Jardiance (Empagliflozin) GFR Thresholds
Stop Jardiance when eGFR persistently falls below 45 mL/min/1.73 m² according to the FDA label, though recent guidelines support continuation down to 20 mL/min/1.73 m² for cardiovascular and renal protection. 1
FDA-Approved Discontinuation Threshold
The official FDA prescribing information is clear and unequivocal:
- Do not initiate Jardiance if eGFR is below 45 mL/min/1.73 m² 1
- Discontinue Jardiance if eGFR falls persistently below 45 mL/min/1.73 m² 1
- Jardiance is contraindicated in severe renal impairment, end-stage renal disease, or dialysis 1
Guideline-Based Approach (More Permissive)
Recent high-quality guidelines diverge significantly from the FDA label, reflecting newer evidence:
For Cardiovascular and Renal Protection
- The 2023-2024 American Diabetes Association guidelines recommend SGLT2 inhibitors (including empagliflozin) can be used down to eGFR ≥20 mL/min/1.73 m² for reducing CKD progression and cardiovascular events 2
- This represents a major shift from the FDA label, based on trials like EMPA-REG OUTCOME which demonstrated renal benefits even at lower eGFR levels 3, 4
For Glycemic Control Specifically
- Do not use Jardiance for glucose lowering when eGFR <45 mL/min/1.73 m² as the glucose-lowering efficacy is significantly reduced due to its mechanism of action 2, 5
- The drug works by blocking glucose reabsorption in the kidney, which becomes ineffective as kidney function declines 5
Clinical Decision Algorithm
If eGFR 45-60 mL/min/1.73 m²:
If eGFR 30-44 mL/min/1.73 m²:
- FDA label says discontinue 1
- However, 2023-2024 guidelines support continuation for cardiovascular/renal protection if patient has heart failure, established cardiovascular disease, or albuminuria 2
- Expect minimal glucose-lowering effect; consider adding GLP-1 receptor agonist for glycemic control 2, 6
If eGFR 20-29 mL/min/1.73 m²:
- FDA label says discontinue 1
- Guidelines support continuation for cardiovascular/renal protection in patients already on therapy 2, 6
- Do not initiate at this level 6
- Switch to GLP-1 receptor agonist for glycemic management 2, 7
If eGFR <20 mL/min/1.73 m²:
Critical Monitoring Points
- Assess renal function before initiating and periodically thereafter 1
- Expect an initial eGFR dip of 3-5 mL/min/1.73 m² within the first 1-4 weeks, which is hemodynamic and reversible 8
- Do not discontinue for this initial dip alone unless accompanied by volume depletion 8
- Confirm persistent eGFR decline with repeat measurement before stopping 1
Common Pitfalls to Avoid
- Don't stop Jardiance solely because eGFR drops below 45 mL/min/1.73 m² if the patient has heart failure or CKD with albuminuria – the cardiovascular and renal protective benefits persist even when glucose-lowering effects are lost 2, 3
- Don't confuse the initial hemodynamic eGFR dip with true kidney injury – this early decline actually predicts better long-term renal outcomes 8
- Assess volume status before discontinuing, as volume depletion may be the culprit rather than true kidney function decline 1
Practical Recommendation
For real-world practice: Follow FDA labeling and discontinue at eGFR <45 mL/min/1.73 m² unless the patient has compelling cardiovascular or renal indications (heart failure, established CVD, or albuminuria), in which case continuation down to eGFR 20 mL/min/1.73 m² is supported by strong guideline evidence. 2, 1