Xgeva® (denosumab): Risk of Multiple Vertebral Fractures (MVF) Following Treatment Discontinuation

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Date: 8 September 2017

 

Description:

Cases of multiple vertebral fractures (MVF) have occurred rarely following discontinuation of Xgeva® in patients participating in ongoing clinical trials, particularly patients with risk factors such as osteoporosis or prior fracture. The fractures were not due to bone metastases. Healthcare professionals are advised to counsel patients not to interrupt Xgeva® therapy without their physician’s advice. When Xgeva® treatment is discontinued, healthcare professionals should also evaluate the individual patient’s risk for vertebral fractures.

A Direct Healthcare Professional Communication (DHPC) has been issued by Zuellig Pharma Sdn. Bhd. in agreement with NPRA to highlight this safety issue. Please refer to this DHPC for further information.

 

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