fenofibrate

REMS

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 effects:

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/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)

ROUTE	ONSET	PEAK	DURATION
PO	unknown	2 wk	unknown

Contraind./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: Lactation.

Use Cautiously in:

Concurrent warfarin or HMG-CoA reductase inhibitor therapy;
OB: Safety not established in pregnancy;
Pedi: Safety and effectiveness not established in children;
Geri: Age-related in renal function may make older patients more susceptible to adverse reactions.

Adv. Reactions/Side Effects ⬆ ⬇

CV: arrhythmia, DEEP VEIN THROMBOSIS

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

GI: ↑liver enzymes, cholelithiasis, HEPATOTOXICITY, pancreatitis

Metab: ↓HDL levels

MS: rhabdomyolysis

Neuro: fatigue/weakness, headache

Resp: INTERSTITIAL LUNG DISEASE, PULMONARY EMBOLISM

Misc: HYPERSENSITIVITY REACTIONS (INCLUDING ANAPHYLAXIS AND ANGIOEDEMA)

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: 130 mg once daily; Fenoglide: 120 mg once daily; Tricor: 145 mg once daily; Lipofen: 150 mg once daily.

Renal Impairment

PO (Adults ): CCr 30–89 mL/min:Antara: 43 mg once daily initially; may titrate, if needed, up to 130 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: 43–130 mg once daily; Fenoglide: 40–120 mg once daily; Tricor: 48–145 mg once daily; Lipofen: 50–150 mg once daily.

Renal Impairment

PO (Adults ): CCr 30–89 mL/min:Antara: 43 mg once daily initially; may titrate, if needed, up to 130 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
Micronized capsules (Antara): 43 mg; 130 mg
Tablets (Fenoglide): 40 mg; 120 mg
Tablets (Tricor): 48 mg; 145 mg

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, ALT, and total bilirubin at baseline and periodically during therapy. May cause ↑ levels. Therapy should be discontinued if levels rise >3 times the normal limit. If signs or symptoms of liver injury occur or if elevated enzyme levels persist (ALT or AST >3 × upper limit of normal, or if accompanied by elevation of bilirubin), discontinue fenofibrate. Do not restart fenofibrate if there is no alternative explanation for the liver injury.
- If patient develops muscle tenderness during therapy, monitor CK levels. If CK 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.

Implementation ⬆ ⬇

Do not confuse Tricor with Tracleer.
Place patients on a triglyceride-lowering diet before therapy and encourage them to remain on this diet during therapy.
- Dose may be increased after repeated serum triglyceride levels every 4–8 wk.
- Brands are not interchangeable.
PO: Administer Fenoglide, and Lipofen, products with meals. Antara and Tricor can be administered without regard to meals. DNC: Swallow capsules whole; do not open, break, dissolve, or chew.

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 signs and symptoms of liver injury (jaundice, abdominal pain, nausea, malaise, dark urine, abnormal stool, pruritus), unexplained muscle pain, tenderness, or weakness occurs, especially if accompanied by fever or malaise.
Instruct patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and to consult health care professional before taking other Rx, OTC, or herbal products.
Advise patient to notify health care professional of medication regimen before treatment or surgery.
Rep: Advise females of reproductive potential to notify health care professional promptly if pregnancy is planned or suspected and to avoid breastfeeding 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.

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Pronunciation ⬇

Classifications ⬆ ⬇

Indications ⬆ ⬇