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TableofPharmacogenomicBiomarkersinDrugLabeling
Pharmacogenomicscanplayanimportantroleinidentifyingrespondersandnon-responderstomedications,avoidingadverseevents,andoptimizingdrugdose.Druglabelingmaycontaininformationongenomicbiomarkersandcandescribe:
Drugexposureandclinicalresponsevariability
Riskforadverseevents
Genotype-specificdosing
Mechanismsofdrugaction
Polymorphicdrugtargetanddispositiongenes
ThetablebelowlistsFDA-approveddrugswithpharmacogenomicinformationintheirlabeling.Thelabelingforsome,butnotall,oftheproductsincludesspecificactionstobetakenbasedonthebiomarkerinformation.Pharmacogenomicinformationcanappearindifferentsectionsofthelabelingdependingontheactions.Formoreinformation,pleaserefertotheappropriatelabelingguidance.
Biomarkersinthetableincludebutarenotlimitedtogerm-lineorsomaticgenevariants,functionaldeficiencies,expressionchanges,andchromosomalabnormalities;selectedproteinbiomarkersthatareusedtoselectpatientsfortreatmentarealsoincluded.
Thistabledoesnotincludenon-humangeneticbiomarkers(e.g.,microbialvariantsthatinfluencesensitivitytoantibiotics),orbiomarkersthatareusedsolelyfordiagnosticpurposes(e.g.,forgeneticdiseases)unlesstheyarelinkedtodrugactivityorusedtoidentifyaspecificsubsetinwhomprescribinginformationdiffers.Fordrugsthatareavailableinmultipledosageforms,salts,orcombinations,asinglerepresentativeproductislisted.Inthecaseofcombinationproducts,thesingleagentassociatedwiththebiomarkerislistedunlesstheagentisonlyapprovedasacombinationproduct,inwhichcaseallagentsarelisted.
PharmacogenomicBiomarkersinDrugLabeling
Drug
TherapeuticArea*
Biomarker?
ReferencedSubgroup?
LabelingSections
Abacavir
InfectiousDiseases
HLA-B
HLA-B*5701allelecarriers
BoxedWarning,Contraindications,WarningsandPrecautions
Ado-TrastuzumabEmtansine
Oncology
ERBB2
HER2proteinoverexpressionorgeneamplificationpositive
IndicationsandUsage,WarningsandPrecautions,AdverseReactions,ClinicalPharmacology,ClinicalStudies
Afatinib
Oncology
EGFR
EGFRexon19deletionorexon21substitution(L858R)positive
IndicationsandUsage,DosageandAdministration,AdverseReactions,ClinicalPharmacology,ClinicalStudies
Alectinib
Oncology
ALK
ALKgenerearrangementpositive
IndicationsandUsage,AdverseReactions,ClinicalPharmacology,ClinicalStudies
Alirocumab
Endocrinology
LDLR
LDLreceptormutationheterozygotes
IndicationsandUsage,AdverseReactions,ClinicalStudies
Amitriptyline
Psychiatry
CYP2D6
CYP2D6poormetabolizers
Precautions
Anastrozole
Oncology
ESR1,PGR
Hormonereceptorpositive
IndicationsandUsage,AdverseReactions,DrugInteractions,ClinicalStudies
Arformoterol(1)
Pulmonary
UGT1A1
UGT1A1poormetabolizers
ClinicalPharmacology
Arformoterol(2)
Pulmonary
CYP2D6
CYP2D6intermediateorpoormetabolizers
ClinicalPharmacology
Aripiprazole
Psychiatry
CYP2D6
CYP2D6poormetabolizers
DosageandAdministration,UseinSpecificPopulations,DrugInteractions,ClinicalPharmacology
