Contraindications of Empagliflozin
Empagliflozin is contraindicated in patients with history of serious hypersensitivity reaction to the drug, severe renal impairment, end-stage renal disease (ESRD), or patients on dialysis. 1
Absolute Contraindications
- History of serious hypersensitivity reaction to empagliflozin or any of its excipients 1
- Severe renal impairment (eGFR <30 mL/min/1.73 m²) 2, 1
- End-stage renal disease (ESRD) 2, 1
- Patients on dialysis 2, 1
Relative Contraindications and Precautions
Renal Function Considerations
- Should not be initiated in patients with eGFR <45 mL/min/1.73 m² for glycemic control 2
- Should be discontinued if eGFR is persistently <45 mL/min/1.73 m² 1
- Glucose-lowering effect is minimal at eGFR <45 mL/min/1.73 m² 2
Volume Status Concerns
- Use with caution in patients at risk for hypotension 1:
- Elderly patients
- Patients with low systolic blood pressure
- Patients on diuretics
- Patients with renal impairment
Risk of Diabetic Ketoacidosis (DKA)
- Discontinue at least 3 days before planned surgery to prevent postoperative ketoacidosis 2, 3
- Use with caution in patients with insulin deficiency 2
- Avoid during critical illness or prolonged fasting 2
Special Populations to Monitor Closely
- Patients with prior amputation 2
- Patients with severe peripheral neuropathy 2
- Patients with severe peripheral vascular disease 2
- Patients with active diabetic foot ulcers or soft tissue infections 2
- Patients at high risk for genital mycotic infections 2
Important Clinical Considerations
- Assessment of renal function is recommended prior to initiation and periodically thereafter 1
- Correct volume depletion prior to initiation 1
- Monitor for signs and symptoms of hypotension after initiating therapy 1
- Consider reducing diuretic dose if patient is on diuretic therapy 3
- Monitor for signs of euglycemic diabetic ketoacidosis, which can occur even with normal blood glucose levels 2
- Be aware that empagliflozin can cause intravascular volume contraction 2, 1
Medication Interactions
- If HbA1c is well-controlled at baseline or patient has history of frequent hypoglycemic events, consider reducing doses of sulfonylureas, glinides, or insulin (by approximately 20%) when starting empagliflozin 2
Despite these contraindications, it's important to note that empagliflozin has demonstrated significant cardiovascular and renal benefits in patients with type 2 diabetes and established cardiovascular disease or chronic kidney disease with eGFR ≥20 mL/min/1.73 m² 2, 4, 5. For patients with heart failure, empagliflozin has shown benefits regardless of baseline diabetes status 6.