SITAVITAE FILM-COATED TABLETS 100 MG [SIN17162P]

Product Info

SITAVITAE FILM-COATED TABLETS 100 MG

[SIN17162P]

4.1 INDICATIONS AND USAGE

4.1.1 Monotherapy
Sitavitae is indicated as an adjunct to diet and exercise to improve glycemic control in patients with type 2 diabetes mellitus.

4.1.2 Combination with Metformin
Sitavitae is indicated in patients with type 2 diabetes mellitus to improve glycemic control in combination with metformin as initial therapy or when the single agent alone, with diet and exercise, does not provide adequate glycemic control.

4.1.3 Combination with a Sulfonylurea
Sitavitae is indicated in patients with type 2 diabetes mellitus to improve glycemic control in combination with a sulfonylurea when treatment with the single agent alone, with diet and exercise, does not provide adequate glycemic control.

4.1.4 Combination with a PPARγ agonist
Sitavitae is indicated in patients with type 2 diabetes mellitus to improve glycemic control in combination with a PPARγ agonist (e.g., thiazolidinediones) when the single agent alone, with diet and exercise, does not provide adequate glycemic control.

4.1.5 Combination with Metformin and a Sulfonylurea
Sitavitae is indicated in patients with type 2 diabetes mellitus to improve glycemic control in combination with metformin and a sulfonylurea when dual therapy with these agents, with diet and exercise, does not provide adequate glycemic control.

4.1.6 Combination with Insulin
Sitavitae is also indicated as add-on to insulin (with or without metformin) when diet and exercise plus stable dose of insulin do not provide adequate glycemic control.

4.1.7 Important Limitations of Use
Sitavitae 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.
Sitavitae 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 Sitavitae.

4.2 DOSAGE AND ADMINISTRATION

4.2.1 Recommended Dosing
The recommended dose of Sitavitae is 100 mg once daily. Sitavitae can be taken with or without food.

4.2.2 Patients with Renal Impairment
Because there is a dosage adjustment based upon renal function, assessment of renal function is recommended prior to initiation of Sitavitae and periodically thereafter.

For patients with mild renal impairment (estimated glomerular filtration rate [eGFR] ≥ 60 mL/min/1.73 m² to < 90 mL/min/1.73 m²), no dosage adjustment for SITAVITAE is required.

For patients with moderate renal impairment (eGFR ≥ 45 mL/min/1.73 m² to < 60 mL/min/1.73 m²), no dosage adjustment for Sitavitae is required.

For patients with moderate renal impairment (eGFR ≥ 30 mL/min/1.73 m² to < 45 mL/min/1.73 m²), the dose of Sitavitae is 50 mg once daily.

For patients with severe renal impairment (eGFR ≥ 15 mL/min/1.73 m² to < 30 mL/min/1.73 m²) or with end-stage renal disease (ESRD) (eGFR < 15 mL/min/1.73 m²), including those requiring hemodialysis or peritoneal dialysis, the dose of Sitavitae is 25 mg once daily. Sitavitae may be administered without regard to the timing of dialysis.

4.2.3 Concomitant Use with an Insulin Secretagogue (e.g., Sulfonylurea) or with Insulin
When Sitavitae is used in combination with an insulin secretagogue (e.g., sulfonylurea) or with insulin, a lower dose of the insulin secretagogue or insulin may be required to reduce the risk of hypoglycemia.

4.3 Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.