| Document Date: 2014-10-07 13:49:25
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City Philadelphia / / Company ARIAD Pharmaceuticals Inc. / / Event Man-Made Disaster / FDA Phase / / IndustryTerm multi-site / food / administration site / Hypertension Treatment / / MedicalCondition distal extremity necrosis / glaucoma / positive acute lymphoblastic leukemia / macular edema / Cerebrovascular occlusion / serious venous thromboembolism / chest pain / peripheral arterial disease / headache / Hypertension Treatment-emergent hypertension / cardiac failure / leukopenia / blast phase / ulcerative keratitis / liver failure / alcohol abuse / Cerebral hemorrhage / nausea / pericardial effusion / stomatitis / iridocyclitis / Thrombocytopenia / peripheral neuropathy / polyneuropathy / fatigue / gastrointestinal hemorrhage / superficial thrombophlebitis / fatal myocardial infarction / gastritis / chronic phase / pulmonary edema / hypoesthesia / bradycardia / lymphopenia / iritis / pulmonary embolism / tachycardia / hematemesis / treatment-emergent symptomatic hypertension / peripheral neuropathies / constipation / infections / retinal hemorrhage / Constipation Nausea Diarrhea Vomiting Oral mucositis / neutropenia Infections / blindness / atrial flutter / T315I-positive chronic myeloid leukemia / leukemia / abdominal pain / Insomnia / hematochezia / tachyarrhythmia / acute liver failure / Hypertension / ventricular dysfunction / rash / abdominal pain / gastric ulcer / disease / cataracts / arthralgia / severe peripheral vascular disease / fainting / heart block / aphthous stomatitis / shortness of breath / Chills / asymptomatic radiologic pancreatitis / brain edema / Carcinogenesis / hyperesthesia / Cardiac Arrhythmias / deep venous thrombosis / venous thrombosis / neutropenia / stroke / thromboembolism / diabetes / sick sinus syndrome / Back pain Muscle spasms Bone pain General disorders / hyperlipidemia / Tumor Lysis Syndrome / Fulminant hepatic failure / neuralgia / melena / retinal vein thrombosis / blister / myocardial infarction / serious heart failure / fatal stroke / HEART FAILURE / pleural effusion / cardiogenic shock / Arterial and venous thrombosis / Pancreatitis / cranial neuropathy / retinal vein occlusion / supraventricular tachycardia / atrial fibrillation / irritation / chronic myeloid leukemia / dizziness / tachyarrhythmias / thrombosis / lab Pancreatitis / rash / paresthesia / anemia / / MedicalTreatment surgery / major surgery / amputations / / Organization DOSAGE AND ADMINISTRATION / FDA / / / Position General / Back pain Muscle spasms Bone pain General / Major / / Product Iclusig / / Technology Pharmacokinetics / 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 ICLUSIG safely and effectively. See full prescribing information for ICLUSIG. ICLUSIG® (ponatinib) tablets for oral