GLIXAFOR

What it is

GLIXAFOR contains dapagliflozin . GLIXAFOR 10 mg tablets each contain 10 mg dapagliflozin . The tablets are film coated, round, yellow coloured biconvex tablets with bevelled edges debossed with "DP" on one side and "10" on the other side . Dapagliflozin is a reversible competitive inhibitor of sodium glucose co-transporter 2 (SGLT2) that improves glycaemic control in patients with type 2 diabetes mellitus by reducing renal glucose reabsorption leading to urinary glucose excretion .

Approved indications —

GLIXAFOR is indicated in adults with type 2 diabetes mellitus as monotherapy as an adjunct to diet and exercise in patients for whom metformin is otherwise indicated but was not tolerated. — GLIXAFOR is indicated as initial combination therapy with metformin, as an adjunct to diet and exercise, to improve glycaemic control when diet and exercise have failed to provide adequate glycaemic control and there are poor prospects for response to metformin monotherapy (for example, high initial haemoglobin A1c levels). — GLIXAFOR is indicated in combination with other anti-hyperglycaemic agents to improve glycaemic control, when these together with diet and exercise, do not provide adequate glycaemic control.

Dosing overview

The recommended dose of GLIXAFOR is 10 mg taken once daily at any time of the day regardless of meals . When GLIXAFOR is used as an add-on therapy with insulin or an insulin secretagogue (such as sulfonylurea), a lower dose of insulin or an insulin secretagogue may be considered to reduce the risk of hypoglycaemia . No dose adjustment is required for patients with eGFR ≥45 mL/min/1.73 m² . No dosage adjustment for GLIXAFOR is necessary for patients with mild or moderate hepatic impairment .

Key safety warnings

Dapagliflozin should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis . There have been postmarketing reports of acute kidney injury, some requiring hospitalisation and dialysis, in patients receiving SGLT2 inhibitors, including dapagliflozin; some reports involved patients younger than 65 years of age . Monitoring of renal function is recommended prior to initiation of dapagliflozin and at least yearly thereafter; prior to initiation of concomitant medicines that may reduce renal function and periodically thereafter; and for renal function approaching eGFR 45 mL/min/1.73 m², at least 2 to 4 times per year . There have been reports of ketoacidosis, including diabetic ketoacidosis, a serious life-threatening condition requiring urgent hospitalisation in patients taking dapagliflozin and other SGLT2 inhibitors. Fatal cases of ketoacidosis have been reported in patients taking dapagliflozin . Patients treated with dapagliflozin who present with signs and symptoms consistent with ketoacidosis, including nausea, vomiting, abdominal pain, malaise and shortness of breath, should be assessed for ketoacidosis, even if blood glucose levels are below 14 mmol/L. If ketoacidosis is suspected, dapagliflozin should be suspended, the patient should be evaluated and prompt treatment initiated . There have been postmarketing reports of serious urinary tract infections including urosepsis and pyelonephritis requiring hospitalisation in patients receiving SGLT2 inhibitors, including dapagliflozin. Urinary tract infections were more frequently reported for dapagliflozin 10 mg compared to control in a placebo-pooled analysis up to 24 weeks (4.7% vs. 3.5%, respectively) . Postmarketing cases of necrotising fasciitis of the perineum (also known as Fournier's gangrene), a rare, but serious and potentially life-threatening necrotising infection, have been reported in female and male patients with diabetes mellitus treated with SGLT2 inhibitors, including dapagliflozin. Serious outcomes have included hospitalisation, multiple surgeries, and death .

Contraindications

Known hypersensitivity to any of the ingredients . As the efficacy of dapagliflozin is dependent on renal function, dapagliflozin should not be used in patients with eGFR persistently below 45 mL/min/1.73 m² . GLIXAFOR should not be used in patients with severe hepatic impairment . Dapagliflozin must not be used during the second and third trimesters of pregnancy. When pregnancy is detected, treatment with dapagliflozin should be discontinued . Dapagliflozin must not be used by breastfeeding women .

PBS listing

No source document contains PBS listing information for GLIXAFOR.

Regulatory history

GLIXAFOR dapagliflozin 10 mg tablets were first listed on the ARTG on 14 November 2025 . In July 2023, PBAC recommended GLIXAFOR for chronic heart failure .