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

Maximum Dose of Fenofibrate

The maximum dose of fenofibrate is 160 mg once daily for patients with normal renal function. 1

Dosing Guidelines by Indication

• For primary hypercholesterolemia or mixed dyslipidemia, the standard dose is 160 mg once daily 1
• For severe hypertriglyceridemia, the dose range is 54 mg to 160 mg per day, with 160 mg once daily being the maximum dose 1
• Dosage should be individualized according to patient response, with adjustments made after lipid determinations at 4-8 week intervals 1

Dosing in Special Populations

Renal Impairment

• For mild to moderate renal impairment (eGFR 30-59 mL/min/1.73m²), the initial dose should be 54 mg per day, with a maximum of 54 mg daily 1, 2
• Fenofibrate should be avoided in patients with severe renal impairment (eGFR <30 mL/min/1.73m²) or those receiving dialysis 2, 1
• Renal function should be evaluated before initiating therapy, within 3 months after initiation, and every 6 months thereafter 2
• If eGFR decreases persistently to <30 mL/min/1.73m², fenofibrate should be discontinued 2

Hepatic Impairment

• Fenofibrate is contraindicated in patients with active liver disease, including those with primary biliary cirrhosis and unexplained persistent liver function abnormalities 1
• In patients with mild hepatic impairment, fenofibric acid exposure is approximately 25% higher than in healthy individuals 3
• In patients with advanced fibrosis due to metabolic-associated fatty liver disease, fenofibric acid exposure can be 60-80% higher than in healthy individuals 3

Elderly Patients

• Dose selection for elderly patients should be made based on renal function rather than age 1

Administration Considerations

• Fenofibrate should be given with meals to optimize bioavailability 1
• It can be administered at any time of day, as there is no specific time requirement that impacts its efficacy 4
• If combined with bile acid sequestrants, fenofibrate should be taken either ≥2 hours before or ≥4 hours after the bile acid sequestrant to avoid interference with absorption 4

Formulation Considerations

• Different formulations of fenofibrate have different bioavailabilities:
  • 105 mg of fenofibric acid tablets are bioequivalent to 145 mg of fenofibrate tablets 5
  • The micronized formulation (54-160 mg) can be administered as a single daily dose 6

Clinical Efficacy and Safety

• Fenofibrate produces substantial reductions in plasma triglyceride levels in hypertriglyceridemic patients and in plasma total cholesterol levels in hypercholesterolemic patients 7
• HDL-cholesterol levels are generally increased in patients with low pretreatment values 7
• The influence of fenofibrate on the plasma lipid profile is sustained during long-term (2-7 years) treatment 7
• Common adverse effects include gastrointestinal disturbances, headache, and muscle cramps 7
• Transient elevations in transaminase and creatine phosphokinase levels commonly occur 7

Important Considerations for Combination Therapy

• When combined with statins, there is an increased risk of muscle symptoms and rhabdomyolysis 2
• If combination therapy is necessary, use with low or moderate-intensity statins only 2
• For patients who cannot tolerate fenofibrate, gemfibrozil may be an alternative, though it has different dosing (600 mg twice daily) 6