Indications for LIPOFEN:
Adjunct to diet in severe hypertriglyceridemia and to reduce elevated LDL-C, total-C, TG, and apo B, and to increase HDL-C, in primary hyperlipidemia or mixed dyslipidemia.
Limitations of Use:
Not shown to reduce coronary heart disease morbidity and mortality in patients with type 2 diabetes.
Swallow whole. Take with food. Hypertriglyceridemia: 50–150mg/day, adjust at 4–8 week intervals; max 150mg/day. Hypercholesterolemia, dyslipidemia: 150mg/day. Mild to moderate renal impairment: initially 50mg/day. Discontinue if inadequate response after 2 months on max dose.
Severe renal impairment (including dialysis). Active liver disease. Unexplained persistent liver function abnormalities. Primary biliary cirrhosis. Gallbladder disease. Nursing mothers (during and for 5 days after last dose).
Renal impairment; monitor. Monitor CBCs for first year; monitor liver function; discontinue if ALT (SGPT) levels >3×ULN persist. Discontinue if markedly elevated CPK levels, myopathy, gallstones, hypersensitivity reactions (acute and delayed), or severely depressed HDL levels occur. Elderly. Pregnancy.
Avoid statins. Potentiates oral anticoagulants (reduce anticoagulant dose and monitor PT/INR). Allow at least 1hr before or 4–6hrs after bile acid sequestrants. Caution with immunosuppressants (eg, cyclosporine, tacrolimus), colchicine, other nephrotoxic drugs.
Abnormal liver function tests, elevated CPK, respiratory or GI effects, myopathy, cholelithiasis, pancreatitis, hypersensitivity reactions (may be severe), rash; rare: rhabdomyolysis, transient hematologic changes, blood dyscrasias.