| Document Date: 2011-08-11 15:27:07
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City Reference / / Company SGPT/ALT / NVR / SUSPECTED ADVERSE REACTIONS / Novartis Pharmaceuticals Corporation / / Event FDA Phase / Product Issues / / Facility Laboratory Tests Measure / Laboratory Parameter Serum Creatinine Creatinine / Perform laboratory / Laboratory Tests Reference ID / / IndustryTerm food / / MedicalCondition cholelithiasis / Skin disorders / myelodysplastic syndrome / rash / gastrointestinal disorders / drug-induced hepatitis / duodenal ulcer / myelodysplastic syndromes / esophagitis / subcutaneous tissue disorders / Fanconi’s syndrome / Includes ‘abdominal pain / lens opacities / nausea / skin rash / anaphylaxis / thrombocytopenia / Known hypersensitivity / Hepatic Dysfunction / fatigue / gastrointestinal hemorrhage / glycosuria/proteinuria / gastritis / Erythema multiforme / liver cirrhosis / Hypersensitivity / diarrhea / hepatitis / hearing loss / infections / hemosiderosis / high-risk myelodysplastic syndromes / agranulocytosis / gallstones / purpura / proteinuria / abdominal pain / pigmentation disorder / cataracts / disease / gastric ulcer / chronic dosing / HEPATIC FAILURE AND/OR GASTROINTESTINAL HEMORRHAGE / iron overload / Carcinogenesis / optic neuritis / chronic / sleep disorder / neutropenia / alopecia Immune system disorders / hematologic malignancies / Serious hypersensitivity / vomiting / pain / leukocytoclastic vasculitis / anemias / hepatic failure / urticaria / angioedema / pancreatitis / proteinuria / monthly monitoring / sickle cell disease / hyperactivity/insomnia / irritation / early cataract / dizziness / renal failure / Cell Disease / Rash / cataract / atypical tuberculosis / disorders / dehydration / / MedicalTreatment chelation therapy / blood transfusions / clinical protocols / dialysis / / Organization DOSAGE AND ADMINISTRATION / FDA / / Person Henoch Schönlein / / / Product Exjade / haloperidol / simvastatin / cyclosporine / repaglinide / olanzapine / phenytoin / theophylline / paclitaxel / cholestyramine / / Technology UDP / Pharmacokinetics / Pharmacodynamics / dialysis / / URL www.fda.gov/medwatch / /
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HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use Exjade safely and effectively. See full prescribing information for Exjade. EXJADE® (deferasirox) tablets for oral