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 or fenofibrate.
The most commonly reported adverse reactions (>2% and at least 1% greater than placebo) are abnormal liver tests, increased AST, increased ALT, increased CPK, and rhinitis.
Fenofibrate can increase serum transaminases. Monitor liver tests, including ALT, periodically during therapy. In addition, myopathy and rhabdomyolysis have been reported in patients taking fenofibrate. Fibrates increase the risk for myopathy and have been associated with rhabdomyolysis. The risk for serious muscle toxicity appears to be increased in elderly patients and in patients with diabetes, renal failure, or hypothyroidism. Patients should be advised to report promptly unexplained muscle pain, tenderness or weakness particularly if accompanied by malaise or fever. Creatine phosphokinase (CPK) levels should be assessed in these patients. Treatment should be discontinued if markedly elevated CPK levels occur or myopathy/myositis is suspected or diagnosed. Fenofibrate can reversibly increase serum creatinine levels. The clinical relevance of these findings is unknown. Patients with renal impairment and those at risk for renal insufficiency should be periodically monitored. Fenofibrates may increase cholesterol excretion into the bile, leading to risk of cholelithiasis. If cholelithiasis is suspected, gallbladder studies are indicated. Discontinue treatment if gallstones are found.
You are encouraged to report adverse reactions to Athena Bioscience, LLC at 1-833-874-2664 or to the FDA: 1-800-FDA-1088 or www.fda.gov/medwatch.
Please see the accompanying Full Prescribing Information.
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