fenofibric acid (Rx)

Brand and Other Names:Fibricor, Trilipix
  • Print

Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

tablet (Fibricor)

  • 35mg
  • 105mg

capsule, delayed-release (Trilipix)

  • 45mg
  • 135mg
more...

Hypertriglyceridemia

Indicated as adjunct to diet for severe hypertriglyceridemia (>500 mg/dL)

Fibricor: 35-105 mg PO qDay

Trilipix: 45-135 mg PO qDay

Primary Hypercholesterolemia or Mixed Lipidemia

Indicated as adjunct to diet to reduce elevated LDL-C, Total-C, TG, and Apo B, and to increase HDL-C in patients with primary hypercholesterolemia or mixed dyslipidemia

Fibricor: 105 mg PO qDay

Trilipix: 135 mg PO qDay

Dosage Modifications

Renal impairment

  • Mild-to-moderate (CrCl 30-80 mL/min): Initiate at lowest available dose and increase only after evaluating effects on renal function and lipid levels
  • Severe (CrCl <30 mL/min): Contraindicated

Dosing Considerations

Hypertriglyceridemia: Improving glycemic control in diabetic patients with fasting chylomicronemia will usually obviate the need for pharmacological intervention

Fenofibrate was not shown to reduce coronary heart disease morbidity and mortality in patients with type 2 diabetes mellitus

Indication for use with statins withdrawn by FDA

  • April 15, 2016: Based on several large cardiovascular outcome trials including AIM-HIGH, ACCORD, and HPS2-THRIVE, the FDA decided that "scientific evidence no longer supports the conclusion that a drug-induced reduction in triglyceride levels and/or increase in HDL-cholesterol levels in statin-treated patients results in a reduction in the risk of cardiovascular events"
  • Consistent with this conclusion, the FDA has determined that the benefits of fenofibric-acid (delayed-release) capsules (eg, Trilipix) for coadministration with statins no longer outweigh the risks, and the approval for this indication should be withdrawn

Safety and efficacy not established

Next:

Interactions

Interaction Checker

and fenofibric acid

No Results

     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

            All Interactions Sort By:
             activity indicator 
            Previous
            Next:

            Adverse Effects

            >10%

            Headache (11.9-13.1%)

            1-10%

            Back pain (4.1-6.3%)

            Nausea (3.5-5.5%)

            Upper respiratory tract infection (3.7-5.3%)

            Nasopharyngitis (3.5-4.7%)

            Diarrhea (3.1-3.7%)

            Myalgia (3.1-3.5%)

            Increased AST (3.4%)

            Increased ALT (3%)

            Increased CPK (3%)

            Postmarketing Reports

            Myalgia, rhabdomyolysis, muscle spasms, arthralgia

            Pancreatitis

            Renal failure

            Hepatitis, cirrhosis

            Anemia

            Severely depressed HDL levels

            Previous
            Next:

            Warnings

            Contraindications

            Hypersensitivity

            Severe renal impairment (including dialysis)

            Active liver disease, including primary biliary cirrhosis and unexplained persistent liver function abnormalities

            Pre-existing gallbladder disease

            Breastfeeding women

            Cautions

            Effect on coronary heart disease morbidity and mortality not established

            Increases risk of myositis or myopathy, and has been associated with rhabdomyolysis; risk may increase when coadministered with statins

            Higher doses or coadministration with statins associated with increased serum transaminases

            May increase serum creatinine

            May increase cholesterol excretion in bile, potentially leading to cholelithiasis

            Coadministration with warfarin may increase anticoagulant effects resulting in PT/INR prolongation

            Pancreatitis reported; may be a failure of efficacy with severe hypertriglyceridemia, a direct drug effect, or secondary effect via biliary stone or sludge formation

            May decrease hemoglobin, hematocrit, and leukocytes

            Thrombocytopenia and agranulocytosis reported

            Acute hypersensitivity reactions (eg, Stevens-Johnson syndrome, toxic necrolysis) reported PE and DVT reported

            Paradoxical decreases in HDL cholesterol reported

            Previous
            Next:

            Pregnancy & Lactation

            Pregnancy Category: C

            Lactation: Contraindicated

            Pregnancy Categories

            A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

            B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

            C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

            D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

            X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

            NA:Information not available.

            more...
            Previous
            Next:

            Pharmacology

            Mechanism of Action

            Fenofibric acid is the active metabolite of fenofibrate

            Activates peroxisome proliferator activated receptor-alpha (PPAR-alpha); increases lipolysis and elimination of triglyceride-rich particles from plasma by activating lipoprotein lipase and reduces Apo CIII production (lipoprotein lipase inhibitor)

            Reduces TC, LDL-C, Apo B, TG, and VLDL; increases HDL-C, Apo AI, and Apo AII

            Absorption

            Bioavailability: 81% (Trilipix)

            Peak Plasma Time: 4-5 hr (Trilipix); 2.5 hr (Fibricor)

            Distribution

            Time to steady-state: 8 days (Trilipix); 9 days (Fibricor)

            Protein Bound: 99%

            Metabolism

            Primarily conjugated with glucuronic acid; a small amount is reduced at the carbonyl moiety to a benzhydrol metabolite which is, in turn, conjugated with glucuronic acid

            Elimination

            Half-life: 20 hr

            Excretion: Primarily in urine as fenofibric acid and fenofibric acid glucuronide

            Pharmacogenomics

            Genotyping patients with atherogenic dyslipidemia might establish who will benefit most from therapy with fenofibric to increase HDL-C

            Previous
            Next:

            Images

            Previous
            Next:

            Formulary

            FormularyPatient Discounts

            Adding plans allows you to compare formulary status to other drugs in the same class.

            To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.

            Adding plans allows you to:

            • View the formulary and any restrictions for each plan.
            • Manage and view all your plans together – even plans in different states.
            • Compare formulary status to other drugs in the same class.
            • Access your plan list on any device – mobile or desktop.

            The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
            2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
            3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
            4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
            PA Prior Authorization
            Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
            QL Quantity Limits
            Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
            ST Step Therapy
            Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
            OR Other Restrictions
            Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
            Additional Offers
            Email to Patient

            From:

            To:

            The recipient will receive more details and instructions to access this offer.

            By clicking send, you acknowledge that you have permission to email the recipient with this information.

            Email Forms to Patient

            From:

            To:

            The recipient will receive more details and instructions to access this offer.

            By clicking send, you acknowledge that you have permission to email the recipient with this information.

            Previous