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1、TableofPharmacogenomicBiomarkersinDrugLabelingPharmacogenomicscanplayanimportantroleinidentifyingrespondersandnon-responderstomedications,avoidingadverseevents,andoptimizingdrugdose.Druglabelingmaycontaininformationongenomicbiomarkersandcandescribe:·Drugexposureandclinica
2、lresponsevariability·Riskforadverseevents·Genotype-specificdosing·Mechanismsofdrugaction·PolymorphicdrugtargetanddispositiongenesThetablebelowlistsFDA-approveddrugswithpharmacogenomicinformationintheirlabeling.Thelabelingforsome,butnotall,oftheproductsincludesspecificacti
3、onstobetakenbasedonthebiomarkerinformation.Pharmacogenomicinformationcanappearindifferentsectionsofthelabelingdependingontheactions.Formoreinformation,pleaserefertotheappropriatelabelingguidance.Biomarkersinthetableincludebutarenotlimitedtogerm-lineorsomaticgenevariants,f
4、unctionaldeficiencies,expressionchanges,andchromosomalabnormalities;selectedproteinbiomarkersthatareusedtoselectpatientsfortreatmentarealsoincluded.Thistabledoesnotincludenon-humangeneticbiomarkers(e.g.,microbialvariantsthatinfluencesensitivitytoantibiotics),orbiomarkerst
5、hatareusedsolelyfordiagnosticpurposes(e.g.,forgeneticdiseases)unlesstheyarelinkedtodrugactivityorusedtoidentifyaspecificsubsetinwhomprescribinginformationdiffers.Fordrugsthatareavailableinmultipledosageforms,salts,orcombinations,asinglerepresentativeproductislisted.Inthec
6、aseofcombinationproducts,thesingleagentassociatedwiththebiomarkerislistedunlesstheagentisonlyapprovedasacombinationproduct,inwhichcaseallagentsarelisted.PharmacogenomicBiomarkersinDrugLabelingDrugTherapeuticArea*Biomarker†ReferencedSubgroup‡LabelingSectionsAbacavirInfecti
7、ousDiseasesHLA-BHLA-B*5701allelecarriersBoxedWarning,Contraindications,WarningsandPrecautionsAdo-TrastuzumabEmtansineOncologyERBB2HER2proteinoverexpressionorgeneamplificationpositiveIndicationsandUsage,WarningsandPrecautions,AdverseReactions,ClinicalPharmacology,ClinicalS
8、tudiesAfatinibOncologyEGFREGFRexon19deletionorexon21substitution(L858R)positiveIndicationsandUsa