What is the recommended dose of fenofibrate (fibric acid derivative) for an adult patient with hypertriglyceridemia, considering their renal function and medical history?

Fenofibrate Dosing for Hypertriglyceridemia

For adults with hypertriglyceridemia and normal renal function (eGFR ≥60 mL/min/1.73m²), start fenofibrate at 160 mg once daily with meals; for moderate renal impairment (eGFR 30-59 mL/min/1.73m²), use 54 mg once daily and do not exceed this dose; fenofibrate is contraindicated in severe renal impairment (eGFR <30 mL/min/1.73m²) including dialysis patients. 1

Standard Dosing by Indication

Severe Hypertriglyceridemia

• Initial dose: 54-160 mg once daily with meals, individualized based on triglyceride levels and renal function 1
• Maximum dose: 160 mg once daily 1
• Reassess lipid panel at 4-8 week intervals and adjust dosing accordingly 1
• Discontinue if no adequate response after 2 months at maximum dose 1

Primary Hypercholesterolemia or Mixed Dyslipidemia

• Standard dose: 160 mg once daily with meals 1

Renal Function-Based Dosing Algorithm

Step 1: Assess Baseline Renal Function

• Obtain serum creatinine and calculate eGFR before initiating therapy 2, 3
• This is mandatory—never start fenofibrate without knowing renal function 2

Step 2: Apply Renal-Adjusted Dosing

eGFR ≥60 mL/min/1.73m²:

• Standard dosing: 54-160 mg daily based on indication 3, 1
• No dose adjustment required 3

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

• Start at 54 mg once daily 2, 3, 1
• Maximum dose: 54 mg daily—do not exceed 2, 3
• Increase dose only after evaluating renal function and lipid response at this initial dose 1

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

• Fenofibrate is contraindicated—do not use 2, 3, 1
• This includes all dialysis patients 3, 1
• Risk of severe drug accumulation and rhabdomyolysis 4

Step 3: Monitoring Schedule

• Recheck renal function within 3 months of initiation 2, 3
• Continue monitoring every 6 months thereafter 2, 3
• Assess both serum creatinine and eGFR at each visit 2

Step 4: Management of GFR Decline During Therapy

• If eGFR persistently decreases to <30 mL/min/1.73m², discontinue fenofibrate immediately 2, 3, 4
• An acute rise in serum creatinine of approximately 0.13 mg/dL is expected and reversible—this does not represent true nephrotoxicity 3
• Discontinue if acute kidney injury develops from intercurrent illness, volume depletion, or concurrent nephrotoxic medications 3

Geriatric Dosing Considerations

• Base dose selection entirely on renal function, not age alone 1
• Start with 54 mg daily and assess renal function before any dose escalation 5
• Elderly patients have increased risk of myopathy, particularly when combining with statins 5

Critical Safety Considerations

Hepatic Monitoring

• Obtain baseline hepatic transaminases before initiation 2
• Monitor liver function tests as clinically indicated 2
• Discontinue if persistent ALT elevations ≥3 times upper limit of normal occur 2, 4

Statin Combination Therapy Warnings

• Never combine fenofibrate with gemfibrozil—this is absolutely contraindicated due to rhabdomyolysis risk 2, 4, 5
• Fenofibrate may be considered with low- or moderate-intensity statins only if benefits outweigh risks 2, 4
• Use lower statin doses when combining to minimize myopathy risk 5
• Monitor creatine kinase (CPK) at baseline and if muscle symptoms develop 5

Additional Contraindications

• Active liver disease including primary biliary cirrhosis 1
• Preexisting gallbladder disease 1
• Known hypersensitivity to fenofibrate or fenofibric acid 1
• Nursing mothers 1

Common Pitfalls to Avoid

• Never start fenofibrate without checking renal function first—this is the most common and dangerous error 2, 3
• Do not exceed 54 mg daily in patients with eGFR 30-59 mL/min/1.73m², even if triglycerides remain elevated 2, 3
• Do not use bile acid sequestrants when triglycerides are >200 mg/dL, as they worsen hypertriglyceridemia 5
• When triglycerides are ≥500 mg/dL, do not start with statin monotherapy—fibrates must be initiated first to prevent acute pancreatitis 5
• Always administer fenofibrate with meals to optimize bioavailability 1

Alternative for Severe Renal Impairment

• Gemfibrozil may be considered at reduced dose of 600 mg daily (versus standard 1200 mg daily) in patients with severe renal impairment where fenofibrate is contraindicated 3, 5
• However, gemfibrozil cannot be combined with statins due to dramatically increased rhabdomyolysis risk 4, 5
• Consider omega-3 fatty acids and therapeutic lifestyle modifications as alternatives 4