMP). 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 (a dummy treatment) 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 bone metastases called 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 Zytiga (abiraterone acetate) and the corticosteroid prednisone or prednisolone.

On 26 July 2018, the European Medicines Agency concluded its review of the cancer medicine Xofigo (radium-223 dichloride), and recommended restricting its use to patients who have had two previous treatments for metastatic prostate cancer (prostate cancer that has spread to the bone) or who cannot receive other treatments. EMA restricts use of prostate cancer medicine Xofigo Medicine to be used only after two previous treatments or when other treatments cannot be taken