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SGLT2 inhibitor Pregnancy: There are limited data in pregnant women; based on animal studies ertugliflozin may affect renal development and maturation, so it should not be used during pregnancy. Should not be used during breast-feeding - no information on presence in human milk; ertugliflozin is present in the milk of lactating rats and caused effects in offspring, and a risk to newborns/infants cannot be excluded since human kidney maturation occurs in utero and during the first 2 years of life. Effect on human fertility has not been studied.

Ertugliflozin

Brand names: Steglatro

Ertugliflozin is an oral sodium-glucose co-transporter 2 (SGLT2) inhibitor used to improve glycaemic control in 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 (recommended starting dose); in patients tolerating 5 mg once daily the dose can be increased to 15 mg once daily if additional glycaemic control is needed
Route: Oral
Frequency: Once daily in the morning, with or without food
Max: 15 mg once daily
UK SPC (Steglatro 15 mg film-coated tablets) §4.2. When used in combination with insulin or an insulin secretagogue, a lower dose of the insulin or insulin secretagogue may be required to reduce the risk of hypoglycaemia. In patients with volume depletion, correcting this condition prior to initiation is recommended. Missed dose: take as soon as the patient remembers; patients should not take two doses on the same day. Hepatic impairment: no dose adjustment in mild or moderate impairment; not studied and not recommended in severe hepatic impairment. Elderly: no dose adjustment based on age, but renal function and risk of volume depletion should be taken into account. In case of swallowing difficulties the tablet can be broken or crushed as it is an immediate-release dosage form. PAEDIATRIC: safety and efficacy in children under 18 years of age have not been established and no data are available; no paediatric dose is given.

Dose adjustments

Renal

Assessment of renal function is recommended prior to initiation and periodically thereafter. Initiation is not recommended in patients with eGFR less than 45 mL/min/1.73 m2 or CrCl less than 45 mL/min. In patients with eGFR >= 45 to < 60 mL/min/1.73 m2, initiate at 5 mg and up-titrate to 15 mg as needed for glycaemic control. Discontinue when eGFR is persistently less than 30 mL/min/1.73 m2 or CrCl persistently less than 30 mL/min. Should not be used in severe renal impairment, end-stage renal disease or in patients receiving dialysis. Glycaemic lowering efficacy is reduced in moderate and likely absent in severe renal impairment - consider adding other anti-hyperglycaemic agents.

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
  • Should not be used in patients with type 1 diabetes mellitus (§4.4 - may increase the risk of diabetic ketoacidosis in these patients)

Side effects

  • Urinary tract infections (very common)
  • Vulvovaginal mycotic infection and other female genital mycotic infections (common); balanitis candida and other male genital mycotic infections (common); vulvovaginal pruritus (common); necrotising fasciitis of the perineum / Fournier's gangrene (not known)
  • Hypoglycaemia (common); diabetic ketoacidosis (rare)
  • Volume depletion (common) and thirst (common)
  • Increased urination (common); dysuria and blood creatinine increased / glomerular filtration rate decreased (uncommon); serum lipids changed, haemoglobin increased and BUN increased (common)

Interactions

  • Insulin or an insulin secretagogue (§4.2) - a lower dose of insulin or the insulin secretagogue may be required to reduce the risk of hypoglycaemia
  • Diuretics and anti-hypertensive therapy (§4.4) - patients on these agents are at higher risk of symptomatic hypotension/volume depletion after initiation
  • Note: §4.5 was not captured in the fetched bundle - full interaction data must be verified against the SPC

Clinical monograph

How it works

It blocks SGLT2 in the proximal renal tubule, reducing glucose reabsorption and increasing urinary glucose excretion in a manner independent of insulin.

Prescribing in practice

  • It can precipitate diabetic ketoacidosis, sometimes with near-normal blood glucose, so it should be stopped during acute illness, before major surgery and if ketoacidosis is suspected.
  • There is an increased risk of genital and urinary tract infection and, rarely, of Fournier's gangrene of the perineum, which requires urgent assessment.
  • Volume depletion and hypotension can occur, particularly in older patients or those on diuretics, and glycaemic efficacy falls with declining renal function.

Monitoring

Monitor renal function, hydration and volume status, and remain alert for genitourinary infection and ketoacidosis.

Counselling the patient

  • Learn the warning signs of ketoacidosis and seek urgent help if unwell, even if glucose readings are not high.
  • Maintain good genital hygiene and report symptoms of infection or severe perineal pain, swelling or redness.
  • Stay hydrated and follow sick-day advice about pausing the medicine during acute illness.

Evidence & guidelines

The VERTIS CV cardiovascular outcome trial established the cardiovascular safety profile of ertugliflozin in type 2 diabetes.

Reference: NICE NG28; MHRA Drug Safety Update; ADA-EASD consensus; 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).

Related

Curated clinical cross-links plus same-class fallbacks.