Indications for: ANTARA
Adjunct to diet when response to nondrug therapy is inadequate in hypertriglyceridemia, 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 was not shown to reduce coronary heart disease morbidity and mortality in patients with type 2 diabetes.
Swallow whole. Take without regard to food. Hypertriglyceridemia: 30–90mg/day, adjust at 4–8 week intervals; max 90mg/day. Hypercholesterolemia, dyslipidemia: 90mg/day. Renal impairment (mild to moderate): initially 30mg/day; (severe): avoid. Elderly: select dose based on renal function. Discontinue if inadequate response after 2 months on max dose.
Severe renal impairment including on dialysis. Active liver disease. Primary biliary cirrhosis. Unexplained persistent liver function abnormalities. Gallbladder disease. Nursing mothers.
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 (acute and delayed), or paradoxical decreases in HDL-C occur (do not reinitiate). Diabetes. Hypothyroidism. Renal impairment: monitor. Elderly. Pregnancy (Cat.C).
Avoid statins. Potentiates oral anticoagulants (reduce anticoagulant dose and monitor PT/INR); caution. Allow at least 1hr before or 4–6hrs after bile acid sequestrants. Caution with colchicine, immunosuppressants (eg, cyclosporine, tacrolimus), other nephrotoxic drugs.
Abnormal LFTs, increased AST/ALT, increased CPK, rhinitis, respiratory or GI effects; hepatotoxicity, myopathy, cholelithiasis, pancreatitis, increased serum creatinine, hypersensitivity reactions (may be severe), rash; rare: rhabdomyolysis, transient hematologic changes, blood dyscrasias.
Generic Drug Availability:
Caps 30mg—30; 90mg—30, 90, 100