| Document Date: 2014-05-06 14:14:01
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City Reference / / Company NVR / SUSPECTED ADVERSE REACTIONS / Alteon Inc. / Novartis Pharmaceuticals Corporation / / Event FDA Phase / / IndustryTerm food effect study / treatment of patients with anaplastic lymphoma / administration site / chemical structure / / MedicalCondition paresthesia / muscular weakness / glucose intolerance / acneiform dermatitis / cardiac tamponade / positive metastatic nonsmall cell lung cancer / dysesthesia / Bradycardia Bradycardia / congenital long QT syndrome / hypoesthesia / peripheral sensory neuropathy / paina Constipation Esophageal disorderb General disorders / convulsion / pneumothorax / nausea / presbyopia / brain metastasis / bradyarrhythmias / peripheral neuropathy / polyneuropathy / Torsade de pointes / fatigue / NSCLC adenocarcinoma histology / pulmonary symptoms indicative / Bradycardia / diarrhea / ILD/pneumonitis / sinus bradycardia / constipation / gastroesophageal reflux disease / Pneumonitis / sepsis / accommodation disorder / hypotension / cancers / asymptomatic bradycardia / tumor / abdominal pain / treatment-related ILD/pneumonitis / congestive heart failure / pneumonia / Interstitial Lung Disease/Pneumonitis / disease / respiratory failure / NSCLC / dyspnea / pulmonary tuberculosis / dysphagia / fatal ILD/pneumonitis / Carcinogenesis / Hyperglycemia / Hyperglycemia Hyperglycemia / diabetes / upper abdominal pain / ALK-dependent cancer / Clinically significant bradycardia requiring intervention / neuralgia / vomiting / Esophageal disorder / maculopapular rash / lung cancer / Symptomatic bradycardia / polymorphic ventricular tachycardia / Persistent hyperglycemia / Persistent Gastrointestinal Toxicity Diarrhea / intolerable nausea / hypotonia / increased ALT / anaplastic lymphoma kinase / Rash / cholestasis / serious arrhythmia / Interstitial Lung Disease / vision disorder / dehydration / / MedicalTreatment antibiotics / contraception / / Organization DOSAGE AND ADMINISTRATION / FDA / / / Position paina Constipation Esophageal disorderb General / / Product cyclosporine / alfentanil / carbamazepine / Rifampin / CL / phenytoin / digoxin / Ketoconazole / fentanyl / CYP3A / / 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 ZYKADIA safely and effectively. See full prescribing information for ZYKADIA. ZYKADIA™ (ceritinib) capsules, for o