HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use JANUVIA safely and effectively. See full prescribing information for JANUVIA.
JANUVIA(sitagliptin)Tablets
Initial U.S. Approval: 2006
RECENT MAJOR CHANGES
Warnings and Precautions
  Bullous Pemphigoid (5.6) 01/2017
INDICATIONS AND USAGE
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. (1.1)
Important Limitations of Use:
JANUVIA should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis. (1.2)
JANUVIA has not been studied in patients with a history of pancreatitis. (1.2, 5.1)
DOSAGE AND ADMINISTRATION
The recommended dose of JANUVIA is 100 mg once daily. JANUVIA can be taken with or without food. (2.1)
Dosage adjustment is recommended for patients with moderate or severe renal insufficiency or end-stage renal disease. (2.2)
Dosage Adjustment in Patients With Moderate, Severe and End Stage Renal Disease (ESRD) (2.2)
50 mg once daily 25 mg once daily
Moderate
CrCl ≥30 to <50 mL/min
~Serum Cr levels [mg/dL]
Men: >1.7– ≤3.0;
Women: >1.5– ≤2.5
Severe and ESRD
CrCl <30 mL/min
~Serum Cr levels [mg/dL]
Men: >3.0;
Women: >2.5;
or on dialysis
DOSAGE FORMS AND STRENGTHS
Tablets: 100 mg, 50 mg, and 25 mg (3)
CONTRAINDICATIONS
History of a serious hypersensitivity reaction to sitagliptin, such as anaphylaxis or angioedema (5.4, 6.2)
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 JANUVIA. (5.1)
There have been postmarketing reports of acute renal failure, sometimes requiring dialysis. Dosage adjustment is recommended in patients with moderate or severe renal insufficiency and in patients with ESRD. Assessment of renal function is recommended prior to initiating JANUVIA and periodically thereafter. (2.2, 5.2, 6.2)
There is an increased risk of hypoglycemia when JANUVIA is added to an insulin secretagogue (e.g., sulfonylurea) or insulin therapy. Consider lowering the dose of the sulfonylurea or insulin to reduce the risk of hypoglycemia. (2.3, 5.3)
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. In such cases, promptly stop JANUVIA, assess for other potential causes, institute appropriate monitoring and treatment, and initiate alternative treatment for diabetes. (5.4, 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 appropriate. (5.5)
There have been postmarketing reports of bullous pemphigoid requiring hospitalization in patients taking DPP-4 inhibitors. Tell patients to report development of blisters or erosions. If bullous pemphigoid is suspected, discontinue JANUVIA. (5.6)
There have been no clinical studies establishing conclusive evidence of macrovascular risk reduction with JANUVIA or any other anti-diabetic drug. (5.7)
ADVERSE REACTIONS
A