Patients using Xofigo have an increase in bone fractures and mortality when used in combination with abiraterone acetate and prednisone/prednisolone. Increased Fractures and Mortality in Combination with Abiraterone plus Prednisone/Prednisolone: You should report signs of bleeding or infections to your health care provider. It is important to be compliant with blood cell count monitoring appointments while receiving Xofigo. Male patients should use condoms and their female partners (of reproductive potential) should use effective contraception during and for 6 months after completing treatment with Xofigo.īased on how Xofigo works it may impair a male's ability to father children if they are of reproductive potential. Male patients should not get female partners pregnant during treatment with Xofigo and for 6 months after stopping treatment. It is important to warn pregnant females and females of reproductive potential of the potential risk to a fetus. Xofigo can cause fetal harm when administered to a pregnant female. The safety and efficacy of Xofigo have not been established in females. This medicine should be discontinued in patients who experience life-threatening complications despite supportive care measures. Monitor patients with compromised bone marrow reserve closely. Discontinue Xofigo if hematologic values do not recover within 6 to 8 weeks after treatment. Warningsīone Marrow Suppression: Blood counts should be measured before the first treatment and also before every dose of Xofigo. Once Xofigo is attached to the bone cancer, it gives off radiation that breaks the DNA of the cancer cells, which kills the prostate cancer cells. Xofigo works as it acts like calcium and goes to areas of bone that are growing quickly, which is where the bone cancer is in the body. Xofigo contains a radioactive ingredient called radium 233 that concentrates in the bone where there is cancer and kills the cancer cells. Xofigo (radium 223 dichloride) is an intravenous injection used for the treatment of prostate cancer when hormonal or surgical treatment that lowers testosterone is no longer working, and the prostate cancer has spread to bones but has not spread to other parts of the body. Medically reviewed by Melisa Puckey, BPharm. The PRAC also confirmed its previous interim recommendation that the medicine must not be used with Zytiga and prednisone/prednisolone.Drug class: Therapeutic radiopharmaceuticals 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). Medicine should only be used after two previous treatments or when other treatments cannot be takenĮMA’s safety committee PRAC 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.
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