Dapagliflozin

Class
Hypoglycemic agents
Subclass
Sodium-glucose cotransporter-2 inhibitors
Substance name
Dapagliflozin
Brand names
Farxiga®
Common formulations
Film-coated tablet
Contained in
Dapagliflozin / metformin ER (Xigduo XR®)
Dapagliflozin / saxagliptin (Qtern®)
Dosage and administration
Adults patients
CKD • Reduction of decline in renal function, progression to end-stage kidney disease, cardiovascular mortality, and HF hospitalization
•
10 mg PO daily
Do not initiate in patients with eGFR greater than 25 mL/min/1.73m2. May continue if eGFR falls below 25 mL/min/1.73m2 in patients already on therapy.
Diabetes mellitus type 2 • Glycemic control
•
Start at: 5 mg PO daily
•
Maintenance: 5-10 mg PO daily
Use in eGFR greater than 45 mL/min/1.73m2.
Diabetes mellitus type 2 in patients with CVD • Reduction of HF hospitalization
•
10 mg PO daily
Do not initiate in patients with eGFR greater than 25 mL/min/1.73m2. May continue if eGFR falls below 25 mL/min/1.73m2 in patients already on therapy.
HF • Reduction of cardiovascular mortality and HF hospitalization
•
10 mg PO daily
Do not initiate in patients with eGFR greater than 25 mL/min/1.73m2. May continue if eGFR falls below 25 mL/min/1.73m2 in patients already on therapy.
MASLD • Off-label
•
5-10 mg PO daily
Indications for use
Labeled indications
Adults
•
Treatment of CKD (reduction of decline in renal function, progression to end-stage kidney disease, cardiovascular mortality, and HF hospitalization)
•
Treatment of diabetes mellitus type 2 (glycemic control)
•
Treatment of diabetes mellitus type 2 in patients with CVD (reduction of HF hospitalization)
•
Treatment of HF (reduction of cardiovascular mortality and HF hospitalization)
Children
•
Treatment of diabetes mellitus type 2 (in patients ≥ 10 years)
Off-label indications
Adults
•
Treatment of MASLD
Safety risks
Contraindications
Hypersensitivity to dapagliflozin or its components
Surgery
•
Discontinue dapagliflozin for at least 3 days before major surgery or procedures associated with prolonged fasting, and resume once clinically stable with oral intake resumed.
T1DM or diabetic ketoacidosis
Warnings and precautions
Acute pyelonephritis, urosepsis
•
Maintain a high level of suspicion, as SGLT-2 inhibitors have been associated with an increased risk of serious UTIs, including pyelonephritis and urosepsis.
Decreased blood glucose
•
Use caution in patients taking insulin or insulin secretagogues. Consider reducing the insulin or insulin secretagogue dose.
Diabetic ketoacidosis
•
Maintain a high level of suspicion, as SGLT-2 inhibors have been associated with an increased risk of diabetic ketoacidosis, especially in patients with pancreatic disorders, acute febrile illness, reduced caloric intake, ketogenic diet, recent surgery, reduced insulin dose, volume depletion, or excessive alcohol use. Consider obtaining ketone monitoring in patients at risk for ketoacidosis as indicated. Assess for ketoacidosis in patients presenting with signs and symptoms consistent with severe metabolic acidosis, regardless of blood glucose levels. Withhold dapagliflozin at least 3 days, if possible, before major surgery or procedures associated with prolonged fasting. Resume once clinically stable and after oral intake has resumed.
Fournier's gangrene
•
Maintain a high level of suspicion, as SGLT-2 inhibors have been associated with an increased risk of Fournier's gangrene.
Reactivation of genital mycotic infections
•
Use caution in patients with a history of chronic or recurrent genital mycotic infections.
Volume depletion
•
Maintain a high level of suspicion, as SGLT-2 inhibitors have been associated with an increased risk of volume depletion, especially in patients with renal impairment, taking loop diuretics, or advanced age. Assess and correct volume status before initiating dapagliflozin. Monitor for volume depletion throughout treatment.
Specific populations
Renal impairment
eGFR > 60 mL/min/1.73 m²
•
Use acceptable. No dose adjustment required.
eGFR 45-60 mL/min/1.73 m²
•
Use acceptable. No dose adjustment required. Monitor renal function. Monitor for hypotension.
eGFR 25-45 mL/min/1.73 m²
•
Use with caution. Monitor renal function. Monitor for hypotension. Do not initiate for glycemic control in patients without established cardiovascular disease or cardiovascular risk factors.
eGFR < 25 mL/min/1.73 m²
•
Do not initiate therapy. Consider continuing previously initiated dapagliflozin at 10 mg orally once daily for reducing the risk of estimated glomerular filtration rate decline, end-stage renal disease, cardiovascular death, and heart failure hospitalization. Do not use for glycemic control in patients without established cardiovascular disease or cardiovascular risk factors.
Renal replacement therapy
Any modality
•
Do not use.
Hepatic impairment
Child-Pugh A (mild)
•
Use acceptable. No dose adjustment required.
Child-Pugh B (moderate)
•
Use acceptable. No dose adjustment required.
Child-Pugh C (severe)
•
Use with caution.
Pregnancy and breastfeeding
Pregnancy
First trimester • Australia Category: D
•
Avoid use.
Second and third trimesters • Australia Category: D
•
Do not use.
Breastfeeding
Do not use during breastfeeding.
Unknown amount excreted in breastmilk.
Unknown drug levels in breastfed infants.
Adverse reactions
Common 1-10%
•
Dyslipidemia, genital mycotic infections, ↑ hematocrit, influenza virus infection, nasopharyngitis, back pain, constipation, dysuria, nausea, pain in extremity, urinary frequency, urinary tract infections, volume depletion
Uncommon < 1%
•
Angioedema, ↓ blood glucose, ↓ serum bicarbonate, diabetic ketoacidosis
Unknown frequency
•
Renal failure, Fournier's gangrene, urosepsis, acute pyelonephritis, acute kidney injury, urticaria, skin rash, ↑ serum creatinine, hypotension, orthostatic hypotension
Interactions
Drug(s)
Check Interactions
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