Transcription of HIGHLIGHTS OF PRESCRIBING INFORMATION - Amgen
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HIGHLIGHTS OF PRESCRIBING INFORMATION - Amgen
Page 1 HIGHLIGHTS OF PRESCRIBING INFORMATIONT hese HIGHLIGHTS do not include all the INFORMATION needed to use XGEVA safely and full PRESCRIBING INFORMATION for (denosumab) injection, for subcutaneous useInitial Approval: 2010------------------------------RECENT MAJOR CHANGES------------------------Warnings and Precautions, Hypocalcemia ( ) 02/2020---------------------------INDICA TIONS AND USAGE----------------------------Xgeva is a RANK ligand (RANKL) inhibitor indicated for: Prevention of skeletal-related events in patients with multiple myeloma and 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.
5.5 Atypical Subtrochanteric and Diaphyseal Femoral Fracture 5.6 Hypercalcemia Following Treatment Discontinuation in Patients with Giant Cell Tumor of Bone and in Patients with Growing Skeletons 5.7 Multiple Vertebral Fractures (MVF) Following Treatment Discontinuation 5.8 Embryo-Fetal Toxicity 6 ADVERSE REACTIONS 6.1 Clinical Trials Experience
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