Trilipix
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Uses
Trilipix is indicated as an adjunct to diet in combination with a statin to reduce TG and increase HDL-C in patients with mixed dyslipidemia and CHD or a CHD risk equivalent who are on optimal statin therapy to achieve their LDL-C goal.
CHD risk equivalents comprise:
- Other clinical forms of atherosclerotic disease (peripheral arterial disease, abdominal aortic aneurysm, and symptomatic carotid artery disease);
- Diabetes;
- Multiple risk factors that confer a 10-year risk for CHD > 20%
Trilipix is indicated as adjunctive therapy to diet to reduce TG in patients with severe hypertriglyceridemia. Improving glycemic control in diabetic patients showing fasting chylomicronemia will usually obviate the need for pharmacological intervention. Markedly elevated levels of serum triglycerides (e.g. > 2,000 mg/dL) may increase the risk of developing pancreatitis. The effect of Trilipix therapy on reducing this risk has not been adequately studied.
Trilipix is indicated as adjunctive therapy to diet to reduce elevated LDL-C, Total-C, TG, and Apo B, and to increase HDL-C in patients with primary hyperlipidemia or mixed dyslipidemia.
No incremental benefit of Trilipix on cardiovascular morbidity and mortality over and above that demonstrated for statin monotherapy has been established. Fenofibrate at a dose equivalent to 135 mg of Trilipix was not shown to reduce coronary heart disease morbidity and mortality in 2 large, randomized controlled trials of patients with type 2 diabetes mellitus.
Laboratory studies should be performed to establish that lipid levels are abnormal before instituting Trilipix therapy.
Every reasonable attempt should be made to control serum lipids with non-drug methods including appropriate diet, exercise, weight loss in obese patients, and control of any medical problems such as diabetes mellitus and hypothyroidism that may be contributing to the lipid abnormalities. Medications known to exacerbate hypertriglyceridemia (beta-blockers, thiazides, estrogens) should be discontinued or changed if possible, and excessive alcohol intake should be addressed before triglyceride-lowering drug therapy is considered. If the decision is made to use lipid-altering drugs, the patient should be instructed that this does not reduce the importance of adhering to diet.
Drug therapy is not indicated for patients who have elevations of chylomicrons and plasma triglycerides, but who have normal levels of VLDL.
History
There is currently no drug history available for this drug.
Other Information
Trilipix (fenofibric acid) is a lipid regulating agent available as delayed release capsules for oral administration. Each delayed release capsule contains choline fenofibrate, equivalent to 45 mg or 135 mg of fenofibric acid. The chemical name for choline fenofibrate is ethanaminium, 2-hydroxy-N,N,N-trimethyl, 2-{4-(4-chlorobenzoyl)phenoxy] -2-methylpropanoate (1:1) with the following structural formula:
The empirical formula is C22H28ClNO5 and the molecular weight is 421.91. Choline fenofibrate is freely soluble in water. The melting point is approximately 210°C. Choline fenofibrate is a white to yellow powder, which is stable under ordinary conditions.
Each delayed release capsule contains enteric coated mini-tablets comprised of choline fenofibrate and the following inactive ingredients: hypromellose, povidone, water, hydroxylpropyl cellulose, colloidal silicon dioxide, sodium stearyl fumarate, methacrylic acid copolymer, talc, triethyl citrate. The capsule shell of the 45 mg capsule contains the following inactive ingredients: gelatin, titanium dioxide, yellow iron oxide, black iron oxide, and red iron oxide. The capsule shell of the 135 mg capsule contains the following inactive ingredients: gelatin, titanium dioxide, yellow iron oxide, and FD&C Blue #2.
Sources
Trilipix Manufacturers
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Physicians Total Care, Inc.
![Trilipix (Fenofibric Acid) Capsule, Delayed Release [Physicians Total Care, Inc.]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Trilipix | Physicians Total Care, Inc.
2.1 General ConsiderationsPatients should be placed on an appropriate lipid-lowering diet before receiving Trilipix as monotherapy or co-administered with a statin [see DOSAGE AND ADMINISTRATION (2.2, 2.3 and 2.4)], and should continue this diet during treatment. Trilipix delayed release capsules can be taken without regard to meals. Serum lipids should be monitored periodically. The maximum dose is 135 mg once daily.
