| Document Date: 2014-08-21 00:16:10
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Company GlaxoSmithKline / / IndustryTerm medicinal products / colorless solution / parenteral drug products / / MedicalCondition Virus Reactivation Hepatitis B / anaphylactic reaction / dyspnea / laryngeal edema / Tumor Lysis Syndrome Tumor lysis syndrome / Headache / HBV / genital herpes / Leukopenia / chronic lymphocytic leukemia / liver failure / bronchitis / nausea / thrombocytopenia / Herpes / hepatitis B / syncope / fulminant hepatitis / fatigue / Progressive Multifocal Leukoencephalopathy / pulmonary edema / bradycardia / Lymphopenia / angina / diarrhea / hepatitis / prior HBV infection / pruritus / infections / back pain / agranulocytosis / sepsis / hypotension / Previously Untreated Chronic Lymphocytic Leukemia / prolonged neutropenia / arrhythmia / abdominal pain / tumor / pneumonia / hypertension / fatal neutropenic sepsis / bronchospasm / HBV infection / flushing / Arthralgia / dyspnea / high tumor burden / chills / Carcinogenesis / VIRUS REACTIVATION AND PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY / Neutropenia / Tumor Lysis Syndrome / acute coronary syndrome / Virus Infection Fatal infection / Virus Infection / urticaria / hepatic failure / infection / cough / anaphylactoid/anaphylactic reactions / angioedema / cytokine release syndrome / rash / hepatitis B. Insufficient / herpes simplex / anemia / myocardial ischemia / upper respiratory tract infections / Pancytopenia / / MedicalTreatment immunization / Premedication / Immunizations / chemotherapy / intravenous infusion / antiviral therapy / / Organization DOSAGE AND ADMINISTRATION / FDA / / / Position treating physician / / Product acetaminophen / Sodium Chloride / prednisolone / / Technology antibodies / Pharmacokinetics / chemotherapy / Pharmacodynamics / / URL www.fda.gov/medwatch / /
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HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use ARZERRA safely and effectively. See full prescribing information for ARZERRA. •