SGLT2 inhibitor + DPP-4 inhibitor (fixed-dose) Pregnancy: There are no data from the use of empagliflozin and linagliptin in pregnant women; as a precautionary measure it is preferable to avoid use during pregnancy. Animal studies with empagliflozin have shown adverse effects on postnatal development. Should not be used during breast-feeding (both substances are excreted in milk in animals; a risk to newborns or infants cannot be excluded). No human fertility trials.

Empagliflozin with linagliptin

Brand names: Glyxambi

A fixed-dose oral combination of empagliflozin, an SGLT2 inhibitor, with linagliptin, a DPP-4 inhibitor, used for type 2 diabetes when dual incretin-plus-SGLT2 therapy is appropriate.

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 film-coated tablet of 10 mg empagliflozin plus 5 mg linagliptin once daily (recommended starting dose)

Route: Oral

Frequency: Once daily, with or without a meal, at any time of the day at regular intervals

Max: One tablet of 25 mg empagliflozin plus 5 mg linagliptin once daily - the highest dose described in §4.2 (dose limited to 10 mg/5 mg daily where eGFR < 60 mL/min/1.73 m2 or CrCl < 60 mL/min)

UK SPC (Glyxambi 10 mg/5 mg film-coated tablets) §4.2. In patients who tolerate the starting dose and require additional glycaemic control the dose can be increased to 25 mg/5 mg once daily. When used in combination with metformin, the metformin dose should be continued. When used with a sulphonylurea or with insulin, a lower dose of the sulphonylurea or insulin may be considered to reduce the risk of hypoglycaemia. Patients switching from separate empagliflozin (10 mg or 25 mg daily) and linagliptin (5 mg daily) should receive the same daily dose of each in the fixed-dose combination. Missed dose: if 12 hours or more remain until the next dose, take as soon as remembered and take the next dose at the usual time; if less than 12 hours remain, skip the dose - never take a double dose. Hepatic impairment: no dose adjustment in mild to moderate impairment; 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 patients 75 years and older. Tablets should be swallowed whole with water. PAEDIATRIC: safety and efficacy in patients below 18 years of age have not been established; a clinical trial did not establish efficacy of linagliptin in patients 10 to 17 years of age, so treatment of children and adolescents is not recommended, and the product has not been studied under 10 years of age. No paediatric dose is given.

Dose adjustments

Renal

§4.2 Table 1: eGFR >= 60 mL/min/1.73 m2 or CrCl >= 60 mL/min - initiate empagliflozin 10 mg, may increase to 25 mg if tolerated and additional glycaemic control is needed; eGFR 45 to < 60 and 30 to < 45 - initiate with 10 mg (in patients with type 2 diabetes and established cardiovascular disease) or continue with 10 mg in patients already taking empagliflozin; eGFR < 30 - empagliflozin is not recommended. No dose adjustment for linagliptin is required at any eGFR. For cardiovascular risk reduction as add-on to standard of care, empagliflozin 10 mg once daily should be used in patients with eGFR below 60 mL/min/1.73 m2. Glycaemic efficacy of empagliflozin is reduced in moderate and likely absent in severe renal impairment - consider adding other anti-hyperglycaemic agents. Should not be used in end stage renal disease or in patients on dialysis.

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, to any other sodium-glucose co-transporter-2 (SGLT2) inhibitor, to any other dipeptidyl peptidase-4 (DPP-4) inhibitor, or to any of the excipients
Should not be used in patients with type 1 diabetes (§4.4 - increased DKA occurrence seen with empagliflozin as adjunct to insulin in type 1 diabetes)

Side effects

Urinary tract infection including pyelonephritis and urosepsis (common); vaginal moniliasis, vulvovaginitis, balanitis and other genital infections (common)
Hypoglycaemia when used with sulphonylurea or insulin (common); thirst (common)
Increased urination (common); dysuria (uncommon); blood creatinine increased / glomerular filtration rate decreased (uncommon)
Pruritus and rash (common); nasopharyngitis, cough and constipation (common)
Diabetic ketoacidosis (rare) and necrotising fasciitis of the perineum / Fournier's gangrene (rare); pancreatitis (uncommon); hypersensitivity, angioedema and urticaria (uncommon); volume depletion (uncommon)

Interactions

Sulphonylurea or insulin (§4.2) - a lower dose of the sulphonylurea or insulin may be considered to reduce the risk of hypoglycaemia
Metformin (§4.2) - when Glyxambi is used in combination with metformin, the metformin dose should be continued
Note: §4.5 was not captured in the fetched bundle - full interaction data must be verified against the SPC

Clinical monograph

How it works

Empagliflozin promotes urinary glucose excretion via SGLT2 inhibition, while linagliptin raises incretin hormone levels to enhance glucose-dependent insulin secretion and suppress glucagon.

Prescribing in practice

The most important safety point is the risk of euglycaemic diabetic ketoacidosis from the SGLT2 component, requiring sick-day rules and withholding during acute illness, dehydration, or surgery.
Linagliptin carries a risk of acute pancreatitis and, rarely, severe joint pain and bullous pemphigoid, while empagliflozin predisposes to genital and urinary infections and rare Fournier's gangrene.
Linagliptin needs no renal dose adjustment, but empagliflozin has renal thresholds governing use, so confirm renal function before starting.

Monitoring

Monitor renal function, HbA1c, hydration and weight, and remain alert for ketoacidosis and for symptoms of pancreatitis.

Counselling the patient

Stop the medicine and seek urgent help if acutely unwell, dehydrated, or if you develop nausea, vomiting, abdominal pain, or breathlessness.
Report severe or persistent abdominal pain, which could indicate pancreatitis.
Report any genital soreness or itching and maintain good genital hygiene.

Evidence & guidelines

NICE recommends SGLT2 inhibitors in type 2 diabetes, and empagliflozin's cardiovascular benefit was established in the EMPA-REG OUTCOME trial.

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).

Curated clinical cross-links plus same-class fallbacks.

Calculators

Pathways