What is the maximum recommended dose of fenofibrate (fibric acid derivative)?

Maximum Recommended Dose of Fenofibrate

The maximum recommended dose of fenofibrate is 160 mg once daily. 1

Dosing Guidelines

Fenofibrate dosing depends on the indication and patient characteristics:

For Primary Hypercholesterolemia or Mixed Dyslipidemia

• Initial dose: 160 mg once daily 1
• Maximum dose: 160 mg once daily 1

For Severe Hypertriglyceridemia

• Initial dose range: 54 mg to 160 mg once daily 1
• Dosage should be individualized according to patient response
• Dose adjustments can be made following lipid determinations at 4-8 week intervals
• Maximum dose: 160 mg once daily 1

Renal Impairment Considerations

• Mild to moderate renal impairment: Start at 54 mg per day 1
• eGFR 30-59 mL/min/1.73 m²: ≤54 mg/day 2
• eGFR <30 mL/min/1.73 m² (severe renal impairment): Avoid use 2, 1

Administration Recommendations

• Fenofibrate should be given with meals to optimize bioavailability 1
• Patients should be placed on an appropriate lipid-lowering diet before and during treatment 1
• Lipid levels should be monitored periodically to assess efficacy 1
• Consider discontinuing therapy if inadequate response after two months at maximum dose 1

Special Populations

Chronic Kidney Disease

• In patients with CKD, fenofibrate dosing should be adjusted based on kidney function 3
• For patients with CCr <50 mL/min, minimize doses as drug clearance is greatly reduced 3
• Regular monitoring of kidney function is essential when using fenofibrate 2

Elderly Patients

• Dose selection should be based on renal function rather than age 1

Clinical Considerations

• Fenofibrate is contraindicated in patients with:

  • Severe renal impairment
  • Active liver disease
  • Preexisting gallbladder disease
  • Known hypersensitivity to fenofibrate or fenofibric acid 1

• When used in combination with statins, there is an increased risk of myopathy 3

  • Pravastatin may be the preferred statin when combination therapy is necessary 3

• Fenofibrate is effective in reducing triglyceride levels by up to 50%, making it one of the most potent triglyceride-lowering agents 3

Formulation Considerations

Different formulations of fenofibrate have varying bioavailability:

• 67 mg and 200 mg micronized capsules are equivalent to 54 mg and 160 mg suprabioavailable tablets, respectively 4

By following these dosing guidelines and considering patient-specific factors, particularly renal function, the maximum recommended dose of 160 mg once daily can be safely administered to appropriate patients.