| Document Date: 2009-03-31 14:11:47
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Company SUSPECTED ADVERSE REACTIONS / Celgene Corporation / / IndustryTerm administration site / / MedicalCondition tumor / Insomnia / pneumonia / Hypertension / petechiae / chronic myelomonocytic leukemia / Chest pain / Tumors / disease / Arthralgia / Headache / myelodysplastic syndrome / leukopenia / Myelodysplastic Syndromes / RAEB / thoracic and mediastinal disorders Dyspnea / Refractory anemia / neutropenia / nausea / thrombocytopenia / infestations Nasopharyngitis / erythema / vomiting / pain / malignant hepatic tumors / British (FAB) myelodysplastic syndrome / febrile neutropenia / hepatic coma / Abdominal pain Constipation Dyspepsia Nausea Vomiting General disorders / Injury / Urticaria / rigors / poisoning / also included petechiae / diarrhea / Hypersensitivity / rash Injection site reaction Pyrexia Infections / Anemia Anemia / Dizziness / renal failure / renal tubular acidosis / Mouth hemorrhage Nausea Stomatitis Vomiting General disorders / constipation / liver disease / hypokalemia / Infections / injection site erythema / Rash / thoracic and mediastinal disorders Dyspnea Dyspnea / anemia / respiratory tract infection / Hypotension / / Organization DOSAGE AND ADMINISTRATION / FDA / Subcutaneous Administration / / Person Nadir Counts / / / Position Abdominal pain Constipation Dyspepsia Nausea Vomiting General / Mouth hemorrhage Nausea Stomatitis Vomiting General / / Product Injection site induration Injection site pain Injection / etoposide / Fatigue Injection site bruising Injection / SC / Sodium Chloride / VIDAZA / Injection site reaction Injection / Injection site pain Injection / Dextrose / Chest pain Injection site bruising Injection / mannitol / sterile water for injection / / ProvinceOrState South Carolina / / Technology Pharmacokinetics / / URL www.fda.gov/medwatch / /
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HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use VIDAZA safely and effectively. See full prescribing information for VIDAZA. •