JARDIAMET

What it is

JARDIAMET contains empagliflozin and metformin hydrochloride and is available in six strengths: 5 mg/500 mg, 5 mg/850 mg, 5 mg/1000 mg, 12.5 mg/500 mg, 12.5 mg/850 mg, and 12.5 mg/1000 mg. JARDIAMET are film-coated tablets for oral administration.

Approved indications

— Type 2 diabetes mellitus in adults and children aged 10 years and above, as an adjunct to diet and exercise to improve glycaemic control, when treatment with both empagliflozin and metformin is appropriate. — Type 2 diabetes mellitus with established cardiovascular disease in adults, to reduce the risk of cardiovascular death.

Dosing overview

The recommended dose is one JARDIAMET tablet twice daily. For treatment naïve patients, the recommended starting dose is 5 mg/500 mg twice daily. The maximum recommended daily dose is 25 mg of empagliflozin and 2000 mg of metformin. JARDIAMET should be given with meals to reduce gastrointestinal undesirable effects associated with metformin. When JARDIAMET is used in combination with a sulfonylurea and/or insulin, a lower dose of sulfonylurea and/or insulin may be required to reduce the risk of hypoglycaemia.

Key safety warnings

Life-threatening lactic acidosis can occur due to accumulation of metformin, with risk factors including renal impairment, old age, and the use of high doses of metformin above 2000 mg per day. Renal function, including eGFR, should be assessed before initiation of treatment 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, for example every 3–6 months.

Contraindications

JARDIAMET is contraindicated for use in patients with severe renal impairment (creatinine clearance <30 mL/min).

Regulatory history

JARDIAMET was registered on the ARTG on 24 July 2015 across six strengths (5 mg/500 mg, 5 mg/850 mg, 5 mg/1000 mg, 12.5 mg/500 mg, 12.5 mg/850 mg, and 12.5 mg/1000 mg).