What is the recommended dose of fenofibrate?

Recommended Dosage of Fenofibrate

The recommended dose of fenofibrate ranges from 54 mg to 160 mg once daily, with 160 mg being the maximum daily dose for primary hypercholesterolemia or mixed dyslipidemia, and 54-160 mg for severe hypertriglyceridemia, with dosing individualized according to patient response and renal function. 1

Dosing Guidelines by Indication

Primary Hypercholesterolemia or Mixed Dyslipidemia

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

Severe Hypertriglyceridemia

• Initial dose: 54 mg to 160 mg once daily 1
• Dosage should be adjusted based on lipid level response at 4-8 week intervals 1
• Maximum dose: 160 mg once daily 1

Dosing Adjustments for Special Populations

Renal Impairment

• Mild to moderate renal impairment: Start with 54 mg per day 1
• Increase dose only after evaluating effects on renal function and lipid levels 1
• eGFR 30-59 mL/min per 1.73 m²: ≤54 mg/day 2
• eGFR <30 mL/min per 1.73 m² or severe renal impairment: Avoid use 2, 1

Elderly Patients

• Base dose selection on renal function rather than age 2, 1
• Start with lower doses due to age-related decline in renal function 2

Administration Guidelines

• Take with meals to optimize bioavailability 1
• Patients should be on an appropriate lipid-lowering diet before and during treatment 1

Monitoring Recommendations

• Monitor lipid levels periodically 1
• Consider dose reduction if lipid levels fall significantly below target range 1
• Withdraw therapy if inadequate response after two months at maximum dose 1
• Regular monitoring of liver function tests, renal function, and creatine phosphokinase (CPK) levels 2

Bioequivalence of Different Formulations

• 67 mg micronized capsule = 54 mg suprabioavailable tablet 3
• 200 mg micronized capsule = 160 mg suprabioavailable tablet 3
• 105 mg fenofibric acid tablet = 145 mg fenofibrate tablet 4

Important Considerations and Precautions

• Fenofibrate is contraindicated in patients with:

  • Severe renal impairment, including those on dialysis 1
  • Active liver disease 1
  • Preexisting gallbladder disease 1
  • Known hypersensitivity to fenofibrate or fenofibric acid 1

• When combined with statins, fenofibrate has a lower risk of myopathy than gemfibrozil 2

• Address underlying factors before initiating therapy:

  • Excess body weight
  • Excess alcohol intake
  • Physical inactivity
  • Secondary causes of dyslipidemia (hypothyroidism, diabetes mellitus) 1

The evidence consistently shows that fenofibrate dosing should be based primarily on the indication and renal function, with careful monitoring of lipid response and potential adverse effects, particularly in patients with renal impairment or those taking concomitant statin therapy.