fenofibrate

fenofibrate

(fee no fye' brate)

Antara, Lofibra, Tricor, Triglide

Pregnancy Category C

Drug class

Antihyperlipidemic drug

Therapeutic actions

Inhibits triglyceride synthesis in the liver resulting in a reduction in VLDL released into circulation; may also stimulate the breakdown of triglyceride-rich lipoproteins.

Indications

·        Adjunct to diet in treating adults with primary hypercholesterolemia or mixed dyslipidemia

·        Adjunct to diet for treatment of adults with hypertriglyceridemia

·        Unlabeled use: Hyperuricemia

Contraindications and cautions

·        Contraindicated with allergy to fenofibrate, hepatic or severe renal dysfunction, primary biliary cirrhosis, gall bladder disease, pregnancy.

·        Use cautiously with lactation and in the elderly.

Available forms

Tablets—48, 50, 145, 160 mg; capsules—43, 67, 87, 130, 134, 200 mg

Dosages

ADULTS

·        Hypertriglyceridemia: Initially, 48–145 mg/day (tablet form) or 67–200 mg (Lofibra), or 43–130 mg/day (Antara), or 50–160 mg/day (Triglide) daily PO with a meal.

·        Primary hypercholesterolemia or mixed dyslipidemia: 145 mg/day PO with a meal (Tricor); 130 mg/day (Antara), or 200 mg/day (Lofibra), or 160 mg/day (Triglide).

PEDIATRIC PATIENTS

Safety and efficacy not established.

GERIATRIC PATIENTS

Initial dose, 48 mg/day PO (Tricor), 43 mg/day (Antara), or 67 mg/day (Lofibra), or 50 mg/day (Triglide); adjust slowly with close monitoring.

PATIENTS WITH RENAL IMPAIRMENT

Initiate therapy with 48 mg/day PO; monitor renal function tests carefully for 4–8 wk before increasing.

Pharmacokinetics

Route	Onset	Peak	Duration
Oral	Varies	6–8 hr	Wks

Metabolism: Hepatic; T_1/2: 20 hr

Distribution: Crosses placenta; enters breast milk

Excretion: Urine

Adverse effects

·        CV: Angina, arrhythmias, swelling, phlebitis, thrombophlebitis

·        Dermatologic: Rash, alopecia, dry skin, dry and brittle hair, pruritus, urticaria

·        GI: Nausea, vomiting, diarrhea, dyspepsia, flatulence, bloating, stomatitis, gastritis, pancreatitis, peptic ulcer, GI hemorrhage

·        GU: Impotence, decreased libido, dysuria, hematuria, proteinuria, decreased urine output

·        Hematologic: Leukopenia, anemia, eosinophilia, increased AST and ALT, increased CPK

·        Other: Myalgia, flulike syndromes, arthralgia, weight gain, polyphagia, increased perspiration, systemic lupus erythematosus, blurred vision, gynecomastia

Interactions

Drug-drug

·        Increased bleeding tendencies if oral anticoagulants are given with fenofibrate; reduce dosage of anticoagulant

·        Possible rhabdomyolysis, acute renal failure if given with any statins; avoid this combination

·        Decreased absorption and effectiveness if given with bile acid sequestrants; administer at least 1 hr before or 4–6 hr after these drugs

·        Increased risk of renal toxicity if combined with immunosuppressants or other nephrotoxic drugs; use caution and monitor patient carefully

Nursing considerations

Assessment

·        History: Allergy to fenofibrate, hepatic dysfunction, primary biliary cirrhosis, gall bladder disease, pregnancy, renal impairment, lactation

·        Physical: Skin lesions, color, T; P, BP, auscultation, baseline ECG, peripheral perfusion, edema; bowel sounds, normal output, liver evaluation; lipid studies, CBC, LFTs, renal function tests, urinalysis

Interventions

·        Differentiate between brand names used; dosage varies.

·        Administer drug with meals.

·        Monitor patient carefully.

·        Ensure that patient continues strict dietary restrictions and exercise program.

·        Arrange for regular follow-up including blood tests for lipids, liver function, and CBC during long-term therapy.

·        Give frequent skin care to deal with rashes and dryness.

·        Monitor patient for muscle weakness, aches, especially if patient takes Tricor in combination with other cholesterol lowering drugs.

Teaching points

·        Take the drug with meals.

·        Continue to follow strict dietary regimen and exercise program.

·        Arrange to have regular follow-up visits to your health care provider, which will include blood tests.

·        You may experience these side effects: Diarrhea, loss of appetite (ensure ready access to the bathroom if this occurs; frequent small meals may help).

·        Report chest pain, shortness of breath, palpitations, myalgia, malaise, excessive fatigue, fever.

Adverse effects in Italic are most common; those in Bold are life-threatening.