DPP-4 + SGLT2 inhibitor Pregnancy: Should not be used during pregnancy — there are no data from use of saxagliptin and dapagliflozin in pregnant women, and animal studies have shown reproductive toxicity (saxagliptin) and toxicity to the developing kidney (dapagliflozin). If pregnancy is detected, treatment should be discontinued. Should not be used while breast-feeding — a risk to newborns/infants cannot be excluded.

Saxagliptin with dapagliflozin

Brand names: Qtern

Used in: Chronic Kidney Disease

This fixed-dose combination tablet for type 2 diabetes pairs the DPP-4 inhibitor saxagliptin with the SGLT2 inhibitor dapagliflozin, providing two complementary glucose-lowering mechanisms in one product.

Auto-extracted from the source labelling — not yet independently clinician-verified. These values were distilled from the UK SPC (or the US label where noted) but have not had a clinician sign-off. Confirm against the current SmPC before prescribing.

Adult dose

Dose: One 5 mg saxagliptin / 10 mg dapagliflozin tablet once daily

Route: Oral — taken orally once daily; may be taken at any time of day with or without food. Tablet is to be swallowed whole

Frequency: Once daily

Missed dose: if it is 12 hours or more until the next dose, the dose should be taken; if it is less than 12 hours until the next dose, the missed dose should be skipped and the next dose taken at the usual time. Hepatic impairment: can be used in mild or moderate hepatic impairment — patients with moderate impairment should be evaluated prior to initiation and during treatment; not recommended in severe hepatic impairment. Elderly (65 years and over): no dose adjustment recommended based on age, but renal function and risk of volume depletion should be taken into account. Paediatric population: safety and efficacy in children and adolescents aged 0 to under 18 years have not yet been established — no data available. Source: UK SPC for Qtern 5 mg/10 mg film-coated tablets (fixed-dose combination — both components covered by this label). SOURCE GAP: section 4.5 (interactions) was not captured in the fetched bundle — clinician to check the full SPC for interaction data.

Dose adjustments

Renal

Should not be initiated in patients with a glomerular filtration rate (GFR) < 60 mL/min and should be discontinued at GFR persistently below 45 mL/min. Should not be used in patients with end-stage renal disease (ESRD). No dose adjustment is recommended based on renal function. Monitor renal function prior to initiation and at least yearly thereafter; at least 2 to 4 times per year for renal function approaching moderate impairment.

Dose auto-extracted from UK Summary of Product Characteristics (SPC) via the eMC — not yet clinician-verified. Always confirm against the product SmPC and your local formulary before prescribing.

Contraindications

Hypersensitivity to the active substances or to any of the excipients
History of a serious hypersensitivity reaction — including anaphylactic reaction, anaphylactic shock and angioedema — to any dipeptidyl peptidase-4 (DPP-4) inhibitor or to any sodium-glucose co-transporter 2 (SGLT2) inhibitor

Side effects

Upper respiratory tract infection (very common)
Hypoglycaemia when used with a sulphonylurea (very common)
Urinary tract infection, vulvovaginitis, balanitis and related genital infection (common)
Headache, dizziness (common)
Dyslipidaemia (common); rash (common)
Diabetic ketoacidosis (rare); necrotising fasciitis of the perineum (Fournier's gangrene) (very rare)

Clinical monograph

How it works

Saxagliptin increases incretin levels to enhance glucose-dependent insulin secretion and suppress glucagon, while dapagliflozin blocks renal glucose reabsorption in the proximal tubule to promote urinary glucose excretion.

Prescribing in practice

Counsel on diabetic ketoacidosis, which can occur with dapagliflozin even with near-normal glucose; advise withholding during acute illness, dehydration or before major surgery (sick-day rules).
The dapagliflozin component predisposes to genital and urinary infections and volume depletion, and efficacy depends on renal function which must be assessed before and during treatment.
Saxagliptin carries a small risk of acute pancreatitis and rare hypersensitivity; discontinue if pancreatitis is suspected.

Monitoring

Monitor renal function, glycaemic control (HbA1c), volume status and for signs of ketoacidosis or genitourinary infection.

Counselling the patient

Stop the tablet and seek urgent help if you feel very unwell with nausea, vomiting, abdominal pain or rapid breathing, as this can signal ketoacidosis.
Maintain good genital hygiene and report symptoms of thrush or urinary infection.
Pause this medicine if you cannot eat or drink normally and contact your team for advice.

Evidence & guidelines

MHRA has warned that SGLT2 inhibitors such as dapagliflozin can cause life-threatening diabetic ketoacidosis, sometimes with only modestly raised blood glucose.

Reference: NICE NG28; Drug verified in RxNorm (NLM); confirm dosing against the manufacturer SPC (eMC). Verify against your local formulary and current prescribing references before prescribing. The structured dose values shown have been reviewed by a clinician. Monograph status: clinician-reviewed (2026-07-04).

Curated clinical cross-links plus same-class fallbacks.

Calculators

Pathways