FDA基因检测用药指南

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 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 includes 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 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 influence 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, salts, 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 LabelingDrugTherapeutic 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, Warnings 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 rearrangement positiveIndications and Usage, Adverse Reactions, Clinical Pharmacology, Clinical StudiesAlirocumabEndocrinologyLDLRLDL receptor mutation heterozygotesIndications and Usage, Adverse Reactions, Clinical StudiesAmitriptylinePsychiatryCYP2D6CYP2D6 poor metabolizersPrecautionsAnastrozoleOncologyESR1, PGRHormone receptor positiveIndications and Usage, Adverse Reactions, Drug Interactions, Clinical StudiesArformoterol (1)PulmonaryUGT1A1UGT1A1 poor metabolizersClinical PharmacologyArformoterol (2)PulmonaryCYP2D6CYP2D6 intermediate or poor metabolizersClinical PharmacologyAripiprazolePsychiatryCYP2D6CYP2D6 poor metabolizersDosage and Administration, Use in Specific Populations, Drug Interactions, Clinical PharmacologyAripiprazole LauroxilPsychiatryCYP2D6CYP2D6 poor metabolizersDosage and Administration, Use in Specific Populations, Clinical PharmacologyArsenic TrioxideOncologyPML-RARAPML-RAR translocation positiveClinical Pharmacology, Indications and UsageAtomoxetinePsychiatryCYP2D6CYP2D6 poor metabolizersDosage and Administration, Warnings and Precautions, Drug Interactions, Clinical PharmacologyAzathioprineRheumatologyTPMTTPMT intermediate or poor metabolizersClinical Pharmacology, Warnings, Precautions, Drug Interactions, Adverse Reactions, Dosage and AdministrationBelinostatOncologyUGT1A1UGT1A1*28 allele homozygotesDosage and Administration, Clinical PharmacologyBlinatumomabOncologyBCR-ABL1Philadelphia chromosome negativeIndications and Usage, Clinical StudiesBoceprevirInfectious 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 metabolizersDosage 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 MetabolismNAGSN-acetylglutamate synthase deficientIndications and Usage, Warnings and Precautions, Use in Specific Populations, Clinical Pharmacology, Clinical StudiesCarisoprodolRheumatologyCYP2C19CYP2C19 poor metabolizersUse in Specific Populations, Clinical PharmacologyCarvedilolCardiologyCYP2D6CYP2D6 poor metabolizersDrug Interactions, Clinical PharmacologyCelecoxibRheumatologyCYP2C9CYP2C9 poor metabolizersDosage and Administration, Use in Specific Populations, Clinical PharmacologyCeritinibOncologyALKALK gene rearrangement positiveIndications and Usage, Adverse Reactions, Clinical Pharmacology, Clinical StudiesCetuximab (1)OncologyEGFREGFR protein expression positiveIndications and Usage, Dosage and Administration, Warnings and Precautions, Adverse Reactions, Clinical Pharmacology, Clinical StudiesCetuximab (2)OncologyKRASKRAS codon 12 and 13 mutation negativeIndications and Usage, Dosage and Administration, Warnings and Precautions, Adverse Reactions, Clinical Pharmacology, Clinical StudiesCevimelineDentalCYP2D6CYP2D6 poor metabolizersPrecautionsChloroquineInfectious DiseasesG6PDG6PD deficientPrecautionsChlorpropamideEndocrinologyG6PDG6PD deficientPrecautionsCholic AcidInborn Errors of MetabolismAKR1D1, HSD3B7, CYP27A1, AMACR, CYP7A1Bile acid synthesis enzyme deficientIndications and Usage, Warnings and Precautions, Adverse Reactions, Use in Specific