What is the highest recommended total daily dose of micronized fenofibrate (Feno‑Micro)?

Highest Recommended Dose of Micronized Fenofibrate

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

Standard Dosing by Indication

Primary Hypercholesterolemia or Mixed Dyslipidemia

• Initial and maximum dose: 160 mg once daily 1
• This dose should be taken with meals to optimize bioavailability 1

Severe Hypertriglyceridemia

• Dosing range: 54 mg to 160 mg once daily 1
• The maximum dose remains 160 mg once daily 1
• Dose should be adjusted based on lipid response at 4-8 week intervals 1

Critical Dose Adjustments for Renal Impairment

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

• Maximum dose: 54 mg once daily 2, 3, 1
• Must initiate at 54 mg daily and do not exceed this dose 2, 4
• The American College of Cardiology specifically recommends not exceeding 54 mg/day in this population 2

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

• Fenofibrate is contraindicated 2, 1
• This includes patients on dialysis 1
• The American Journal of Kidney Diseases recommends avoiding fenofibrate entirely in this population 2

Monitoring Requirements

Renal function monitoring is mandatory:

• Evaluate renal status before initiating therapy 2, 3
• Reassess within 3 months after initiation 2, 3
• Continue monitoring every 6 months thereafter 2, 3
• Discontinue fenofibrate if eGFR persistently decreases to <30 mL/min/1.73m² 2, 3

Important Clinical Context

Evidence from Major Trials

• The FIELD study used micronized fenofibrate 200 mg/day in patients with type 2 diabetes 5
• However, the 200 mg dose refers to the older capsule formulation 6
• The newer tablet formulation at 160 mg is bioequivalent to the 200 mg capsule 6
• This explains why current FDA labeling lists 160 mg as the maximum dose 1

Common Pitfall to Avoid

• Do not confuse the older capsule formulation (200 mg maximum) with the current micronized tablet formulation (160 mg maximum) 6
• The 160 mg tablet has improved bioavailability and is therapeutically equivalent to the 200 mg capsule 7, 6

Combination Therapy Caution

• Do not initiate fenofibrate in patients already on statin therapy due to increased risk of rhabdomyolysis 2
• If combination therapy is necessary, use only with low or moderate-intensity statins 2, 3
• Pravastatin or fluvastatin may be preferred statins when combining with fenofibrate 5

Administration Timing

• Can be taken at any time of day 3, 4
• Should be taken with meals for optimal absorption 1
• If combined with bile acid sequestrants, administer fenofibrate ≥2 hours before or ≥4 hours after the sequestrant 3, 4