ertugliflozin L-pyroglutamic acid: clinical use

Prescribing considerations

• Licensed for adults with insufficiently controlled type 2 diabetes; it should not be used for type 1 diabetes.
• Assess renal function and volume status before initiation and review renal function periodically.
• Consider susceptibility to hypotension or dehydration, particularly with renal impairment, older age, diuretics or antihypertensives.
• The glycaemic effect declines as renal function worsens; follow current product-specific renal restrictions.
• Consider previous urinary or genital infections and reinforce foot care.

Contraindications and cautions

• Hypersensitivity to ertugliflozin or any excipient.
• The formulation contains lactose and should not be used in rare hereditary galactose intolerance, total lactase deficiency or glucose-galactose malabsorption.

Monitoring

• Renal function before treatment and periodically thereafter.
• Volume status, blood pressure and symptoms of dehydration or postural hypotension.
• Glycaemic control using methods other than urine glucose or the 1,5-anhydroglucitol assay.
• Blood ketones when ketoacidosis is suspected.
• Genital and urinary infection symptoms and foot health.

Clinical pharmacology

Ertugliflozin is a selective, reversible SGLT2 inhibitor. It reduces renal glucose reabsorption and the renal threshold for glucose, increasing urinary glucose excretion. Clearance is mainly through UGT1A9- and UGT2B7-mediated glucuronidation; oxidative CYP metabolism is minor.

Formulation and product differences

• The selected product consists of immediate-release film-coated tablets.
• Tablet strengths differ in colour, size, markings and lactose content.
• The tablets may be broken or crushed when swallowing is difficult and are essentially sodium-free.

Tablet

Route: Oral

Strengths: 5 mg, 15 mg