| Document Date: 2013-10-28 20:30:08
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Company Vertex Pharmaceuticals Incorporated / / Event Reorganization / Product Issues / FDA Phase / / Facility Laboratory Tests / / IndustryTerm food / treatment of erectile dysfunction / Healthcare providers / intrauterine devices / / MedicalCondition Serious Skin Reactions/Rash / rash progresses / *Rash / anal pruritus / myopathy / skin disorders / Stevens Johnson Syndrome / pulmonary arterial hypertension / hemorrhoids / nausea / nephritis / cirrhosis / compensated liver disease / hepatitis C / Toxic Epidermal Necrolysis / syncope / gout / Torsade de Pointes / fatigue / gout/gouty arthritis / estrogen deficiency / bullae / Pre-renal azotemia / diarrhea / Anemia Anemia / hepatitis / end-stage renal disease / liver disease / pruritus / birth defects / familial Mediterranean fever / progressive severe rash / skin and subcutaneous tissue disorders / hypotension / fetal deaths / Urinary Disorders / sinus tachycardia / dysgeusia / Carcinogenesis / erectile dysfunction / triazolam depression / HCV / fever / Rash events / vomiting / acute renal insufficiency / concomitant disease / ANTI GOUT / severe rash / fetal death / respiratory depression / dizziness / rash / progressive rash / Anemia / Chronic Hepatitis C / Eosinophilia / HCV RNA / / MedicalTreatment birth control / blood transfusion / hormone replacement therapy / contraception / hemodialysis / organ transplant / drug therapy / contraceptive methods / / Organization efavirenz* Concomitant administration / Concomitant administration / REVERSE TRANSCRIPTASE INHIBITORS efavirenz* Concomitant administration / US Federal Reserve / DOSAGE AND ADMINISTRATION / FDA / / Person Stevens Johnson / / / Position General / / Product efavirenz / methylprednisolone / INCIVEK tablets / itraconazole / DOSAGE FORMS AND STRENGTHS Each tablet / dexamethasone / escitalopram / simvastatin / cyclosporine / alfentanil / Carbamazepine / triazolam / Each / peginterferon / clarithromycin / erythromycin / repaglinide / nifedipine / Rifampin / Revatio / tenofovir disoproxil fumarate / phenytoin / estradiol / digoxin / ribavirin / lidocaine / ketoconazole / alprazolam / prednisone / fentanyl / felodipine / Lovastatin / zolpidem / CYP3A / ribavirin dose reductions / / Region Mediterranean / / Technology Alpha / ESA / Transplantation / 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 INCIVEK safely and effectively. See full prescribing information for INCIVEK. INCIVEK® (telaprevir) tablets, for or