Here are some of the most commonly asked questions we've received from healthcare professionals about LOFIBRA®.

What is the difference between LOFIBRA® and other brands of fenofibrates?

LOFIBRA® offers the same proven lipid control as other fenofibrates, but it is the only fenofibrate that offers 5 flexible options, including 160 mg and 54 mg tablets; 200 mg, 134 mg, and 67 mg capsules. Plasma concentrations of fenofibric acid after administration of 54 mg and 160 mg tablets are equivalent under fed conditions to 67 mg and 200 mg capsules, respectively.

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How does LOFIBRA® work?

The effects of fenofibric acid seen in clinical practice have been explained in vivo in transgenic mice and in vitro in human hepatocyte cultures by the activation of peroxisome proliferator activated receptor α (PPARα). Through this mechanism, fenofibrate increases lipolysis and elimination of triglyceride-rich particles from plasma by activating lipoprotein lipase and reducing production of apoprotein C-III (an inhibitor of lipoprotein lipase activity).

The resulting fall in triglycerides produces an alteration in the size and composition of LDL from small, dense particles (which are thought to be atherogenic due to their susceptibility to oxidation), to large buoyant particles. These larger particles have a greater affinity for cholesterol receptors and are catabolized rapidly. Activation of PPARα also induces an increase in the synthesis of apoproteins A-I, A-II, and HDL-cholesterol.

Fenofibrate also reduces serum uric acid levels in hyperuricemic and normal individuals by increasing the urinary excretion of uric acid.

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Does LOFIBRA® have to be taken at mealtimes?

Yes. LOFIBRA® is more efficacious when taken with a meal. We believe this consistent dosing schedule enhances compliance by giving patients a regular daily routine.

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What are the approved indications?

LOFIBRA® [fenofibrate tablets and capsules (micronized)] is indicated as adjunctive therapy to diet for the treatment of adult patients with hypertriglyceridemia (Fredrickson Types IV and V hyperlipidemia). Improving glycemic control in diabetic patients showing fasting chylomicronemia usually obviates the need for pharmacologic intervention. Markedly elevated levels of serum triglycerides (e.g., >2000 mg/dL) may increase the risk of developing pancreatitis. The effect of LOFIBRA® in relation to this risk has not been adequately studied.

LOFIBRA® [fenofibrate tablets and capsules (micronized)] is also indicated as adjunctive therapy to diet for the reduction of LDL-C, total-C, triglycerides, and apo B in adult patients with primary hypercholesterolemia or mixed dyslipidemia (Fredrickson Types IIa and IIb). Lipid-altering agents should be used in addition to a diet restricted in saturated fat and cholesterol when response to diet and non-pharmacologic interventions alone has been inadequate.

LOFIBRA® Tablets are also indicated to increase HDL-C in adult patients with hypercholesterolemia or mixed dyslipidemia.

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What are the safety considerations?

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.


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.

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What are the possible drug interactions?

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.


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Who is GATE Pharmaceuticals?

Click here to see information about GATE.

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Please see accompanying prescribing information.