domingo, 7 de septiembre de 2014

Genomics > Table of Pharmacogenomic Biomarkers in Drug Labeling

Genomics > Table of Pharmacogenomic Biomarkers in Drug Labeling



Table of Pharmacogenomic Biomarkers in Drug Labeling

Pharmacogenomics 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 genes
The 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. Biomarkers in the table include are not limited to germline or somatic gene variants, functional deficiencies, expression changes, and chromosomal abnormalities.
This table does not include non-human genetic biomarkers (e.g., viral or bacterial) i.e., microbial variants that influence sensitivity to anti-invectives; biomarkers that are used solely for diagnostic purposes unless they are linked to drug activity or used to identify a specific subset in whom prescribing information differs (e.g., for genetic diseases). Therapeutic areas do not necessarily reflect the FDA review division.
Pharmacogenomic information can appear in different sections of the labeling. Relevant sections of the labeling with such information are noted in the last column of the table. For more information on the relevance of information in various parts of drug labeling (e.g. Indications and Usage, Dosage and Administration, Boxed Warning, etc.), please refer to the appropriate labeling guidance. For information on the FDA's initiative to improve prescription drug labeling, visit the FDA/CDER Learn website.
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Pharmacogenomic Biomarkers in Drug Labeling

    DrugTherapeutic AreaHUGO SymbolReferenced SubgroupLabeling Sections
    AbacavirInfectious DiseasesHLA-BHLA-B*5701 allele carriersBoxed Warning, Contraindications, Warnings and Precautions, Patient Counseling Information
    Ado-Trastuzumab EmtansineOncologyERBB2HER2 protein overexpression or gene amplification positiveIndications and Usage, Warnings and Precautions, Adverse Reactions, Clinical Pharmacology, Clinical Studies
    AfatinibOncologyEGFREGFR exon 19 deletion or exon 21 substitution (L858R) mutation positiveIndications and Usage, Dosage and Administration, Adverse Reactions, Clinical Pharmacology, Clinical Studies, Patient Counseling Information
    AmitriptylinePsychiatryCYP2D6CYP2D6 poor metabolizersPrecautions
    AnastrozoleOncologyESR1, PGRHormone receptor positiveIndications and Usage, Clinical Pharmacology, Clinical Studies
    AripiprazolePsychiatryCYP2D6CYP2D6 poor metabolizersClinical Pharmacology, Dosage and Administration
    Arsenic TrioxideOncologyPML/RARAPML/RARα (t(15;17)) gene expression positiveBoxed Warning, Clinical Pharmacology, Indications and Usage, Warnings
    AtomoxetinePsychiatryCYP2D6CYP2D6 poor metabolizersDosage and Administration, Warnings and Precautions, Drug Interactions, Clinical Pharmacology
    AtorvastatinEndocrinologyLDLRHomozygous familial hypercholesterolemiaIndications and Usage, Dosage and Administration, Warnings and Precautions, Clinical Pharmacology, Clinical Studies
    AzathioprineRheumatologyTPMTTPMT intermediate or poor metabolizersDosage and Administration, Warnings and Precautions, Drug Interactions, Adverse Reactions, Clinical Pharmacology
    BoceprevirInfectious DiseasesIFNL3IL28B rs12979860 T allele carriersClinical Pharmacology
