Should the dosage of Jardiance (Empagliflozin) be adjusted in a patient with Impaired renal function (GFR of 48)?

Jardiance Dosing with GFR 48 mL/min/1.73 m²

Continue Jardiance 25 mg without dose adjustment, as the FDA label permits use at eGFR ≥45 mL/min/1.73 m², and this patient's GFR of 48 falls within the approved range. 1

FDA-Approved Dosing Parameters

• No dose adjustment is required for patients with eGFR ≥45 mL/min/1.73 m², according to the FDA prescribing information for empagliflozin 1
• The FDA label explicitly states that Jardiance should not be initiated in patients with eGFR <45 mL/min/1.73 m², but patients already on therapy can continue if eGFR remains ≥45 1
• Discontinuation is only required if eGFR falls persistently below 45 mL/min/1.73 m² 1

Clinical Context and Monitoring

• This patient with GFR 48 is classified as CKD stage G3a (GFR 45-59), which falls within the FDA-approved treatment range 2
• Renal function should be assessed periodically to ensure eGFR does not decline below the 45 threshold 1
• An initial eGFR dip of 3-5 mL/min/1.73 m² within the first 4 weeks is expected with SGLT2 inhibitors and is not a reason for discontinuation 3

Evidence for Renal Protection at This GFR Level

• The EMPA-REG OUTCOME trial demonstrated that empagliflozin reduced progression of kidney disease (hazard ratio 0.61) in patients with baseline eGFR ≥30 mL/min/1.73 m² 4
• The EMPA-KIDNEY trial showed kidney protection benefits in patients with eGFR as low as 20 mL/min/1.73 m², with a 28% relative risk reduction for kidney disease progression or cardiovascular death 5
• Recent KDIGO 2022 guidelines recommend SGLT2 inhibitor initiation for patients with eGFR ≥20 mL/min/1.73 m², though this represents off-label use below eGFR 45 3

Important Caveats

• Monitor for volume depletion and hypotension, particularly if the patient is on concurrent diuretics or has low baseline blood pressure 1
• Assess volume status before continuing therapy, as empagliflozin causes intravascular volume contraction 1
• The glucose-lowering efficacy decreases with declining renal function, but cardiovascular and renal protective benefits persist 3
• Temporarily discontinue during serious intercurrent illness that increases risk of acute kidney injury, per KDIGO recommendations 6

Practical Algorithm

1. Continue current dose (25 mg daily) as eGFR is 48 mL/min/1.73 m² 1
2. Recheck eGFR in 2-4 weeks to assess for expected initial decline 3
3. Monitor eGFR every 3-6 months thereafter, or more frequently if clinical deterioration occurs 2
4. Discontinue only if eGFR persistently falls below 45 mL/min/1.73 m² on repeat testing 1
5. Hold temporarily during acute illness, dehydration, or contrast procedures 6