| Document Date: 2015-06-10 19:02:19
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Company Onyx Pharmaceuticals Inc. / / Event Product Issues / Product Recall / / IndustryTerm neuroradiological imaging / medicinal products / cardiac imaging / colorless solution / neuro-radiological imaging / drug products / Monitor for signs and symptoms / / MedicalCondition IV heart failure / Multiple Myeloma KYPROLIS / Tumor Lysis Syndrome Tumor lysis syndrome / multiple myeloma / Thrombotic Thrombocytopenic Purpura /Hemolytic Uremic Syndrome / headache / Cardiac failure / arterial hypertension / refractory multiple myeloma / nausea / Thrombocytopenia / Peripheral Neuropathy / syncope / Pulmonary Complications Dyspnea / fatigue / Thrombotic thrombocytopenic purpura/hemolytic uremic syndrome / angina / diarrhea / Cardiac Arrest / Thrombocytopenic Thrombotic Purpura/Hemolytic Uremic Syndrome / sepsis / blindness / hypotension / cardiac disorder / Congestive Heart Failure / pneumonia / hypertension / disease / arthralgia / dyspnea / WARNINGS AND PRECAUTIONS Cardiac Arrest / shortness of breath / chills / Carcinogenesis / neurological disorder / Neutropenia / congestive / pulmonary edema / Reversible Posterior Leukoencephalopathy Syndrome / myalgia / facial flushing / Pulmonary Hypertension / fever / Tumor Lysis Syndrome / lethargy / acute coronary syndrome / high tumor / seizure / vomiting / Pulmonary Hypertension Pulmonary / myocardial infarction / heart failure / Hepatic Failure / Posterior reversible encephalopathy syndrome / Thrombocytopenia KYPROLIS / chest tightness / infection / renal failure / anemia / Myocardial Ischemia / / MedicalTreatment premedication / dialysis / / Organization KYPROLIS administration / Intravenous Administration / DOSAGE AND ADMINISTRATION / FDA / following KYPROLIS administration / / / Position physician / / Product dexamethasone / Dextrose / calculated dose / Sterile Water for Injection / / Technology MRI / Pharmacokinetics / Pharmacodynamics / dialysis / / URL www.fda.gov/medwatch / / |
HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use KYPROLIS safely and effectively. See full prescribing information for KYPROLIS. KYPROLIS® (carfilzomib) for Injecti