Generic Name and Formulations:
Fenofibric acid (as choline fenofibrate) 45mg, 135mg; del-rel caps.
Adjunct to diet: In combination with a statin, to reduce triglycerides (TG) and increase high-density lipoprotein cholesterol (HDL-C) in patients with mixed dyslipidemia and CHD or a CHD risk equivalent who are on optimal statin therapy to achieve LDL-C goal; As monotherapy to reduce TG in severe hypertriglyceridemia, and to reduce elevated LDL-C, total cholesterol (total-C), TG, and apolipoprotein B (Apo B), and to increase HDL-C in primary hyperlipidemia or mixed dyslipidemia.
Swallow whole. Mixed dyslipidemia, primary hyperlipidemia: 135mg once daily. Hypertriglyceridemia: 45–135mg once daily. Titrate at 4–8week intervals; max 135mg/day. Mild to moderate renal impairment: initially 45mg once daily.
Severe renal dysfunction (including dialysis). Active liver disease. Primary biliary cirrhosis. Unexplained persistent liver function abnormalities. Gallbladder disease. Nursing mothers.
The effect on coronary heart disease morbidity and mortality and non-cardiovascular mortality has not been established. Renal failure, diabetes, hypothyroidism, elderly: increased risk of myopathy with concomitant statins. Discontinue if markedly elevated CPK levels occur or myopathy or myositis is suspected. Monitor liver function; discontinue if LFTs >3xULN persist. Renal impairment: monitor renal function. Discontinue therapy if gallstones are found. Check HDL-C levels within first few months after initiating therapy; withdraw if severely depressed levels detected, monitor and do not re-initate. Pregnancy (Cat.C).
Avoid with max doses of a statin (myopathy). Potentiates warfarin (monitor). Separate dosing of bile acid sequestrants. Caution with cyclosporine, tacrolimus, colchicine.
Headache, back pain, nasopharyngitis, nausea, myalgia, diarrhea, URI, elevated LFTs, serum creatinine; myopathy, rhabdomyolysis, hematological changes (eg, hgb, hct), cholelithiasis, pancreatitis, possible hypersensitivity reactions.
Hepatic; 99% protein bound.