Indications for: FIBRICOR
Adjunct to diet in severe hypertriglyceridemia (≥500mg/dL), and to reduce elevated total-C, LDL-C, apo B, and TG, and to increase HDL-C, in primary hypercholesterolemia and mixed dyslipidemia.
Limitations of Use:
Fenofibrate (at a dose equivalent to 105mg of Fibricor) was not shown to reduce coronary heart disease morbidity and mortality in patients with type 2 diabetes.
Hypertriglyceridemia: 35–105mg/day, adjust at 4–8 week intervals. Hypercholesterolemia, dyslipidemia: 105mg/day. Mild to moderate renal impairment: initially 35mg/day. Elderly: select dose based on renal function. Discontinue if inadequate response after 2 months on max dose.
Severe renal dysfunction (including dialysis). Active liver disease. Primary biliary cirrhosis. Unexplained persistent liver function abnormalities. Gallbladder disease. Nursing mothers (during and for 5 days after last dose).
Risk of serious liver injury. Monitor liver function at baseline and periodically during therapy; discontinue if liver injury develops or if elevated enzymes persist (ALT or AST >3×ULN, or if accompanied by elevated bilirubin); do not restart if no alternative explanation. Monitor CBCs during the first year. Discontinue if markedly elevated CPK levels, myopathy, gallstones, hypersensitivity reactions, or paradoxical decreases in HDL occur (do not reinitiate). Mild to moderate renal impairment: reduce dose; monitor. Diabetes. Hypothyroidism. Elderly. Pregnancy.
May potentiate oral anticoagulants (reduce anticoagulant dose and monitor PT/INR); caution. Allow at least 1 hour before or 4–6 hours after bile acid sequestrants. Caution with colchicine, immunosuppressants (eg, cyclosporine, tacrolimus), other nephrotoxic drugs.
Abnormal liver tests, increased AST, increased ALT, increased CPK, rhinitis; rhabdomyolysis, myopathy, pancreatitis, cholelithiasis, hematological changes, hypersensitivity reactions (may be severe).
Generic Drug Availability: