Xgeva PI - Amgen

HIGHLIGHTS OF PRESCRIBING INFORMATION Hypocalcemia: Xgeva can cause severe symptomatic hypocalcemia, and These highlights do not include all the information needed to use fatal cases have been reported. Correct hypocalcemia prior to initiating Xgeva safely and effectively. See full prescribing information for Xgeva . Monitor calcium levels during therapy, especially in the first Xgeva . weeks of initiating therapy, and adequately supplement all patients with Xgeva (denosumab) injection, for subcutaneous use calcium and vitamin D. ( ). Initial Approval: 2010 Osteonecrosis of the jaw (ONJ) has been reported in patients receiving Xgeva . Perform an oral examination prior to starting Xgeva . Monitor for symptoms. Avoid invasive dental procedures during treatment with ------------------------------RECENT MAJOR CHANGES------------------------ Xgeva .

Page 1 HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use XGEVA® safely …

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