What is the recommended dose of fenofibrate (fibric acid derivative) for adults with hyperlipidemia?

Fenofibrate Dosing for Hyperlipidemia

For adults with primary hypercholesterolemia or mixed dyslipidemia, initiate fenofibrate at 160 mg once daily with meals; for severe hypertriglyceridemia, start at 54-160 mg daily based on individual response, with a maximum dose of 160 mg once daily. 1

Standard Dosing Regimens

Primary Hypercholesterolemia or Mixed Dyslipidemia

• The initial and standard dose is 160 mg once daily, taken with meals to optimize bioavailability. 1
• Fenofibrate should be administered with food as this significantly enhances absorption and therapeutic effect. 1

Severe Hypertriglyceridemia

• Initial dosing ranges from 54 mg to 160 mg per day, with individualization based on patient response. 1
• Lipid levels should be reassessed at 4-8 week intervals to guide dose adjustments. 1
• The maximum recommended dose is 160 mg once daily regardless of indication. 1
• Therapy should be discontinued if there is no adequate response after 2 months at the maximum dose of 160 mg daily. 1

Dose Adjustments for Renal Impairment

Mild to Moderate Renal Impairment (eGFR 30-59 mL/min/1.73m²)

• Initiate treatment at 54 mg per day in patients with mild to moderately impaired renal function. 1
• The dose should not exceed 54 mg daily in this population. 2
• Increase the dose only after evaluating effects on both renal function and lipid levels at the initial dose. 1
• The American College of Cardiology recommends monitoring renal function before initiation, within 3 months after starting therapy, and every 6 months thereafter. 2, 3

Severe Renal Impairment (eGFR <30 mL/min/1.73m²)

• Fenofibrate is contraindicated in patients with severe renal impairment, including those on dialysis. 1
• Patients with severe renal impairment show a 2.7-fold increase in fenofibric acid exposure with increased drug accumulation during chronic dosing. 1
• If eGFR decreases persistently to <30 mL/min/1.73m² during treatment, fenofibrate must be discontinued. 2

Special Populations

Elderly Patients

• Dose selection should be based on renal function rather than age alone. 1
• Elderly volunteers (77-87 years) with normal renal function showed similar oral clearance (1.2 L/h) compared to young adults (1.1 L/h), indicating no need for dose adjustment in the absence of renal impairment. 1

Hepatic Impairment

• Fenofibrate is contraindicated in patients with active liver disease, including primary biliary cirrhosis and unexplained persistent liver function abnormalities. 1
• The American College of Cardiology recommends evaluating liver function before starting fenofibrate, within 3 months after initiation, and every 6 months thereafter. 4

Important Clinical Considerations

Administration Guidelines

• Fenofibrate tablets must be taken with meals to optimize bioavailability. 1
• Different formulations have varying food requirements; the standard tablet formulation requires food for adequate absorption. 1

Monitoring Requirements

• Lipid levels should be monitored periodically, with consideration given to dose reduction if levels fall significantly below target range. 1
• Liver function tests should be checked before initiation, at 3 months, and every 6 months during therapy. 4
• Renal function requires the same monitoring schedule as liver function. 2, 3

Combination Therapy Warnings

• Fenofibrate should not be initiated in patients already on statin therapy due to increased risk of muscle symptoms and rhabdomyolysis. 2
• If combination therapy is deemed necessary, use only with low or moderate-intensity statins after careful risk-benefit assessment. 3
• Gemfibrozil should never be used with statins due to significantly higher risk of adverse effects. 3

Common Pitfalls to Avoid

• Do not use fenofibrate in patients with preexisting gallbladder disease, as it is contraindicated. 1
• Avoid initiating standard doses in patients with any degree of renal impairment without first assessing eGFR. 1
• Do not continue therapy beyond 2 months at maximum dose if lipid response is inadequate. 1