Populations, Clinical Pharmacology, Clinical StudiesCisplatinOncologyTPMTTPMT intermediate or poor metabolizersAdverse ReactionsCitalopram (1)PsychiatryCYP2C19CYP2C19 poor metabolizersClinical Pharmacology, Warnings, Dosage and AdministrationCitalopram (2)PsychiatryCYP2D6CYP2D6 poor metabolizersClinical PharmacologyClobazamNeurologyCYP2C19CYP2C19 poor metabolizersDosage and Administration, Use in Specific Populations, Clinical PharmacologyClomipraminePsychiatryCYP2D6CYP2D6 poor metabolizersPrecautionsClopidogrelCardiologyCYP2C19CYP2C19 intermediate or poor metabolizersBoxed Warning, Dosage and Administration, Warnings and Precautions, Clinical PharmacologyClozapinePsychiatryCYP2D6CYP2D6 poor metabolizersDosage and Administration, Use in Specific Populations, Clinical PharmacologyCobimetinibOncologyBRAFBRAF V600E/K mutation positiveIndications and Usage, Dosage and Administration, Adverse Reactions, Clinical Pharmacology, Clinical StudiesCodeineAnesthesiologyCYP2D6CYP2D6 ultrarapid metabolizersBoxed Warning, Warnings and Precautions, Use in Specific Populations, Patient Counseling InformationCrizotinibOncologyALKALK gene rearrangement positiveIndications and Usage, Dosage and Administration, Adverse Reactions, Clinical Pharmacology, Clinical StudiesDabrafenib (1)OncologyBRAFBRAF V600E/K mutation positiveIndications and Usage, Dosage and Administration, Warnings and Precautions, Adverse Reactions, Clinical Pharmacology, Clinical Studies, Patient Counseling InformationDabrafenib (2)OncologyG6PDG6PD deficientWarnings and Precautions, Adverse Reactions, Patient Counseling InformationDapsone (1)DermatologyG6PDG6PD deficientWarnings and Precautions, Use in Specific Populations, Patient Counseling InformationDapsone (2)Infectious DiseasesG6PDG6PD deficientPrecautions, Adverse Reactions, OverdosageDasatinibOncologyBCR-ABL1Philadelphia chromosome positive, T315I mutation positiveIndications and Usage, Dosage and Administration, Warnings and Precautions, Adverse Reactions, Clinical Pharmacology, Clinical StudiesDenileukin DiftitoxOncologyIL2RACD25 antigen positiveIndications and Usage, Warnings and Precautions, Clinical StudiesDesipraminePsychiatryCYP2D6CYP2D6 poor metabolizersPrecautionsDexlansoprazoleGastroenterologyCYP2C19CYP2C19 poor metabolizersDrug Interactions, Clinical PharmacologyDextromethorphan and QuinidineNeurologyCYP2D6CYP2D6 poor metabolizersWarnings and Precautions, Clinical PharmacologyDiazepamNeurologyCYP2C19CYP2C19 poor metabolizersClinical PharmacologyDinutuximabOncologyMYCNMYCN amplification positiveClinical StudiesDolutegravirInfectious DiseasesUGT1A1UGT1A1 poor metabolizersClinical PharmacologyDoxepin (1)PsychiatryCYP2D6CYP2D6 poor metabolizersClinical PharmacologyDoxepin (2)PsychiatryCYP2C19CYP2C19 poor metabolizersClinical PharmacologyDrospirenone and Ethinyl EstradiolGynecologyCYP2C19CYP2C19 intermediate metabolizersClinical PharmacologyEliglustatInborn Errors of MetabolismCYP2D6CYP2D6 ultrarapid, intermediate or poor metabolizersIndications and Usage, Dosage and Administration, Contraindications, Warnings and Precautions, Drug Interactions, Use in Specific Populations, Clinical Pharmacology, Clinical StudiesElosulfaseInborn Errors of MetabolismGALNSN-acetylgalactosamine-6-sulfatase deficientIndications and Usage, Warnings and Precautions, Use in Specific Populations, Clinical Pharmacology, Clinical StudiesEltrombopag (1)HematologyF5Factor V Leiden carriersWarnings and PrecautionsEltrombopag (2)HematologySERPINC1Antithrombin III deficientWarnings