    BosutinibOncologyBCR/ABL1Philadelphia chromosome (t(9;22)) positiveIndications and Usage, Adverse Reactions, Clinical Studies
    Brentuximab VedotinOncologyTNFRSF8CD30 positiveIndications and Usage, Description, Clinical Pharmacology
    BusulfanOncologyPh ChromosomePh Chromosome negativeClinical Studies
    CapecitabineOncologyDPYDDPD deficientContraindications, Warnings and Precautions, Patient Information
    Carbamazepine (1)NeurologyHLA-BHLA-B*1502 allele carriersBoxed Warning, Warnings and Precautions
    Carbamazepine (2)NeurologyHLA-AHLA-A*3101 allele carriersBoxed Warning, Warnings and Precautions
    Carglumic AcidMetabolic DisordersNAGSN-acetylglutamate synthase deficientIndications and Usage, Warnings and Precautions, Special Populations, Clinical Pharmacology, Clinical Studies
    CarisoprodolRheumatologyCYP2C19CYP2C19 poor metabolizersClinical Pharmacology, Special Populations
    CarvedilolCardiologyCYP2D6CYP2D6 poor metabolizersDrug Interactions, Clinical Pharmacology
    CelecoxibRheumatologyCYP2C9CYP2C9 poor metabolizersDosage and Administration, Drug Interactions, Use in Specific Populations, Clinical Pharmacology
    Cetuximab (1)OncologyEGFREGFR protein expression positiveIndications and Usage, Warnings and Precautions, Description, Clinical Pharmacology, Clinical Studies
    Cetuximab (2)OncologyKRASKRAS codon 12 and 13 mutation negativeIndications and Usage, Dosage and Administration, Warnings and Precautions, Adverse Reactions, Clinical Pharmacology, Clinical Studies
    CevimelineDentalCYP2D6CYP2D6 poor metabolizersDrug Interactions
    ChloroquineInfectious DiseasesG6PDG6PD deficientPrecautions
    ChlorpropamideEndocrinologyG6PDG6PD deficientPrecautions
    CisplatinOncologyTPMTTPMT intermediate or poor metabolizersClinical Pharmacology, Warnings, Precautions
    Citalopram (1)PsychiatryCYP2C19CYP2C19 poor metabolizersDrug Interactions, Warnings
    Citalopram (2)PsychiatryCYP2D6CYP2D6 poor metabolizersDrug Interactions
    ClobazamNeurologyCYP2C19CYP2C19 poor metabolizersClinical Pharmacology, Dosage and Administration, Use in Specific Populations
    ClomipraminePsychiatryCYP2D6CYP2D6 poor metabolizersDrug Interactions
    ClopidogrelCardiologyCYP2C19CYP2C19 intermediate or poor metabolizersBoxed Warning, Dosage and Administration, Warnings and Precautions, Drug Interactions, Clinical Pharmacology
    ClozapinePsychiatryCYP2D6CYP2D6 poor metabolizersDrug Interactions, Clinical Pharmacology
    CodeineAnesthesiologyCYP2D6CYP2D6 ultra-rapid metabolizersBoxed Warnings, Warnings and Precautions, Use in Specific Populations, Clinical Pharmacology , Patient Counseling Information
    CrizotinibOncologyALKALK gene rearrangement positiveIndications and Usage, Dosage and Administration, Drug Interactions, Warnings and Precautions, Adverse Reactions, Clinical Pharmacology, Clinical Studies
    Dabrafenib (1)OncologyBRAFBRAF V600E mutation positiveIndications and Usage, Dosage and Administration, Warnings and Precautions, Clinical Pharmacology, Clinical Studies, Patient Counseling Information
    Dabrafenib (2)OncologyG6PDG6PD deficientWarnings and Precautions, Adverse Reactions, Patient Counseling Information
    Dapsone (1)DermatologyG6PDG6PD deficientIndications and Usage, Precautions, Adverse Reactions, Patient Counseling Information
