QTERN™ (saxagliptin/dapagliflozin)

QTERN™ is a fixed dose combination of saxagliptin and dapagliflozin and is indicated in adults aged 18 years and older with type 2 diabetes mellitus1

Clinical Considerations

Things to consider when prescribing QTERN™1

  • QTERN™ must not be used in patients who have had any serious hypersensitivity reaction to a DPP-4 inhibitor or a SGLT2 inhibitor.
  • QTERN™ should not be used in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis.
  • DPP-4 inhibitors have been associated with risk of developing acute pancreatitis. Inform patients of the characteristic symptoms of acute pancreatitis: persistent, severe abdominal pain. If pancreatitis suspected, discontinue use. If acute pancreatitis confirmed, treatment should not be restarted. Exercise caution in patients with a history of pancreatitis.
  • QTERN™ is not recommended for use in patients with moderate to severe renal impairment (patients with creatinine clearance [CrCl] <60 ml/min or estimated glomerular filtration rate [eGFR] <60 ml/min/1.73 m2). This medicinal product has not been studied in severe renal impairment (CrCl < 30 ml/min or eGFR < 30 ml/min/1.73m2 ) or end stage renal disease.
  • If QTERN™ is used in combination with insulin secretagogue (sulphonylurea), a reduction in the dose of sulphonylurea may be required to minimise the risk of hypoglycaemia.
  • Rare cases of diabetic ketoacidosis (DKA), including life-threatening and fatal cases, have been reported in patients treated with SGLT2 inhibitors, including dapagliflozin. In a number of cases, the presentation of the condition was atypical with only moderately increased blood glucose values, below 14 mmol/l (250 mg/dl). In patients where DKA is suspected or diagnosed, treatment with QTERN™ should be discontinued immediately.
  • QTERN™ can be used in patients with mild or moderate hepatic impairment. Patients with moderate hepatic impairment should be evaluated prior to initiation and during treatment. This medicinal product is not recommended for use in patients with severe hepatic impairment.
  • Experience in NYHA class I-II is limited in dapagliflozin. There is no experience in clinical trials with dapagliflozin in NYHA class III-IV. Experience in NYHA class III-IV is limited with saxagliptin.
  • In the SAVOR trial, a small increase in the rate for hospitalisation for heart failure was observed in the saxagliptin-treated patients compared to placebo, although a causal relationship has not been established. Additional analysis did not indicate a differential effect among NYHA classes.
  • Caution is warranted if QTERN™ is used in patients who have known risk factors for hospitalisation for heart failure, such as a history of heart failure or moderate to severe renal impairment. Patients should be advised of the characteristic symptoms of heart failure, and to immediately report such symptoms.
  • QTERN™ is not recommended for patients concomitantly treated with pioglitazone.
  • Continuation of therapy should be individually assessed if patients experience severe joint pain.
  • Lower limb amputations: Counsel patients on routine preventative foot care as an increase in cases of lower limb amputation (primarily of the toe) has been observed in ongoing long-term, clinical studies with another SGLT2 inhibitor.

For further information please consult the QTERN™ SPC.

When a metformin plus FORXIGA® patients' disease progresses, replace their FORXIGA® tablet with QTERN™.1 

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