GLYXAMBI

What it is

GLYXAMBI contains empagliflozin and linagliptin as film-coated tablets available in two strengths: GLYXAMBI 25 mg/5 mg (containing 25 mg empagliflozin and 5 mg linagliptin) and GLYXAMBI 10 mg/5 mg (containing 10 mg empagliflozin and 5 mg linagliptin). Empagliflozin and linagliptin act by separate and complementary mechanisms to treat type 2 diabetes mellitus.

Approved indications

— GLYXAMBI tablets are indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus when treatment with both empagliflozin and linagliptin is appropriate.

Dosing overview

The recommended starting dose is GLYXAMBI 10 mg/5 mg (empagliflozin 10 mg/linagliptin 5 mg) once daily. In patients tolerating GLYXAMBI 10 mg/5 mg once daily and requiring additional glycaemic control, the dose can be increased to GLYXAMBI 25 mg/5 mg (empagliflozin 25 mg/linagliptin 5 mg) once daily. GLYXAMBI can be taken with or without food and at any time of day.

Key safety warnings

Cases of diabetic ketoacidosis (DKA), a serious life-threatening condition requiring urgent hospitalisation, have been reported in postmarketing surveillance in patients treated with SGLT2 inhibitors, including empagliflozin. Fatal cases of ketoacidosis have been reported in patients taking empagliflozin. Patients treated with GLYXAMBI who present with signs and symptoms consistent with severe metabolic acidosis should be assessed for ketoacidosis regardless of presenting blood glucose levels as ketoacidosis associated with GLYXAMBI may be present even if blood glucose levels are less than 13.8 mmol/L. There have been postmarketing reports of serious urinary tract infections including urosepsis and pyelonephritis requiring hospitalisation in patients receiving SGLT2 inhibitors, including empagliflozin. Treatment with SGLT2 inhibitors increases the risk for urinary tract infections. Cases of necrotising fasciitis of the perineum (also known as Fournier's gangrene), a rare, but serious and life-threatening necrotising infection, have been reported in female and male patients treated with SGLT2 inhibitors, including empagliflozin. Serious outcomes have included hospitalisation, multiple surgeries, and death. There have been postmarketing reports of acute kidney injury, some requiring hospitalisation and dialysis, in patients receiving SGLT2 inhibitors, including empagliflozin; some reports involved patients younger than 65 years of age.

Contraindications

GLYXAMBI is contraindicated in patients with hypersensitivity to empagliflozin or linagliptin or any of the excipients. GLYXAMBI is contraindicated in patients with severe renal impairment (eGFR <30 mL/min/1.73 m²), end-stage renal disease and patients on dialysis.

PBS listing

GLYXAMBI was recommended by the PBAC in November 2017 for use in combination with metformin for the treatment of type 2 diabetes. The PBAC noted that listing was not recommended for patients with mild to moderate renal impairment due to insufficient data.

Regulatory history

GLYXAMBI 10 mg/5 mg and GLYXAMBI 25 mg/5 mg were first registered on the Australian Register of Therapeutic Goods on 19 December 2016. The PBAC recommended the medicine in November 2017 for use in combination with metformin for the treatment of type 2 diabetes.