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Sitagliptin tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Limitations of Use Sitagliptin tablets should not be used in patients with type 1 diabetes. Sitagliptin has not been studied in patients with a history of pancreatitis. It is unknown whether patients with a history of pancreatitis are at increased risk for the development of pancreatitis while using sitagliptin [See Warnings and Precautions ( 5.1 )]. Sitagliptin tablets are 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) Limitations of Use: Sitagliptin tablets should not be used in patients with type 1 diabetes (1) Sitagliptin has not been studied in patients with a history of pancreatitis. (1, 5.1 )

History of a serious hypersensitivity reaction to sitagliptin, such as anaphylaxis or angioedema [See Warnings and Precautions (5.5); Adverse Reactions (6.2)] . History of a serious hypersensitivity reaction to sitagliptin, such as anaphylaxis or angioedema. ( 5.5 , 6.2 )

Pancreatitis: There have been postmarketing reports of acute pancreatitis, including fatal and non-fatal hemorrhagic or necrotizing pancreatitis. If pancreatitis is suspected, promptly discontinue sitagliptin tablets. ( 5.1 ) Heart failure: Heart failure has been observed with two other members of the DPP-4 inhibitor class. Consider risks and benefits of sitagliptin tablets in patients who have known risk factors for heart failure. Monitor patients for signs and symptoms. ( 5.2 ) Acute Renal Failure: Has been reported postmarketing, sometimes requiring dialysis. Assessment of renal function is recommended prior to initiating sitagliptin tablets and periodically thereafter. ( 5.3 ) Hypoglycemia with Concomitant Use with Insulin or Insulin Secretagogues: Increased risk of hypoglycemia when used in combination with insulin and/or an insulin secretagogue. Lower dose of insulin or insulin secretagogue may be required. ( 5.4 , 7.1 ) Hypersensitivity Reactions: There have been postmarketing reports of serious allergic and hypersensitivity reactions in patients treated with sitagliptin tablets such as anaphylaxis, angioedema, and exfoliative skin conditions including Stevens-Johnson syndrome. Promptly stop sitagliptin tablets, assess for other potential causes, institute appropriate monitoring and treatment. ( 5.5 , 6.2 ) Severe and Disabling Arthralgia: Has been reported in patients taking DPP-4 inhibitors. Consider as a possible cause for severe joint pain and discontinue drug if …

8.1 Pregnancy Risk Summary The limited available data with sitagliptin tablets in pregnant women are not sufficient to inform a drug- associated risk for major birth defects and miscarriage. There are risks to the mother and fetus associated with poorly controlled diabetes in pregnancy [see Clinical Considerations] . No adverse developmental effects were observed when sitagliptin was administered to pregnant rats and rabbits during organogenesis at oral doses up to 30-times and 20-times, respectively, the 100 mg clinical dose, based on AUC [see Data] . The estimated background risk of major birth defects is 6 to 10% in women with pre-gestational diabetes with a Hemoglobin A1c >7% and has …