Fenofibric acid

FDA label, Leading Pharma, LLC, oral, effective 2025-08-22. Full label on DailyMed

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Quoted from the FDA label. Product labels differ by manufacturer and change over time; confirm against the label for the product you are using.

Peroxisome Proliferator Receptor alpha Agonist

Dosing in kidney impairment

Recommended Dosage in Patients with Renal Impairment Assess renal function prior to initiation of fenofibric acid delayed-release capsules and periodically thereafter [see Warnings and Precautions ]. Treatment with fenofibric acid delayed-release capsules should be initiated at a dosage of 45 mg orally once daily in patients with mild to moderately impaired renal function (eGFR 30 to <60 mL/min/1.73m 2 ), and increased only after evaluation of the effects on renal function and TG levels at this dosage.

Fenofibric acid delayed-release capsules are contraindicated in patients with severe renal impairment (eGFR <30 mL/min/1.73m 2 ), including those with end-stage renal disease (ESRD) and those receiving dialysis [see Use in Specific Populations and Clinical Pharmacology ].

Dosing in liver impairment

Hepatic Impairment The use of fenofibric acid has not been evaluated in patients with hepatic impairment. Fenofibric acid are contraindicated in patients with active liver disease, including those with unexplained persistent liver function abnormalities [see Clinical Pharmacology ].

Preparation and administration

Recommended Dosage and Administration Severe hypertriglyceridemia: The recommended dosage of fenofibric acid delayed-release capsules are 45 mg or 135 mg orally once daily. Dosage should be individualized according to patient response, and should be adjusted if necessary following repeat lipid determinations at 4 to 8 week intervals.

Primary hyperlipidemia: The recommended dosage of fenofibric acid delayed-release capsules are 135 mg orally once daily. Administer fenofibric acid delayed-release capsules as a single dose at any time of day, with or without food. Advise patients to swallow fenofibric acid delayed-release capsules whole. Do not crush, break, dissolve, or chew capsules.

Assess TG when clinically appropriate, as early as 4 to 8 weeks after initiating fenofibric acid delayed-release capsules. Discontinue fenofibric acid delayed-release capsules in patients who do not have an adequate response after two months of treatment. If a dose is missed, advise patients not to take an extra dose. Resume treatment with the next dose.

Advise patients to take fenofibric acid delayed-release capsules at least 1 hour before or 4 hours to 6 hours after a bile acid binding resin to avoid impeding its absorption.

Drug interactions

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Label text (6 paragraphs)

Table 2 presents clinically important drug interactions with fenofibric acid. Table 2. Clinically Important Drug Interactions with fenofibric acid Statins Clinical Impact: Fibrates may cause myopathy when given alone. The risk of myopathy and rhabdomyolysis is increased with concomitant use of fibrates with statins. Intervention: Consider if the benefit of using fenofibric acid concomitantly with statin therapy outweighs the increased risk of myopathy and rhabdomyolysis. If concomitant use is decided, monitor patients for signs and symptoms of myopathy, particularly during initiation of therapy and during upward dosage titration of statin therapy.

Colchicine Clinical Impact: Cases of myopathy and rhabdomyolysis have been reported with concomitant use of colchicine with fenofibrates. Intervention: Consider if the benefit of using colchicine concomitantly with fenofibric acid outweighs the increased risk of myopathy and rhabdomyolysis. If concomitant use is decided, monitor patients for signs and symptoms of myopathy, particularly during initiation of therapy and during upward dosage titration of colchicine. Coumarin Anticoagulants Clinical Impact: Fibrates may cause potentiation of coumarin-type anticoagulant effects with prolongation of the PT/INR.

Intervention: Caution should be exercised when coumarin anticoagulants are given in conjunction with fenofibric acid. The dosage of the anticoagulants should be reduced to maintain the PT/INR at the desired level to prevent bleeding complications.

Frequent PT/INR determinations are advisable until it has been definitely determined that the PT/INR has stabilized Immunosuppressants Clinical Impact: Immunosuppressants 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 fenofibric acid, there is a risk that an interaction will lead to deterioration of renal function.

Intervention: The benefits and risks of using fenofibric acid with immunosuppressants and other potentially nephrotoxic agents should be carefully considered, and the lowest effective dosage employed and renal function monitored. Bile-Acid Binding Resins Clinical Impact: Bile-acid binding resins may bind other drugs given concurrently. Intervention: In patients taking a bile acid resin, administer fenofibric acid at least 1 hour before or 4 to 6 hours after the bile acid resin to avoid impeding its absorption. Consider if the benefit of concomitant use of statins or colchicine outweighs the increased risk of myopathy and rhabdomyolysis.

Monitor patients for signs and symptoms of myopathy (7) . Exercise caution in concomitant treatment with coumarin anticoagulants. Reduce the dosage of coumarin to maintain the PT/INR at the desired level to prevent bleeding complications (7) . Consider the benefits and risks of concomitant use with immunosuppressants and other potentially nephrotoxic agents. Use the lowest effective dosage and monitor renal function (7) . Administer fenofibric acid at least 1 hour before or 4 to 6 hours after a bile acid resin to avoid impeding its absorption (7) .

Contraindications

Fenofibric acid delayed-release capsules are contraindicated in patients with: Severe renal impairment, including those with end-stage renal disease (ESRD) and those receiving dialysis [see Clinical Pharmacology (12.3) ] . Active liver disease, including those with unexplained persistent liver function abnormalities [see Warnings and Precautions (5.2) ] . Pre-existing gallbladder disease [see Warnings and Precautions (5.5) ]. Hypersensitivity to fenofibric acid, fenofibrate, or any of the excipients in fenofibric acid delayed-release capsules. Serious hypersensitivity reactions including anaphylaxis and angioedema have been reported with fenofibrate [see Warnings and Precautions (5.9) ] .

Severe renal impairment, including those with end-stage renal disease (ESRD) and those receiving dialysis (4) . Active liver disease including those with unexplained persistent liver function abnormalities (4) . Pre-existing gallbladder disease (4) . Hypersensitivity to fenofibric acid, fenofibrate, or any of the excipients in fenofibric acid delayed-release capsules (4) .

Safety data

Reported adverse events (FAERS)

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Source: FDA Adverse Event Reporting System via openFDA

Liver injury (LiverTox)

LiverTox has no chapter for fenofibric acid. Check the label's hepatic warnings.

Supply and cost

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Recalls (last 24 months)

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Therapeutic equivalence (Orange Book)

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