Ertugliflozin
Regulatory sources consulted
- ema-spc-EMEA/H/C/004315
- aemps-cima-1181267008
- PubMed PMID:34503709 ↗
- RxNorm rxcui 1992672 ↗
Approved indications
- Indicated in adults aged 18 years and older with type 2 diabetes mellitus as an adjunct to diet and exercise to improve glycaemic control: as monotherapy in patients for whom the use of metformin is considered inappropriate due to intolerance or contraindications; in addition to other medicinal products for the treatment of diabetes.
Contraindications
Absolute
- Hypersensitivity to the active substance or to any of the excipients.
Clinical warnings
- Major warning · Diabetic ketoacidosis (DKA): Rare, but serious and sometimes fatal, cases of DKA have been reported in patients treated with SGLT2 inhibitors. Patients should be evaluated promptly for signs or symptoms of ketoacidosis, even with blood glucose levels below 14 mmol/L (250 mg/dL). — EMA SPC
Drug interactions
- ModerateDiuretics (thiazides, loop)C03
Mechanism: Additive osmotic diuretic effect, increasing the risk of volume depletion and hypotension.
Recommendation: Monitor for signs of volume depletion and blood pressure, especially in the elderly and patients with renal impairment.
EMA SPC
Adverse events
Common (≥1%)
Vulvovaginal mycotic infection · Polyuria · Hypoglycemia (with insulin/sulphonylurea) · Urinary tract infection
Rare but serious
Diabetic ketoacidosis · Fournier's gangrene · Lower limb amputation
Pregnancy and lactation
Contraindicated during pregnancy due to reproductive toxicity seen in animals and potential risk to fetal renal development. Not recommended during lactation as risk to the breastfed infant cannot be excluded.
Recent literature (PubMed)
Revisión que destaca la evidencia de los inhibidores de SGLT-2 (clase a la que pertenece ertugliflozina) como un pilar fundamental en el tratamiento de la insuficiencia cardíaca con fracción de eyección reducida (ICFEr), basándose en los resultados de grandes ensayos cardiovasculares que mostraron una reducción consistente en hospitalizaciones por insuficiencia cardíaca.