| Document Date: 2014-12-03 13:04:55
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City Philadelphia / Reference / / Company Amgen Inc. / / Event FDA Phase / / IndustryTerm dangerous machinery / magnetic resonance imaging / Monitor for signs or symptoms / healthcare professional / / MedicalCondition loss of consciousness / prolonged neutropenia / pneumonia / bacteremia / opportunistic infections / hemophagocytic lymphohistiocytosis/macrophage activation syndrome / convulsions / Tumor Lysis Syndrome Tumor lysis syndrome / Flushing / disseminated intravascular coagulation / headache / seizures / Carcinogenesis / Febrile Neutropenia Neutropenia / Neutropenia / nausea / Toxicity Grade* Action Cytokine Release Syndrome / serious infections / disorientation / Known hypersensitivity / Tumor Lysis Syndrome / tremor / acute lymphoblastic leukemia / seizure / febrile neutropenia / capillary leak syndrome / encephalopathy / speech disorders / balance disorders / CYTOKINE RELEASE SYNDROME / hypersensitivity / infection / Cytokine Release Syndrome Cytokine Release Syndrome / constipation / hypokalemia / Infections / rash / sepsis / catheter-site infections / hypotension / / MedicalTreatment medication errors / cranial irradiation / catheter / antibiotics / chemotherapy / intravenous infusion / / Organization BLINCYTO administration / FDA / / / Product For injection / DOSAGE FORMS AND STRENGTHS For injection / dexamethasone / Sodium Chloride / cytarabine / Sterile Water for Injection / for / / Technology Pharmacokinetics / magnetic resonance imaging / chemotherapy / Pharmacodynamics / MRI / / URL www.fda.gov/medwatch / /
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HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use BLINCYTOTM safely and effectively. See full prescribing information for BLINCYTO. BLINCYTO (blinatumomab) for inject