Sitagliptin

For adult patients with type 2 diabetes mellitus, Sitagliptin Medley is indicated to improve glycaemic control: as monotherapy: • in patients inadequately controlled by diet and exercise alone and for whom metformin is inappropriate due to contraindications or intolerance.

as dual oral therapy in combination with: • metformin when diet and exercise plus metformin alone do not provide adequate glycaemic control. • a sulphonylurea when diet and exercise plus maximal tolerated dose of a sulphonylurea alone do not provide adequate glycaemic control and when metformin is inappropriate due to contraindications or intolerance.

e. a thiazolidinedione) when use of a PPARγ agonist is appropriate and when diet and exercise plus the PPARγ agonist alone do not provide adequate glycaemic control. as triple oral therapy in combination with: • a sulphonylurea and metformin when diet and exercise plus dual therapy with these medicinal products do not provide adequate glycaemic control.

• Monotherapy: JANUVIA® (sitagliptin) is indicated for use as an adjunct to diet and exercise to improve glycemic control in adult patients with type 2 diabetes mellitus for whom metformin is inappropriate due to contraindications or intolerance.

• Add-on combination: JANUVIA® is indicated in adult patients with type 2 diabetes mellitus to improve glycemic control, in combination with: . metformin, . metformin and a sulfonylurea, . pioglitazone (alone or with metformin), . premixed or long/intermediate acting insulin (alone or with metformin) when the existing therapy, along with diet and exercise, does not provide adequate glycemic control (see 14 CLINICAL TRIALS).

1 Pediatrics • Pediatrics (<18 years of age): Based on the data submitted and reviewed by Health Canada, the safety and efficacy of JANUVIA®in pediatric patients has not been established; therefore, Health Canada has not authorized an indication for pediatric use.

For adult patients with type 2 diabetes mellitus, Xelevia is indicated to improve glycaemic control: as monotherapy: • in patients inadequately controlled by diet and exercise alone and for whom metformin is inappropriate due to contraindications or intolerance.

as dual oral therapy in combination with: • metformin when diet and exercise plus metformin alone do not provide adequate glycaemic control. • a sulphonylurea when diet and exercise plus maximal tolerated dose of a sulphonylurea alone do not provide adequate glycaemic control and when metformin is inappropriate due to contraindications or intolerance.

e. a thiazolidinedione) when use of a PPAR agonist is appropriate and when diet and exercise plus the PPAR agonist alone do not provide adequate glycaemic control. as triple oral therapy in combination with: • a sulphonylurea and metformin when diet and exercise plus dual therapy with these medicinal products do not provide adequate glycaemic control.

1 INDICATIONS AND USAGE JANUVIA ® is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. 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 ) Limitations of Use: JANUVIA should not be used in patients with type 1 diabetes ( 1 ) JANUVIA has not been studied in patients with a history of pancreatitis. 1 ) 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. ]