| Document Date: 2014-10-02 11:38:28
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Company SUSPECTED ADVERSE REACTIONS / Genzyme Corporation / / IndustryTerm treatment of adult patients with Gaucher disease / chemical structure / food / / MedicalCondition congestive heart failure / disease / headache / Action Gaucher disease / heart block / Carcinogenesis / Cardiac Arrhythmias / nausea / cirrhosis / thrombocytopenia / Gaucher disease / upper abdominal pain / pain / vomiting / enzymatic deficiency / fatigue / bradycardia / cardiac disease / subject experienced dizziness / reflux disease Constipation Palpitations Rash CERDELGA / diarrhea / deficiency / end-stage renal disease / Adverse Reaction Arthralgia CERDELGA / spontaneous abortion / Gaucher disease type / back pain / ventricular arrhythmia / hypotension / acute myocardial infarction / long QT syndrome / / MedicalTreatment Enzyme Replacement Therapy / Hemodialysis / / Organization DOSAGE AND ADMINISTRATION / FDA / administration of CERDELGA / established using an FDA-cleared test / / / Product phenytoin / ranitidine / Each capsule / Digoxin / Swallow capsules / carbamazepine / ketoconazole / perphenazine / rifampin / fluconazole / / Technology Pharmacokinetics / Pharmacodynamics / genotype / / URL www.fda.gov/medwatch / /
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HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use CERDELGATM safely and effectively. See full prescribing information for CERDELGA. CERDELGATM (eliglustat) capsules,