• Text Size:
  • small text
  • med text
  • large text
  • |Print This Page
Home
Cholesterol Guidelines
TRILIPIX Efficacy
TRILIPIX Safety
Dosing
Prescribing TRILIPIX
Patient Assistance & Resources

In patients with mixed dyslipidemia

TRILIPIX safety data with a statin
for up to 116 weeks

TRILIPIX safety data with a statin
for up to 116 weeks

aAdverse effects and laboratory measurements occurring through 30 days after the last dose of study drug were included in analyses. The incidence of specific adverse events and elevated clinical laboratory measurements related to muscle, hepatic, or renal function were also assessed.



Low-dose statin = rosuvastatin 10 mg, simvastatin 20 mg, or atorvastatin 20 mg.
Moderate-dose statin = rosuvastatin 20 mg, simvastatin 40 mg, or atorvastatin 40 mg.
High-dose statin = rosuvastatin 40 mg, simvastatin 80 mg, or atorvastatin 80 mg.

aAdverse effects and laboratory measurements occurring through 30 days after the last dose of study drug were included in analyses. The incidence of specific adverse events and elevated clinical laboratory measurements related to muscle, hepatic, or renal function were also assessed.

Open-label extension data



aAdverse effects and laboratory measurements occurring through 30 days after the last dose of study drug were included in analyses. The incidence of specific adverse events and elevated clinical laboratory measurements related to muscle, hepatic, or renal function were also assessed.

b64-Week Safety Analysis: Safety was assessed in 2201 patients with mixed dyslipidemia who received at least 1 dose of TRILIPIX in combination with either a low- or moderate-dose statin in 1 of the double-blind, controlled studies or TRILIPIX in combination with a moderate-dose statin in a phase 3, multicenter, 52-week, open-label extension study. Patients were exposed to combination therapy for a median of 364 days.3

c116-Week Safety Analysis: Safety was assessed in 310 patients with mixed dyslipidemia who completed 1 of the double-blind, controlled studies and the first 52-week, open-label extension study, then received at least 1 dose of TRILIPIX in combination with a moderate-dose statin in the second phase 3, multicenter, 52-week, open-label extension study. Patients were exposed to combination therapy for a median of 729 days.2,4

Additional Safety Information:

  • Tell patients to promptly report unexplained muscle pain, tenderness or weakness. If markedly elevated CPK levels occur or myopathy/myositis is diagnosed, TRILIPIX and statin therapy should be discontinued.
  • TRILIPIX can cause reversible elevations in serum creatinine. Monitor renal function periodically in patients with or at risk for renal insufficiency.
  • TRILIPIX can increase serum transaminases. Monitor liver function tests regularly, and discontinue therapy if enzyme levels persist above 3 times the upper limit of normal.

For safety data from the fenofibrate monotherapy trials click here.

Please click here for Important Safety Information.

DAW Laws by State

Find your state’s dispensing requirements to ensure that your patients get the TRILIPIX you prescribe


COMBO STUDY
DESIGN

View Study Design

PATIENT SAVINGS

Eligible patients receive special savings on their TRILIPIX prescription


Savings Offer

Important Safety Information and Indications for TRILIPIX®

Important Safety Information for TRILIPIX

  • TRILIPIX is contraindicated in patients with severe renal impairment; active liver disease, including those with unexplained persistent liver function abnormalities; gallbladder disease; in nursing mothers; and in patients with hypersensitivity to fenofibric acid or fenofibrate.
  • Fibrate and statin monotherapy increase the risk of myositis or myopathy and have been associated with rhabdomyolysis. The risks for myopathy and rhabdomyolysis are increased when fibrates are coadministered with a statin, particularly in the elderly and in patients with diabetes, renal failure, or hypothyroidism.
  • Tell patients to promptly report unexplained muscle pain, tenderness, or weakness. If markedly elevated CPK levels occur or myopathy/myositis is diagnosed, TRILIPIX and statin therapy should be discontinued.
  • TRILIPIX can cause reversible elevations in serum creatinine. Monitor renal function periodically in patients with or at risk for renal insufficiency.
  • TRILIPIX can increase serum transaminases. Monitor liver function tests regularly, and discontinue therapy if enzyme levels persist above 3 times the upper limit of normal.
  • TRILIPIX may lead to cholelithiasis. If cholelithiasis is confirmed, TRILIPIX should be discontinued.
  • TRILIPIX may increase the effects of oral coumarin anticoagulants. Monitoring and dosage adjustment of the anticoagulant are recommended.
  • Pancreatitis, hypersensitivity reactions, hematological changes, and venothromboembolic events have been reported with the use of fibrates.
  • The effect of TRILIPIX on coronary heart disease morbidity and mortality and non-cardiovascular mortality has not been established.
  • Co-administration with the maximum dose of a statin has not been evaluated and should be avoided unless the benefits are expected to outweigh the risks.
  • Adverse events reported by ≥4% of patients receiving TRILIPIX alone or co-administered with a statin in controlled clinical trials were dyspepsia, nausea, nasopharyngitis, upper respiratory tract infection, arthralgia, back pain, pain in extremity, dizziness, and headache.

Indications for TRILIPIX® (fenofibric acid) delayed-release capsules

  • Every reasonable attempt should be made to control serum lipids with diet, other disease-state management, and other non-drug methods before and during treatment with TRILIPIX.
  • 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.
  • TRILIPIX is indicated as an adjunct to diet to reduce TG in patients with severe hypertriglyceridemia. Improving glycemic control in diabetics with fasting chylomicronemia will usually obviate the need for drug therapy. The effect of TRILIPIX on pancreatitis risk reduction in patients with markedly elevated serum TG has not been adequately studied.
  • TRILIPIX is indicated as an adjunct to diet to reduce LDL-C, Total-C, TG, and Apo B and to increase HDL-C in patients with primary hyperlipidemia or mixed dyslipidemia.
  • Important Limitations of Use: 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 trials of patients with type 2 diabetes mellitus.


Please see full Prescribing Information for TRILIPIX.

References:

1. TRILIPIX [package insert]. North Chicago, IL: Abbott Laboratories.

2. Data on file, Abbott Laboratories.

3. Bays HE, Jones PH, Mohiuddin SM, et al. Long-term safety and efficacy of fenofibric acid in combination with statin therapy for the treatment of patients with mixed dyslipidemia. J Clin Lipidol. 2008;2:426-435.

4. Kipnes MS, Roth EM, Rhyne JM, et al. Year two assessment of fenofibric acid and moderate-dose statin combination: a phase 3, open-label, extension study. Clin Drug Investig. 2010;30:51-61.

032-630712
Copyright © 2011 Abbott Laboratories. Abbott Park, Illinois, U.S.A.