| Document Date: 2015-01-09 16:45:07
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City Seville / Reference / / Company Ames / Vertex Pharmaceuticals Incorporated / Alteon Inc. / / Event FDA Phase / / Facility Laboratory Abnormalities Transaminase Elevations / / IndustryTerm printing / chemical name / treatment of cystic fibrosis / food containing grapefruit / fat-containing food / food / / MedicalCondition abdominal pain / disease / arthralgia / headache / Cataracts Cataracts / Skin disorders / nasopharyngitis / pharyngeal erythema / Carcinogenesis / subcutaneous tissue disorders / nausea / noncongenital lens opacities/cataracts / rhinitis / nasal congestion / pain / pulmonary / myalgia Nervous system disorders / thoracic and mediastinal disorders / arthralgia / musculoskeletal chest pain / cystic fibrosis transmembrane conductance regulator / diarrhea / connective tissue disorders / dizziness / cystic fibrosis / end-stage renal disease / cough / hypoglycemia / Infections / rash / respiratory tract infection / upper respiratory tract infection / / MedicalTreatment enzyme replacement therapy / antibiotic therapy / / Organization US Federal Reserve / DOSAGE AND ADMINISTRATION / FDA / Administration of KALYDECO / / Person Gene Dose Ranging / Respiratory Domain Score (Points) / / / Position Major / / Product KALYDECO tablets / CL / phenytoin / talc / Estradiol / itraconazole / cyclosporine / digoxin / carbamazepine / ketoconazole / clarithromycin / erythromycin / adenosine / rifampin / fluconazole / tobramycin / KALYDECO / / RadioStation CFTR / / Technology alpha / Pharmacokinetics / radiation / 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 KALYDECO safely and effectively. See full prescribing information for KALYDECO. -------------------------------CONT