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1、Table of Pharmacogenomic Biomarkers in Drug LabelingPharmacogenomics can play an important role in identifying responders and non-responders to medications, avoiding adverse events, and optimizing drug dose. Drug labeling may contain information on genomic biomarkers and can describe: Drug exposure
2、and clinical response variability Risk for adverse events Genotype-specific dosing Mechanisms of drug action Polymorphic drug target and disposition genesThe table below lists FDA-approved drugs with pharmacogenomic information in their labeling. The labeling for some, but not all, of the products i
3、ncludes specific actions to be taken based on the biomarker information. Pharmacogenomic information can appear in different sections of the labeling depending on the actions. For more information, please refer to the appropriate labeling guidance.Biomarkers in the table include but are not limited
4、to germ-line or somatic gene variants, functional deficiencies, expression changes, and chromosomal abnormalities; selected protein biomarkers that are used to select patients for treatment are also included.This table does not include non-human genetic biomarkers (e.g., microbial variants that infl
5、uence sensitivity to antibiotics), or biomarkers that are used solely for diagnostic purposes (e.g., for genetic diseases) unless they are linked to drug activity or used to identify a specific subset in whom prescribing information differs. For drugs that are available in multiple dosage forms, sal
6、ts, or combinations, a single representative product is listed. In the case of combination products, the single agent associated with the biomarker is listed unless the agent is only approved as a combination product, in which case all agents are listed.Pharmacogenomic Biomarkers in Drug LabelingDru
7、gTherapeutic Area*BiomarkerReferenced SubgroupLabeling SectionsAbacavirInfectious DiseasesHLA-BHLA-B*5701 allele carriersBoxed Warning, Contraindications, Warnings and PrecautionsAdo-Trastuzumab EmtansineOncologyERBB2HER2 protein overexpression or gene amplification positiveIndications and Usage, Wa
8、rnings and Precautions, Adverse Reactions, Clinical Pharmacology, Clinical StudiesAfatinibOncologyEGFREGFR exon 19 deletion or exon 21 substitution (L858R) positiveIndications and Usage, Dosage and Administration, Adverse Reactions, Clinical Pharmacology, Clinical StudiesAlectinibOncologyALKALK gene
9、 rearrangement positiveIndications and Usage, Adverse Reactions, Clinical Pharmacology, Clinical StudiesAlirocumabEndocrinologyLDLRLDL receptor mutation heterozygotesIndications and Usage, Adverse Reactions, Clinical StudiesAmitriptylinePsychiatryCYP2D6CYP2D6 poor metabolizersPrecautionsAnastrozoleO
10、ncologyESR1, PGRHormone receptor positiveIndications and Usage, Adverse Reactions, Drug Interactions, Clinical StudiesArformoterol (1)PulmonaryUGT1A1UGT1A1 poor metabolizersClinical PharmacologyArformoterol (2)PulmonaryCYP2D6CYP2D6 intermediate or poor metabolizersClinical PharmacologyAripiprazolePs
11、ychiatryCYP2D6CYP2D6 poor metabolizersDosage and Administration, Use in Specific Populations, Drug Interactions, Clinical PharmacologyAripiprazole LauroxilPsychiatryCYP2D6CYP2D6 poor metabolizersDosage and Administration, Use in Specific Populations, Clinical PharmacologyArsenic TrioxideOncologyPML-
12、RARAPML-RAR translocation positiveClinical Pharmacology, Indications and UsageAtomoxetinePsychiatryCYP2D6CYP2D6 poor metabolizersDosage and Administration, Warnings and Precautions, Drug Interactions, Clinical PharmacologyAzathioprineRheumatologyTPMTTPMT intermediate or poor metabolizersClinical Pha
13、rmacology, Warnings, Precautions, Drug Interactions, Adverse Reactions, Dosage and AdministrationBelinostatOncologyUGT1A1UGT1A1*28 allele homozygotesDosage and Administration, Clinical PharmacologyBlinatumomabOncologyBCR-ABL1Philadelphia chromosome negativeIndications and Usage, Clinical StudiesBoce
14、previrInfectious DiseasesIFNL3IL28B rs12979860 T allele carriers (C/T and T/T genotype)Clinical PharmacologyBosutinibOncologyBCR-ABL1Philadelphia chromosome positiveIndications and Usage, Adverse Reactions, Use in Specific Populations, Clinical StudiesBrexpiprazolePsychiatryCYP2D6CYP2D6 poor metabol
15、izersDosage and Administration, Drug Interactions, Use in Specific Populations, Clinical PharmacologyBusulfanOncologyBCR-ABL1Philadelphia chromosome negativeClinical StudiesCabozantinibOncologyRETRET mutation positiveClinical StudiesCapecitabineOncologyDPYDDPD deficientWarnings and Precautions, Patient Counseling InformationCarbamazepine (1)NeurologyHLA-BHLA-B*1502 allele carriersBoxed Warning, Warnings, PrecautionsCarbamazepine (2)NeurologyHLA-AHLA-A*3101 allele carriersWarningsCarglumic AcidInborn Errors of Met
