引 致 更 改 給 病 人 的 產 品 資 訊 的 藥 物 不 良 反 應 警 示
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| Canada: XOFIGO (radium Ra 223 dichloride) - Increased incidence of fractures and trend for increased deaths with XOFIGO used in combination with abiraterone and prednisone/prednisolone (English Only) |
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Health Canada announces that 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.
This risk communication relates to an investigational study. 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 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. The study was unblinded early following an Independent Data Monitoring Committee (IDMC) review having observed increased fractures and death incidents. In Dec 2017, Bayer Inc. independently communicated this important safety information to Canadian healthcare professionals.
The primary analysis of the ERA-223 study results has now been completed. 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.
XOFIGO in combination with abiraterone acetate and prednisone/prednisolone is not authorized in Canada for the treatment of metastatic castration-resistant prostate cancer.
Healthcare professionals are reminded that:
- 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. This indication of XOFIGO remains unchanged.
- XOFIGO is not recommended for use in combination with abiraterone acetate plus prednisone/prednisolone.
- Safety and efficacy with the combination of XOFIGO and agents other than gonadotropin-releasing hormone analogues have not been established.
Health Canada in collaboration with Bayer Inc. has updated the XOFIGO Canadian Product Monograph.
Please refer to the following website in Health Canada for details:
http://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/../68244a-eng.php
In Hong Kong, Xofigo Solution for Injection 1100 KBQ/ml (HK-64332) is a pharmaceutical product containing radium-223 dichloride which is registered by Bayer Healthcare Limited and is a prescription-only medicine. So far, the Department of Health (DH) has received 11 cases of adverse drug reaction related to Xofigo, but none of them is related to death and fractures. Related news was previously issued by various overseas drug regulatory authorities, and was posted on the Drug Office website since 2 Dec 2017, with the latest update posted on 26 Sep 2018. Letters to inform local healthcare professionals were issued by the DH on 16 Jul 2018. In light of the above Health Canada’s announcement, the matter together with the latest safety updates issued by other overseas drug regulatory authorities will be discussed by the Registration Committee of the Pharmacy and Poisons Board.
Ends/Friday, Nov 9, 2018
Issued at HKT 16:00
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