fenofibrate (Rx)

Brand and Other Names:Tricor, Lofibra tablets, more...Fenoglide, Lipofen, Triglide
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Dosing & Uses

AdultPediatricGeriatric

Dosage Forms & Strengths

TriCor tablet

  • 48mg
  • 145mg

Lofibra tablet

  • 54mg
  • 160mg

Fenoglide tablet

  • 40mg
  • 120mg

Triglide tablet

  • 160mg

Lipofen capsule

  • 50mg
  • 150mg
more...

TriCor

Hypercholesterolemia, mixed dyslipidemia: Initially, 145 mg PO qDay

Hypertriglyceridemia: Initially, 48-145 mg PO qDay

Titrate q4-8week up to no more than 145 mg PO qDay

Triglide

Hypercholesterolemia, Mixed Dyslipidemia: initial 160 mg PO qDay

Hypertriglyceridemia: 50-160 mg PO qDay initially

Lipofen

Hypercholesterolemia, Mixed Dyslipidemia: initial 150 mg PO qDay

Hypertriglyceridemia: initial 50-150 mg PO qDay

Lofibra tablets

Hypercholesterolemia, Mixed Dyslipidemia: 160 mg PO qDay

Hypertriglyceridemia: 54-160 mg PO qDay

Fenoglide

Hypercholesterolemia, Mixed Dyslipidemia: 120 mg PO qDay

Hypertriglyceridemia: 40-120 mg PO qDay

Dosing Considerations

Overdose management

  • Symptoms include GI distress
  • Treatment is supportive

Dosing Modifications

Renal impairment

  • TriCor (CrCl <50 mL/min): 48 mg/day initially; evaluate before increase dose
  • Triglide: Initial, 50 mg/day
  • Lipofen: Initial, no more than 50 mg/day
  • Lofibra tablets: Initial, 54 mg/day
  • Fenoglide: Initial, 40 mg/day

Administration

TriCor, Triglide, and Lofibra tablets can be taken without regard to meals

Lipofen: Take with meals

Safety and efficacy not established

TriCor

Hypercholesterolemia, mixed dyslipidemia, hypertriglyceridemia

Initial: 48 mg/day; evaluate before increase dose

Triglide

Hypercholesterolemia, mixed dyslipidemia, hypertriglyceridemia

Initial: 50 mg/day

Lipofen

Hypercholesterolemia, mixed dyslipidemia, hypertriglyceridemia

Initial: No more than 50 mg/day

Lofibra tablets

Hypercholesterolemia, mixed dyslipidemia, hypertriglyceridemia

Initial: 54 mg/day

Fenoglide

Hypercholesterolemia, mixed dyslipidemia, hypertriglyceridemia

Initial: 40 mg/day

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Interactions

Interaction Checker

and fenofibrate

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    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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            Adverse Effects

            >10%

            Increased LFT's (dose related, 3-13%)

            1-10%

            Respiratory disorder (6%)

            Abdominal pain (5%)

            Back pain (3%)

            CPK increased (3%)

            Headache (3%)

            Constipation (2%)

            Nausea (2%)

            Rhinitis (2%)

            Postmarketing Reports

            Muscle pain

            Myopathies

            Myositis

            Diarrhea

            Flatulence

            Pancreatitis

            Peptic ulcer

            Cholelithiasis

            CNS depression

            Dysrhythmias

            Peripheral vascular disease

            Pulmonary embolus

            Renal damage

            Rash

            Anemia

            Leukopenia

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            Warnings

            Contraindications

            Known hypersensitivity

            Severe renal impairment, including those with end-stage renal disease and those receiving dialysis

            Active liver disease

            Gallbladder disease

            Nursing mothers

            Cautions

            Cholelithiasis reported with use; discontinue if gallstones detected upon gallbladder studies

            Rare myopathy, myositis, or rhabdomyolysis reported with use; monitor

            Increase in hepatic transaminases reported; discontinue if enzyme levels persist 3 times above the upper limit of normal

            Reversibly increases serum creatinine levels; consider monitoring renal function in patients at risk for renal impairment

            Thrombocytopenia and agranulocytosis reported; monitor blood counts periodically during the first year of therapy

            Associated with pulmonary embolism and deep venous thrombosis; use caution in patients with risk factors for VTE

            Concomitant use with oral anticoagulants (monitor and adjust warfarin dose prn)

            May further increase risk for rhabdomyolysis when added to optimal HMG-CoA reductase inhibitor regimen to further decrease TG and increase HDLs

            Paradoxical decreases in HDL cholesterol (HDL-C) level reported

            Rule out secondary causes of hyperlipidemia before initiating therapy

            Withdraw therapy if no adequate response seen after 2-3 months

            Use with caution in the elderly; dose adjustments may be necessary

            Fenofibrate increases cholesterol excretion into bile, leading to risk of cholelithiasis; perform gallbladder studies if cholelithiasis suspected

            Fibric acid derivatives as monotherapy or in combination with simvastatin have not been shown to significantly reduce cardiovascular mortality in major clinical studies

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            Pregnancy & Lactation

            Pregnancy

            Limited available data with fenofibrate use in pregnant women are insufficient to determine a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes

            Animal data

            • In animal reproduction studies, no evidence of embryo-fetal toxicity was observed with oral administration in rats and rabbits during organogenesis at doses less than or equivalent to the maximum recommended clinical dose of 120 mg daily, based on body surface area (mg/m2)
            • Adverse reproductive outcomes occurred at higher doses in presence of maternal toxicity; drug should be used during pregnancy only if potential benefit justifies potential risk to fetus

            Lactation

            There is no available information on presence of drug in human milk, effects on the breastfed infant, or on milk production; drug is present in milk of rats, and likely to be present in human milk; because of potential for serious adverse reactions in breastfed infants, such as disruption of infant lipid metabolism, women should not breastfeed during treatment and for 5 days after final dose

            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

            Increases VLDL catabolism, fatty acid oxidation, and elimination of triglyceride rich particles by enhancing synthesis of lipoprotein lipase, which in turn results in 30-60% decrease in total plasma triglycerides; HDL may increase modestly in some hypertriglyceridemic patients

            Absorption

            Bioavailability: 60-90%

            Onset: 2 wk

            Peak plasma time: 2-8 hr

            Distribution

            Distributes widely to most tissues

            Protein bound: 99%

            Metabolism

            Liver

            Metabolites: Fenofibric acid (active), fenofibric acid glucuronide (activity unknown)

            Elimination

            Half-life: 20 hr (10-35 hr range)

            Dialyzable: No (HD)

            Excretion: Urine (60-93%), feces (5-25%)

            Pharmacogenomics

            Genotyping patients with atherogenic dyslipidemia may establish who will benefit most from fenofibric acid therapy 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

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            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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            Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.