JANUVIA is an orally active, potent, and highly selective inhibitor of the dipeptidyl peptidase-4 (DPP-4) enzyme.

JANUVIA is indicated

In patients with type 2 diabetes mellitus:

Monotherapy and Combination Therapy
JANUVIA is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
Important Limitation of Use
JANUVIA should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis, as it would not be effective in these settings.
JANUVIA has not been studied in combination with insulin.

When administering JANUVIA

The recommended dose of JANUVIA is 100 mg once daily. JANUVIA can be taken with or without food.

When JANUVIA is used in combination with a sulfonylurea or with insulin, a lower dose of sulfonylurea or insulin may be considered to reduce the risk of sulfonylurea- or insulin-induced hypoglycemia.

Patients with renal insufficiency
Dosage adjustment in patients with renal insufficiency is based on degree of renal function:

Because there is a dosage adjustment based upon renal function, assessment of renal function is recommended prior to initiation of JANUVIA and periodically thereafter.

Patients with hepatic insufficiency
No dosage adjustment is necessary for patients with mild to moderate hepatic insufficiency. JANUVIA has not been studied in patients with severe hepatic insufficiency.

Contraindications

JANUVIA is contraindicated in patients who are hypersensitive to any components of this product.

Selected Precautions

General
JANUVIA should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis.

Hypoglycemia
In clinical trials of JANUVIA as monotherapy and as part of combination therapy with agents not known to cause hypoglycemia (ie, metformin or pioglitazone), rates of hypoglycemia reported with JANUVIA were similar to rates in patients taking placebo. As is typical with other antihyperglycemic agents, when JANUVIA was used in combination with a sulfonylurea or with insulin, medications known to cause hypoglycemia, the incidence of sulfonylurea- or insulin-induced hypoglycemia was increased over that of placebo.

Renal insufficiency
JANUVIA is excreted renally. To achieve plasma concentrations of JANUVIA similar to those in patients with normal renal function, lower dosages are recommended in patients with moderate or severe renal insufficiency and in patients with ESRD requiring hemodialysis or peritoneal dialysis.

Pregnant and nursing mothers
There are no adequate and well-controlled studies in pregnant women; therefore, the safety of JANUVIA in pregnant women is not known. JANUVIA, like other oral antihyperglycemic agents, is not recommended for use in pregnancy.

It is not known whether sitagliptin is secreted in human milk. The safety and efficacy of JANUVIA in pregnant or nursing women have not been studied. Therefore, JANUVIA should not be used in these patients.

Pediatric
Safety and effectiveness of JANUVIA in pediatric patients have not been established.

Elderly
No dosage adjustment is required based on age.

Elderly patients are more likely to have renal insufficiency; as with other patients, dosage adjustment may be required in the presence of significant renal insufficiency.

Hypersensitivity reactions
Postmarketing reports of serious hypersensitivity reactions in patients treated with JANUVIA have been reported. These reactions include anaphylaxis, angioedema, rash, urticaria, cutaneous vasculitis, exfoliative skin conditions, including Stevens-Johnson syndrome, and pancreatitis.

Drug Interactions

No clinically significant drug interactions were observed in controlled clinical trials or drug interaction studies.

Before prescribing, please consult the Prescribing Information.