Janumet Dosage/Direction for Use

General: The dosage of antihyperglycaemic 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. 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 associated with metformin.
The starting dose of JANUMET should be based on the patient's current regimen. JANUMET should be given twice daily with meals.
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 glycaemic 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.
Patients switching from coadministration of sitagliptin and metformin: For patients switching from sitagliptin coadministered 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 three antihyperglycaemic 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 glycaemic control and current dose (if any) of metformin should be considered. Gradual dose escalation to reduce the gastrointestinal (GI) side effect associated with metformin should be considered. Patients currently on or initiating a sulfonylurea may require lower sulfonylurea doses to reduce the risk of hypoglycemia.
For patients inadequately controlled on dual combination therapy with the maximal tolerated dose of metformin and a PPARγ agonist: The dose of JANUMET should provide sitagliptin dosed as 50 mg twice daily (100 mg total daily dose) and a dose of metformin similar to the dose already being taken.
For patients inadequately controlled on dual combination therapy with insulin and the maximal tolerated dose of metformin: The dose of JANUMET should provide sitagliptin dosed as 50 mg twice daily (100 mg total daily dose) and a dose of metformin similar to the dose already being taken. When JANUMET is used in combination with insulin, a lower dose of insulin may be required to reduce the risk of hypoglycemia (see Precautions).
No studies have been performed specifically examining the safety and efficacy of JANUMET in patients previously treated with other oral antihyperglycaemia agents and switched to JANUMET. Any change in therapy of type 2 diabetes should be undertaken with care and appropriate monitoring as changes in glycaemic control can occur.
Renal impairment: An eGFR should be assessed before initiation of treatment with metformin containing products and at least annually thereafter. In patients at an increased risk of further progression of renal impairment and in the elderly, renal function should be assessed more frequently, e.g. every 3-6 months.
The maximum daily dose of metformin should preferably be divided into 2-3 daily doses. Factors that may increase the risk of lactic acidosis should be reviewed before considering initiation of metformin in patients with eGFR <60 mL/min/1.73m².
If no adequate strength of JANUMET is available, individual monocomponents should be used instead of the fixed dose combination. (See Table 7.)

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