| Document Date: 2014-10-23 12:05:46
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Company SUSPECTED ADVERSE REACTIONS / Dendreon Corporation / / Event FDA Phase / Person Communication and Meetings / / IndustryTerm infusion site / / MedicalCondition Urinary tract infection Rash / tumor / Insomnia / strokes / Cardiovascular disorders / hypertension / bronchospasm / Influenza-like illness / Nervous system disorders / headache / Vascular Disorders / metastatic castrate-resistant prostate cancer / dyspnea / joint ache / muscle ache / chills / sterility / Musculoskeletal chest pain / Hematuria / deep venous thrombosis / pulmonary conditions / Muscle spasms / nausea / Anemia Constipation / infectious sequelae / Joint ache Headache / fever / transient ischemic attack / rhabdomyolysis / Tremor / transmissible infectious diseases / Syncope / Pain / vomiting / myocardial infarction / fatigue / myositis / diseases / infectious diseases / Any Adverse Event Hypertension / non-metastatic androgen-dependent prostate cancer / tachycardia / pulmonary embolism / Diarrhea / myocardial infarctions / dizziness / Infectious Disease PROVENGE / Cough / prostate cancer / Neck pain / transient ischemic attacks / infections / back pain / Infectious Disease / paresthesia / respiratory tract infection / eosinophilia / sepsis / Vascular Disorders Cerebrovascular disease / myasthenia gravis / hypotension / hemorrhagic and ischemic strokes / / MedicalTreatment leukapheresis / catheters / Immunosuppressive Therapy / chemotherapy / Intravenous Infusion / immunotherapy / / Organization FDA / Dosage and Administration Administration / Administration Administration / / / Position physician / treating physician / / Product acetaminophen / PROVENGE / / Technology chemotherapy / / URL www.fda.gov/medwatch / /
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HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all of the information needed to use PROVENGE® (sipuleucel-T) safely and effectively. See full prescribing information for PROVENGE.