Dapagliflozin
Regulatory sources consulted
- EMA EPAR: EMEA/H/C/004161
- AEMPS CIMA: 1151052007
- EMA SmPC Edistride (ES, EN, FR) dated 2023
- AEMPS CIMA · nº registro 1151052007 ↗
- EMA EPAR · EMEA/H/C/004161 ↗
- RxNorm rxcui 1488564 ↗
Approved indications
- Treatment of insufficiently controlled type 2 diabetes mellitus in adults and children aged 10 years and above as an adjunct to diet and exercise.
- Treatment of symptomatic chronic heart failure in adults.
- Treatment of chronic kidney disease in adults.
Contraindications
Absolute
- Hypersensitivity to the active substance or to any of the excipients.
Clinical warnings
- Major warning · Diabetic ketoacidosis (DKA): Rare cases of DKA have been reported, including cases with only moderately increased blood glucose levels (euglycemic). Patients should be evaluated for ketoacidosis if they present with non-specific signs or symptoms such as nausea, vomiting, anorexia, abdominal pain, excessive thirst, difficulty breathing, confusion, unusual fatigue or sleepiness. — EMA SPC
Drug interactions
- ModerateDiureticsC03
Mechanism: Additive diuretic effect, increasing the risk of dehydration and hypotension.
Recommendation: Monitor volume status and blood pressure, especially at treatment initiation, in elderly patients, or those on loop diuretics.
EMA SPC
Adverse events
Common (≥1%)
Genitourinary infections (vulvovaginitis, balanitis) · Hypoglycaemia (when used with sulphonylurea or insulin) · Polyuria · Urinary tract infection
Rare but serious
Diabetic ketoacidosis · Fournier's gangrene (necrotising fasciitis of the perineum) · Acute kidney injury · Anaphylactic reactions
Pregnancy and lactation
There are no data from the use of dapagliflozin in pregnant women. Should not be used during the second and third trimesters of pregnancy. Should not be used during breast-feeding.