2.2 Co-administration Therapy with Statins for the Treatment of Mixed DyslipidemiaTrilipix 135 mg may be co-administered with an HMG-CoA reductase inhibitor (statin) in patients with mixed dyslipidemia. For convenience, the daily dose of Trilipix may be taken at the same time as a statin, according to the dosing recommendations for each medication. Co-administration with the maximum dose of a statin has not been evaluated in clinical studies and should be avoided unless the benefits are expected to outweigh the risks.
2.3 Severe HypertriglyceridemiaThe initial dose of Trilipix is 45 to 135 mg once daily. Dosage should be individualized according to patient response, and should be adjusted if necessary following repeat lipid determinations at 4 to 8 week intervals. The maximum dose is 135 mg once daily.
2.4 Primary Hyperlipidemia or Mixed DyslipidemiaThe dose of Trilipix is 135 mg once daily.
2.5 Impaired Renal FunctionTreatment with Trilipix should be initiated at a dose of 45 mg once daily in patients with mild to moderate renal impairment and should only be increased after evaluation of the effects on renal function and lipid levels at this dose. The use of Trilipix should be avoided in patients with severely impaired renal function.
2.6 Elderly PatientsDose selection for the elderly should be made on the basis of renal function [see USE IN SPECIFIC POPULATIONS (8.5)].
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Abbvie Inc.
Trilipix | Abbvie Inc.
2.1 General ConsiderationsPatients should be placed on an appropriate lipid-lowering diet before receiving Trilipix and should continue this diet during treatment. Trilipix delayed release capsules can be taken without regard to meals. Patients should be advised to swallow Trilipix capsules whole. Do not open, crush, dissolve, or chew capsules. Serum lipids should be monitored periodically.
2.2 Severe HypertriglyceridemiaThe initial dose of Trilipix is 45 to 135 mg once daily. Dosage should be individualized according to patient response, and should be adjusted if necessary following repeat lipid determinations at 4 to 8 week intervals. The maximum dose is 135 mg once daily.
2.3 Primary Hypercholesterolemia or Mixed DyslipidemiaThe dose of Trilipix is 135 mg once daily.
2.4 Impaired Renal FunctionTreatment with Trilipix should be initiated at a dose of 45 mg once daily in patients with mild to moderate renal impairment and should only be increased after evaluation of the effects on renal function and lipid levels at this dose. The use of Trilipix should be avoided in patients with severely impaired renal function [see Use in Specific Populations (8.6) and Clinical Pharmacology (12.3)].
2.5 Geriatric PatientsDose selection for the elderly should be made on the basis of renal function [see Use in Specific Populations (8.5)].
2.1 General ConsiderationsPatients should be placed on an appropriate lipid-lowering diet before receiving Trilipix and should continue this diet during treatment. Trilipix delayed release capsules can be taken without regard to meals. Patients should be advised to swallow Trilipix capsules whole. Do not open, crush, dissolve, or chew capsules. Serum lipids should be monitored periodically.
2.2 Severe HypertriglyceridemiaThe initial dose of Trilipix is 45 to 135 mg once daily. Dosage should be individualized according to patient response, and should be adjusted if necessary following repeat lipid determinations at 4 to 8 week intervals. The maximum dose is 135 mg once daily.
2.3 Primary Hypercholesterolemia or Mixed DyslipidemiaThe dose of Trilipix is 135 mg once daily.
2.4 Impaired Renal FunctionTreatment with Trilipix should be initiated at a dose of 45 mg once daily in patients with mild to moderate renal impairment and should only be increased after evaluation of the effects on renal function and lipid levels at this dose. The use of Trilipix should be avoided in patients with severely impaired renal function [see Use in Specific Populations (8.6) and Clinical Pharmacology (12.3)].
2.5 Geriatric PatientsDose selection for the elderly should be made on the basis of renal function [see Use in Specific Populations (8.5)].
![Trilipix (Fenofibric Acid) Capsule, Delayed Release [Abbvie Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=bbf3e782-d163-49c8-0e81-4eeabef48190&name=label-trilipix-135mg-90ct.jpg)
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