    Dapsone (2)Infectious DiseasesG6PDG6PD deficientPrecautions, Adverse Reactions, Overdosage
    DasatinibOncologyBCR/ABL1Philadelphia chromosome (t(9;22)) positive; T315I mutation-positiveIndications and Usage, Clinical Studies, Patient Counseling Information
    Denileukin DiftitoxOncologyIL2RACD25 antigen positiveIndications and Usage, Warnings and Precautions, Clinical Studies
    DesipraminePsychiatryCYP2D6CYP2D6 poor metabolizersDrug Interactions
    Dexlansoprazole (1)GastroenterologyCYP2C19CYP2C19 poor metabolizersClinical Pharmacology, Drug Interactions
    Dexlansoprazole (2)GastroenterologyCYP1A2CYP1A2 genotypesClinical Pharmacology
    Dextromethorphan and QuinidineNeurologyCYP2D6CYP2D6 poor metabolizersClinical Pharmacology, Warnings and Precautions, Drug Interactions
    DiazepamPsychiatryCYP2C19CYP2C19 poor metabolizersDrug Interactions, Clinical Pharmacology
    DoxepinPsychiatryCYP2D6CYP2D6 poor metabolizersPrecautions
    Drospirenone and Ethinyl EstradiolNeurologyCYP2C19CYP2C19 poor metabolizersClinical Pharmacology, Warnings and Precautions, Drug Interactions
    Eltrombopag (1)HematologyF5Factor V Leiden carriersWarnings and Precautions
    Eltrombopag (2)HematologySERPINC1Antithrombin III deficientWarnings and Precautions
    Erlotinib (1)OncologyEGFREGFR protein expression positiveClinical Pharmacology
    Erlotinib (2)OncologyEGFREGFR exon 19 deletion or exon 21 substitution (L858R) positiveIndications and Usage, Dosage and Administration, Clinical Pharmacology, Clinical Studies
    EsomeprazoleGastroenterologyCYP2C19CYP2C19 poor metabolizersDrug Interactions, Clinical Pharmacology
    Everolimus (1)OncologyERBB2HER2 protein overexpression negativeIndications and Usage, Boxed Warning, Adverse Reactions, Use in Specific Populations, Clinical Pharmacology, Clinical Studies
    Everolimus (2)OncologyESR1Estrogen receptor positiveClinical Pharmacology, Clinical Studies
    ExemestaneOncologyESR1Estrogen receptor positiveIndications and Usage, Dosage and Administration, Clinical Studies, Clinical Pharmacology
    Fluorouracil (1)DermatologyDPYDDPD deficientContraindications, Warnings, Patient Information
    Fluorouracil (2)OncologyDPYDDPD deficientWarnings
    FluoxetinePsychiatryCYP2D6CYP2D6 poor metabolizersWarnings, Precautions, Clinical Pharmacology
    FlurbiprofenRheumatologyCYP2C9CYP2C9 poor metabolizersClinical Pharmacology, Special Populations
    FluvoxaminePsychiatryCYP2D6CYP2D6 poor metabolizersDrug Interactions
    FulvestrantOncologyESR1Estrogen receptor positiveIndications and Usage, Clinical Pharmacology, Clinical Studies, Patient Counseling Information
    GalantamineNeurologyCYP2D6CYP2D6 poor metabolizersSpecial Populations
    GlimepirideEndocrinologyG6PDG6PD deficientWarning and Precautions
    GlipizideEndocrinologyG6PDG6PD deficientPrecautions
    GlyburideEndocrinologyG6PDG6PD deficientPrecautions
    Ibritumomab TiuxetanOncologyMS4A1CD20 positiveIndications and Usage, Clinical Pharmacology, Description
    IloperidonePsychiatryCYP2D6CYP2D6 poor metabolizersClinical Pharmacology, Dosage and Administration, Drug Interactions, Specific Populations, Warnings and Precautions
    Imatinib (1)OncologyKITc-KIT D816V mutation negativeIndications and Usage, Dosage and Administration Clinical Pharmacology, Clinical Studies
