Dietary therapy, reduction in excess weight and alcohol intake, and treatment of medical problems contributing to lipid abnormalities should be attempted prior to treatment with LOFIBRA®. Discontinuation of estrogen therapy, thiazide diuretics, and beta-blockers in familial hypertriglyceridemia may avoid the need for specific drug therapy.
Fenofibrate is contraindicated in hepatic or severe renal dysfunction, including primary biliary cirrhosis, unexplained liver function abnormality, preexisting gallbladder disease, and hypersensitivity to fenofibrate.
Fenofibrate has been associated with increases in serum transaminases (ALT or AST) and creatine phosphokinase. Regular periodic monitoring of liver function should be performed for the duration of therapy and fenofibrate discontinued if enzyme levels persist three times above normal.
Fenofibrate may increase cholesterol excretion into the bile, leading to cholelithiasis. LOFIBRA® should be discontinued if gallstones are found.
LOFIBRA® may increase the effects of coumarin-type anticoagulants. Dosage adjustment based on frequent prothrombin time/INR determinations is advisable.
Use with HMG-CoA reductase inhibitors should be avoided unless the benefits outweigh the risks. The use of fenofibrate alone may be associated with myositis, myopathy, or rhabdomyolysis and should be stopped if myopathy/myositis is suspected or diagnosed. The effect of fenofibrate on coronary heart disease morbidity and mortality and non-cardiovascular mortality has not been established. Pancreatitis has been reported in patients taking fenofibrate. Increases in liver function tests were the most frequent events, causing discontinuation of fenofibrate in 1.6% of patients.
Please see accompanying prescribing information.
