Generic Name and Formulations:
Fenofibric acid (as choline fenofibrate) 45mg, 135mg; del-rel caps.
Indications for TRILIPIX:
Adjunct to diet to reduce TG in severe hypertriglyceridemia, and to reduce elevated LDL-C, Total-C, TG, and apo B, and to increase HDL-C in primary hypercholesterolemia or mixed dyslipidemia.
Limitations Of use:
Fenofibrate (at a dose equivalent to 135mg of Trilipix) did not reduce coronary heart disease morbidity and mortality in 2 controlled trials of patients with type 2 diabetes.
Swallow whole. Primary hypercholesterolemia or mixed dyslipidemia: 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 impairment (including on 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. Patients with diabetes, renal failure, hypothyroidism, elderly: increased risk of myopathy. 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. Monitor RBC and WBC counts during first 12 months of therapy. 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).
Increased risk of myopathy/rhabdomyolysis with concomitant statins, colchicine. Potentiates warfarin (monitor PT/INR). Separate dosing of bile acid sequestrants by at least 4–6 hours. Risk of nephrotoxicity with cyclosporine, tacrolimus.
Abnormal LFTs, increased AST/ALT, increased CPK, rhinitis; myopathy, rhabdomyolysis, hematological changes (eg, hgb, hct), cholelithiasis, pancreatitis, hypersensitivity reactions (eg, SJS).
Hepatic; 99% protein bound.
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