fenofibrate

General

Pronunciation:
fen-o-fi-brate


fenofibrate

Trade Name(s)

  • Antara
  • Fenoglide
  • Fenomax Canadian Tradename
  • Lipidil EZ Canadian Tradename
  • Lipidil Supra Canadian Tradename
  • Lipofen
  • Tricor
  • Triglide

Ther. Class.
lipid-lowering agents

Pharm. Class.
fibric acid derivatives

Indications

  • With dietary therapy to decrease LDL cholesterol, total cholesterol, triglycerides, and apolipoprotein B in adult patients with hypercholesterolemia or mixed dyslipidemia.
  • With dietary management in the treatment of severe hypertriglyceridemia (types IV and V hyperlipidemia) in patients who are at risk for pancreatitis and do not respond to nondrug therapy.

Action

Fenofibric acid primarily inhibits triglyceride synthesis.

Therapeutic Effect(s):

Lowering of cholesterol and triglycerides with subsequent decreased risk of pancreatitis.

Pharmacokinetics

Absorption: Well absorbed (60%) after oral administration; absorption ↑ by food.

Distribution: Unknown.

Protein Binding: 99%.

Metabolism and Excretion: Rapidly converted to fenofibric acid, which is the active metabolite; fenofibric acid is metabolized by the liver. Fenofibric acid and its metabolites are primarily excreted in urine (60%).

Half-life: 20 hr.

TIME/ACTION PROFILE (lowering of triglycerides)

ROUTEONSET PEAKDURATION
POunknown 2 wkunknown

Contraindication/Precautions

Contraindicated in:

  • Hypersensitivity;
  • Hepatic impairment (including primary biliary cirrhosis);
  • Pre-existing gallbladder disease;
  • Severe renal impairment;
  • Concurrent use of HMG-CoA reductase inhibitors;
  • Lactation.

Use Cautiously in:

  • Concurrent warfarin or HMG-CoA reductase inhibitor therapy;
  • OB:  Use only if potential benefits outweigh risks to the fetus;
  • Pedi:  Safety not established;
  • Geri:  Age-related ↓ in renal function may make older patients more susceptible to adverse reactions.

Adverse Reactions/Side Effects

CNS: fatigue/weakness, headache

CV: PULMONARY EMBOLISM, arrhythmias, deep vein thrombosis

Derm: DRUG REACTION WITH EOSINOPHILIA AND SYSTEMIC SYMPTOMS (DRESS), STEVENS-JOHNSON SYNDROME, TOXIC EPIDERMAL NECROLYSIS, rash, urticaria

GI: cholelithiasis, pancreatitis

Metabolic: ↓ HDL levels

MS: rhabdomyolysis

Resp: INTERSTITIAL LUNG DISEASE

Misc: HYPERSENSITIVITY REACTIONS (INCLUDING ANAPHYLAXIS AND ANGIOEDEMA)

* CAPITALS indicate life-threatening.
Underline indicate most frequent.

Interactions

Drug-Drug

  • ↑ anticoagulant effects of  warfarin.
  •  HMG-CoA reductase inhibitors  ↑ risk of rhabdomyolysis (concurrent use should be avoided).
  • Absorption is ↓ by  bile acid sequestrants  (fenofibrate should be given 1 hr before or 4–6 hr after).
  • ↑ risk of nephrotoxicity with  cyclosporine.
  • Concurrent use with  colchicine  may ↑ risk of rhabdomyolysis

Route/Dosage

Primary Hypercholesterolemia/Mixed Dyslipidemia

PO (Adults):  Antara– 90 mg once daily;  Fenoglide– 120 mg once daily;  Tricor– 145 mg once daily;  Triglide– 160 mg once daily;  Lipofen– 150 mg once daily.

Renal Impairment 
PO (Adults):  CCr 30–89 mL/min–  Antara– 30 mg once daily initially; may titrate, if needed, up to 90 mg once daily.  Fenoglide– 40 mg once daily initially; may titrate, if needed, up to 120 mg once daily.  Lipofen– 50 mg once daily initially; may titrate, if needed, up to 150 mg once daily.  Tricor– 48 mg once daily initially; may titrate, if needed, up to 145 mg once daily.

