| Document Date: 2015-01-26 22:27:51
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City Reference / / Company Study 1 Abiraterone / Janssen Biotech Inc. / / Event FDA Phase / / Facility Laboratory Abnormality / Laboratory Abnormalities / Laboratory Abnormality All Grades / / IndustryTerm food / / MedicalCondition IV heart failure / Ventricular tachycardia / Chest pain / Left ventricular dysfunction / myopathy / Cardiac failure / Arthritis / Insomnia Injury / tract infection / Muscle spasms / Cardiomegaly / metastatic castration-resistant prostate cancer / Adrenocortical Insufficiency Adrenal insufficiency / fatigue / Angina pectoris / Injury / Atrioventricular block / Bradycardia / Bradyarrhythmia / poisoning / lymphopenia / Tachycardia / diarrhea / Angina / Constipation / Infections / respiratory tract infection / Falls Infections / Atrial flutter / correct hypokalemia / ventricular arrhythmia / Arrhythmia / Mediastinal Disorders / liver metastases / hypertension / Cardiomyopathy / Control hypertension / infestations Urinary tract infection / Arthralgia / urinary disorders / dyspnea / thoracic and mediastinal disorders Cough / hypertriglyceridemia / Carcinogenesis / hypophosphatemia / hyperglycemia / Hematology Lymphopenia / dyspnea / urinary tract infection / cardiovascular disease / rhabdomyolysis / pain / vomiting / concurrent infection / Hypernatremia / myocardial infarction / Conduction disorder / thoracic and mediastinal disorders / heart failure / Cardiogenic shock / Supraventricular tachycardia / Atrial fibrillation / infection / Connective Tissue Disorders / Atrial tachycardia / cough / hypokalemia / Rash / anemia / hypercholesterolemia / Myocardial ischemia / / MedicalTreatment Retreatment / chemotherapy / / Organization New York Heart Association / DOSAGE AND ADMINISTRATION / FDA / / / Position General / System/Organ Class Adverse reaction General / / Product carbamazepine / ACTH / rifampin / phenytoin / prednisone / for / / Technology Pharmacokinetics / Chemotherapy / / URL www.fda.gov/medwatch / /
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HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use ZYTIGA safely and effectively. See full prescribing information for ZYTIGA. ZYTIGA® (abiraterone acetate) Tablets F