Janumet™ Tablet 50mg/850mg

MSD PHARMA (SINGAPORE) PTE. LTD.

MSD PHARMA (SINGAPORE) PTE. LTD.

Therapeutic

Prescription Only

TABLET, FILM COATED

**2 DOSAGE AND ADMINISTRATION** **2.1 Recommended Dosing** The dosage of antihyperglycemic therapy with JANUMET should be individualized on the basis of the patient’s current regimen, effectiveness, and tolerability while not exceeding the maximum recommended daily dose of 100 mg sitagliptin and 2000 mg metformin. Initial combination therapy or maintenance of combination therapy should be individualized and left to the discretion of the health care provider. JANUMET should generally be given twice daily with meals, with gradual dose escalation, to reduce the gastrointestinal (GI) side effects due to metformin. The starting dose of JANUMET should be based on the patient’s current regimen. JANUMET should be given twice daily with meals. The following doses are available: 50 mg sitagliptin/500 mg metformin hydrochloride 50 mg sitagliptin/850 mg metformin hydrochloride 50 mg sitagliptin/1000 mg metformin hydrochloride. _Patients inadequately controlled with diet and exercise alone_ If therapy with a combination tablet containing sitagliptin and metformin is considered appropriate for a patient with type 2 diabetes mellitus inadequately controlled with diet and exercise alone, the recommended starting dose is 50 mg sitagliptin/500 mg metformin hydrochloride twice daily. Patients with inadequate glycemic control on this dose can be titrated up to 50 mg sitagliptin/1000 mg metformin hydrochloride twice daily. _Patients inadequately controlled on metformin monotherapy_ If therapy with a combination tablet containing sitagliptin and metformin is considered appropriate for a patient inadequately controlled on metformin alone, the recommended starting dose of JANUMET should provide sitagliptin dosed as 50 mg twice daily (100 mg total daily dose) and the dose of metformin already being taken. _Patients inadequately controlled on sitagliptin monotherapy_ If therapy with a combination tablet containing sitagliptin and metformin is considered appropriate for a patient inadequately controlled on sitagliptin alone, the recommended starting dose of JANUMET is 50 mg sitagliptin/500 mg metformin hydrochloride twice daily. Patients with inadequate control on this dose can be titrated up to 50 mg sitagliptin/1000 mg metformin hydrochloride twice daily. Patients taking sitagliptin monotherapy dose-adjusted for renal impairment should not be switched to JANUMET _\[see **CONTRAINDICATIONS** (4)\]._ _Patients switching from co-administration of sitagliptin and metformin_ For patients switching from sitagliptin co-administrated with metformin, JANUMET may be initiated at the dose of sitagliptin and metformin already being taken. _Patients inadequately controlled on dual combination therapy with any two of the following antihyperglycemic agents: sitagliptin, metformin or a sulfonylurea_ If therapy with a combination tablet containing sitagliptin and metformin is considered appropriate in this setting, the usual starting dose of JANUMET should provide sitagliptin dosed as 50 mg twice daily (100 mg total daily dose). In determining the starting dose of the metformin component, the patient’s level of glycemic control and current dose (if any) of metformin should be considered. Gradual dose escalation to reduce the gastrointestinal (GI) side effects associated with metformin should be considered. Patients currently on or initiating a sulfonylurea may require lower sulfonylurea doses to reduce the risk of hypoglycemia _\[see **WARNINGS AND PRECAUTIONS** (5.9) – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information\]._ _For patients inadequately controlled on dual combination therapy with insulin and metformin:_ The usual starting dose of JANUMET should provide sitagliptin dosed as 50 mg twice daily (100 mg total daily dose). In determining the starting dose of the metformin component, the patient’s level of glycemic control and current dose (if any) of metformin should be considered. Gradual dose escalation to reduce the gastrointestinal (GI) side effects associated with metformin should be considered. Patients currently on or initiating insulin therapy may require lower doses of insulin to reduce the risk of hypoglycemia _\[see **WARNINGS AND PRECAUTIONS** (5.9) – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information\]._ No studies have been performed specifically examining the safety and efficacy of JANUMET in patients previously treated with other oral antihyperglycemic agents and switched to JANUMET. Any change in therapy of type 2 diabetes should be undertaken with care and appropriate monitoring as changes in glycemic control can occur. _Recommendations for use in renal impairment:_ Assess renal function prior to initiation of JANUMET and periodically thereafter. JANUMET is contraindicated in patients with an estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73 m2. JANUMET is not recommended in patients with an eGFR ≥ 30 mL/min/1.73 m2 and < 45 mL/min/1.73 m2 because these patients require a lower dosage of sitagliptin than what is available in the fixed combination JANUMET product. _Discontinuation for iodinated contrast imaging procedures:_ Discontinue JANUMET at the time of, or prior to, an iodinated contrast imaging procedure in patients with an eGFR ≥ 30 to < 60 mL/min/1.73 m2; in patients with a history of liver disease, alcoholism or heart failure; or in patients who will be administered intra-arterial iodinated contrast. Re-evaluate eGFR 48 hours after the imaging procedure; restart JANUMET if renal function is acceptable _(see **WARNINGS AND PRECAUTIONS** – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information)_.