JANUMET™ TABLET 50MG/850MG [SIN13443P]

Product Info

JANUMET™ TABLET 50MG/850MG

[SIN13443P]

1 INDICATIONS AND USAGE

JANUMET is indicated as initial therapy in adult patients with type 2 diabetes mellitus to improve glycemic control when diet and exercise do not provide adequate glycemic control.

JANUMET is indicated as an adjunct to diet and exercise to improve glycemic control in adult patients with type 2 diabetes mellitus who are not adequately controlled on metformin or sitagliptin alone or in patients already being treated with the combination of sitagliptin and metformin.

JANUMET is also indicated in combination with a sulfonylurea (i.e., triple combination therapy) as an adjunct to diet and exercise in adult patients with type 2 diabetes mellitus inadequately controlled with any two of the three agents: metformin, sitagliptin, or a sulfonylurea.

JANUMET is indicated as add-on to insulin (i.e., triple combination therapy) as an adjunct to diet and exercise to improve glycemic control in patients when insulin and metformin alone do not provide adequate glycemic control.

Important Limitations of Use
JANUMET should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis.

JANUMET 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 JANUMET [See WARNINGS AND PRECAUTIONS (5.2) – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information].

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).

4 CONTRAINDICATIONS

JANUMET (sitagliptin and metformin HCl) is contraindicated in patients with:

• Severe renal impairment (eGFR < 30 mL/min/1.73 m²) (see WARNINGS AND PRECAUTIONS, Lactic Acidosis – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

• Hypersensitivity to metformin hydrochloride.

• Acute or chronic metabolic acidosis, including diabetic ketoacidosis. Diabetic ketoacidosis should be treated with insulin.

• History of a serious hypersensitivity reaction to JANUMET or sitagliptin (one of the components of JANUMET), such as anaphylaxis or angioedema. [see WARNINGS AND PRECAUTIONS (5.14); ADVERSE REACTIONS (6.2) – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information].