Fenofibrate capsules (micronized) are 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-pharmacological interventions alone has been inadequate (see National Cholesterol Education Program [NCEP] Treatment Guidelines, below).

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HYPOBETALIPOPROTEINEMIA, FAMILIAL, ASSOCIATED WITH APOB87 --

LOFIBRA® is contraindicated in patients who exhibit hypersensitivity to fenofibrate.LOFIBRA® is contraindicated in patients with hepatic or severe renal dysfunction, including primary biliary cirrhosis, and patients with unexplained persistent liver function abnormality.LOFIBRA® is contraindicated in patients with preexisting gallbladder disease (see WARNINGS).

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Hypersensitivity -- Altered reactivity to an antigen, which can result in pathologic reactions upon subsequent exposure to that particular antigen.

Primary biliary cirrhosis -- a form of biliary cirrhosis in which small intrahepatic ducts are destroyed while the major intra and extra hepatic ducts remain patent; most patients are middle aged females and have circulating antimitochondrial antibodies.

Gall Bladder Diseases -- Diseases of the GALLBLADDER. They generally involve the impairment of BILE flow, GALLSTONES in the BILIARY TRACT, infections, neoplasms, or other diseases.

LOFIBRA® at doses equivalent to 134 mg to 200 mg fenofibrate per day has been associated with increases in serum transaminases [AST (SGOT) or ALT (SGPT)].

In a pooled analysis of 10 placebo-controlled trials, increases to > 3 times the upper limit of normal occurred in 5.3% of patients taking fenofibrate versus 1.1% of patients treated with placebo.When transaminase determinations were followed either after discontinuation of treatment or during continued treatment, a return to normal limits was usually observed.

The incidence of increases in transaminase related to fenofibrate therapy appear to be dose related.

In an 8-week dose-ranging study, the incidence of ALT or AST elevations to at least three times the upper limit of normal was 13% in patients receiving dosages equivalent to 134 mg to 200 mg fenofibrate per day and was 0% in those receiving dosages equivalent to 34 mg or 67 mg of fenofibrate per day or placebo.

Hepatocellular, chronic active and cholestatic hepatitis associated with fenofibrate therapy have been reported after exposures of weeks to several years.

In extremely rare cases, cirrhosis has been reported in association with chronic active hepatitis.Regular periodic monitoring of liver function, including serum ALT (SGPT) should be performed for the duration of therapy with fenofibrate, and therapy discontinued if enzyme levels persist above three times the normal limit.