Fenofibrate Maximum Dose
The strongest dose of fenofibrate is 160 mg daily (micronized tablet formulation) or 145 mg daily (nanoparticle formulation), both of which are bioequivalent and represent the maximum approved dosing for patients with normal renal function. 1, 2, 3, 4
Standard Maximum Dosing by Formulation
- Micronized tablet formulation: 160 mg once daily is the maximum dose 3, 4
- Nanoparticle formulation: 145 mg once daily is the maximum dose and is bioequivalent to the 160 mg micronized tablet due to enhanced bioavailability 5
- Older micronized capsule formulation: 200 mg once daily was the maximum dose, which is equivalent to the 160 mg tablet 3, 4
Dose Adjustments for Renal Impairment
For patients with moderate renal impairment (eGFR 30-59 mL/min/1.73 m²), the maximum dose must be reduced to 48-54 mg daily. 6, 1, 2
- Normal renal function or mild impairment (eGFR ≥60 mL/min/1.73 m²): 96-160 mg daily 6, 2
- Moderate renal impairment (eGFR 30-59 mL/min/1.73 m²): Maximum 48-54 mg daily 6, 1, 2
- Severe renal impairment (eGFR <30 mL/min/1.73 m²): Fenofibrate should be avoided entirely 6, 2
- Kidney transplant recipients: Fenofibrate should be avoided 6, 2
Critical Safety Considerations
Renal function must be evaluated before initiating therapy, within 3 months after initiation, and every 6 months thereafter, with discontinuation required if eGFR persistently falls below 30 mL/min/1.73 m². 1, 2
Combination Therapy Restrictions
- Fenofibrate should not be initiated in patients already on statin therapy due to increased risk of myopathy and rhabdomyolysis 1, 2
- If combination therapy is absolutely necessary, use only with low or moderate-intensity statins 1, 2
- When combined with bile acid sequestrants, fenofibrate must be taken either ≥2 hours before or ≥4 hours after the sequestrant 1
Historical Dose-Response Data
Early dose-response studies demonstrated that 400 mg daily of older fenofibrate formulations had the best lipid-lowering effects, but this was before the development of more bioavailable formulations. 7
- The 400 mg dose reduced LDL-cholesterol by 28% in type IIA+B patients and VLDL-triglycerides by 65% in type IIB+IV patients 7
- However, modern micronized and nanoparticle formulations achieve equivalent or superior effects at lower doses (145-160 mg) due to enhanced bioavailability 3, 4, 5
Common Pitfall to Avoid
Do not use the older 200 mg capsule dosing if prescribing the newer tablet formulations—the 160 mg tablet and 145 mg nanoparticle formulation are the appropriate maximum doses for current formulations. 3, 4, 5 Using outdated dosing references could lead to inappropriate prescribing of higher-than-necessary doses.