Empagliflozin

ATC code

A10BK03

Therapeutic class

Sodium-glucose co-transporter 2 (SGLT2) inhibitor · Drugs used in diabetes, blood glucose lowering drugs, excl. insulins

Forms

film-coated tablet

Brand names

Jardiance (EU)

Overall confidence

high

Regulatory sources consulted

Indicated in adults and children aged 10 years and above for the treatment of insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise, as monotherapy when metformin is considered inappropriate due to intolerance, or in addition to other medicinal products for the treatment of diabetes.
Indicated in adults for the treatment of symptomatic chronic heart failure.
Indicated in adults for the treatment of chronic kidney disease.

Major warning · Diabetic ketoacidosis: Rare cases, including life-threatening ones, have been reported. Promptly evaluate patients with signs/symptoms of ketoacidosis, even with non-elevated blood glucose levels. — EMA
Major warning · Fournier's gangrene (necrotising fasciitis of the perineum): Post-marketing cases have been reported. Advise patients to seek urgent medical attention if they experience severe pain, tenderness, erythema, or swelling in the genital or perineal area, accompanied by fever or malaise. — EMA

ModerateDiureticsC03
Mechanism: Pharmacodynamic synergism: additive diuretic effect may increase the risk of dehydration and hypotension.
Recommendation: Monitor for signs of volume depletion and hypotension, especially in the elderly, patients with renal disease, or those with low blood pressure. Dose adjustment of the diuretic may be necessary.
EMA SPC
ModerateInsulin and insulin secretagoguesA10A, A10BB
Mechanism: Pharmacodynamic synergism that increases the risk of hypoglycaemia.
Recommendation: A lower dose of insulin or an insulin secretagogue may be required to reduce the risk of hypoglycaemia when used in combination with empagliflozin.
EMA SPC

hypoglycaemia (with sulphonylurea or insulin) · vulvovaginal candidiasis · urinary tract infection · increased urination · thirst

diabetic ketoacidosis · Fournier's gangrene · anaphylaxis · angioedema

As a precautionary measure, it is preferable to avoid the use of empagliflozin during pregnancy. It should not be used during breast-feeding.