ADR that result in revision of patient information
|
| |
| Singapore: Xgeva® (denosumab 120 mg) – Risk of atypical femoral fracture |
| |
The Health Sciences Authority (HSA) announced that GlaxoSmithKline (GSK) would like to notify healthcare professionals of the risk of atypical femoral fractures with Xgeva® use. GSK and Amgen have proactively evaluated the potential for atypical femoral fractures in patients treated with Xgeva® in clinical trials and the postmarketing setting. A single case of atypical femoral fracture was reported in the open label extension phase of an ongoing clinical trial of Xgeva® in men with hormone-refractory prostate cancer. To communicate this important information, the Xgeva® package insert has been updated with a new warning on atypical femoral fracture and the inclusion of atypical femoral fracture as an adverse drug reaction.
Please refer to the following website in HSA for details:
http://www.hsa.gov.sg/publish/hsaportal/../DHCPL.html
In Hong Kong, Xgeva Solution For Injection 120mg (HK-61163) is registered by GSK Limited and is a prescription-only medicine. Xgeva is indicated for the prevention of skeletal related events (pathological fracture, radiation to bone, spinal cord compression or surgery to bone) in adults with bone metastases from solid tumours. GSK Limited has submitted the application to change the package insert by including the risk of atypical femoral fracture, and the approved insert has included the relevant safety information. The Department of Health will keep vigilant against any updated safety issue of the product.
Ends/ Thursday, April 18, 2013
Issued at HKT 15:30
|
| |
