Regulatory Information
MSD PHARMA (SINGAPORE) PTE. LTD.
MSD PHARMA (SINGAPORE) PTE. LTD.
Therapeutic
Prescription Only
Formulation Information
TABLET
**2 DOSAGE AND ADMINISTRATION** **2.1 Recommended Dosing** The recommended dose of JANUVIA is 100 mg once daily. JANUVIA can be taken with or without food. **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 JANUVIA 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 JANUVIA 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 JANUVIA 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 JANUVIA 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 JANUVIA is 25 mg once daily. JANUVIA may be administered without regard to the timing of dialysis. **2.3 Concomitant Use with an Insulin Secretagogue (e.g., Sulfonylurea) or with Insulin** When JANUVIA 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. _\[See Warnings and Precautions (5.3) – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.\]_
ORAL
Medical Information
**1 INDICATIONS AND USAGE** **1.1 Monotherapy** JANUVIA is indicated as an adjunct to diet and exercise to improve glycemic control in patients with type 2 diabetes mellitus. **1.2 Combination with Metformin** JANUVIA 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. **1.3 Combination with a Sulfonylurea** JANUVIA 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. **1.4 Combination with a PPARγ agonist** JANUVIA 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. **1.5 Combination with Metformin and a Sulfonylurea** JANUVIA 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. **1.6 Combination with Insulin** JANUVIA 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. **1.7 Important Limitations 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 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. _\[See Warnings and Precautions (5.1) – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.\]_
**4 CONTRAINDICATIONS** History of a serious hypersensitivity reaction to sitagliptin, such as anaphylaxis or angioedema. _\[See Warnings and Precautions (5.4); Adverse Reactions (6.2) – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.\]_
A10BH01
sitagliptin
Manufacturer Information
MSD PHARMA (SINGAPORE) PTE. LTD.
PT. Organon Pharma Indonesia Tbk (Primary and Secondary Packager)
Organon Pharma (UK) Limited