Hypertriglyceridemia

PO (Adults):  Antara– 30–90 mg once daily;  Fenoglide– 40–120 mg once daily;  Tricor– 48–145 mg once daily;  Triglide– 160 mg once daily;  Lipofen– 50–150 mg once daily.

Renal Impairment 
PO (Adults):  CCr 30–89 mL/min–  Antara– 30 mg once daily initially; may titrate, if needed, up to 90 mg once daily.  Fenoglide– 40 mg once daily initially; may titrate, if needed, up to 120 mg once daily.  Lipofen– 50 mg once daily initially; may titrate, if needed, up to 150 mg once daily.  Tricor– 48 mg once daily initially; may titrate, if needed, up to 145 mg once daily.

Availability (generic available)

Capsules (Lipofen): 50 mg, 150 mg

Cost: 50 mg $213.58/90, 150 mg $468.24/90

Micronized capsules (Antara): 30 mg, 90 mg

Tablets (Fenoglide): 40 mg, 120 mg

Cost: 40 mg $289.44/90, 120 mg $869.40/90

Tablets (Tricor): 48 mg, 145 mg

Cost:

Generic: 48 mg $171.86/90, 145 mg $515.58/90

Tablets (Triglide): 160 mg

Cost:

Generic: 160 mg $176.40/100

Assessment

  • Obtain a diet history, especially with regard to fat consumption. Attempt to obtain normal serum triglyceride levels with diet, exercise, and weight loss in obese patients before fenofibrate therapy is instituted.
  • Assess patient for cholelithiasis. If symptoms occur, gallbladder studies are indicated. Discontinue therapy if gallstones are found.
  • Assess patient for skin reactions throughout therapy. Reactions may be severe and life threatening. Discontinue therapy if severe reactions or moderate rashes with systemic symptoms occur.

Lab Test Considerations:

Monitor serum lipids before therapy to determine consistent elevations, then monitor periodically during therapy.

  • Monitor serum AST and ALT periodically during therapy. May cause ↑ levels. Therapy should be discontinued if levels rise >3 times the normal limit.
  • If patient develops muscle tenderness during therapy, monitor CPK levels. If CPK levels are markedly ↑ or myopathy occurs, discontinue therapy.
  • May cause mild to moderate ↓ in hemoglobin, hematocrit, and WBCs. Monitor periodically during first 12 mo of therapy. Levels usually stabilize during long-term therapy.
  • Monitor prothrombin levels frequently until levels stabilize in patients taking anticoagulants concurrently.

Potential Diagnoses

Implementation

  • Do not confuse Tricor (fenofibrate) with Tracleer (bosentan).
  • Place patients on a triglyceride-lowering diet before therapy and encourage them to remain on this diet throughout therapy.

    • Dose may be increased after repeated serum triglyceride levels every 4–8 wk.
    • Brands are not interchangeable.
  • PO Administer  Antara, Fenoglide, Lipofen, Lipidil Supra, Lofibra,  and  Tricor  products with meals.  Triglide  formulation may be taken without regard to meals.

Patient/Family Teaching

  • Instruct patient to take medication as directed, not to skip doses or double up on missed doses. Medication helps control but does not cure elevated serum triglyceride levels.
  • Advise patient that this medication should be used in conjunction with diet restrictions (fat, cholesterol, carbohydrates, alcohol), exercise, and cessation of smoking.
  • Instruct patient to notify health care professional if unexplained muscle pain, tenderness, or weakness occurs, especially if accompanied by fever or malaise.
  • Advise patient to notify health care professional of medication regimen before treatment or surgery.
  • Instruct female patients to notify health care professional promptly if pregnancy is planned or suspected and to avoid breast feeding during and for at least 5 days after last dose of therapy.
  • Emphasize the importance of follow-up exams to determine effectiveness and to monitor for side effects.

Evaluation/Desired Outcomes

Decrease in serum triglycerides and cholesterol to normal levels. Therapy should be discontinued in patients who do not have an adequate response in 2 mo of therapy.

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