From the Guidelines
Fenofibrate should be dosed at 48-145 mg once daily for the management of hypertriglyceridemia, with the specific dose depending on the formulation used and renal function, as recommended by the 2013 ACC/AHA guideline 1. The dosing of fenofibrate varies depending on the formulation, with standard fenofibrate typically started at 67-200 mg daily, while micronized formulations (Tricor) are generally prescribed at 48-145 mg daily.
- Key considerations for fenofibrate dosing include:
- Renal function: for patients with moderate to severe renal dysfunction (eGFR <50 mL/min), the dose should be reduced to 48 mg daily, and fenofibrate should not be used if moderate or severe renal impairment, defined as eGFR <30 mL/min per 1.73 m2, is present 1.
- Formulation: the specific dose depends on the formulation used, and the medication should be taken with food to enhance absorption.
- Monitoring: treatment efficacy should be monitored after 4-8 weeks with a lipid panel, and patients typically see a 20-50% reduction in triglyceride levels.
- Side effects: common side effects include gastrointestinal disturbances, myalgia, and potential elevation of liver enzymes, so baseline and periodic liver function tests are recommended during treatment. It is essential to consult the manufacturer’s prescribing information as there are several forms of fenofibrate available, and to evaluate renal status before fenofibrate initiation, within 3 months after initiation, and every 6 months thereafter, assessing renal safety with both a serum creatinine level and an eGFR based on creatinine 1.
From the FDA Drug Label
2.3 Severe Hypertriglyceridemia The initial dose is 54 mg per day to 160 mg per day. Dosage should be individualized according to patient response and should be adjusted if necessary following repeat lipid determinations at 4 to 8 week intervals. The maximum dose is 160 mg once daily.
The recommended dosing for fenofibrate in the management of severe hypertriglyceridemia is an initial dose of 54 mg per day to 160 mg per day, with a maximum dose of 160 mg once daily. The dosage should be individualized according to patient response and adjusted as necessary after evaluating lipid levels at 4 to 8 week intervals 2.
From the Research
Fenofibrate Dosing for Hypertriglyceridemia
The recommended dosing for fenofibrate in the management of hypertriglyceridemia varies depending on the formulation and the patient's specific condition.
- Fenofibrate is available in various formulations, including micronized fenofibrate, fenofibric acid, and nanoparticle formulations, each with different bioavailability and dosing requirements 3.
- The typical dose of fenofibrate for hypertriglyceridemia is between 40-200 mg per day, depending on the formulation and the patient's response to treatment 3.
- Some studies have shown that fenofibrate can be effective in reducing triglyceride levels when taken with or without food, although the bioavailability may vary depending on the formulation 4, 5.
- The dosing of fenofibrate should be individualized based on the patient's response to treatment and their renal function, as fenofibrate can increase serum creatinine levels and worsen renal function in some patients 6.
Formulations and Bioavailability
- Micronized fenofibrate formulations have improved bioavailability compared to earlier formulations, and can be taken with or without food 3.
- Fenofibric acid formulations have the highest bioavailability among marketed formulations and can be taken without regard to meals 3.
- Nanoparticle formulations of fenofibrate have also been developed, which can improve bioavailability and reduce the required dose 3.
Safety and Efficacy
- Fenofibrate has been shown to be effective in reducing triglyceride levels and improving lipid profiles in patients with hypertriglyceridemia 7, 5.
- However, fenofibrate can also increase serum creatinine levels and worsen renal function in some patients, particularly those with pre-existing renal disease 6.
- The safety and efficacy of fenofibrate should be carefully monitored in patients with renal disease or other comorbidities 6.