About Ezetimibe Tablets
Therapy with lipid-altering agents should be only one component of multiple risk factor intervention in individuals at significantly increased risk for atherosclerotic vascular disease due to hypercholesterolemia. Drug therapy is indicated as an adjunct to diet when the response to a diet restricted in saturated fat and cholesterol and other nonpharmacologic measures alone has been inadequate.
Ezetimibe tablets, administered alone, are indicated as adjunctive therapy to diet for the reduction of elevated total cholesterol (total-C), low-density lipoprotein cholesterol (LDL-C), apolipoprotein B (Apo B), and non-high-density lipoprotein cholesterol (non-HDL-C) in patients with primary (heterozygous familial and non-familial) hyperlipidemia. Ezetimibe tablets, administered in combination with a 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase inhibitor (statin), are indicated as adjunctive therapy to diet for the reduction of elevated total-C, LDL-C, Apo B, and non-HDL-C in patients with primary (heterozygous familial and non-familial) hyperlipidemia.
Ezetimibe tablets, administered in combination with fenofibrate, are indicated as adjunctive therapy to diet for the reduction of elevated total-C, LDL-C, Apo B, and non-HDL-C in adult patients with mixed hyperlipidemia. The combination of ezetimibe and atorvastatin or simvastatin is indicated for the reduction of elevated total-C and LDL-C levels in patients with HoFH, as an adjunct to other lipid-lowering treatments (e.g., LDL apheresis) or if such treatments are unavailable. Ezetimibe tablets are indicated as adjunctive therapy to diet for the reduction of elevated sitosterol and campesterol levels in patients with homozygous familial sitosterolemia.
Limitations of Use: The effect of ezetimibe tablets on cardiovascular morbidity and mortality has not been determined. Ezetimibe tablets have not been studied in Fredrickson Type I, III, IV, and V dyslipidemias.
Important Safety Information
Statin contraindications apply when ezetimibe is used with a statin: active liver disease, which may include unexplained persistent elevations in hepatic transaminase levels; women who are pregnant or may become pregnant; and nursing mothers. Ezetimibe tablets are contraindicated in patients with a known hypersensitivity to any component of this product. Hypersensitivity reactions including anaphylaxis, angioedema, rash and urticaria have been reported with ezetimibe.
Concurrent administration of ezetimibe with a specific statin or fenofibrate should be in accordance with the product labeling for that medication. Persistent elevations in hepatic transaminase were reported in controlled clinical combination studies of ezetimibe initiated concurrently with a statin. Cases of myopathy and rhabdomyolysis have been reported in patients treated with ezetimibe coadminstered with a statin; with ezetimibe monotherapy; and with the addition of ezetimibe to agents known to be associated with increased risk of rhabdomyolysis, such as fibrates. Risk for skeletal muscle toxicity increases with higher doses of statin, advanced age (greater than 65), hypothyroidism, renal impairment, and depending on the statin used, concomitant use of other drugs. Due to the unknown effects of the increased exposure to ezetimibe in patients with moderate to severe hepatic impairment, ezetimibe is not recommended in these patients.
The most commonly reported adverse reactions (incidence greater than or equal to 2% and greater than placebo) in the ezetimibe monotherapy controlled clinical trials were: upper respiratory tract infection, diarrhea, arthralgia, sinusitis, and pain in extremity. The most commonly reported adverse reactions (incidence greater than or equal to 2% and greater than statin alone) in the ezetimibe plus statin controlled clinical trials were: nasopharyngitis, myalgia, upper respiratory tract infection, arthralgia, and diarrhea.
For more information, please see accompanying Full Prescribing Information.