| Document Date: 2013-06-13 10:38:35
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Company Amgen Inc. / / Event Product Issues / / IndustryTerm yellow solution / healthcare / healthcare professional / / MedicalCondition severe hypocalcemia / giant cell tumors / tumor / Osteonecrosis / jaw pain / cancer / multiple myeloma / tooth infection / disease / hypocalcemia / headache / arthralgia / Recommended Dosage Bone Metastasis / tooth abscess / dyspnea / GENERAL Fatigue / Metastasis / hypophosphatemia / Carcinogenesis / severe symptomatic hypocalcemia / solid tumors / osteomyelitis / nausea / bone metastases / Bone Metastasis / pain / fatigue / Jaw (ONJ) Osteonecrosis / toothache / Correct preexisting hypocalcemia / RESPIRATORY Dyspnea Cough / osteitis / periodontal infection / giant cell tumor / GASTROINTESTINAL Nausea Diarrhea / NEUROLOGICAL Headache / bone resorption / osseous metastasis / prostate cancer / osseous metastases / back pain / breast cancer / Correct hypocalcemia / osteolysis / / MedicalTreatment contraception / dental surgery / chemotherapy / hormone therapy / surgery / dialysis / / Organization DOSAGE AND ADMINISTRATION / FDA / / / Position dentist / mediator / oral surgeon / Contraception Females Counsel / / Product vitamin D / sorbitol / lactation / / Technology Pharmacokinetics / antibodies / chemotherapy / Pharmacodynamics / dialysis / / URL www.fda.gov/medwatch / /
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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 subcuta