"June 10, 2015 -- A new class of medications can lower "bad" LDL cholesterol to unheard-of levels, and it may be on the horizon.
The new class is called PCSK9 inhibitors. An FDA advisory panel on Tuesday recommended that the agency approve t"...
Treatment Of Severe Hypertriglyceridemia
Trilipix is indicated as adjunctive therapy to diet to reduce triglycerides (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.
Treatment Of Primary Hypercholesterolemia Or Mixed Dyslipidemia
Trilipix is indicated as adjunctive therapy to diet to reduce elevated low-density lipoprotein cholesterol (LDL-C), total cholesterol (Total-C), triglycerides (TG), and apolipoprotein B (Apo B), and to increase high-density lipoprotein cholesterol (HDL-C) in patients with primary hypercholesterolemia or mixed dyslipidemia.
Limitations Of Use
Fenofibrate at a dose equivalent to 135 mg of Trilipix did not reduce coronary heart disease morbidity and mortality in 2 large, randomized controlled trials of patients with type 2 diabetes mellitus [see WARNINGS AND PRECAUTIONS].
General Considerations For Treatment
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.
DOSAGE AND ADMINISTRATION
Patients 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.
The 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.
Primary Hypercholesterolemia Or Mixed Dyslipidemia
The dose of Trilipix is 135 mg once daily.
Impaired Renal Function
Treatment 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 and CLINICAL PHARMACOLOGY].
Dose selection for the elderly should be made on the basis of renal function [see Use in Specific Populations].
Dosage Forms And Strengths
- 45 mg capsules with a reddish-brown cap imprinted in white ink the “a” logo and a yellow body imprinted in black ink the number “45”.
- 135 mg capsules with a blue cap imprinted in white ink the “a” logo and a yellow body imprinted in black ink the number “135”.
Storage And Handling
Trilipix (fenofibric acid) delayed release capsules 45 mg have a reddish-brown cap imprinted in white ink the “a” logo and a yellow body imprinted in black ink the number “45”.
Bottles of 90 (NDC 0074-9642-90).
Trilipix (fenofibric acid) delayed release capsules 135 mg have a blue cap imprinted in white ink the “a” logo and a yellow body imprinted in black ink the number “135”.
Bottles of 90 (NDC 0074-9189-90).
Store at 25°C (77°F); excursions permitted to 15°-30°C (59° to 86°F) [See USP controlled room temperature]. Keep out of the reach of children. Protect from moisture.
Manufactured for AbbVie Inc., North Chicago, IL 60064, U.S.A. by Fournier Laboratories Ireland Limited, Anngrove, Carrigtwohill Co. Cork, Ireland, or AbbVie LTD, Barceloneta, PR 00617. Revised: April 2015
Last reviewed on RxList: 5/11/2015
This monograph has been modified to include the generic and brand name in many instances.
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