Fenofibrate Starting Dose Based on Renal Function
The recommended starting dose of fenofibrate should be 54 mg per day in patients with mild to moderately impaired renal function (eGFR 30-59 mL/min/1.73 m²), and the use of fenofibrate should be avoided completely in patients with severe renal impairment (eGFR <30 mL/min/1.73 m²). 1
Dosing Algorithm Based on Renal Function
| Renal Function | Recommended Starting Dose |
|---|---|
| Normal or mild CKD (eGFR ≥60 mL/min/1.73 m²) | 96-160 mg/day |
| Moderate CKD (eGFR 30-59 mL/min/1.73 m²) | 54 mg/day |
| Severe CKD (eGFR <30 mL/min/1.73 m²) | Avoid use (contraindicated) |
Rationale for Dose Adjustment
Fenofibrate is primarily eliminated through the kidneys, making dose adjustment essential in patients with impaired renal function. The FDA-approved labeling specifically states that treatment should be initiated at a dose of 54 mg per day in patients with mild to moderately impaired renal function 1. This lower starting dose helps minimize the risk of adverse effects while still providing therapeutic benefit.
Contraindications
Fenofibrate is absolutely contraindicated in:
- Patients with severe renal impairment, including those receiving dialysis 1
- Patients with active liver disease 1
- Patients with preexisting gallbladder disease 1
- Nursing mothers 1
- Patients with known hypersensitivity to fenofibrate or fenofibric acid 1
Monitoring Recommendations
When initiating fenofibrate therapy in patients with impaired renal function:
- Assess baseline renal function before starting therapy
- Follow up within 3 months after initiation
- Continue monitoring every 6 months thereafter 2
- Monitor for increases in serum creatinine levels ≥30%, which may warrant treatment discontinuation 3
- Monitor for myopathy, especially if combined with statins 2
Clinical Considerations
Fenofibrate can cause transient increases in serum creatinine levels, which may not necessarily reflect true deterioration of renal function 3. This effect appears to be reversible upon discontinuation of the medication. However, caution is still warranted, particularly in patients with pre-existing renal impairment.
Dose Titration
For patients with severe hypertriglyceridemia, the dose may be titrated from the initial 54 mg per day up to a maximum of 160 mg per day based on patient response, but only after evaluating the effects on renal function and lipid levels at the initial dose 1. Dose adjustments should be made at 4-8 week intervals after repeat lipid determinations.
Important Precautions
- Avoid combining fenofibrate with statins in patients with CKD due to increased risk of myopathy 2
- Elderly patients should have their dose selected based on renal function 1
- Regular monitoring of liver function is also recommended due to potential hepatotoxicity 1
By following these guidelines for fenofibrate dosing based on renal function, clinicians can optimize the risk-benefit ratio for patients requiring treatment for hypertriglyceridemia or mixed dyslipidemia.