Fenofibrate

DEA Class; Rx

Common Brand Names; Tricor, Lofibra tablets, Fenoglide, Lipofen, Triglide

Indicated for use as an adjunct to diet for the treatment of adult patients with severe hypertriglyceridemia.

For the treatment of primary hypercholesterolemia or mixed hyperlipoproteinemia as an adjunct to diet to reduce elevated total-C, LDL-C, Apo B, and triglycerides and to increase HDL-C.

Known hypersensitivity

Severe renal impairment, including those with end-stage renal disease and those receiving dialysis

Active liver disease

Gallbladder disease

Nursing mothers

Cholelithiasis reported with use; discontinue if gallstones detected upon gallbladder studies

Rare myopathy, myositis, or rhabdomyolysis reported with use; monitor

Increase in hepatic transaminases reported; discontinue if enzyme levels persist 3 times above the upper limit of normal

Reversibly increases serum creatinine levels; consider monitoring renal function in patients at risk for renal impairment

Thrombocytopenia and agranulocytosis reported; monitor blood counts periodically during the first year of therapy

Associated with pulmonary embolism and deep venous thrombosis; use caution in patients with risk factors for VTE

Concomitant use with oral anticoagulants (monitor and adjust warfarin dose prn)

May further increase risk for rhabdomyolysis when added to optimal HMG-CoA reductase inhibitor regimen to further decrease TG and increase HDLs

Paradoxical decreases in HDL cholesterol (HDL-C) level reported

Rule out secondary causes of hyperlipidemia before initiating therapy

Withdraw therapy if no adequate response seen after 2-3 months

Use with caution in the elderly; dose adjustments may be necessary

Fenofibrate increases cholesterol excretion into bile, leading to risk of cholelithiasis; perform gallbladder studies if cholelithiasis suspected

Fibric acid derivatives as monotherapy or in combination with simvastatin have not been shown to significantly reduce cardiovascular mortality in major clinical studies

Limited available data with fenofibrate use in pregnant women are insufficient to determine a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes

There is no available information on presence of drug in human milk, effects on the breastfed infant, or on milk production