XGEVA® (denosumab) Solution for Injection 120mg/vial - Risk of Multiple Vertebral Fractures (MVF) following treatment discontinuation

Amgen Singapore Manufacturing Pte Ltd would like to inform healthcare professionals of the risk of Multiple Vertebral Fractures (MVF), that may occur following discontinuation of treatment with XGEVA® (denosumab), particularly in patients with risk factors such as osteoporosis or prior fractures. Cases of MVF, not due to bone metastases, have occurred rarely following discontinuation of XGEVA® in patients participating in ongoing clinical trials. These fractures had occurred in post-menopausal women with malignancies who had previous fractures or who had known osteoporosis. Healthcare professionals are advised to evaluate the individual patient’s risk for vertebral fractures, following treatment discontinuation with XGEVA®. Patients should also be advised not to interrupt XGEVA® treatment without their physician’s advice. The local package insert for XGEVA® will be updated to include warnings regarding the risk of MVF. Please refer to the letter for more information. Published: 21 Jul 2017

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