Fenofibratedosage

Severe hypertriglyceridemia: 48 to 145 mg orally once daily; the dosage should be adjusted according to patient response.

Primary hyperlipidemia: 145 mg orally once daily. Administer as a single dose, at any time of day, with or without food. Assess TG when clinically appropriate, as early as 4 to 8 weeks after initiating fenofibrate tablets. Discontinue fenofibrate tablets in patients who do not have an adequate response after 2 months of treatment.

Renal impairment: Initial dosage of 48 mg orally once daily.

Geriatric patients: Select the dosage on the basis of renal function.

2.1 Prior to

Initiation of Fenofibrate tablets Assess lipid levels before initiating therapy. Identify other causes (e.g., diabetes mellitus, hypothyroidism, or medications) of high TG levels and manage as appropriate. Patients should be placed on an appropriate lipid-lowering diet before receiving fenofibrate tablets, and should continue this diet during treatment with fenofibrate tablets. In patients with diabetes and fasting chylomicronemia, improve glycemic control prior to considering starting fenofibrate tablets.

2.2 Recommended

Dosage and Administration Severe hypertriglyceridemia: The recommended dosage of fenofibrate tablets are 48 mg or 145 mg orally once daily. Dosage should be individualized according to patient response, and should be adjusted if necessary following repeat lipid determinations at 4 to 8 week intervals.

Primary hyperlipidemia: The recommended dosage of fenofibrate tablets is 145 mg orally once daily. Administer fenofibrate tablets as a single dose at any time of day, with or without food. Advise patients to swallow fenofibrate tablets whole. Do not crush, break, dissolve, or chew tablets. Assess TG when clinically appropriate, as early as 4 to 8 weeks after initiating fenofibrate tablets. Discontinue fenofibrate tablets in patients who do not have an adequate response after 2 months of treatment. If a dose is missed, advise patients not to take an extra dose. Resume treatment with the next dose. Advise patients to take fenofibrate tablets at least 1 hour before or 4 hours to 6 hours after a bile acid binding resin to avoid impeding its absorption.

2.3 Recommended

Dosage in Patients with Renal Impairment Assess renal function prior to initiation of fenofibrate tablets and periodically thereafter. Treatment with fenofibrate tablets should be initiated at a dosage of 48 mg orally once daily in patients with mild to moderately impaired renal function (eGFR 30 to <60 mL/min/1.73m2), and increased only after evaluation of the effects on renal function and TG levels at this dosage. Fenofibrate tablets is contraindicated in patients with severe renal impairment (eGFR <30 mL/min/1.73m2), including those with end-stage renal disease (ESRD) and those receiving dialysis.

2.4 Recommended

Dosage in Geriatric Patients Dosage selection for geriatric patients should be made on the basis of renal function.