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  • • The effect of ZETIA on cardiovascular morbidity and mortality has not been determined.
  • • ZETIA, administered alone or in combination with an HMG-CoA reductase inhibitor (statin), is 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 nonfamilial) hyperlipidemia when diet alone is not enough.
  • SELECTED CAUTIONARY INFORMATION
  • • Because renal impairment is a risk factor for statin-associated myopathy, doses of simvastatin exceeding 20 mg should be used with caution and close monitoring when administered concomitantly with ZETIA in patients with moderate to severe renal impairment (eGFR <60 mL/min/1.73 m2).
  • • ZETIA is not recommended in patients with moderate to severe hepatic impairment.
  • • The coadministration of ZETIA with fibrates other than fenofibrate is not recommended until use in patients is adequately studied.
  • • Exercise caution when using ZETIA and cyclosporine concomitantly because exposure to both drugs is increased. Cyclosporine concentrations should be monitored in these patients.
  • • ZETIA should be used in pregnant or nursing women only if the benefit outweighs the risk.
  • • In clinical trials, regardless of causality assessment, the most frequent side effects for ZETIA coadministered with a statin vs statin alone included nasopharyngitis (3.7% vs 3.3%), myalgia (3.2% vs 2.7%), upper respiratory tract infection (2.9% vs 2.8%), arthralgia (2.6% vs 2.4%), and diarrhea (2.5% vs 2.2%); for ZETIA administered alone vs placebo: upper respiratory tract infection (4.3% vs 2.5%), diarrhea (4.1% vs 3.7%), arthralgia (3.0% vs 2.2%), sinusitis (2.8% vs 2.2%), pain in extremity (2.7% vs 2.5%), and fatigue (2.4% vs 1.5%).

Additional Important Safety Information

Before prescribing ZETIA, please read the Prescribing Information. The Patient Information also is available.


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