GALVUS MET TABLET 50MG/850MG [SIN13685P]

Product Info

GALVUS MET TABLET 50MG/850MG

[SIN13685P]

INDICATIONS

Galvus Met is indicated in adults with type 2 diabetes mellitus as an adjunct to diet and exercise to improve glycemic control:

• as initial therapy when diabetes is not adequately controlled by diet and exercise alone

• as therapy in patients inadequately controlled with metformin hydrochloride or vildagliptin alone or who are already treated with the combination of vildagliptin and metformin hydrochloride, as separate tablets

• as combination therapy- in combination with other medicinal products, including insulin, when these do not provide adequate glycemic control (see section on Warnings and precautions, section on Interactions and section on Clinical Studies for available data on different combinations – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Important limitations of Use

Galvus Met 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.

DOSAGE REGIMEN AND ADMINISTRATION

Method of administration

For oral use.

Galvus Met should be given with meals to reduce the gastrointestinal side effects associated with metformin hydrochloride.

If a dose of Galvus Met is missed, it should be taken as soon as the patient remembers. A double dose should not be taken on the same day.

Dosage

Adults

Based on the patient’s current dose of vildagliptin and/or metformin, Galvus Met may be initiated at either the 50 mg/500 mg or 50mg/850mg or 50mg/1000mg tablet strength twice daily, one tablet in the morning and the other in the evening. The recommended daily dose is 100mg vildagliptin plus 2000mg metformin hydrochloride.

Patients receiving vildagliptin and metformin from separate tablets may be switched to Galvus Met containing the same doses of each component.

In treatment naïve patients, Galvus Met may be initiated at 50mg/500 mg once daily and gradually titrated to a maximum dose of 50mg/1000 mg twice daily after assessing the adequacy of therapeutic response.

The dose of Galvus Met used in combination therapy with sulfonylurea (SU) or insulin would provide vildagliptin dosed as 50 mg twice daily (100 mg total daily dose) and a dose of metformin similar to the dose already being taken.

When used in combination with a sulfonylurea, a lower dose of the sulfonylurea may be considered to reduce the risk of hypoglycaemia.

Initial combination therapy or maintenance of combination therapy should be individualized and are left to the discretion of the health care provider.

Doses higher than 100mg of vildagliptin are not recommended.

The use of antihyperglycaemic therapy in the management of type 2 diabetes should be individualized on the basis of effectiveness and tolerability. The recommended starting dose of Galvus Met should be based on the patient’s current regimen of vildagliptin and/or metformin hydrochloride.

General target population

Adults 18 years of age and above

Special populations

Renal impairment

A GFR should be assessed before initiation of treatment with metformin-containing products (such as Galvus Met) and at least annually thereafter. In patients at increased risk of further progression of renal impairment and in the elderly, renal function should be assessed more frequently, e.g. every 3 to 6 months.

The maximum daily dose of metformin should preferably be divided into 2 to 3 daily doses. Factors that may increase the risk of lactic acidosis (see section WARNINGS AND PRECAUTIONS – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information) should be reviewed before considering initiation of metformin-containing products (such as Galvus Met) in patients with GFR<60 ml/min. Galvus Met is contraindicated in patients with GFR <30 ml/min because of its metformin component (see section CONTRAINDICATIONS).

The following dosing recommendations apply to metformin and Vildagliptin, used separately or in combination, in patients with renal impairment. If no adequate strength of Galvus Met is available, individual components should be used instead of the fixed dose combination.

Hepatic impairment

Galvus Met is not recommended in patients with clinical or laboratory evidence of hepatic impairment including patients with a pre-treatment ALT or AST >2.5X the upper limit of normal (see section WARNINGS AND PRECAUTIONS – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Geriatric patients (65 years or above)

As metformin is excreted via the kidneys, and elderly patients tend to exhibit decreased renal function, elderly patients taking metformin-containing products (such as Galvus Met) should have their renal function monitored regularly.

Pediatric patients (below 18 years)

The safety and effectiveness of Galvus Met in pediatric patients have not been established. Therefore, Galvus Met is not recommended for use in children below 18 years of age.

CONTRAINDICATIONS

Hypersensitivity

Galvus Met is contraindicated in patients with known hypersensitivity to vildagliptin or metformin hydrochloride or to any of the excipients (see section DESCRIPTION AND COMPOSITION, sub-section EXCIPIENTS – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Patients with renal impairment

Galvus Met is contraindicated in patients with severe renal impairment (GFR <30 ml/min) (see section DOSAGE REGIMEN AND ADMINISTRATION and section WARNINGS AND PRECAUTIONS – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). Acute conditions with the potential to alter renal function, such as dehydration, severe infection, shock and intravascular administration of iodinated contrast agents.

Congestive heart failure

Galvus Met is contraindicated in patients with congestive heart failure requiring pharmacological treatment (see WARNINGS AND PRECAUTIONS – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Metabolic acidosis

Galvus Met is contraindicated in patients with acute or chronic metabolic acidosis, including lactic acidosis or diabetic ketoacidosis, with or without coma. Diabetic ketoacidosis should be treated with insulin.

Acute or chronic disease which may cause tissue hypoxia, such as: cardiac or respiratory failure, recent myocardial infarction and shock;

Acute alcohol intoxication, alcoholism;

Breast-feeding.