Xgeva® (denosumab 120 mg) – Risk of atypical femoral fracture

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 letter for more information.
Healthcare professional, Therapeutic Products
Published:

Dear Healthcare Professional Letters

12 Dec 2019

Only abstracts of the Dear Healthcare Professional Letters (DHCPL) are provided on this website. Details of the letters can be found on the MOH Alert System, which is accessible via the Health Professionals Portal (HPP). HPP is a one-stop portal for all healthcare professionals in Singapore. Dentists, medical doctors and pharmacists may access HPP at https://www.moh.gov.sg/hpp/, and follow the procedures below to access the MOH Alert system.

Step 1: On the top navigation ribbon of webpage, select 'For Healthcare Professionals' followed by 'Health Professionals Portal' and click on the choice of profession. User will be redirected to the specific HPP webpage for the selected profession.

Step 2: Click on the Restricted Content icon on the left panel of webpage and login via SingPass.

Step 3: Click on the MOH Alert icon under ‘Applications’ section

Step 4: Click on the Drug Alert tab to view the DHCPLs.