and PrecautionsErlotinib (1)OncologyEGFREGFR protein expression positiveClinical StudiesErlotinib (2)OncologyEGFREGFR exon 19 deletion or exon 21 substitution (L858R) positiveIndications and Usage, Dosage and Administration, Adverse Reactions, Clinical Pharmacology, Clinical StudiesEscitalopram (1)PsychiatryCYP2D6CYP2D6 poor metabolizersDrug InteractionsEscitalopram (2)PsychiatryCYP2C19CYP2C19 poor metabolizersAdverse ReactionsEsomeprazoleGastroenterologyCYP2C19CYP2C19 poor metabolizersDrug Interactions, Clinical PharmacologyEverolimus (1)OncologyERBB2HER2 protein overexpression negativeIndications and Usage, Dosage and Administration, Warnings and Precautions, Adverse Reactions, Drug Interactions, Use in Specific Populations, Clinical Pharmacology, Clinical StudiesEverolimus (2)OncologyESR1Estrogen receptor positiveClinical StudiesEvolocumabEndocrinologyLDLRLDL receptor mutation heterozygotes and homozygotesIndications and Usage, Dosage and Administration, Adverse Reactions, Use in Specific Populations, Clinical StudiesExemestane (1)OncologyESR1Estrogen receptor positiveIndications and Usage, Dosage and Administration, Clinical StudiesExemestane (2)OncologyPGRProgesterone receptor positiveClinical StudiesFesoterodineUrologyCYP2D6CYP2D6 poor metabolizersDrug Interactions, Clinical PharmacologyFluorouracil (1)DermatologyDPYDDPD deficientContraindications, WarningsFluorouracil (2)OncologyDPYDDPD deficientWarningsFluoxetinePsychiatryCYP2D6CYP2D6 poor metabolizersWarnings and Precautions, Drug Interactions, Clinical PharmacologyFlurbiprofenRheumatologyCYP2C9CYP2C9 poor metabolizersClinical PharmacologyFluvoxamine PsychiatryCYP2D6CYP2D6 poor metabolizersDrug InteractionsFulvestrantOncologyESR1, PGRHormone receptor positiveIndications and Usage, Clinical Pharmacology, Clinical StudiesGalantamineNeurologyCYP2D6CYP2D6 poor metabolizersClinical PharmacologyGefitinibOncologyEGFREGFR exon 19 deletions or exon 21 substitution (L858R) mutation positiveIndications and Usage, Dosage and Administration, Clinical Pharmacology, Clinical StudiesGlimepirideEndocrinologyG6PDG6PD deficientWarnings and Precautions, Adverse ReactionsGlipizideEndocrinologyG6PDG6PD deficientPrecautionsGlyburideEndocrinologyG6PDG6PD deficientPrecautionsHydralazineCardiologyNAT1-2NAT 1-2 slow acetylatorsClinical PharmacologyIbrutinibOncologydel (17p)Chromosome 17p deletion positiveIndications and Usage, Clinical StudiesIloperidonePsychiatryCYP2D6CYP2D6 poor metabolizersDosage and Administration, Warnings and Precautions, Drug Interactions, Clinical PharmacologyImatinib (1)OncologyKITKIT protein expression positive, c-KIT D816V mutation negativeIndications and Usage, Dosage and Administration, Warnings and Precautions, Adverse Reactions, Use in Specific Populations, Clinical Pharmacology, Clinical StudiesImatinib (2)OncologyBCR-ABL1Philadelphia chromosome positiveIndications and Usage, Dosage and Administration, Warnings and Precautions, Adverse Reactions, Use in Specific Populations, Clinical Pharmacology, Clinical StudiesImatinib (3)OncologyPDGFRBPDGFR gene rearrangement positiveIndications and Usage, Dosage and Administration, Clinical StudiesImatinib (4)OncologyFIP1L1-PDGFRAFIP1L1-PDGFR fusion kinase (or CHIC2 deletion) positiveIndications and Usage, Dosage and Administration, Clinical StudiesImipraminePsychiatryCYP2D6CYP2D6 poor metabolizersPrecautionsIndacaterolPulmonaryUGT1A1UGT1A1*28 allele homozygotesClinical PharmacologyIrinotecanOncologyUGT1A1UGT1A1*28 allele carriersDosage and Administration, Warnings