Sitagliptin

• JANUVIA 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.
• Limitations of Use: JANUVIA should not be used in patients with type 1 diabetes
• JANUVIA 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 JANUVIA.

• 100 mg tablets are beige, round, film-coated tablets with "277" on one side. 50 mg tablets are light beige, round, film-coated tablets with "112" on one side. 25 mg tablets are pink, round, film-coated tablets with "221" on one side.
• Tablets: 100 mg, 50 mg, and 25 mg

• The recommended dose of JANUVIA is 100 mg once daily. JANUVIA can be taken with or without food.
• Dosage adjustment is recommended for patients with eGFR less than 45 mL/min/1.73 m 2.

The following adverse reactions are also discussed elsewhere in the labeling: Pancreatitis Heart Failure Acute Renal Failure Hypoglycemia with Concomitant Use with Insulin or Insulin Secretagogues Hypersensitivity Reactions Severe and Disabling Arthralgia Bullous Pemphigoid Adverse reactions reported in ≥5% of patients treated with JANUVIA and more commonly than in patients treated with placebo...

• Pancreatitis: There have been postmarketing reports of acute pancreatitis, including fatal and non-fatal hemorrhagic or necrotizing pancreatitis. If pancreatitis is suspected, promptly discontinue JANUVIA.
• Heart failure: Heart failure has been observed with two other members of the DPP-4 inhibitor class. Consider risks and benefits of JANUVIA in patients who have known risk factors for heart failure. Monitor patients for signs and symptoms.
• Acute Renal Failure: Has been reported postmarketing, sometimes requiring dialysis. Assessment of renal function is recommended prior to initiating JANUVIA and periodically thereafter.
• 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.
• Hypersensitivity Reactions: There have been postmarketing reports of serious allergic and hypersensitivity reactions in patients treated with JANUVIA such as anaphylaxis, angioedema, and exfoliative skin conditions including Stevens-Johnson syndrome. Promptly stop JANUVIA, assess for other potential causes, institute appropriate monitoring and treatment.
• 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 appropriate.
• Bullous Pemphigoid: There have been postmarketing reports requiring hospitalization in patients taking DPP-4 inhibitors. Tell patients to report development of blisters or erosions. If bullous pemphigoid is suspected, discontinue JANUVIA.

History of a serious hypersensitivity reaction to sitagliptin, such as anaphylaxis or angioedema. [See Warnings and Precautions;

Insulin Secretagogues or Insulin Coadministration of JANUVIA 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.

The limited available data with JANUVIA 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. 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.