    Imatinib (2)OncologyBCR/ABL1Philadelphia chromosome (t(9;22)) positiveIndications and Usage, Dosage and Administration, Clinical Pharmacology, Clinical Studies
    Imatinib (3)OncologyPDGFRBPDGFR gene rearrangement positiveIndications and Usage, Dosage and Administration, Clincal Studies
    Imatinib (4)OncologyFIP1L1/PDGFRAFIP1L1/PDGFRα fusion kinase (or CHIC2 deletion) positiveIndications and Usage, Dosage and Administration, Clinical Studies
    ImipraminePsychiatryCYP2D6CYP2D6 poor metabolizersDrug Interactions
    IndacaterolPulmonaryUGT1A1UGT1A1*28 allele homozygotesClinical Pharmacology
    IrinotecanOncologyUGT1A1UGT1A1*28 allele carriersDosage and Administration, Warnings, Clinical Pharmacology
    Isosorbide and HydralazineCardiologyNAT1-2Slow acetylatorsClinical Pharmacology
    IvacaftorPulmonaryCFTRCFTR G551D, G1244E, G1349D, G178R, G551S, S1251N, S1255P, S549N, or S549R mutation carriersIndications and Usage, Adverse Reactions, Use in Specific Populations, Clinical Pharmacology, Clinical Studies
    LansoprazoleGastroenterologyCYP2C19CYP2C19 poor metabolizersDrug Interactions, Clinical Pharmacology
    LapatinibOncologyERBB2HER2 protein overexpression positiveIndications and Usage, Clinical Pharmacology, Patient Counseling Information
    LenalidomideHematologydel (5q)Chromosome 5q deletionBoxed Warning, Indications and Usage, Clinical Studies, Patient Counseling
    LetrozoleOncologyESR1, PGRHormone receptor positiveIndications and Usage, Adverse Reactions, Clinical Studies, Clinical Pharmacology
    LomitapideEndocrinologyLDLRHomozygous familial hypercholesterolemiaIndication and Usage, Adverse Reactions, Clinical Studies
    MafenideInfectious DiseasesG6PDG6PD deficientWarnings, Adverse Reactions
    MaravirocInfectious DiseasesCCR5CCR5 positiveIndications and Usage, Warnings and Precautions, Clinical Pharmacology, Clinical Studies, Patient Counseling Information
    MercaptopurineOncologyTPMTTPMT intermediate or poor metabolizersDosage and Administration, Precautions, Adverse Reactions, Clinical Pharmacology
    Methylene BlueHematologyG6PDG6PD deficientPrecautions
    MetoclopramideGastroentrologyCYB5R1-4NADH cytochrome b5 reductase deficientPrecautions
    MetoprololCardiologyCYP2D6CYP2D6 poor metabolizersPrecautions, Clinical Pharmacology
    MipomersenEndocrinologyLDLRHomozygous familial hypercholesterolemiaIndication and Usage, Clinical Studies, Use in Specific Populations
    ModafinilPsychiatryCYP2D6CYP2D6 poor metabolizersDrug Interactions
    Mycophenolic AcidTransplantationHPRT1HGPRT deficientPrecautions
    Nalidixic AcidInfectious DiseasesG6PDG6PD deficientPrecautions, Adverse Reactions
    NefazodonePsychiatryCYP2D6CYP2D6 poor metabolizersDrug Interactions
    Nilotinib (1)OncologyBCR/ABL1Philadelphia chromosome (t(9 :22)) positiveIndications and Usage, Patient Counseling Information
    Nilotinib (2)OncologyUGT1A1UGT1A1*28 allele homozygotesWarnings and Precautions, Clinical Pharmacology
    NitrofurantoinInfectious DiseasesG6PDG6PD deficientWarnings, Adverse Reactions
    NortriptylinePsychiatryCYP2D6CYP2D6 poor metabolizersDrug Interactions
    ObinutuzumabOncologyMS4A1CD20 positiveIndication and Usage, Warnings and Precautions, Description, Clinical Pharmacology, Clinical Studies
