ZITUVIO

The pharmacokinetics of sitagliptin have been extensively characterized in healthy subjects and patients with type 2 diabetes mellitus. Following a single oral 100-mg dose to healthy volunteers, mean plasma AUC of sitagliptin was 8.52 μM

• hr, C max was 950 nM, and apparent terminal half-life (t 1/2 ) was 12.4 hours. Plasma AUC of sitagliptin increased in a dose-proportional manner and increased approximately 14% following 100 mg doses at steady-state compared to the first dose. The intra-subject ...

There were approximately 5,200 patients with type 2 diabetes mellitus randomized in nine double-blind, placebo-controlled clinical safety and efficacy trials conducted to evaluate the effects of sitagliptin on glycemic control. In a pooled analysis of seven of these trials, the ethnic/racial distribution was approximately 59% White, 20% Hispanic or Latino ethnicity, 10% Asian, 6% Black or African American, and 6% other groups. Patients had an overall mean age of approximately 55 years (range 18 to 87 years). In addition, an active (glipizide)-controlled trial of 52-weeks duration was conducted...

The following adverse reactions are also discussed elsewhere in the prescribing information: Pancreatitis [see Warnings and Precautions (5.1) ] Heart Failure [see Warnings and Precautions (5.2) ] Acute Renal Failure [see Warnings and Precautions (5.3) ] Hypoglycemia with Concomitant Use with Insulin or Insulin Secretagogues [see Warnings and Precautions (5.4) ] Hypersensitivity Reactions [see Warnings and Precautions (5.5) ] Severe and Disabling Arthralgia [see Warnings and Precautions (5.6) ] B...

ZITUVIO is contraindicated in patients with a history of a serious hypersensitivity reaction to sitagliptin or any of the excipients in ZITUVIO. Serious hypersensitivity reactions, including anaphylaxis and angioedema have been reported with sitagliptin. [see Warnings and Precautions (5.5) ; Adverse Reactions (6.2) ]. History of a serious hypersensitivity reaction to sitagliptin or any of the exci...

Pancreatitis: There have been postmarketing reports of acute pancreatitis, including fatal and non-fatal hemorrhagic or necrotizing pancreatitis. If pancreatitis is suspected, promptly discontinue ZITUVIO. ( 5.1 ) Heart failure: Heart failure has been observed with two other members of the DPP-4 inhibitor class. Consider risks and benefits of ZITUVIO in patients who have known risk factors for heart failure. Monitor patients for signs and symptoms. ( 5.2 ) Acute Renal Failure: Has been reported ...

7 DRUG INTERACTIONS 7.1 Insulin Secretagogues or Insulin Sitagliptin lowers blood glucose in patients with type 2 diabetes mellitus. Coadministration of ZITUVIO with an insulin secretagogue (e.g., sulfonylurea) or insulin may require lower doses of the insulin secretagogue or insulin to reduce the risk of hypoglycemia. [see Warnings and Precautions (5.4) ].