| Document Date: 2014-06-06 13:13:18
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City Reference / / Company Amgen Inc. / / Continent Asia / / Event Product Issues / / IndustryTerm yellow solution / healthcare / healthcare professional / / MedicalCondition severe hypocalcemia / severe dysfunction / Osteonecrosis / multiple myeloma / hypocalcemia / Recommended Dosage Bone Metastasis / headache / Metastasis / thigh pain / clinically significant allergic reaction / solid tumors / osteomyelitis / nausea / anaphylaxis / fatigue / osteitis / periodontal infection / giant cell tumor / GASTROINTESTINAL Nausea Diarrhea / renal disease / clinically significant hypersensitivity / Hypocalcemia Pre-existing hypocalcemia / Hypersensitivity / anaphylactic reactions / significant hypersensitivity / osseous metastasis / prostate cancer / renal dysfunction / pruritus / breast cancer / back pain / Correct hypocalcemia / hypotension / severe renal dysfunction / dyspnea / upper airway edema / jaw pain / cancer / tooth infection / disease / arthralgia / tooth abscess / dyspnea / GENERAL Fatigue / Carcinogenesis / hypophosphatemia / severe symptomatic hypocalcemia / bone metastases / Bone Metastasis / pain / Jaw (ONJ) Osteonecrosis / toothache / Correct pre existing hypocalcemia / RESPIRATORY Dyspnea Cough / urticaria / NEUROLOGICAL Headache / osseous metastases / rash / / MedicalTreatment chemotherapy / hormone therapy / surgery / contraception / dental surgery / dialysis / / Organization DOSAGE AND ADMINISTRATION / FDA / ded / / / Position dentist / oral surgeon / / Product vitamin D / prednisone / lactation / / Technology antibodies / chemotherapy / dialysis / / URL www.fda.gov/me / /
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HIGHLIGHTS OF PRESCRIBING INFORMATION These hig hlights do not include all the informatio n nee ded to use XGEVA® safely and effectively. See full prescribing information for XGEVA. Xgeva (denosumab) injection, for subc