Transcription of Reference ID: 3324257 - Food and Drug Administration
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Reference ID: 3324257 - Food and Drug Administration
Page 1 HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use XGEVA safely and effectively. See full prescribing information for XGEVA. Xgeva (denosumab) injection, for subcutaneous use Initial Approval: 2010 ------------------------------RECENT MAJOR CHANGES------------------------ Indications and Usage ( ) 06/ 2013 Dosage and Administration ( ) 06/ 2013 Warnings and Precautions ( ) 02/ 2013 Warnings and Precautions ( ) 09/2012 Warnings and Precautions ( ) 06/ 2013 --------------------------- INDICATIONS AND USAGE---------------------------- Xgeva is a RANK ligand (RANKL) inhibitor indicated for: Prevention of skeletal-related events in patients with bone metastases from solid tumors ( ) Treatment of adults and skeletally mature adolescents with giant cell tumor of bone that is unresectable or where surgical resection is likely to result in severe morbidity ( , ) Limitation of use.
30 mL/min or receiving dialysis are at risk for hypocalcemia. Adequately supplement with calcium and vitamin D (8.6) See 17 for PATIENT COUNSELING INFORMATION. Revised: 06/2013 FULL PRESCRIBING INFORMATION: CONTENTS* 1 INDICATIONS AND USAGE 1.1 Bone Metastasis from Solid Tumors 1.2 Giant Cell Tumor of Bone 2 DOSAGE AND ADMINISTRATION
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