fenofibrate

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;
Lactation: Lactation.

Use Cautiously in:

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: arrhythmias, 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-C

MS: RHABDOMYOLYSIS

Neuro: fatigue, headache

Resp: INTERSTITIAL LUNG DISEASE, PULMONARY EMBOLISM

Misc: HYPERSENSITIVITY REACTIONS (INCLUDING ANAPHYLAXIS AND ANGIOEDEMA)

Interactions ⬆ ⬇

Drug-drug:

↑risk of bleeding with warfarin.
Absorption ↓ by bile acid sequestrants; give fenofibrate ≥1 hr before or 4–6 hr after.
↑risk of nephrotoxicity with cyclosporine.
Colchicine may ↑ risk of rhabdomyolysis.

Route/Dosage ⬆ ⬇

Hypertriglyceridemia

PO (Adults ): Antara: 43–130 mg once daily. Generic tablets: 40–160 mg once daily. Lipofen: 50–150 mg once daily. Trilipix: 45–135 mg once daily.

Renal Impairment

PO (Adults ): CCr 30–<60 mL/min:Antara: 43 mg once daily initially; may titrate, if needed, up to 130 mg once daily. Lipofen: 50 mg once daily initially; may titrate, if needed, up to 150 mg once daily. Generic tablets: 40–48 mg once daily initially; may titrate, if needed, up to 120–145 mg once daily. Trilipix: 45 mg once daily; may titrate, if needed, up to 135 mg once daily.

Primary Hyperlipidemia

PO (Adults ): Generic tablets: 120–145 mg once daily. Lipofen: 150 mg once daily. Trilipix: 135 mg once daily.

Renal Impairment

PO (Adults ): CCr 30–<60 mL/min:Generic tablets: 40–48 mg once daily; may titrate, if needed, up to 120–145 mg once daily. Lipofen: 50 mg once daily initially; may titrate, if needed, up to 150 mg once daily. Trilipix: 45 mg once daily; may titrate, if needed, up to 135 mg once daily.

Availability ⬆ ⬇

(Generic available)

Capsules (generic): 43 mg; 50 mg; 67 mg; 130 mg; 134 mg; 150 mg; 200 mg
Capsules (Lipofen): 50 mg; 150 mg
Micronized capsules (Antara): 30 mg; 90 mg
Delayed-release capsules (Trilipix): 45 mg; 135 mg
Tablets (generic): 40 mg; 48 mg; 54 mg; 120 mg; 145 mg; 160 mg

Assessment ⬆ ⬇

Before starting therapy with fenofibrate, obtain a diet history. Assess for hyperlipidemia-contributing diseases (hypothyroidism, diabetes mellitus) and medications (estrogen therapy, thiazide diuretics, beta blockers). Intervene as indicated.
Assess for cholelithiasis. If symptoms occur, complete gallbladder studies; discontinue therapy if gallstones found.
Assess for skin reactions throughout therapy. Reactions may be severe and life-threatening. If severe reaction or moderate rash with systemic symptoms occurs, discontinue fenofibrate.

Lab Test Considerations:

Assess serum lipids, including triglycerides, before and periodically during therapy.
- Monitor AST, ALT, and total bilirubin at baseline and periodically during therapy. If signs of liver injury occur or if elevated enzyme levels persist (ALT or AST >3 times upper limit of normal, or if accompanied by ↑ bilirubin), discontinue fenofibrate. Do not restart fenofibrate if there is no alternative explanation for hepatotoxicity.
- Assess renal function before and periodically during therapy.
- Monitor for rhabdomyolysis. If markedly ↑ CK occurs or myopathy suspected, permanently discontinue fenofibrate.
- May cause mild to moderate ↓ in hemoglobin, hematocrit, and WBC count. Monitor for hematologic changes periodically during 1st 12 mo of therapy. Levels usually stabilize during long-term therapy.
- Monitor PT/INR levels frequently until levels stabilize in patients taking warfarin concurrently.

Implementation ⬆ ⬇

Encourage a triglyceride-lowering diet before and throughout therapy.
- Dose may be ↑ after repeated serum triglyceride levels every 4–8 wk. Discontinue if response is not adequate after 2 mo of therapy.
- Brands are not interchangeable.
PO: Administer Lipofen with food. Antara and Trilipix may be administered any time of day and without regard to food. DNC: Swallow capsules and tablets whole; do not open, break, dissolve, or chew.

Patient/Family Teaching ⬆ ⬇

Explain purpose and side effects of medication to patient. Advise patient to read Patient Information before starting therapy.
Instruct patient to omit missed dose and resume with next scheduled dose; do not double dose.
Advise patient to follow diet restrictions (fat, cholesterol, carbohydrates, alcohol) and exercise regimen and to stop smoking.
Instruct patient to notify health care provider if signs and symptoms of liver injury (jaundice, abdominal pain, nausea, malaise, dark urine, abnormal stool, pruritus) or unexplained muscle pain, tenderness, or weakness occurs, especially if accompanied by fever or malaise.
Instruct patient to notify health care provider of all Rx or OTC medications, vitamins, or herbal products being taken and to consult health care provider before taking other Rx, OTC, or herbal products, especially bile acid sequestrants to avoid impeding absorption.
Rep: Advise women of reproductive potential to notify health care provider promptly if pregnancy is planned or suspected and to avoid breastfeeding during therapy and for ≥5 days after last dose.
Emphasize the importance of follow-up exams to determine effectiveness or need for change in dosing and to monitor for side effects.

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Pronunciation ⬇

Classifications ⬆ ⬇

Indications ⬆ ⬇

Action ⬆ ⬇

Pharmacokinetics ⬆ ⬇

Time/Action Profile ⬆ ⬇

Contraind./Precautions ⬆ ⬇

Adv. Reactions/Side Effects ⬆ ⬇

Interactions ⬆ ⬇

Route/Dosage ⬆ ⬇

Availability ⬆ ⬇

Assessment ⬆ ⬇

Implementation ⬆ ⬇

Patient/Family Teaching ⬆ ⬇

Evaluation/Desired Outcomes ⬆ ⬇

US Brand Names ⬆ ⬇

Canadian Brand Names ⬆ ⬇

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