Generic Name and Clinical Profile of Farxiga
The generic name of Farxiga is dapagliflozin, a sodium-glucose cotransporter-2 (SGLT2) inhibitor approved for type 2 diabetes mellitus, chronic kidney disease, and heart failure (both reduced and preserved ejection fraction). 1, 2
Approved Indications
Chronic kidney disease: Reduces the risk of sustained eGFR decline ≥50%, end-stage kidney disease, cardiovascular death, and heart failure hospitalization in adults with CKD at risk of progression (eGFR 25–75 mL/min/1.73 m² with albuminuria UACR 200–5000 mg/g). 2
Heart failure with reduced ejection fraction (HFrEF): Decreases cardiovascular death, hospitalization for heart failure, and urgent heart failure visits, regardless of diabetes status. 2, 3
Heart failure with preserved ejection fraction (HFpEF): Lowers the composite of worsening heart failure or cardiovascular death. 2
Type 2 diabetes mellitus: Reduces hospitalization for heart failure in adults with established cardiovascular disease or multiple cardiovascular risk factors. 2, 4
Recommended Dosing
Standard dose: Dapagliflozin 10 mg orally once daily for all approved indications (heart failure, CKD, and type 2 diabetes with cardiovascular/renal protection). 1, 2
Glycemic control in type 2 diabetes: Start 5 mg once daily if eGFR ≥45 mL/min/1.73 m², with optional increase to 10 mg once daily if additional glucose lowering is needed. 1
No dose adjustment required for cardiovascular or renal protection when eGFR is 25–75 mL/min/1.73 m². 1, 2
Do not initiate dapagliflozin if eGFR <25 mL/min/1.73 m²; however, if already on treatment, 10 mg daily may be continued until dialysis is required. 1
For glycemic control: Do not initiate if eGFR <45 mL/min/1.73 m², as glucose-lowering efficacy is significantly reduced. 1
Contraindications and Precautions
Absolute contraindications: Pregnancy, breastfeeding, dialysis, or end-stage renal disease. 5, 6
Withhold at least 3 days before major surgery or procedures requiring prolonged fasting to prevent postoperative ketoacidosis. 1, 5
Use caution in patients with:
Assess volume status before initiation and correct any depletion; consider reducing concurrent diuretic doses. 1, 5
Monitoring Parameters
Renal function (eGFR):
Volume status: Assess for signs of dehydration, especially in elderly patients or those on diuretics. 5
Glucose monitoring: Closely monitor for the first 2–4 weeks, particularly if on insulin or sulfonylureas; reduce insulin dose by ~20% and discontinue sulfonylureas if HbA1c <8.5%. 1
Genital and urinary infections: Educate patients on recognition and prevention; genital mycotic infections occur in ~6% of patients versus 1% on placebo. 1, 5
Euglycemic diabetic ketoacidosis (DKA): Warn patients to seek immediate care for malaise, nausea, vomiting, or abdominal pain even with normal blood glucose. 1, 5
Common Adverse Effects
Genital mycotic infections: Most common adverse event, particularly in women; daily hygienic measures may reduce risk. 5, 7, 8
Urinary tract infections: More frequent with dapagliflozin than placebo. 5, 7, 8
Volume depletion: Risk increases in elderly patients, those on diuretics, or with low baseline blood pressure. 1, 5
Euglycemic DKA: Rare but life-threatening; can occur even with normal glucose levels. 1, 5
Fournier's gangrene (necrotizing fasciitis of the perineum): Rare but serious; requires prompt treatment if suspected. 1, 6
Hypoglycemia: Low risk when used alone or with metformin, but increases when combined with insulin or sulfonylureas. 7, 8
Sick Day Management Rules
Temporarily discontinue dapagliflozin during:
- Acute illness with reduced food/fluid intake
- Fever, vomiting, or diarrhea
- Any intercurrent illness requiring hospitalization 1
Maintain at least low-dose insulin in insulin-requiring patients even when dapagliflozin is held. 1
Resume dapagliflozin only after:
- Recovery from acute illness
- Normal oral intake is re-established 1
Alternative Treatment Options
For Type 2 Diabetes with Cardiovascular/Renal Risk:
GLP-1 receptor agonists (e.g., semaglutide, liraglutide, dulaglutide): Provide cardiovascular protection and additional glycemic control; can be used when eGFR >30 mL/min/1.73 m² without dose adjustment. 1
Other SGLT2 inhibitors:
DPP-4 inhibitors (e.g., linagliptin): Can be used without dose adjustment at any eGFR level, though they lack the robust cardiorenal benefits of SGLT2 inhibitors. 1
Insulin therapy: Remains effective regardless of kidney function; can be dose-adjusted based on clinical response. 1
For Heart Failure:
Empagliflozin: Approved for HFrEF and HFpEF with similar efficacy to dapagliflozin. 1
Sacubitril/valsartan (ARNI): Recommended for HFrEF as part of foundational therapy alongside SGLT2 inhibitors. 1
Beta-blockers, ACE inhibitors/ARBs, and mineralocorticoid receptor antagonists: Continue as part of guideline-directed medical therapy. 1, 2
Common Pitfalls to Avoid
Do not discontinue dapagliflozin when eGFR falls below 45 mL/min/1.73 m²; cardiovascular and renal benefits persist despite loss of glycemic efficacy. 1
Do not stop dapagliflozin in response to the expected early eGFR dip (2–5 mL/min/1.73 m²) within the first 2–4 weeks; this change is hemodynamic and reversible. 1
Do not reduce the dose below 10 mg for cardiovascular or renal indications, even at lower eGFR levels; all outcome trials used the fixed 10 mg dose. 1
Do not combine dapagliflozin with sulfonylureas when HbA1c <8.5%, as this increases hypoglycemia risk without additional cardiovascular benefit. 1