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
Indications and Usage 
  Important Limitations of Use (1.3) 09/2012
Dosage and Administration 
  Recommended Dosing (2.1) 02/2013
  Patients with Renal Impairment (2.2) 09/2012
  Coadministration with Other Drugs (2.4) 10/2012
  Patients with Homozygous Familial Hypercholesterolemia (2.5) 09/2012
  Chinese Patients Taking Lipid-Modifying Doses (greater than or 
  equal to 1 g/day Niacin) of Niacin-Containing Products (2.6) 09/2012
Contraindications (4) 10/2012
Warnings and Precautions 
  Myopathy/Rhabdomyolysis (5.2) 10/2012
  Renal Impairment (5.4) 09/2012

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 severe renal impairment who require sitagliptin 25 mg should not use JUVISYNC due to the unavailability of this dosage strength for JUVISYNC. (1.3)
DOSAGE AND ADMINISTRATION
•Doses are 100 mg/10 mg, 100 mg/20 mg, 100 mg/40 mg, 50 mg/10 mg, 50 mg/20 mg, and 50 mg/40 mg per day. (2.1)
•Recommended usual starting dose for patients with normal or mildly impaired renal function is 100 mg/40 mg once a day in the evening. (2.1)
•Adjustment of the starting dose to 50 mg/40 mg once a day is recommended for patients with moderate renal impairment (CrCl greater than or equal to 30 to less than 50 mL/min, equivalent to serum Cr levels greater than 1.7 to less than or equal to 3.0 mg/dL for men and greater than 1.5 to less than or equal to 2.5 mg/dL for women). (2.2)
•Patients already taking simvastatin (10, 20, or 40 mg) can initiate JUVISYNC at a dose of 100 or 50 mg sitagliptin and the dose of simvastatin already being taken. (2.1)
DOSAGE FORMS AND STRENGTHS
Tablets (sitagliptin/simvastati