FIBRICOR (fenofibric acid) tablets
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Safety Profile

Contraindications

  • Severe renal dysfunction, including patients receiving dialysis.
  • Active liver disease.
  • Gallbladder disease.
  • Nursing Mothers.
  • Known hypersensitivity to fenofibric acid or fenofibrate.

Warnings and Precautions

Myopathy and rhabdomyolysis have been reported in patients taking fenofibrate. The risks of myopathy and rhabdomyolysis appears to be increased when fibrates are co-administered with a statin (with a significantly higher rate observed for gemfibrozil), particularly in elderly patients and patients with diabetes, renal failure, or hypothyroidism.

Fenofibrate can increase serum transaminases. Monitor liver tests, including ALT, periodically during therapy.

Fenofibrate can reversibly increase serum creatinine levels. Monitor renal function periodically in patients with renal insufficiency.

Fenofibrate increases cholesterol excretion into the bile, leading to risk of cholelithiasis. If cholelithiasis is suspected, gallbladder studies are indicated.

Exercise caution in concomitant treatment with oral coumarin anticoagulants. Adjust the dosage of coumarin anticoagulant to maintain the prothrombin time/INR at the desired level to prevent bleeding complications.

Acute hypersensitivity reactions, including anaphylaxis and angioedema, and delayed hypersensitivity reactions, including severe cutaneous adverse drug reactions have been reported postmarketing. Some cases, were life-threatening and required emergency treatment. Discontinue fenofibrate and treat patients appropriately if reactions occur.

Adverse Reactions 

Most common adverse reactions (> 2% and at least 1% greater than placebo) are abnormal liver tests, increased AST, increased ALT, increased CPK, and rhinitis.

Adverse reactions chart

To report SUSPECTED ADVERSE REACTIONS, contact Athena Bioscience, LLC. at 1-833-874-2664 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Drug Interactions

Coumarin Anticoagulants

Potentiation of coumarin-type anticoagulant effects has been observed with prolongation of the PT/INR. Caution should be exercised when coumarin anticoagulants are given in conjunction with FIBRICOR®. The dosage of the anticoagulants should be reduced to maintain the prothrombin time/INR at the desired level to prevent bleeding complications. Frequent prothrombin time/INR determinations are advisable until it has been definitely determined that the prothrombin time/INR has stabilized.

Bile-Acid Binding Resins

Since bile-acid binding resins may bind other drugs given concurrently, patients should take FIBRICOR at least 1 hour before or 4 to 6 hours after taking a bile-acid binding resin to avoid impeding its absorption.

Immunosuppressants

Immunosuppressant agents such as cyclosporine and tacrolimus can produce nephrotoxicity with decreases in creatinine clearance and rises in serum creatinine, and because renal excretion is the primary elimination route of fibrate drugs, including FIBRICOR, there is a risk that an interaction will lead to deterioration of renal function. The benefits and risks of using FIBRICOR with immunosuppressants and other potentially nephrotoxic agents should be carefully considered, and the lowest effective dose employed and renal function monitored.

Colchicine

Cases of myopathy, including rhabdomyolysis, have been reported with fenofibrates co-administered with colchicine, and caution should be exercised when prescribing fenofibrate with colchicine.

Use in Specific Populations

Geriatric Use: Determine dose selection based on renal function

Renal Impairment: Avoid in patients with severe renal impairment; dose reduction required in patients with mild-to- moderate renal impairment.

References:

  1. FIBRICOR [prescribing information]. Athens, GA: Athena Bioscience, LLC.; 2019.

 

FIBRICOR® (fenofibric acid) Important Safety Information

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.