ABOUT FIBRICOR

FIBRICOR: AN ALTERNATIVE TO TRICOR® AND TRILIPIX®*

FIBRICOR and TriCor were bioequivalent under fasted conditions and following a standard meal (Figure 1)†1

Like TriCor and Trilipix, FIBRICOR can be taken without regard to meals2-4

Fenofibric acid, the active ingredient of FIBRICOR, is the same active ingredient found in Trilipix‡2-3

Bar

*FIBRICOR is not AB-rated to TriCor or Trilipix.
Standard breakfast meal consisting of 36% fat and 575 kcal.
Fenofibric acid is the only pharmacologically active moiety following administration of Trilipix.

FIBRICOR, TRICOR, AND TRILIPIX ARE APPROVED TO TREAT THE FOLLOWING CONDITIONS2-4


Recommended dosing for FIBRICOR


  • Dosing should be adjusted to patient response and for patients with impaired renal function
  • FIBRICOR may be taken with or without food

FIBRICOR is a peroxisome proliferator receptor alpha (PPARα) activator indicated:

  • To reduce triglyceride (TG) levels in patients with severe hypertriglyceridemia (≥ 500 mg/dl)
  • To reduce elevated total cholesterol (TC), low-density-lipoprotein cholesterol (LDL-C), TG and apolipoprotein (Apo) B and to increase high-density lipoprotein cholesterol (HDL-C) in patients with primary hyperlipidemia or mixed dyslipidemia

Important Safety Information HCP

FIBRICOR® is contraindicated in patients with severe renal impairment including those on dialysis, with active liver disease including primary biliary cirrhosis and unexplained persistent liver function abnormalities and with gallbladder disease. FIBRICOR is also contraindicated in nursing mothers and patients with hypersensitivity to fenofibric acid, choline fenofibrate or fenofibrate.

The most commonly reported adverse reactions (> 2% and greater than placebo) are increases in liver test values, abdominal pain, back pain, and headache.

Fenofibrate can increase serum transaminases, so patients should be monitored for AST or ALT changes periodically for the duration of the therapy. In addition, myopathy and rhabdomyolysis have been reported in patients taking fenofibrate. The risks of myopathy and rhabdomyolysis may be increased in patients who are elderly, have diabetes, renal failure, or hypothyroidism. Patients should be advised to report unexplained muscle pain, tenderness or weakness promptly, especially if accompanied by malaise or fever. Creatine phosphokinase (CPK) levels should be assessed in these patients. Fenofibrate can reversibly increase serum creatinine levels. Patients with renal impairment and those at risk for renal insufficiency should be periodically monitored. Fenofibrate increases cholesterol excretion into the bile, leading to risk of cholelithiasis. If cholelithiasis is suspected, gallbladder studies are indicated.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit MedWatch or call 1-800-FDA-1088.

References: 1. Data on file, URL Pharma, Inc. 2. Fibricor [package insert]. Philadelphia, PA: URL Pharma, Inc.; 2009. 3. Trilipix [package insert]. North Chicago, IL: Abbott Laboratories; 2008. 4. TriCor [package insert]. North Chicago, IL: Abbott Laboratories; 2008. 5. Dorland's Illustrated Medical Dictionary. 28th ed. Philadelphia, PA: W.B. Saunders Company; 1994.

TriCor® and Trilipix® are registered trademarks of Fournier Industrie et Santé Corporation, France.