    OfatumumabOncologyMS4A1CD20 positiveIndications and Usage, Clinical Pharmacology
    OmacetaxineOncologyBCR/ABL1BCR-ABL T315IClinical Pharmacology
    OmeprazoleGastroenterologyCYP2C19CYP2C19 poor metabolizersDosage and Administration, Warnings and Precautions, Drug Interactions
    Panitumumab (1)OncologyEGFREGFR protein expression positiveIndications and Usage, Warnings and Precautions, Clinical Pharmacology, Clinical Studies
    Panitumumab (2)OncologyKRASKRAS codon 12 and 13 mutation negativeIndications and Usage, Clinical Pharmacology, Clinical Studies
    PantoprazoleGastroenterologyCYP2C19CYP2C19 poor metabolizersClinical Pharmacology, Drug Interactions, Special Populations
    ParoxetinePsychiatryCYP2D6CYP2D6 poor metabolizersClinical Pharmacology, Drug Interactions
    PazopanibOncologyUGT1A1(TA)7/(TA)7 genotype (UGT1A1*28/*28)Clinical Pharmacology, Warnings and Precautions
    PEG-3350, Sodium Sulfate, Sodium Chloride, Potassium Chloride, Sodium Ascorbate, and Ascorbic AcidGastroenterologyG6PDG6PD deficientWarnings and Precautions
    Peginterferon alfa-2bInfectious DiseasesIFNL3IL28B rs12979860 T allele carriersClinical Pharmacology
    PegloticaseRheumatologyG6PDG6PD deficientContraindications, Patient Counseling Information
    PerphenazinePsychiatryCYP2D6CYP2D6 poor metabolizersClinical Pharmacology, Drug Interactions
    PertuzumabOncologyERBB2HER2 protein overexpression positiveIndications and Usage, Warnings and Precautions, Adverse Reactions, Clinical Studies, Clinical Pharmacology
    PhenytoinNeurologyHLA-BHLA-B*1502 allele carriersWarnings
    PimozidePsychiatryCYP2D6CYP2D6 poor metabolizersWarnings, Precautions, Contraindications, Dosage and Administration
    PonatinibOncologyBCR –ABL T315IBCR –ABL T315I mutationIndications and Usage, Adverse Reactions, Clinical Pharmacology, Clinical Studies
    PrasugrelCardiologyCYP2C19CYP2C19 poor metabolizersUse in Specific Populations, Clinical Pharmacology, Clinical Studies
    PravastatinEndocrinologyLDLRHomozygous familial hypercholesterolemiaClinical Studies, Use in Specific Populations
    PrimaquineInfectious DiseasesG6PDG6PD deficientWarnings and Precautions, Adverse Reactions
    PropafenoneCardiologyCYP2D6CYP2D6 poor metabolizersClinical Pharmacology
    PropranololCardiologyCYP2D6CYP2D6 poor metabolizersPrecautions, Drug Interactions, Clinical Pharmacology
    ProtriptylinePsychiatryCYP2D6CYP2D6 poor metabolizersPrecautions
    QuinidineCardiologyCYP2D6CYP2D6 poor metabolizersPrecautions
    Quinine SulfateInfectious DiseasesG6PDG6PD deficientContraindications, Patient Counseling Information
    RabeprazoleGastroenterologyCYP2C19CYP2C19 poor metabolizersDrug Interactions, Clinical Pharmacology
    RasburicaseOncologyG6PDG6PD deficientBoxed Warning, Contraindications
    Rifampin, Isoniazid, and PyrazinamideInfectious DiseasesNAT1-2Slow inactivatorsAdverse Reactions, Clinical Pharmacology
    RisperidonePsychiatryCYP2D6CYP2D6 poor metabolizersDrug Interactions, Clinical Pharmacology
    RituximabOncologyMS4A1CD20 positiveIndication and Usage, Clinical Pharmacology, Description, Precautions
    RosuvastatinEndocrinologyLDLRHomozygous familial hypercholesterolemiaIndications and Usage, Dosage and Administration, Clinical Pharmacology, Clinical Studies
