GALVUMET

What it is

GALVUMET is a film-coated tablet containing vildagliptin and metformin hydrochloride. It is available in three strengths: 50 mg vildagliptin with 500 mg metformin hydrochloride; 50 mg vildagliptin with 850 mg metformin hydrochloride; and 50 mg vildagliptin with 1,000 mg metformin hydrochloride.

Approved indications

— Adjunct to diet and exercise to improve glycaemic control in patients with Type 2 diabetes mellitus whose diabetes is not adequately controlled on metformin hydrochloride alone or who are already treated with the combination of vildagliptin and metformin hydrochloride as separate tablets. — Triple combination therapy in combination with a sulfonylurea as an adjunct to diet and exercise in patients inadequately controlled with metformin and a sulfonylurea. — Add-on to insulin as an adjunct to diet and exercise to improve glycaemic control in patients when stable dose of insulin and metformin alone do not provide adequate glycaemic control.

Dosing overview

For patients inadequately controlled on metformin hydrochloride monotherapy, GALVUMET may be initiated at either the 50 mg/500 mg, 50 mg/850 mg or 50 mg/1,000 mg tablet strength twice daily, based on the patient's current dose of metformin hydrochloride. When used in combination with a sulfonylurea or with insulin, the dose of GALVUMET should 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. GALVUMET should be given with meals to reduce the gastrointestinal side effects associated with metformin hydrochloride. The maximum daily dose of vildagliptin (100 mg) should not be exceeded.

Key safety warnings

Life-threatening lactic acidosis can occur due to accumulation of metformin, with the main risk factor being renal impairment; other risk factors include old age associated with reduced renal function and high doses of metformin above 2 g per day. To minimise the risk of lactic acidosis, only one strength of GALVUMET should be prescribed and used at any one time, and patients should be advised to discard their previous metformin medication when initiated on GALVUMET.

Contraindications

GALVUMET is contraindicated in patients with GFR less than 30 ml/min because of its metformin component.

Regulatory history

GALVUMET was first registered on the ARTG on 13 December 2010 in three strengths: 50/500, 50/850, and 50/1000. In March 2016, the PBAC recommended vildagliptin with metformin fixed-dose combination for use with a sulfonylurea on a cost-minimisation basis with its individual components taken concomitantly.