DPP-4 inhibitor Pregnancy: Use has not been studied in pregnant women; animal studies show reproductive toxicity at high doses and the potential risk for humans is unknown — saxagliptin should not be used during pregnancy unless clearly necessary. It is unknown whether saxagliptin is excreted in human breast milk (excreted in animal milk); a decision must be made whether to discontinue breast-feeding or therapy (§4.6).

Saxagliptin

Brand names: Onglyza

Saxagliptin is an oral dipeptidyl peptidase-4 (DPP-4) inhibitor used to improve glycaemic control in adults with type 2 diabetes.

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: 5 mg once daily

Route: Oral

Frequency: Once daily

Source: UK SPC §4.2 for Saxagliptin 2.5 mg Film-coated Tablet. Tablets can be taken with or without a meal at any time of day, and must not be split or cut. If a dose is missed it should be taken as soon as the patient remembers; a double dose should not be taken on the same day. When used in combination with insulin or a sulphonylurea, a lower dose of the insulin or sulphonylurea may be required to reduce the risk of hypoglycaemia. Safety and efficacy as triple oral therapy with metformin plus a thiazolidinedione have not been established. Should not be used in type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis, and is not a substitute for insulin in insulin-requiring patients. Elderly (65 years and over): no dose adjustment recommended based on age alone. Hepatic impairment: no dose adjustment for mild or moderate impairment, but use with caution in moderate impairment; not recommended in severe hepatic impairment. Paediatric: efficacy in children aged 10 to under 18 years has not been established and treatment of children and adolescents is not recommended; not studied under 10 years of age. No maximum dose is stated. eMC §4.5 (interactions) was not captured in this bundle — clinician to check the full interaction list against the current SPC.

Dose adjustments

Renal

No dose adjustment for mild renal impairment, or for moderate renal impairment with GFR >= 45 mL/min. Reduce to 2.5 mg once daily in moderate renal impairment with GFR < 45 mL/min and in severe renal impairment. Not recommended for patients with end-stage renal disease requiring haemodialysis. Assess renal function before initiation and periodically thereafter (§4.2, §4.4).

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 substance or to any of the excipients
History of a serious hypersensitivity reaction — including anaphylactic reaction, anaphylactic shock and angioedema — to any dipeptidyl peptidase-4 (DPP4) inhibitor

Side effects

Upper respiratory tract infection (7.7%) — common
Urinary tract infection (6.8%) — common
Headache (6.5%) — common
Gastroenteritis, sinusitis and nasopharyngitis — common
Hypoglycaemia — very common when used as add-on to metformin plus a sulphonylurea; dyslipidaemia uncommon
Hypersensitivity reactions (uncommon); anaphylactic reactions including anaphylactic shock (rare); acute pancreatitis and bullous pemphigoid reported post-marketing

Interactions

Sulphonylureas — known to cause hypoglycaemia; a lower sulphonylurea dose may be required when combined with saxagliptin (§4.4)
Insulin — known to cause hypoglycaemia; a lower insulin dose may be required when combined with saxagliptin (§4.4)
eMC §4.5 not captured in this bundle — clinician to verify the full interaction list (including CYP3A4/5 inhibitors) against the current SPC

Clinical monograph

How it works

By inhibiting DPP-4 it prolongs the activity of incretin hormones, increasing glucose-dependent insulin secretion and suppressing glucagon, thereby lowering blood glucose.

Prescribing in practice

DPP-4 inhibitors including saxagliptin have been associated with acute pancreatitis, so treatment should be stopped if pancreatitis is suspected.
A signal for increased heart-failure hospitalisation was observed in cardiovascular outcome data, so caution is advised in patients with heart failure risk factors.
Dose adjustment is required in renal impairment, and rare hypersensitivity reactions including angioedema have been reported.

Monitoring

Monitor glycaemic control with HbA1c and assess renal function periodically to guide continued dosing.

Counselling the patient

Report severe, persistent abdominal pain, which could indicate pancreatitis.
Report worsening breathlessness or swelling, which may suggest heart failure.
Hypoglycaemia is uncommon alone but more likely if combined with insulin or a sulfonylurea.

Evidence & guidelines

The SAVOR-TIMI 53 trial confirmed glycaemic efficacy and characterised the heart-failure hospitalisation signal, consistent with the SPC.

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.

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