2 Information about dapagliflozin

2 Information about dapagliflozin

Marketing authorisation

Dapagliflozin (Forxiga, AstraZeneca) is indicated for the treatment of 'type 1 diabetes mellitus as an adjunct to insulin in patients with a BMI ≥ 27 kg/m2, when insulin alone does not provide adequate glycaemic control despite optimal insulin therapy'.

Dapagliflozin should not be started in people with type 1 diabetes with a 'low insulin need'. It should not be started in people with a glomerular filtration rate (GFR) of less than 60 ml/min and should be stopped at a GFR persistently below 45 ml/min. During treatment with dapagliflozin, insulin therapy should be continuously optimised to prevent ketosis and diabetic ketoacidosis, and the insulin dose should only be reduced to avoid hypoglycaemia. This treatment should only be 'started and supervised by specialist doctors'. Patients should be able and committed to control ketone levels in their body. They should be educated about risk factors for diabetic ketoacidosis and how to recognise its signs and symptoms.

Dosage in the marketing authorisation

Administered orally at a dosage of 5 mg once daily.

Price

The list price of dapagliflozin is £36.59 for 28 tablets (excluding VAT; BNF online, accessed April 2019). The treatment cost at list price is £477.30 per year. Costs may vary in different settings because of negotiated procurement discounts.

  • National Institute for Health and Care Excellence (NICE)