FORXIGA

What it is

FORXIGA contains the active ingredient dapagliflozin propanediol monohydrate. Each film-coated tablet contains 10 mg of dapagliflozin. Dapagliflozin is a reversible competitive inhibitor of sodium glucose co-transporter 2 (SGLT2) with nanomolar potency that improves glycaemic control in patients with type 2 diabetes mellitus and provides cardio-renal benefits.

Approved indications

— 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. — Type 2 diabetes mellitus 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. — Type 2 diabetes mellitus in combination with other anti-hyperglycaemic agents to improve glycaemic control, when these together with diet and exercise do not provide adequate glycaemic control. — Type 2 diabetes mellitus with established cardiovascular disease or risk factors for cardiovascular disease to reduce the risk of hospitalization for heart failure. — Symptomatic heart failure independent of left ventricular ejection fraction, as an adjunct to standard of care therapy. — Proteinuric chronic kidney disease (CKD Stage 2, 3 or 4) to reduce the risk of progressive decline in kidney function.

Dosing overview

The recommended dose of FORXIGA is 10 mg taken orally once daily at any time of the day regardless of meals for type 2 diabetes mellitus, heart failure, and chronic kidney disease. When FORXIGA is used as 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. When used as initial combination therapy, the recommended starting doses are 10 mg FORXIGA plus 500 mg metformin once daily.

Key safety warnings

FORXIGA should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis. There have been reports of ketoacidosis, including diabetic ketoacidosis, a serious life-threatening condition requiring urgent hospitalisation in patients taking dapagliflozin and other sodium-glucose cotransporter 2 inhibitors. Fatal cases of ketoacidosis have been reported in patients taking dapagliflozin. Patients treated with FORXIGA 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, FORXIGA should be suspended, the patient should be evaluated and prompt treatment initiated. The diuretic effect of FORXIGA is a potential concern for volume depleted patients. Due to its mechanism of action, FORXIGA induces osmotic diuresis which may lead to modest decrease in blood pressure observed in clinical studies. In case of intercurrent conditions that may lead to volume depletion, such as gastrointestinal illness, heat stress or severe infections, careful monitoring of volume status is recommended. Temporary interruption of FORXIGA is recommended for patients who develop volume depletion until the depletion is corrected. There have been post-marketing reports of serious urinary tract infections including urosepsis and pyelonephritis requiring hospitalisation in patients receiving SGLT2 inhibitors, including FORXIGA. Post-marketing 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. FORXIGA should not be used in patients with severe hepatic impairment. Initiating treatment with FORXIGA in patients with eGFR <25 mL/min/1.73 m² is not recommended.

PBS listing

Information regarding PBS listing, item count, restriction type, and ex-manufacturer price is not available in the provided source documents.

Regulatory history

FORXIGA (dapagliflozin as propanediol monohydrate) 10 mg film-coated tablets were first listed on the ARTG on 22 October 2012. In November 2017, PBAC recommended a change to the PBS listing to allow dapagliflozin to be used in combination with insulin for the treatment of type 2 diabetes mellitus. In September 2021, PBAC recommended a change for heart failure with reduced ejection fraction with matters outstanding regarding the PBS listing change. The TGA approved the extension of indications for FORXIGA on 6 September 2021 for the treatment of chronic kidney disease, based on robust clinical evidence demonstrating efficacy in reducing the risk of progressive decline in kidney function and a favourable benefit-risk profile.