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. Take without regard to food. Primary hypercholesterolemia or mixed dyslipidemia: 135mg once daily. Hypertriglyceridemia: initially 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 (during and for 5 days after final dose).
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. Monitor liver function; discontinue if LFTs >3×ULN persist. Renal impairment: monitor renal function. Discontinue if markedly elevated CPK levels, myopathy, gallstones, hypersensitivity reactions (acute and delayed), or severely depressed HDL-C levels occur (do not reinitiate). Monitor RBC and WBC counts during first 12 months of therapy. Pregnancy.
Increased risk of myopathy/rhabdomyolysis with concomitant statins, colchicine. Potentiates warfarin (monitor PT/INR). Allow at least 1hr before or 4–6hrs after bile acid sequestrants. Risk of nephrotoxicity with immunosuppressants (eg, cyclosporine, tacrolimus), other nephrotoxic drugs.
Abnormal LFTs, increased AST/ALT, increased CPK, rhinitis; myopathy, rhabdomyolysis, hematological changes (eg, hgb, hct), increased serum creatinine, cholelithiasis, pancreatitis, hypersensitivity reactions (may be severe).