GFR Cutoff for Jardiance (Empagliflozin)
According to the FDA label, Jardiance should not be initiated in patients with an eGFR less than 45 mL/min/1.73 m², and should be discontinued if eGFR is persistently less than 45 mL/min/1.73 m². 1
Initiation Threshold
- Do not start Jardiance if eGFR is <45 mL/min/1.73 m² 1
- No dose adjustment is needed for patients with eGFR ≥45 mL/min/1.73 m² 1
- The recommended starting dose is 10 mg once daily, which may be increased to 25 mg in tolerating patients 1
Discontinuation Threshold
- Discontinue Jardiance if eGFR is persistently <45 mL/min/1.73 m² 1
- Assess renal function prior to initiation and periodically thereafter 1
Important Clinical Context: Guidelines vs. FDA Label
Recent guidelines recommend broader use than the FDA label indicates. The KDIGO 2022 guideline recommends SGLT2 inhibitor initiation for patients with type 2 diabetes and CKD who have an eGFR ≥20 mL/min/1.73 m², particularly with concomitant albuminuria or heart failure 2. The ADA 2024 guidelines similarly recommend SGLT2 inhibitors for patients with eGFR 20-60 mL/min/1.73 m² and/or albuminuria 3.
Key Evidence Supporting Lower Thresholds
- The EMPA-KIDNEY trial enrolled patients with eGFR as low as 20 mL/min/1.73 m² and demonstrated a 28% reduction in kidney disease progression or cardiovascular death 4, 5
- 78% of EMPA-KIDNEY participants had eGFR <45 mL/min/1.73 m², and benefits were consistent across all eGFR ranges 4
- Results were consistent in patients with or without diabetes 4
Critical Caveats
- Glucose-lowering efficacy decreases at eGFR <45 mL/min/1.73 m², but cardiovascular and kidney protective benefits persist 2
- An initial eGFR dip of 3-5 mL/min/1.73 m² in the first 4 weeks is expected and generally not a reason to discontinue 2
- For advanced CKD (eGFR <30 mL/min/1.73 m²), GLP-1 receptor agonists are preferred for glycemic management due to lower hypoglycemia risk 3
- Correct volume depletion prior to initiation, especially in patients with renal impairment 1