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Trilipix Generic Name & Formulations
Legal Class
Rx
General Description
Fenofibric acid (as choline fenofibrate) 45mg, 135mg; del-rel caps.
Pharmacological Class
Fibrate.
How Supplied
Caps—90
Manufacturer
Generic Availability
YES
Trilipix Indications
Indications
Adjunct to diet to reduce TG in severe hypertriglyceridemia, and to reduce elevated LDL-C, Total-C, TG, and apo B, and to increase HDL-C in primary hypercholesterolemia or mixed dyslipidemia.
Limitations of Use
Fenofibrate (at a dose equivalent to 135mg of Trilipix) did not reduce coronary heart disease morbidity and mortality in 2 controlled trials of patients with type 2 diabetes.
Trilipix Dosage and Administration
Adult
Swallow whole. Take without regard to food. Primary hypercholesterolemia or mixed dyslipidemia: 135mg once daily. Hypertriglyceridemia: initially 45–135mg once daily. Titrate at 4–8week intervals; max 135mg/day. Mild to moderate renal impairment: initially 45mg once daily.
Children
Not established.
Trilipix Contraindications
Contraindications
Severe renal impairment including on dialysis. Active liver disease. Primary biliary cirrhosis. Unexplained persistent liver function abnormalities. Gallbladder disease. Nursing mothers (during and for 5 days after final dose).
Trilipix Boxed Warnings
Not Applicable
Trilipix Warnings/Precautions
Warnings/Precautions
The effect on coronary heart disease morbidity and mortality and non-cardiovascular mortality has not been established. 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.
Trilipix Pharmacokinetics
See Literature
Trilipix Interactions
Interactions
Increased risk of myopathy/rhabdomyolysis with concomitant statins, colchicine. Potentiates warfarin (monitor PT/INR). Allow at least 1hr before or 4–6hrs after bile acid sequestrants. Risk of nephrotoxicity with immunosuppressants (eg, cyclosporine, tacrolimus), other nephrotoxic drugs.
Trilipix Adverse Reactions
Adverse Reactions
Abnormal LFTs, increased AST/ALT, increased CPK, rhinitis; myopathy, rhabdomyolysis, hematological changes (eg, hgb, hct), increased serum creatinine, cholelithiasis, pancreatitis, hypersensitivity reactions (may be severe).
Trilipix Clinical Trials
See Literature
Trilipix Note
Not Applicable
Trilipix Patient Counseling
See Literature
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