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TRILIPIX
Hyperlipoproteinemias
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Drug Name:

TRILIPIX Rx

Generic Name and Formulations:
Fenofibric acid (as choline fenofibrate) 45mg, 135mg; del-rel caps.

Company:
AbbVie

Therapeutic Use:

Indications for TRILIPIX:

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.

Adult:

Swallow whole. Primary hypercholesterolemia or mixed dyslipidemia: 135mg once daily. Hypertriglyceridemia: 45–135mg once daily. Titrate at 4–8week intervals; max 135mg/day. Mild-to-moderate renal impairment: initially 45mg once daily.

Children:

Not established.

Contraindications:

Severe renal impairment (including on dialysis). Active liver disease. Primary biliary cirrhosis. Unexplained persistent liver function abnormalities. Gallbladder disease. Nursing mothers.

Warnings/Precautions:

The effect on coronary heart disease morbidity and mortality and non-cardiovascular mortality has not been established. Patients with diabetes, renal failure, hypothyroidism, elderly: increased risk of myopathy. Discontinue if markedly elevated CPK levels occur or myopathy or myositis is suspected. Monitor liver function; discontinue if LFTs >3XULN persist. Renal impairment: monitor renal function. Discontinue therapy if gallstones are found. Monitor RBC and WBC counts during first 12 months of therapy. Check HDL-C levels within first few months after initiating therapy; withdraw if severely depressed levels detected, monitor and do not re-initate. Pregnancy (Cat.C).

Interactions:

Increased risk of myopathy/rhabdomyolysis with concomitant statins, colchicine. Potentiates warfarin (monitor PT/INR). Separate dosing of bile acid sequestrants by at least 4–6 hours. Risk of nephrotoxicity with cyclosporine, tacrolimus.

Pharmacological Class:

Fibrate.

Adverse Reactions:

Abnormal LFTs, increased AST/ALT, increased CPK, rhinitis; myopathy, rhabdomyolysis, hematological changes (eg, hgb, hct), cholelithiasis, pancreatitis, hypersensitivity reactions (eg, SJS).

Metabolism:

Hepatic; 99% protein bound.

Elimination:

Renal.

Generic Availability:

YES

How Supplied:

Caps—90

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