From the Guidelines
Farxiga (dapagliflozin) is primarily indicated for adults with type 2 diabetes mellitus to improve glycemic control, alongside diet and exercise, as well as for reducing the risk of hospitalization for heart failure in adults with type 2 diabetes and established cardiovascular disease or multiple cardiovascular risk factors, and for adults with heart failure with reduced ejection fraction to reduce the risk of cardiovascular death and hospitalization, regardless of diabetes status, based on the most recent evidence from 1.
Indications for Farxiga
- Improve glycemic control in adults with type 2 diabetes mellitus as an adjunct to diet and exercise
- Reduce the risk of hospitalization for heart failure in adults with type 2 diabetes and established cardiovascular disease or multiple cardiovascular risk factors
- Reduce the risk of cardiovascular death and hospitalization in adults with heart failure with reduced ejection fraction, regardless of diabetes status
- Reduce the risk of sustained eGFR decline, end-stage kidney disease, cardiovascular death, and hospitalization for heart failure in adults with chronic kidney disease at risk of progression
Key Evidence
- The DAPA-HF trial demonstrated that dapagliflozin reduced the risk of worsening heart failure and cardiovascular death in individuals with heart failure with reduced ejection fraction, regardless of diabetes status 1
- The EMPEROR-Reduced trial showed that empagliflozin reduced the risk of cardiovascular death and hospitalization for heart failure in individuals with heart failure with reduced ejection fraction, regardless of diabetes status 1
- The DELIVER trial found that dapagliflozin reduced the risk of worsening heart failure and cardiovascular death in individuals with heart failure with preserved ejection fraction, regardless of diabetes status 1
Dosage and Administration
- The typical starting dose of Farxiga is 5 mg once daily, taken in the morning, with or without food, which may be increased to 10 mg daily if needed and tolerated
- Farxiga works by inhibiting sodium-glucose cotransporter 2 (SGLT2) in the kidneys, preventing glucose reabsorption and increasing glucose excretion in urine, which lowers blood glucose levels and provides cardiovascular and renal benefits through multiple mechanisms
Important Considerations
- Farxiga is contraindicated in patients with a history of serious hypersensitivity reaction to the drug, and in patients with end-stage renal disease or severe renal impairment 1
- Farxiga may increase the risk of genital fungal infections, urinary tract infections, and euglycemic diabetic ketoacidosis, and may contribute to intravascular volume contraction 1
From the FDA Drug Label
DAPAGLIFLOZIN TABLETS are indicated: • To reduce the risk of sustained eGFR decline, end-stage kidney disease, cardiovascular death, and hospitalization for heart failure in adults with chronic kidney disease at risk of progression • To reduce the risk of cardiovascular death, hospitalization for heart failure, and urgent heart failure visit in adults with heart failure • To reduce the risk of hospitalization for heart failure in adults with type 2 diabetes mellitus and either established cardiovascular disease or multiple cardiovascular risk factors • As an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients aged 10 years and older with type 2 diabetes mellitus
The indications for Farxiga (dapagliflozin) are:
- Reduction of the risk of sustained eGFR decline, end-stage kidney disease, cardiovascular death, and hospitalization for heart failure in adults with chronic kidney disease at risk of progression
- Reduction of the risk of cardiovascular death, hospitalization for heart failure, and urgent heart failure visit in adults with heart failure
- Reduction of the risk of hospitalization for heart failure in adults with type 2 diabetes mellitus and either established cardiovascular disease or multiple cardiovascular risk factors
- Improvement of glycemic control in adults and pediatric patients aged 10 years and older with type 2 diabetes mellitus 2 2 2
From the Research
Farxiga Indications
- Farxiga (dapagliflozin) is indicated for the treatment of type 2 diabetes 3, 4, 5
- It is also approved for the treatment of heart failure with reduced ejection fraction in adults with and without type 2 diabetes 6, 7
- Additionally, dapagliflozin has been approved for the treatment of chronic kidney disease 7
- It is not recommended in patients with moderate or severe renal impairment 4
- Dapagliflozin is contraindicated in patients with type 1 diabetes and end-stage chronic kidney disease 7
Approved Uses
- Monotherapy in patients with type 2 diabetes who are intolerant of metformin 3
- Add-on combination therapy with other glucose-lowering agents, including insulin, for type 2 diabetes when diet and exercise alone do not provide adequate glycaemic control 3
- Reduction of hospitalization risk for heart failure in adults with type 2 diabetes and established cardiovascular disease or risk factors 6
- Treatment of heart failure with reduced ejection fraction in adults with and without type 2 diabetes 6, 7