From the Guidelines
Fenofibrate requires dose adjustment in patients with renal impairment, with a recommended dose not exceeding 54 mg/day if the estimated glomerular filtration rate (eGFR) is between 30 and 59 mL/min per 1.73 m2, and should not be used if moderate or severe renal impairment is present (eGFR <30 mL/min/1.73 m2) 1. When considering fenofibrate for patients with renal impairment, it is crucial to evaluate renal status before initiation, within 3 months after initiation, and every 6 months thereafter, assessing renal safety with both a serum creatinine level and an eGFR based on creatinine 1.
- For patients with mild to moderate renal dysfunction, the dose should be carefully considered to balance the benefits of ASCVD risk reduction or triglyceride lowering against the potential risk for adverse effects.
- Fenofibrate should be used with caution in patients with decreased renal function, as it can accumulate and increase the risk of side effects, including muscle toxicity.
- Regular monitoring of renal function is essential for patients on fenofibrate, and the medication should be reassessed and potentially discontinued if renal function worsens. Key considerations for fenofibrate use in renal impairment include:
- Dose adjustment: The dose should not exceed 54 mg/day for patients with an eGFR between 30 and 59 mL/min per 1.73 m2 1.
- Contraindication: Fenofibrate should not be used in patients with moderate or severe renal impairment (eGFR <30 mL/min/1.73 m2) due to the increased risk of adverse effects 1.
- Monitoring: Regular assessment of renal function is necessary to ensure safe use and adjust the dose as needed 1.
From the FDA Drug Label
Treatment with fenofibrate tablets should be initiated at a dose of 54 mg per day in patients having mild to moderately impaired renal function and increased only after evaluation of the effects on renal function and lipid levels at this dose. The use of fenofibrate tablets should be avoided in patients with severe renal impairment [see Use in Specific Populations (8. 6) and Clinical Pharmacology (12.3)]. Dose reduction is required in patients with mild to moderate renal impairment [see Dosage and Administration (2.4) and Clinical Pharmacology (12.3)]. The use of fenofibrate should be avoided in patients who have severe renal impairment [see Contraindications (4)].
Fenofibrate renal adjustments:
- Mild to moderate renal impairment: Initiate treatment at a dose of 54 mg per day and increase only after evaluation of the effects on renal function and lipid levels at this dose.
- Severe renal impairment: Avoid the use of fenofibrate tablets. 2 2 2
From the Research
Fenofibrate Renal Adjustments
- Fenofibrate has been associated with increases in serum creatinine (SCr) levels, which may raise concerns regarding its effects on renal function 3.
- Clinical studies have shown that fenofibrate can cause a rapid increase in SCr levels, often accompanied by a decline in estimated glomerular filtration rate 3, 4.
- The increase in SCr levels is often transient and reversible, even without treatment discontinuation 3.
- Risk predictors of fenofibrate-associated increased SCr levels may include increased age, impaired renal function, and high-dose treatment 3.
- Concomitant use of medications affecting renal hemodynamics, such as angiotensin-converting enzyme-inhibitors (ACEi) and angiotensin receptor blockers, may also predispose to fenofibrate-associated increased SCr levels 3.
- Fenofibrate may not be a nephrotoxic drug, but close monitoring of SCr levels is relevant, especially in high-risk patients 3, 4.
- Increases in SCr levels ≥30% can impose treatment discontinuation 3.
Renal Function Monitoring
- Regular renal function monitoring should be considered essential during fibrate administration 4.
- Fenofibrate treatment has been shown to result in increased serum creatinine levels and reduced estimated glomerular filtration rates in a primary care setting 4.
- The effects of fenofibrate on renal function may be related to the inhibition of renal vasodilatory prostaglandins, reducing renal plasma flow and glomerular pressure 3.