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Lipofen Generic Name & Formulations
Legal Class
Rx
General Description
Fenofibrate 50mg, 150mg; caps.
Pharmacological Class
Fibrate.
How Supplied
Caps—30, 90
Manufacturer
Generic Availability
YES
Lipofen Indications
Indications
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.
Lipofen Dosage and Administration
Adult
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. Elderly: select dose based on renal function. Discontinue if inadequate response after 2 months on max dose.
Children
Not established.
Lipofen Contraindications
Contraindications
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).
Lipofen Boxed Warnings
Not Applicable
Lipofen Warnings/Precautions
Warnings/Precautions
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 occur (do not reinitiate). Mild to moderate renal impairment: reduce dose; monitor. Elderly. Pregnancy.
Lipofen Pharmacokinetics
See Literature
Lipofen Interactions
Interactions
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 immunosuppressants (eg, cyclosporine, tacrolimus), colchicine, other nephrotoxic drugs.
Lipofen Adverse Reactions
Adverse Reactions
Abnormal liver function tests, increased AST, ALT, CPK, rhinitis; respiratory or GI effects, myopathy, cholelithiasis, pancreatitis, increased serum creatinine, rash, hypersensitivity reactions (may be severe); rare: rhabdomyolysis, transient hematologic changes, blood dyscrasias.
Lipofen Clinical Trials
See Literature
Lipofen Note
Not Applicable
Lipofen Patient Counseling
See Literature
