Your healthcare provider will do blood tests before and during treatment with Xofigo In addition, there were some deaths and blood transfusions that occurred due to severe bone marrow problems. In a clinical trial, some patients had to permanently discontinue therapy because of bone marrow problems. Xofigo can cause your blood cells counts to go down, including red blood cells, white blood cells, and/or platelets. Before taking Xofigo, tell your healthcare provider if you: Men should use condoms and make sure female partners who may become pregnant use birth control (contraception) during treatment and for 6 months after completing treatment with Xofigo. Xofigo can harm unborn babies when given to a pregnant woman. It is not known if Xofigo is safe and effective in women. It is for men whose prostate cancer has spread to the bone with symptoms but not to other parts of the body. More information is available on the EMA website.Xofigo ® (radium Ra 223 dichloride) injection is used to treat prostate cancer that no longer responds to hormonal or surgical treatment that lowers testosterone. Xofigo is authorised and marketed in Belgium in Belgium. The PRAC recommendations will now be sent to the Committee for Medicinal Products for Human Use (CHMP), responsible for questions concerning medicines for human use, which will adopt the Agency’s opinion. The benefits and risks of Xofigo in the restricted indication should also be further characterised. The company marketing Xofigo is requested to conduct studies to investigate, in particular, the mechanisms responsible for the possible risk of earlier death and the increased risk of fractures reported in the study. Preventive measures such as the use of bisphosphonates or denosumab as agents to increase bone strength should be considered before starting or resuming treatment with Xofigo. Patients should be carefully assessed for their risk of fractures before, during and after treatment.
The medicine should not be used in patients who have no symptoms, in line with the current indication, nor in those 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 hormone (hormone therapy).
The PRAC also confirmed its previous interim recommendation that the medicine must not be used with Zytiga and prednisone/prednisolone. However, the reasons for a possible earlier death 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 placebo. In the study, patients given Xofigo with Zytiga (abiraterone acetate) and prednisone/prednisolone died on average 2.6 months earlier than those given placebo with Zytiga and prednisone/prednisolone. The study included patients with no or only mild symptoms, whereas Xofigo is only authorised in patients with symptoms. These restrictions follow a review of data from a study suggesting that patients given Xofigo seemed to be at risk of dying earlier and had more fractures than patients given placebo (a dummy treatment). During its meeting of July 2018, the Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) has recommended restricting the use of the cancer medicine Xofigo (radium-223 dichloride) 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.
0 kommentar(er)
