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 simvastatin) Tablets
Initial U.S. Approval: 2011
RECENT MAJOR CHANGES
Contraindications (4) 03/2012
Warnings and Precautions 
  Myopathy/Rhabdomyolysis (5.2) 03/2012
INDICATIONS AND USAGE
JUVISYNC (sitagliptin and simvastatin) is indicated in patients for whom treatment with both sitagliptin and simvastatin is appropriate. (1) Sitagliptin is a dipeptidyl peptidase-4 (DPP-4) inhibitor indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. (1.1)
Simvastatin is an HMG-CoA reductase inhibitor (statin) indicated as an adjunctive therapy to diet to:
Reduce the risk of total mortality by reducing CHD deaths and reduce the risk of non-fatal myocardial infarction, stroke, and the need for revascularization procedures in patients at high risk of coronary events. (1.2)
Reduce elevated total-C, LDL-C, Apo B, TG and increase HDL-C in patients with primary hyperlipidemia (heterozygous familial and nonfamilial) and mixed dyslipidemia. (1.2)
Reduce elevated TG in patients with hypertriglyceridemia and reduce TG and VLDL-C in patients with primary dysbeta-lipoproteinemia. (1.2)
Reduce total-C and LDL-C in adult patients with homozygous familial hypercholesterolemia. (1.2)
Important Limitations of Use:
JUVISYNC should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis. (1.3)
JUVISYNC has not been studied in patients with a history of pancreatitis. (1.3, 5.1)
JUVISYNC has not been studied in Fredrickson types I and V dyslipidemias. (1.3)
Patients with moderate or severe renal impairment who require sitagliptin 50 or 25 mg should not use JUVISYNC due to the unavailability of these dosage strengths for JUVISYNC. (1.3)
DOSAGE AND ADMINISTRATION
Doses are 100 mg/10 mg, 100 mg/20 mg, and 100 mg/40 mg per day. (2.1)
Recommended usual starting dose is 100 mg/40 mg once a day in the evening. (2.1)
Patients already taking simvastatin (10, 20, or 40 mg) can initiate JUVISYNC at a dose of 100 mg sitagliptin and the dose of simvastatin already being taken. (2.1)
DOSAGE FORMS AND STRENGTHS
Tablets (sitagliptin/simvastatin): 100 mg/10 mg, 100 mg/20 mg, and 100 mg/40 mg (3)
CONTRAINDICATIONS
History of a serious hypersensitivity reaction, such as anaphylaxis or angioedema, to any component of this medication. (4, 5.6, 6.2)
Concomitant administration of strong CYP3A4 inhibitors. (4, 5.2)
Concomitant administration of gemfibrozil, cyclosporine, or danazol. (4, 5.2)
Active liver disease, which may include unexplained persistent elevations in hepatic transaminase levels. (4, 5.3)
Women who are pregnant or may become pregnant. (4, 8.1)
Nursing mothers. (4, 8.3)
WARNINGS AND PRECAUTIONS
There have been postmarketing reports of acute pancreatitis, including fatal and non-fatal hemorrhagic or necrotizing pancreatitis. If pancreatitis is suspected, promptly discontinue JUVISYNC. (5.1)
Skeletal muscle effects (e.g., myopathy and rhabdomyolysis): Risks increase with higher doses and concomitant use of certain medicines. Predisposing factors include advanced age (≥65), female gender, uncontrolled hypothyroidism, and renal impairment