QTERN

What it is

QTERN is a film-coated tablet containing saxagliptin (as hydrochloride) 5 mg and dapagliflozin (as propanediol monohydrate) 10 mg.

Approved indications

Based on the available source documents, no approved indications for QTERN are specified. The documents contain detailed approved indications for dapagliflozin alone (marketed as FORXIGA), but do not describe the indications approved specifically for the QTERN combination product.

Key safety warnings

The combination product QTERN contains dapagliflozin, for which several important safety warnings apply. 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 (SGLT2) inhibitors, and fatal cases of ketoacidosis have been reported in patients taking dapagliflozin. Patients presenting 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, and if ketoacidosis is suspected, QTERN should be suspended, the patient should be evaluated and prompt treatment initiated. There have been post-marketing reports of serious urinary tract infections including urosepsis and pyelonephritis requiring hospitalisation in patients receiving SGLT2 inhibitors, including dapagliflozin-containing products. 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, with serious outcomes including hospitalisation, multiple surgeries, and death.

Contraindications

Known hypersensitivity to any of the ingredients is a contraindication.

Regulatory history

QTERN (5 mg/10 mg) was first listed on the ARTG on 25 October 2016. In November 2017, the PBAC did not recommend QTERN for listing, noting that the clinical evidence presented was insufficient to establish the cost-effectiveness of saxagliptin with dapagliflozin compared to best supportive care for the treatment of type 2 diabetes mellitus.