ARX-VILDAGLIPTIN/METFORMIN

What it is

ARX-VILDAGLIPTIN/METFORMIN is a film-coated tablet containing vildagliptin and metformin hydrochloride, 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

The recommended starting dose of ARX-VILDAGLIPTIN/METFORMIN should be based on the patient's current regimen of vildagliptin and/or metformin hydrochloride. ARX-VILDAGLIPTIN/METFORMIN 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. For patients inadequately controlled on metformin hydrochloride monotherapy, ARX-VILDAGLIPTIN/METFORMIN may be initiated at either the 50 mg/500 mg, 50 mg/850 mg or 50 mg/1,000 mg tablet strength twice daily. For use in combination with a sulfonylurea or with insulin, the dose of ARX-VILDAGLIPTIN/METFORMIN 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.

Key safety warnings

Life-threatening lactic acidosis can occur due to accumulation of metformin. The main risk factor is 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 ARX-VILDAGLIPTIN/METFORMIN should be prescribed and used at any one time. Patients should also be advised to discard their previous metformin medication when initiated on ARX-VILDAGLIPTIN/METFORMIN. A glomerular filtration rate should be assessed before initiation of treatment with ARX-VILDAGLIPTIN/METFORMIN 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, every 3 to 6 months.

Contraindications

ARX-VILDAGLIPTIN/METFORMIN is contraindicated in patients with glomerular filtration rate less than 30 ml/min because of its metformin component.

Regulatory history

ARX-VILDAGLIPTIN/METFORMIN was first listed on the ARTG on 2 July 2025, with three strengths registered: the 50/500, 50/850, and 50/1000 formulations.