    SimeprevirInfectious DiseasesIFNL3IL28B rs12979860 T allele carriersClinical studies, Clinical Pharmacology
    Sodium NitriteAntidotal TherapyG6PDG6PD deficientWarnings and Precautions
    SofosbuvirInfectious DiseasesIFNL3IL28B rs12979860 T allele carriersClinical Pharmacology, Clinical Studies
    SuccimerHematologyG6PDG6PD deficientClinical Pharmacology
    Sulfamethoxazole and TrimethoprimInfectious DiseasesG6PDG6PD deficientPrecautions
    Tamoxifen (1)OncologyESR1, PGRHormone receptor positiveIndications and Usage, Precautions, Medication Guide
    Tamoxifen (2)OncologyF5Factor V Leiden carriersWarnings
    Tamoxifen (3)OncologyF2Prothrombin mutation G20210A positiveWarnings
    TelaprevirInfectious DiseasesIFNL3IL28B rs12979860 T allele carriersClinical Pharmacology
    TerbinafineInfectious DiseasesCYP2D6CYP2D6 poor metabolizersDrug Interactions
    TetrabenazineNeurologyCYP2D6CYP2D6 poor metabolizersDosage and Administration, Warnings, Clinical Pharmacology
    ThioguanineOncologyTPMTTPMT poor metabolizersDosage and Administration, Precautions, Warnings
    ThioridazinePsychiatryCYP2D6CYP2D6 poor metabolizersPrecautions, Warnings, Contraindications
    TicagrelorCardiologyCYP2C19CYP2C19 poor metabolizersClinical Studies
    TolterodineGenitourinaryCYP2D6CYP2D6 poor metabolizersWarnings and Precautions, Drug Interactions, Use in Specific Populations, Clinical Pharmacology
    TositumomabOncologyMS4A1CD20 antigen positiveIndications and Usage, Clinical Pharmacology
    TramadolAnalgesicCYP2D6CYP2D6 poor metabolizersClinical Pharmacology
    TrametinibOncologyBRAFBRAF V600E/K mutation positiveIndications and Usage, Dosage and Administration, Adverse Reactions, Clinical Pharmacology, Clinical Studies, Patient Counseling Information
    TrastuzumabOncologyERBB2HER2 protein overexpression positiveIndications and Usage, Warnings and Precautions, Clinical Pharmacology, Clinical Studies
    TretinoinOncologyPML/RARAPML/RARα (t(15;17)) gene expression positiveClinical Studies, Indications and Usage, Warnings
    TrimipraminePsychiatryCYP2D6CYP2D6 poor metabolizersDrug Interactions
    Valproic Acid (1)NeurologyPOLGPOLG mutation positiveBoxed Warning, Contraindications, Warnings and Precautions
    Valproic Acid (2)NeurologyNAGS, CPS1, ASS1, OTC, ASL, ABL2Urea cycle enzyme deficientContraindications, Warnings and Precautions, Adverse Reactions, Medication Guide
    VemurafenibOncologyBRAFBRAF V600E mutation positiveIndications and Usage, Warning and Precautions, Clinical Pharmacology, Clinical Studies, Patient Counseling Information
    VenlafaxinePsychiatryCYP2D6CYP2D6 poor metabolizersDrug Interactions
    VoriconazoleInfectious DiseasesCYP2C19CYP219 intermediate or poor metabolizersClinical Pharmacology, Drug Interactions
    VortioxetineNeurologyCYP2D6CYP2D6 poor metabolizersDosage and Administration, Drug interactions, Clinical Pharmacology
    Warfarin (1)Cardiology or HematologyCYP2C9CYP2C9 intermediate or poor metabolizersDosage and Administration, Drug Interactions, Clinical Pharmacology
    Warfarin (2)Cardiology or HematologyVKORC1VKORC1 rs9923231 A allele carriersDosage and Administration, Clinical Pharmacology
    Warfarin (3)Cardiology or HematologyPROCProtein C deficientWarning and precautions

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