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Xofigo bayer12/18/2023 ![]() ![]() To correct your mailing address or fax number, contact Bayer Inc. Any case of fracture or death or other serious or unexpected side effects in patients receiving XOFIGO should be reported to Bayer Inc. ![]() Managing marketed health product-related side effects depends on health care professionals and consumers reporting them. This communication update will be further distributed through the MedEffect™ e-Notice email notification system. Health Canada is communicating this important safety information to healthcare professionals and Canadians via the Recalls and Safety Alerts Database on the Healthy Canadians Web Site. has updated the XOFIGO Canadian Product Monograph. Health Canada in collaboration with Bayer Inc. Safety and efficacy with the combination of XOFIGO and agents other than gonadotropin-releasing hormone analogues have not been established. XOFIGO is not recommended for use in combination with abiraterone acetate plus prednisone/prednisolone. Healthcare professionals are reminded that: Patients receiving XOFIGO should also inform their healthcare professional if they experience any side effects. Patients and caregivers should discuss any questions or concerns about this information with their healthcare professional. Patients should not take XOFIGO in combination with these medications. XOFIGO is used in men to treat advanced (castration-resistant) prostate cancer that has spread mainly to the bone and is causing symptoms such as pain.Īn increased number of bone fractures and a trend for increased deaths has been seen in a clinical trial involving patients who started treatment with XOFIGO in combination with two other medications (abiraterone acetate and prednisone/prednisolone). XOFIGO in combination with abiraterone acetate and prednisone/prednisolone is not authorized in Canada for the treatment of metastatic castration-resistant prostate cancer. An increased incidence of fractures (28.6% vs 11.4%) and a trend for increased deaths (38.5% vs 35.5%) was observed among patients receiving XOFIGO in combination with abiraterone acetate plus prednisone/prednisolone, compared to patients receiving placebo in combination with abiraterone acetate plus prednisone/prednisolone. The primary analysis of the ERA-223 study results has now been completed. independently communicated this important safety information to Canadian healthcare professionals. The study was unblinded early following an Independent Data Monitoring Committee (IDMC) review having observed increased fractures and death incidents. This clinical study was conducted to investigate the efficacy and safety of XOFIGO or placebo, concurrently initiated in combination with abiraterone acetate and prednisone/prednisolone in the treatment of asymptomatic or mildly symptomatic chemotherapy-naïve patients with bone predominant metastatic castration-resistant prostate cancer. An increased incidence of fractures and a trend for increased deaths was observed in a randomised, double-blind, placebo-controlled, and multicenter Phase III clinical study (ERA-223 study). This risk communication relates to an investigational study. This indication of XOFIGO remains unchanged. XOFIGO is authorized in Canada for the treatment of patients with castration-resistant prostate cancer with symptomatic bone metastases and no known visceral metastatic disease. XOFIGO (radium Ra 223 dichloride solution for injection), 1100 kBq/mL (29.7 microcurie/mL) An increased incidence of fractures and a trend for increased deaths was observed in a clinical trial assessing the concurrent initiation of XOFIGO in combination with abiraterone acetate and prednisone/prednisolone in the treatment of asymptomatic or mildly symptomatic chemotherapy-naïve patients with bone predominant metastatic castration-resistant prostate cancer. ![]()
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