Dosage Forms. Tablet: 40 mg, 48 mg, 50 mg, 54 mg, 67 mg, 120 mg, 145 mg, 160 mg; Capsule: 43 mg, 50 mg, 67 mg, 130 mg, 134 mg, 150 mg, 200 mg
Common FDA Label Indication, Dosing, and Titration.
1. Hypercholesterolemia, primary hypercholesterolemia, or mixed dyslipidemia (Frederickson Type 2a, 2b): 160 mg po daily
2. Hypertriglyceridemia, Frederickson Types 4 and 5 hyperlipidemia: 54-160 mg po daily
1. Coronary arteriosclerosis: 54-100 mg po daily
MOA. Fibric acid derivatives activate peroxisome proliferator activated receptor α (PPARα), which 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 to large buoyant particles. These larger particles have a greater affinity for cholesterol receptors and are catabolized rapidly.
Drug Characteristics: Fenofibrate
Medication Safety Issues: Fenofibrate
Drug Interactions: Fenofibrate
Adverse Reactions: Fenofibrate
Efficacy Monitoring Parameters. Reduction in total cholesterol, LDL-cholesterol, and triglycerides levels; increase in HDL-cholesterol levels.
Toxicity Monitoring Parameters. Signs/symptoms of rhabdomyolysis (myalgias, dark urine, arthralgias, fatigue), yellowing of eyes or skin, severe abdominal pain; monitor LFT, CBC at baseline, 12 wk after initiation of therapy, or dose increases; serum creatine kinase should be measured in patients experiencing muscle pain and in those receiving other drugs associated with myopathy.
Key Patient Counseling Points. Fenoglide tablets and Lipofen R capsules should be given with food; others can be taken without regard to food. Take 1 h before or 4-6 h after a bile acid binding resin. Products are not interchangeable.
Clinical Pearls. The fibric acid derivatives (gemfibrozil, clofibrate, and fenofibrate) are recommended as alternatives to niacin in the treatment of Types IIb, III, IV, and V hyperlipidemia. Gemfibrozil has less nephrotoxicity than other fibric acid derivatives. Clofibrate appears to have excess cardiovascular toxicity.