- 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.
Most common adverse reactions (> 2% and at least 1% greater than placebo) are abnormal liver tests, increased AST, increased ALT, increased CPK, and rhinitis.
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.
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.
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.
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.
- FIBRICOR [prescribing information]. Athens, GA: Athena Bioscience, LLC.; 2019.