bezafibrate

REMS

Use in conjunction with diet and other modalities in the treatment of hypercholesterolemia (Type IIa and IIb mixed hyperlipidemia, to decrease serum TG, LDL cholesterol and apolipoprotein B and increase HDL cholesterol, and apolipoprotein A).
Treatment of adults with hypertriglyceridemia (Type IV and V hyperlipidemias) at risk of pancreatitis and other sequelae.

Contraind./Precautions ⬆ ⬇

Contraindicated in:

Hypersensitivity/photosensitivity to bezafibrate or other fibric acid or fibrate derivatives;
Severe hepatic or renal impairment (CCr <60 mL/min), primary biliary cirrhosis, gallstone or gallbladder disease or hypoalbuminemia;
OB: Avoid use during pregnancy (discontinue several mo prior to conception);
Lactation: Discontinue breastfeeding.

Use Cautiously in:

History of liver disease;
Doses >400 mg/day in conjunction with HMG CoA reductase inhibitors (statins) with any risk factors (renal impairment, infection, trauma, surgery, hormonal or electrolyte imbalance) ↑ risk for rhabdomyolysis;
Geri: Consider age-related ↓ in renal function; avoid in patients >70 yr;
Pedi: Limited experience in children at a dose of 10–20 mg/kg/day.

Adv. Reactions/Side Effects ⬆ ⬇

CNS: dizziness, headache

GI: dyspepsia, flatulence, gastritis, ↓appetite, abdominal distension, abdominal pain, cholestasis, constipation, diarrhea, nausea

GU: erectile dysfunction, renal failure

Derm: alopecia, photosensitivity reaction, pruritus, rash, urticaria

MS: muscle cramps, muscular weakness, myalgia, RHABDOMYOLYSIS

Misc: hypersensitivity reactions including anaphylaxis

Interactions ⬆ ⬇

Drug-drug:

↑risk of bleeding with oral anticoagulants; ↓ dose of anticoagulant by 50% with frequent monitoring.
Cyclosporine↑ risk of severe myositis/rhabdomyolysis; combination therapy should be undertaken with caution.
Concurrent use of immunosuppressants may ↑ risk of reversible renal impairment.
↑risk of myopathy with HMG CoA reductase inhibitors (statins); combination therapy should be undertaken with extreme caution and must be discontinued at the first signs of myopathy and should not be undertaken in the presence of predisposing factors including impaired renal function, severe infection, trauma, surgery, hormonal /electrolyte imbalance or ↑ alcohol intake.
↑risk of serious hypoglycemia with insulin or sulfonylureas.
Concurrent use with MAO inhibitors may ↑ risk of hepatotoxicity.
Cholestyramine and other bile-acid sequestrants may ↓ absorption; separate administration by ≥2 hr.
Effectiveness may be ↓ by concurrent estrogen.

Availability ⬆ ⬇

Sustained-release tablet: 400 mg

Route/Dosage ⬆ ⬇

PO (Adults ): 400 mg once daily.

Action ⬆ ⬇

Inhibits triglyceride synthesis.

Therapeutic effects:

Lowered cholesterol and triglycerides, increased HDL, with decreased risk of pancreatitis and other sequelae.

Classifications ⬆ ⬇

Therapeutic Classification: lipid-lowering agents

Pharmacologic Classification: fibric acid derivatives

Pharmacokinetics ⬆ ⬇

Absorption: Well absorbed (100%) following oral administration.

Distribution: Unknown.

Metabolism/Excretion: 50% metabolized, 50% excreted unchanged in urine, remainder as metabolites. 3% excreted in feces.

Half-Life: 1–2 hr.

Canadian Brand Names ⬆ ⬇

Time/Action Profile ⬆ ⬇

(blood levels)

ROUTE	ONSET	PEAK	DURATION
PO	unknown	3–4 hr	24 hr

Patient/Family Teaching ⬆ ⬇

Instruct the patient to take the medication as directed, and to not share medication. Missed doses should be taken as soon as remembered; do not double dose. Medication helps control but does not cure elevated serum triglyceride levels.
Advise patient that medication should be taken in conjunction with diet restrictions of fat, cholesterol, carbohydrates, and alcohol, as well as an exercise regimen, and cessation of smoking.
Instruct patient to notify health care professional of unexplained muscle pain or weakness, tiredness, fever, nausea, vomiting, abdominal pain.
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 any other Rx, OTC, or herbal products.
Rep: Advise females of reproductive potential to immediately notify health care professional if pregnancy is planned or suspected.
Emphasize importance of follow-up appointments, and lab tests to evaluate effectiveness.

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Indications ⬇