• Hyperlipoproteinemias

Lipofen Generic Name & Formulations

General Description

Fenofibrate 50mg, 150mg; caps.

Pharmacological Class


How Supplied

Caps—30, 90

Generic Availability


Lipofen 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


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.


Not established.

Lipofen 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


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


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