JARDIANCE

What it is

JARDIANCE is a film-coated tablet containing empagliflozin, available in strengths of 10 mg and 25 mg. Empagliflozin is an SGLT2 inhibitor that works as a reversible competitive inhibitor of SGLT2. It has 5000-fold selectivity over human SGLT1, which is responsible for glucose absorption in the gut.

Approved indications

— Type 2 diabetes mellitus to improve glycaemic control in adults and children aged 10 years and above as monotherapy when diet and exercise alone do not provide adequate glycaemic control in patients for whom metformin is considered inappropriate due to intolerance. — Type 2 diabetes mellitus as add-on combination therapy in combination with other glucose-lowering medicinal products including insulin, when these, together with diet and exercise, do not provide adequate glycaemic control. — Prevention of cardiovascular death in adult patients with type 2 diabetes mellitus and established cardiovascular disease. — Symptomatic heart failure in adults independent of left ventricular ejection fraction, as an adjunct to standard of care therapy. — Reduction of the risk of kidney disease progression in adults with chronic kidney disease (CKD Stages 2 and 3A with urine ACR ≥30 mg/g, or CKD Stages 3B, 4 and 5 irrespective of urine ACR).

Dosing overview

For type 2 diabetes mellitus, the recommended starting dose is 10 mg once daily. In patients tolerating empagliflozin 10 mg once daily who have an eGFR ≥30 mL/min/1.73 m² and requiring additional glycaemic control, the dose can be increased to 25 mg once daily. For heart failure, the recommended dose is 10 mg once daily. For chronic kidney disease, the recommended dose is 10 mg once daily. JARDIANCE can be taken with or without food.

Key safety warnings

Cases of ketoacidosis, a serious life-threatening condition requiring urgent hospitalisation, have been reported in postmarketing surveillance in patients with diabetes mellitus treated with SGLT2 inhibitors including empagliflozin, and fatal cases have been reported. Cases of ketoacidosis have also been reported in patients without diabetes mellitus. Patients presenting with signs and symptoms consistent with severe metabolic acidosis should be assessed for ketoacidosis regardless of blood glucose levels, as ketoacidosis may be present even if blood glucose is less than 13.8 mmol/L. Before initiating JARDIANCE, consider factors that predispose to ketoacidosis including a low carbohydrate diet, dehydration, acute illness, surgery, previous ketoacidosis, insulin deficiency from any cause, malnourishment or reduced caloric intake, and alcohol abuse. Cases of complicated urinary tract infections including urosepsis and pyelonephritis requiring hospitalisation have been reported in patients receiving SGLT2 inhibitors, including JARDIANCE. 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, with serious outcomes including hospitalisation, multiple surgeries, and death. Osmotic diuresis accompanying glucosuria may lead to a modest decrease in blood pressure. Caution should be exercised in patients for whom an empagliflozin-induced drop in blood pressure could pose a risk, such as patients with cardiovascular disease, patients on diuretics, patients with a history of hypotension, or patients aged 75 years and older. Empagliflozin increases serum creatinine and decreases eGFR. There have been postmarketing reports of acute kidney injury, some requiring hospitalisation and dialysis, in patients receiving SGLT2 inhibitors including empagliflozin.

Contraindications

JARDIANCE is contraindicated in patients with hypersensitivity to empagliflozin or any of the excipients. Patients with the rare hereditary condition of galactose intolerance (such as galactosaemia) should not take this medicine.

PBS listing

JARDIANCE 10 mg tablets are listed on the PBS under 8 items with streamlined restriction at an ex-manufacturer price of A$39.02. JARDIANCE 25 mg tablets are listed under 2 items with streamlined restriction at an ex-manufacturer price of A$39.22.

Regulatory history

JARDIANCE 10 mg and 25 mg film-coated tablets were first registered on the ARTG on 30 April 2014. In November 2015, the PBAC recommended PBS listing in combination with insulin and as triple oral therapy with metformin and a sulfonylurea on a cost minimisation basis with dapagliflozin. In November 2017, the PBAC recommended Authority Required (Streamlined) listing for use in triple oral therapy with linagliptin and metformin on the basis of acceptable cost-effectiveness. In November 2021, the PBAC recommended JARDIANCE for chronic heart failure. On 6 February 2024, the TGA approved an extension of indication to reduce the risk of kidney disease progression in adults with chronic kidney disease (CKD Stages 2 and 3A with urine ACR ≥30 mg/g, or CKD Stages 3B, 4 and 5 irrespective of urine ACR). In May 2025, the PBAC recommended expansion of the eligible population for chronic kidney disease treatment and a new CKD listing for an expanded population in line with the EMPA-KIDNEY trial.