Approved December 15, 2008

FENOFIBRIC ACID
(FDA Category 2S)

TRILIPIX (Abbott) is a lipid regulating agent available as a delayed release oral capsule. Fenofibric acid effects have been explained by the activation of peroxisome proliferator activated receptor alpha (PPARalpha). Through this mechanism, fenofibrate activates lipoprotein lipase and reduce production of Apoprotein CIII, thereby increases lipolysis and elimination of triglyceride-rich particles from plasma.

DOSING INFORMATION: The recommended dose is 45 to 135 mg orally once daily, with or without meals.

PHARMACOKINETICS: The absolute bioavailability of fenofibric acid is approximately 81% and food does not effect absorption. Peak plasma concentrations occur within 4 to 5 hours. Serum protein binding is approximately 99%. Fenofibric acid is primarily conjugated with glucuronic acid and excreted in the urine. A small amount is also reduced to a benzhydrol metabolite which is then conjugated with glucuronic acid and excreted. Fenofibric acid does not appear to undergo oxidative metabolism via cytochrome P450 to any significant effect. The half-life is 20 hrs.

CAUTIONS: Fenofibric acid is contraindicated in patients with active liver disease, including those with primary biliary cirrhosis and unexplained persistent liver function abnormalities; gallbladder disease, and severe renal impairment. Myositis, myopathy, rhabdomyolysis, pancreatitis, increased liver enzymes have been reported with fenofibrate. Common adverse events were headache, nausea, and backache.

FDA APPROVED INDICATIONS: Fenofibric Acid is indicated in combination with a statin to reduce triglycerides (TG) and increase high-density lipoprotein cholesterol (HDL-C) in patients with mixed dyslipidemia and coronary heart disease (CHD) or a CHD risk equivalent who are on optimal statin therapy to achieve low-density lipoprotein cholesterol (LDL-C) goal. It is also indicated to reduce triglycerides in patients with severe hypertriglyceridemia.