| Document Date: 2014-03-03 17:25:35
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Company Merck / Merck Sharp & Dohme Corp. / Merck & Co. Inc. / / Currency pence / / Event Product Issues / FDA Phase / / Facility Laboratory Tests / Achieve stable INR / / IndustryTerm medicinal products / cobicistat-containing products / fibrate products / combination product / / MedicalCondition fatal and nonfatal hepatic failure / atherosclerotic vascular disease / HIV / headache / Liver Dysfunction / myopathy / primary dysbetalipoproteinemia / primary hypercholesterolemia / nausea / anaphylaxis / cerebrovascular disease / non-fatal myocardial infarction / Stevens-Johnson syndrome / Homozygous Familial Hypercholesterolemia / significant inflammation / diabetic ketoacidosis / Fredrickson type lll hyperlipidemia / Myopathy/Rhabdomyolysis / hypersensitivity / myoglobinuria / diarrhea / coronary heart disease / familial hypercholesterolemia / end-stage renal disease / constipation / serious liver injury / hypoglycemia / liver disease / respiratory tract infection / proximal muscle weakness / peripheral vessel disease / sepsis / upper respiratory tract infection / hypotension / mixed dyslipidemia / abdominal pain / dysbetalipoproteinemia / long-standing diabetes mellitus / chronic process / CHD / Atherosclerosis / nasopharyngitis / unexplained muscle weakness / hypertriglyceridemia / Carcinogenesis / Fredrickson type lV hyperlipidemia / electrolyte disorders / ESRD / stroke / dyslipidemia / Active liver disease / diabetes / muscle pain / upper respiratory infection / hyperlipidemia / fever / Rhabdomyolysis / serious hypersensitivity / uncontrolled hypothyroidism / myocardial infarction / diabetes mellitus / angioedema / pancreatitis / Active liver diseases / autoimmune myopathy / V dyslipidemias / uncontrolled epilepsy / renal failure / acute pancreatitis / Cause Hypoglycemia / immune-mediated necrotizing myopathy / acute renal failure / hypercholesterolemia / / MedicalTreatment antibiotics / insulin therapy / adjunctive therapy / apheresis / major surgery / Drug therapy / dialysis / / Organization Concomitant administration / DOSAGE AND ADMINISTRATION / FDA / / / Position investigator / / Product pioglitazone / itraconazole / simvastatin / cyclosporine / glimepiride / Niacin / danazol / gemfibrozil / clarithromycin / erythromycin / Digoxin / FDAapproved Medication / ketoconazole / Coumarin / rosiglitazone / JUVISYNC dosage / JUVISYNC / renal function / / Technology 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 JUVISYNC safely and effectively. See full prescribing information for JUVISYNC. JUVISYNC™ (sitagliptin and simvast