fenofibrate micronized (Rx)

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Brand and Other Names:Antara, Lofibra capsules

Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

capsule (Antara)

  • 30mg
  • 90mg

capsule (Lofibra)

  • 67mg
  • 134mg
  • 200mg
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Hypertriglyceridemia

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

Individualize dose according to patient response

Antara: 30-90 mg PO qDay

Lofibra capsules: 67-200 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

Antara: 90 mg PO qDay initially; discontinue if inadequate response after 2 months of treatment; may decrease dose if patient responds

Lofibra capsules: 200 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

Administration

Antara: May take with or without meals

Lofibra capsules: Take with meals to optimize bioavailability

Safety and efficacy not established

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Interactions

Interaction Checker

and fenofibrate micronized

No Results

     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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            Adverse Effects

            1-10%

            Abdominal pain (4.6%)

            Back pain (3.4%)

            Increased AST (3.4%)

            Headache (3.2%)

            Increased ALT (3%)

            Increased CPK (3%)

            Nausea (2.3%)

            Constipation (2.1%)

            Postmarketing Reports

            Myalgia, rhabdomyolysis, muscle spasms, arthralgia

            Pancreatitis

            Renal failure

            Hepatitis, cirrhosis

            Anemia

            Severely depressed HDL levels

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            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

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            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.

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            Pharmacology

            Mechanism of Action

            Fenofibrate is a prodrug that is metabolized to the active moiety, fenofibric acid

            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

            Peak Plasma Time: 4-8 hr (fenofibric acid)

            Distribution

            Time to steady-state: within 7 days (Antara); within 5 days (Lofibra capsules)

            Protein Bound: 99%

            Metabolism

            Fenofibrate converted by ester hydrolysis to fenofibric acid (active moiety)

            Fenofibric acid is 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: 20-23 hr

            Excretion: 66% in urine, primarily as fenofibric acid and fenofibric acid glucuronide; 25% feces

            Pharmacogenomics

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

            Three single-nucleotide polymorphisms (SNPs) in the APOA5 region have been associated with increases in HDL-C

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            Formulary

            FormularyPatient Discounts

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

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            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.
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