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The combination of ZETIA and atorvastatin or simvastatin is indicated for the reduction of elevated total-C and LDL-C levels in patients with HoFHas an adjunct to other lipid-lowering treatmentse.gLDL apheresisor if such treatments are unavailable.
No evidence of mutagenicity was observed in vitro in a microbial mutagenicityAmestest with Salmonella typhimurium and Escherichia coli with or without metabolic activationNo evidence of clastogenicity was observed in vitro in a chromosomal aberration assay in human peripheral blood lymphocytes with or without metabolic activationIn additionthere was no evidence of genotoxicity in the in vivo mouse micronucleus test.
The combination of ZETIA with a statin is contraindicated in patients with active liver disease or unexplained persistent elevations in hepatic transaminase levelsWomen who are pregnant or may become pregnantBecause statins decrease cholesterol synthesis and possibly the synthesis of other biologically active substances derived from cholesterolZETIA in combination with a statin may cause fetal harm when administered to pregnant womenAdditionallythere is no apparent benefit to therapy during pregnancyand safety in pregnant women has not been establishedIf the patient becomes pregnant while taking this drugthe patient should be apprised of the potential hazard to the fetus and the lack of known clinical benefit with continued use during pregnancySee Use in Specific PopulationsNursing mothersBecause statins may pass into breast milkand because statins have the potential to cause serious adverse reactions in nursing infantswomen who require ZETIA treatment in combination with a statin should be advised not to nurse their infantssee Use in Specific PopulationsPatients with a known hypersensitivity to any component of this productHypersensitivity reactions including anaphylaxisangioedemarash and urticaria have been reported with ZETIAsee ADVERSE REACTIONS
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