| Document Date: 2012-04-20 13:17:56
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City Disorders Reference / Grade Reference / Term Reference / Reference / / Company Single-Agent TARCEVA Group / Placebo Group / TARCEVA Group / OSI Pharmaceuticals LLC / / Event Product Issues / / IndustryTerm treatment / treatment of NSCLC / pancreatic cancer / food / gemcitabine / / MedicalCondition metastatic lung disease / acute /worsening ocular disorders / Headache / hyperpigmentation / progressive unexplained pulmonary symptoms / interstitial pneumonia / cerebral hemorrhage / nausea / skin rash / stomatitis / thrombocytopenia / gastroduodenal ulcers / Alopecia / carcinoma / Toxic epidermal necrolysis / pulmonary fibrosis / Stevens-Johnson syndrome / colitis / syncope / Conjunctivitis / serious Interstitial Lung Disease / fatigue / metastatic non-small cell lung cancer / parenchymal lung disease / Cerebrovascular accidents / significant liver tumor / gastritis / Non-Small Cell Lung Cancer / renal disease / hirsutism / diarrhea / hematemesis / Microangiopathic Hemolytic Anemia / constipation / Pruritus / exfoliative skin disorders / pneumonitis / Infections / hepatorenal syndrome / radiation pneumonitis / diverticular disease / pancreatic cancer / Paronychia / severe dehydration / abdominal pain / keratoconjunctivitis sicca / keratitis / Insomnia / hematochezia / peptic ulcer / hemolytic anemia / progressive pulmonary symptoms / cancer / Acne / pulmonary infections / disease / NSCLC / dyspnea / Acute Respiratory Distress Syndrome / M icroangiopathic Hemolytic Anemia / Carcinogenesis / Stevens-Johnson syndrome/Toxic epidermal necrolysis / advanced solid tumors / deep venous thrombosis / Pancreatic Cancer TARCEVA / progressive disease / obliterative bronchiolitis / severe diarrhea / ileus / itching / pancreatic carcinoma / fever / melena / P ancreatic Cancer / pain / vomiting / metastatic pancreatic cancer / renal insufficiency / Myocardial infarction / lung cancer / hepatic failure / pancreatitis / eye pain / Rigors / Ocular Disorders / infection / rapidly progressing liver failure / Dizziness / renal failure / cough / Depression / hypokalemia / hypersensitivity pneumonitis / metastases / rash / acute renal failure / Interstitial Lung Disease / disorders / dehydration / / MedicalTreatment chemotherapy / radiotherapy / chemotherapies / radiation / contraceptive methods / / Organization DOSAGE AND ADMINISTRATION / FDA / / / Product carboplatin / cisplatin / itraconazole / carbamazepine / clarithromycin / phenytoin / paclitaxel / TAO / ketoconazole / ciprofloxacin / TARCEVA / hepatic function / / Technology radiation / 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 TARCEVA safely and effectively. See full prescribing information for TARCEVA. TARCEVA® (erlotinib) tablets, oral In