What is the recommended adult dose of fenofibrate for hypertriglyceridaemia or mixed dyslipidaemia, and how should it be adjusted in moderate or severe renal impairment and in elderly patients?

Fenofibrate Dosing for Hypertriglyceridemia and Mixed Dyslipidemia

For adults with normal renal function (eGFR ≥60 mL/min/1.73m²), initiate fenofibrate at 160 mg once daily with meals; in patients with mild-to-moderate renal impairment (eGFR 30-59 mL/min/1.73m²), start at 54 mg once daily and do not exceed this dose; fenofibrate is contraindicated when eGFR falls below 30 mL/min/1.73m². 1, 2, 3

Standard Adult Dosing Algorithm

Normal Renal Function (eGFR ≥60 mL/min/1.73m²):

• Start fenofibrate 160 mg once daily with meals 1, 3
• The FDA label specifies an initial dose range of 67-200 mg daily for hypertriglyceridemia, with 200 mg as the maximum dose 3
• Taking fenofibrate with meals optimizes bioavailability 3

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

• Initiate at 54 mg once daily 2, 3
• Do not exceed 54 mg daily in this population 2
• Increase the dose only after evaluating renal function and lipid response at the 54 mg dose 2
• The most common prescribing error is using the 160 mg dose in patients with eGFR 30-59 mL/min/1.73m²; always start at 54 mg 2

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

• Fenofibrate is absolutely contraindicated due to high risk of renal toxicity 1, 2, 4

Elderly Patients

• Limit the initial dose to 67 mg daily in elderly patients 3
• Elderly patients have higher risk of myopathy, particularly when fenofibrate is combined with statins 4
• Assess renal function before initiating therapy, as age-related decline in kidney function may necessitate dose reduction 2, 3

Mandatory Pre-Treatment Assessment

Before prescribing fenofibrate, obtain:

• Serum creatinine and calculate eGFR to confirm renal function 1, 2
• Fasting lipid panel to verify triglycerides ≥200 mg/dL 2
• Baseline liver function tests (ALT, AST, total bilirubin) 2

Ongoing Monitoring Schedule

Renal Function Monitoring:

• Recheck serum creatinine and eGFR at 3 months after initiation 2
• Subsequently monitor every 6 months while on therapy 2, 4
• Discontinue fenofibrate if eGFR persistently declines to <30 mL/min/1.73m² during treatment 2, 4

Lipid Monitoring:

• Reassess lipid levels at 4-8 week intervals 3
• Individualize dosage based on patient response 3
• Consider reducing the dose if lipid levels fall significantly below target range 3

Dose Titration

• After initiating therapy, adjust the dose every 4-8 weeks based on lipid response and tolerability 3
• In patients with eGFR 30-59 mL/min/1.73m², only consider dose escalation after confirming renal safety and inadequate lipid response at 54 mg daily 2
• Maximum dose is 200 mg daily in patients with normal renal function 3

Critical Safety Warnings When Combining with Statins

If fenofibrate is used with a statin:

• Use only low- or moderate-intensity statins (e.g., atorvastatin 10-20 mg maximum) 1, 4
• Pravastatin or fluvastatin are the safest statin options for combination therapy 1
• Never combine gemfibrozil with any statin due to markedly increased rhabdomyolysis risk 1, 2, 4
• Monitor closely for muscle symptoms and obtain baseline and follow-up CPK levels 4
• Consider taking fibrates in the morning and statins in the evening to minimize peak dose concentrations 4

Additional Contraindications

Fenofibrate is contraindicated in:

• Active liver disease 1
• Preexisting gallbladder disease 1
• Severe renal impairment (eGFR <30 mL/min/1.73m²) 1, 2, 4

Common Pitfalls to Avoid

• Do not prescribe 160 mg in patients with eGFR 30-59 mL/min/1.73m²—this is the most frequent dosing error 2
• Do not initiate fenofibrate without first assessing renal function 2
• Do not combine with gemfibrozil under any circumstances 1, 2, 4
• Do not use fenofibrate as first-line therapy for LDL-C lowering; statins have superior cardiovascular outcomes data 2, 4
• Fenofibrate added to statins did not reduce cardiovascular events in most patients with type 2 diabetes in the ACCORD trial, though it effectively lowers triglycerides 1, 4