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[PDF: 248 KB, 11 pages]
| The effects of ZETIA, either alone or in addition to a statin or fenofibrate, on the risk of cardiovascular morbidity and mortality have not been established. | |
| ZETIA administered in combination with fenofibrate is 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 when diet alone is not enough. | |
| SELECTED CAUTIONARY INFORMATION | |
| 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%). | |
| Incidence rates (95% CI) for clinically important elevations (≥3 × ULN, consecutive) in hepatic transaminase levels were 4.5% (1.9, 8.8) and 2.7% (1.2, 5.4) for fenofibrate monotherapy (n=188) and ZETIA coadministered with fenofibrate (n=183), respectively, adjusted for treatment exposure. | |
| When ZETIA was coadministered with fenofibrate, incidence rates for cholecystectomy were 0.6% and 1.7% for fenofibrate monotherapy and ZETIA coadministered with fenofibrate, respectively. | |
Before prescribing ZETIA, please read the Prescribing Information.
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