2 The technology

2 The technology

Description of the technology

Dapagliflozin (Forxiga, AstraZeneca) is a selective sodium–glucose cotransporter 2 (SGLT‑2) inhibitor, which blocks the reabsorption of glucose in the kidneys and promotes excretion of excess glucose in the urine.

Marketing authorisation

Dapagliflozin has a UK marketing authorisation for treating type 2 diabetes mellitus to improve glycaemic control in adults:

  • as monotherapy: when diet and exercise alone do not provide adequate glycaemic control in people for whom use of metformin is considered inappropriate due to intolerance or contraindications

  • as add-on combination therapy: with other glucose-lowering medicinal products including insulin, when these, together with diet and exercise, do not provide adequate glycaemic control.

Adverse reactions

The summary of product characteristics lists the following adverse reactions for dapagliflozin: back pain, balanitis, creatinine renal clearance decrease, dizziness, dysuria, dyslipidaemia, elevated haematocrit, polyuria, urinary tract and genital infection, and vulvovaginitis. Dapagliflozin is not recommended for people with moderate to severe renal impairment (people with a creatinine clearance rate of less than 60 ml/min or an estimated glomerular filtration rate [eGFR] of less than 60 ml/min/1.73 m2). For full details of adverse reactions and contraindications, see the summary of product characteristics.

Recommended dose and schedule

The recommended dosage is 10 mg dapagliflozin orally once daily for monotherapy and add-on combination therapy with other glucose-lowering medicinal products including insulin.

Price

The list price of dapagliflozin is £36.59 for a 28‑tablet pack of 5‑mg or 10‑mg tablets (excluding VAT; 'British national formulary' [BNF], accessed online August 2016). Costs may vary in different settings because of negotiated procurement discounts.

  • National Institute for Health and Care Excellence (NICE)