and Precautions, Clinical PharmacologyIvacaftorPulmonaryCFTRCFTR G551D, G1244E, G1349D, G178R, G551S, S1251N, S1255P, S549N, S549R, R117H mutation positive, F508del mutation homozygotesIndications and Usage, Adverse Reactions, Use in Specific Populations, Clinical Pharmacology, Clinical StudiesLacosamideNeurologyCYP2C19CYP2C19 poor metabolizersClinical PharmacologyLansoprazoleGastroenterologyCYP2C19CYP2C19 intermediate or poor metabolizersDrug InteractionsLapatinib (1)OncologyERBB2HER2 protein overexpression positiveIndications and Usage, Dosage and Administration, Adverse Reactions, Use in Specific Populations, Clinical Pharmacology, Clinical StudiesLapatinib (2)OncologyHLA-DQA1, HLA-DRB1HLA-DQA1*0201 or HLA-DRB1*0701 allele carriersClinical PharmacologyLenalidomideHematologydel (5q)Chromosome 5q deletion positiveBoxed Warning, Indications and Usage, Adverse Reactions, Use in Specific Populations, Clinical StudiesLesinuradRheumatologyCYP2C9CYP2C9 poor metabolizersClinical PharmacologyLetrozoleOncologyESR1, PGRHormone receptor positiveIndications and Usage, Adverse Reactions, Clinical Pharmacology, Clinical StudiesLomitapideEndocrinologyLDLRLDL receptor mutation homozygotesIndication and Usage, Warnings and Precautions, Adverse Reactions, Clinical StudiesIvacaftor and LumacaftorPulmonaryCFTRCFTR F508del mutation homozygotesIndications and Usage, Adverse Reactions, Clinical Pharmacology, Clinical StudiesMafenideInfectious DiseasesG6PDG6PD deficientWarnings, Adverse ReactionsMercaptopurineOncologyTPMTTPMT intermediate or poor metabolizersClinical Pharmacology, Warnings, Precautions, Adverse Reactions, Dosage and AdministrationMethylene BlueHematologyG6PDG6PD deficientPrecautionsMetoclopramide (1)GastroenterologyCYB5R1-4NADH cytochrome b5 reductase deficientPrecautionsMetoclopramide (2)GastroenterologyG6PDG6PD deficientPrecautionsMetoprololCardiologyCYP2D6CYP2D6 poor metabolizersClinical PharmacologyMipomersenEndocrinologyLDLRLDL receptor mutation heterozygotes and homozygotesIndications and Usage, Warnings and Precautions, Adverse Reactions, Use in Specific Populations, Clinical StudiesModafinilPsychiatryCYP2D6CYP2D6 poor metabolizersClinical Pharmacology, PrecautionsMycophenolic AcidTransplantationHPRT1HGPRT deficientWarnings and PrecautionsNalidixic AcidInfectious DiseasesG6PDG6PD deficientPrecautions, Adverse ReactionsNefazodonePsychiatryCYP2D6CYP2D6 poor metabolizersPrecautionsNilotinib (1)OncologyBCR-ABL1Philadelphia chromosome positiveIndications and Usage, Dosage and Administration, Adverse Reactions, Use in Specific Populations, Clinical Pharmacology, Clinical StudiesNilotinib (2)OncologyUGT1A1UGT1A1*28 allele homozygotesClinical PharmacologyNitrofurantoinInfectious DiseasesG6PDG6PD deficientWarnings, Adverse ReactionsNivolumab (1)OncologyBRAFBRAF V600 mutation positiveIndications and Usage, Adverse Reactions, Clinical StudiesNivolumab (2)OncologyCD274PD-L1 protein expression positiveClinical PharmacologyNortriptylinePsychiatryCYP2D6CYP2D6 poor metabolizersPrecautionsObinutuzumabOncologyMS4A1CD20 antigen positiveClinical StudiesOlaparibOncologyBRCA1-2BRCA1-2 mutation positiveIndications and Usage, Dosage and Administration, Warnings and Precautions, Adverse Reactions, Clinical Pharmacology, Clinical StudiesOmacetaxineOncologyBCR-ABL1Philadelphia chromosome positiveClinical Pharmacology, Clinical StudiesOmbitasvir, Paritaprevir, Ritonavir, and DasabuvirInfectious DiseasesIFNL3IL28B rs12979860 T allele carriers (non-C/C genotype)Clinical StudiesOmeprazoleG