MedPath
HSA Approval

JANUMET XR TABLET 50MG/1000MG

SIN14703P

JANUMET XR TABLET 50MG/1000MG

JANUMET XR TABLET 50MG/1000MG

December 22, 2014

MSD PHARMA (SINGAPORE) PTE. LTD.

MSD PHARMA (SINGAPORE) PTE. LTD.

Regulatory Information

MSD PHARMA (SINGAPORE) PTE. LTD.

MSD PHARMA (SINGAPORE) PTE. LTD.

Therapeutic

Prescription Only

Formulation Information

TABLET, FILM COATED, EXTENDED RELEASE

**III. DOSAGE AND ADMINISTRATION** _General:_ The dosage of antihyperglycemic therapy with JANUMET XR 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. JANUMET XR should be given once daily with a meal preferably in the evening. The dose should be escalated gradually to reduce the gastrointestinal (GI) side effects due to metformin. Additionally, administration of JANUMET XR with food enhances plasma concentrations of metformin. To preserve the modified-release properties, the tablets must not be split, broken, crushed, or chewed before swallowing. There have been reports of incompletely dissolved JANUMET XR tablets being eliminated in the feces. It is not known whether this material seen in feces contains active drug. If a patient reports repeatedly seeing tablets in feces, the healthcare provider should assess adequacy of glycemic control. After 10 to 15 days the dose should be adjusted on the basis of blood glucose measurements. _Dosing Recommendations:_ The starting dose of JANUMET XR should be based on the patient’s current regimen. In patients already treated with metformin, the starting dose of JANUMET XR should include the equivalent daily dose of metformin while not exceeding the maximum recommended daily dose of 100 mg sitagliptin and 2000 mg metformin. JANUMET XR should be given once daily with a meal preferably in the evening. JANUMET XR tablets are available in the following strengths: 50 mg sitagliptin/500 mg extended-release metformin hydrochloride 50 mg sitagliptin/1000 mg extended-release metformin hydrochloride 100 mg sitagliptin/1000 mg extended-release metformin hydrochloride For patients using the 50 mg sitagliptin/500 mg metformin hydrochloride extended-release tablet or the 50 mg sitagliptin/1000 mg metformin hydrochloride extended-release tablet, two tablets should be taken together once daily. The 100 mg sitagliptin/1000 mg metformin hydrochloride extended-release tablet should be taken as a single tablet once daily. _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 total daily starting dose of JANUMET XR is 100 mg sitagliptin and 1000 mg metformin hydrochloride. Patients with inadequate glycemic control on this dose can be titrated gradually to reduce gastrointestinal side effects associated with metformin, up to the maximum recommended daily metformin dose of 2000 mg. _For 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 total daily starting dose of JANUMET XR is 100 mg sitagliptin and the previously prescribed dose of metformin. _For 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 XR is 100 mg sitagliptin and 1000 mg metformin hydrochloride. The metformin dose can be titrated as needed to achieve glycemic control. Gradual dose escalation to reduce the gastrointestinal (GI) side effects associated with metformin should be considered. Patients taking sitagliptin monotherapy dose-adjusted for renal impairment should not be switched to JANUMET XR (see **CONTRAINDICATIONS**). _For patients switching from coadministration of sitagliptin and metformin:_ For patients switching from coadministration of sitagliptin and metformin, JANUMET XR may be initiated at the previously prescribed dose of sitagliptin and metformin. _For patients inadequately controlled on dual combination therapy with any two of the following three 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 XR should provide 100 mg total daily dose of sitagliptin. 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 sulfonylurea-induced hypoglycemia (see **PRECAUTIONS** – _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 XR should provide 100 mg total daily dose of sitagliptin. 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 **PRECAUTIONS** – _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 XR in patients previously treated with other oral antihyperglycemic agents and switched to JANUMET XR. 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 XR and periodically thereafter. JANUMET XR is contraindicated in patients with an estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73 m2. Discontinue JANUMET XR if the patient’s eGFR later falls below 30 mL/min/1.73 m2 (see **CONTRAINDICATIONS** and **PRECAUTIONS** – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). Initiation of JANUMET XR in patients with an eGFR ≥ 30 mL/min/1.73 m2 and < 45 mL/min/1.73 m2 is not recommended. In patients taking JANUMET XR whose eGFR later falls below 45 mL/min/1.73 m2, assess the benefit and risk of continuing therapy and limit dose of the sitagliptin component to 50 mg once day. _Discontinuation for iodinated contrast imaging procedures:_ Discontinue JANUMET XR 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 XR if renal function is acceptable (see **PRECAUTIONS** – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_).

ORAL

Medical Information

**II. INDICATIONS** JANUMET XR 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 XR 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 XR 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 XR 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 XR 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. JANUMET XR 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 XR (see **PRECAUTIONS** – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_).

**V. CONTRAINDICATIONS** JANUMET XR (sitagliptin phosphate/metformin HCl extended-release) are contraindicated in patients with: 1. Severe renal impairment (eGFR < 30 mL/min/1.73 m2) (see **PRECAUTIONS**, _Metformin hydrochloride_, Lactic Acidosis – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). 2. Known hypersensitivity to sitagliptin phosphate, metformin hydrochloride or any other component of JANUMET XR (see **PRECAUTIONS**, _Sitagliptin phosphate_, Hypersensitivity Reactions and **SIDE EFFECTS**, _Postmarketing Experience_ – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). 3. Acute or chronic metabolic acidosis, including diabetic ketoacidosis, with or without coma. JANUMET XR should be temporarily discontinued in patients undergoing radiologic studies involving intravascular administration of iodinated contrast materials, because the use of such products may result in acute alteration of renal function (see **PRECAUTIONS**; _Metformin hydrochloride_ – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_).

A10BD07

metformin and sitagliptin

Manufacturer Information

MSD PHARMA (SINGAPORE) PTE. LTD.

MSD INTERNATIONAL GMBH (PUERTO RICO BRANCH) LLC (LAS PIEDRAS)

AIAC International Pharma, LLC

Merck Sharp & Dohme BV (Primary & Secondary Packager)

Active Ingredients

Metformin 780mg eqv to metformin hydrochloride

1000mg

Metformin

Sitagliptin Phosphate 64.25mg eqv to Sitagliptin

50 mg

Sitagliptin

Documents

Package Inserts

JANUMET XR TABLET PI.pdf

Approved: November 30, 2022

Download

MedPath

Empowering clinical research with data-driven insights and AI-powered tools.

© 2025 MedPath, Inc. All rights reserved.

JANUMET XR TABLET 50MG/1000MG - HSA Approval | MedPath