From the Guidelines
For a patient with a GFR of 50 mL/min, the recommended dose of fenofibrate is 54 mg daily, as this dose minimizes the risk of adverse effects while still providing therapeutic benefits. This dose adjustment is necessary because fenofibrate and its metabolites are primarily eliminated by the kidneys, and a GFR of 50 mL/min indicates moderate renal impairment, which slows drug clearance and can lead to accumulation of fenofibrate in the body if not properly adjusted 1. According to the 2013 ACC/AHA guideline on the treatment of blood cholesterol, if the eGFR is between 30 and 59 mL/min per 1.73 m2, the dose of fenofibrate should not exceed 54 mg/day 1.
Key considerations for fenofibrate therapy in patients with renal impairment include:
- Monitoring renal function periodically, as further decline in kidney function may necessitate additional dose adjustments or discontinuation
- Monitoring for muscle pain or weakness, as the risk of myopathy may be increased in patients with renal impairment
- Checking liver function tests before initiating therapy and periodically thereafter, as fenofibrate can affect liver enzymes
- Taking the dose with food to enhance absorption
It is essential to weigh the potential benefits of fenofibrate therapy against the potential risks in patients with renal impairment, and to adjust the dose accordingly to minimize adverse effects while still providing therapeutic benefits 1.
From the FDA Drug Label
2.4 Impaired Renal Function 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 recommended dose of fenofibrate for a patient with a GFR of 50 is 54 mg per day 2. This dose should be initiated and increased only after evaluation of the effects on renal function and lipid levels at this dose.
From the Research
Fenofibrate Dose Adjustment in Patients with Renal Impairment
- The dose of fenofibrate may need to be adjusted in patients with renal impairment, as it is excreted by the kidneys 3.
- A study found that fenofibrate therapy does not worsen renal function in patients with mild to moderate renal failure, despite a significant rise in creatininemia 4.
- The estimated glomerular filtration rate (eGFR) can be used to guide dose adjustment in patients with stable kidney function 3.
- For a patient with a GFR of 50, the dose of fenofibrate may need to be reduced, but the exact adjustment is not specified in the available evidence.
- The Cockcroft-Gault formula or direct measures of glomerular filtration rate using exogenous isotope compounds can be used as alternative methods for quantifying kidney function 3.
Clinical Recommendations for Drug Dose Adjustment
- Clinical recommendations for drug dose adjustment in renal disease can vary depending on the literature reference used 5.
- A study found that the use of electronic prescribing and automated reporting of eGFR can reduce medication errors, but patients with renal insufficiency may still be exposed to inappropriate drug use 6.
- The choice of literature source may have a greater impact on drug management than the choice of equation used to estimate GFR alone 5.
Specific Considerations for Fenofibrate
- Fenofibrate increases blood creatinine, but does not change the glomerular filtration rate in patients with mild renal insufficiency 4.
- The mechanism of the fenofibrate-induced increase in urinary creatinine excretion remains to be determined 4.
- Close monitoring of drug effect and toxicity is needed, and can be supported by therapeutic drug monitoring 3.