AripiprazoleLauroxil
Psychiatry
CYP2D6
CYP2D6poormetabolizers
DosageandAdministration,UseinSpecificPopulations,ClinicalPharmacology
ArsenicTrioxide
Oncology
PML-RARA
PML-RARαtranslocationpositive
ClinicalPharmacology,IndicationsandUsage
Atomoxetine
Psychiatry
CYP2D6
CYP2D6poormetabolizers
DosageandAdministration,WarningsandPrecautions,DrugInteractions,ClinicalPharmacology
Azathioprine
Rheumatology
TPMT
TPMTintermediateorpoormetabolizers
ClinicalPharmacology,Warnings,Precautions,DrugInteractions,AdverseReactions,DosageandAdministration
Belinostat
Oncology
UGT1A1
UGT1A1*28allelehomozygotes
DosageandAdministration,ClinicalPharmacology
Blinatumomab
Oncology
BCR-ABL1
Philadelphiachromosomenegative
IndicationsandUsage,ClinicalStudies
Boceprevir
InfectiousDiseases
IFNL3
IL28Brs12979860Tallelecarriers(C/TandT/Tgenotype)
ClinicalPharmacology
Bosutinib
Oncology
BCR-ABL1
Philadelphiachromosomepositive
IndicationsandUsage,AdverseReactions,UseinSpecificPopulations,ClinicalStudies
Brexpiprazole
Psychiatry
CYP2D6
CYP2D6poormetabolizers
DosageandAdministration,DrugInteractions,UseinSpecificPopulations,ClinicalPharmacology
Busulfan
Oncology
BCR-ABL1
Philadelphiachromosomenegative
ClinicalStudies
Cabozantinib
Oncology
RET
RETmutationpositive
ClinicalStudies
Capecitabine
Oncology
DPYD
DPDdeficient
WarningsandPrecautions,PatientCounselingInformation
Carbamazepine(1)
Neurology
HLA-B
HLA-B*1502allelecarriers
BoxedWarning,Warnings,Precautions
Carbamazepine(2)
Neurology
HLA-A
HLA-A*3101allelecarriers
Warnings
CarglumicAcid
InbornErrorsofMetabolism
NAGS
N-acetylglutamatesynthasedeficient
IndicationsandUsage,WarningsandPrecautions,UseinSpecificPopulations,ClinicalPharmacology,ClinicalStudies
Carisoprodol
Rheumatology
CYP2C19
CYP2C19poormetabolizers
UseinSpecificPopulations,ClinicalPharmacology
Carvedilol
Cardiology
CYP2D6
CYP2D6poormetabolizers
DrugInteractions,ClinicalPharmacology
Celecoxib
Rheumatology
CYP2C9
CYP2C9poormetabolizers
DosageandAdministration,UseinSpecificPopulations,ClinicalPharmacology
Ceritinib
Oncology
ALK
ALKgenerearrangementpositive
IndicationsandUsage,AdverseReactions,ClinicalPharmacology,ClinicalStudies
Cetuximab(1)
Oncology
EGFR
EGFRproteinexpressionpositive
IndicationsandUsage,DosageandAdministration,WarningsandPrecautions,AdverseReactions,ClinicalPharmacology,ClinicalStudies
Cetuximab(2)
Oncology
KRAS
KRAScodon12and13mutationnegative
IndicationsandUsage,DosageandAdministration,WarningsandPrecautions,AdverseReactions,ClinicalPharmacology,ClinicalStudies
Cevimeline
Dental
CYP2D6
CYP2D6poormetabolizers
Precautions
Chloroquine
InfectiousDiseases
G6PD
G6PDdeficient
Precautions
Chlorpropamide
Endocrinology
G6PD
G6PDdeficient
Precautions
CholicAcid
InbornErrorsofMetabolism
AKR1D1,HSD3B7,CYP27A1,AMACR,CYP7A1
Bileacidsynthesisenzymedeficient
IndicationsandUsage,WarningsandPrecautions,AdverseReactions,UseinSpecificPopulations,ClinicalPharmacology,ClinicalStudies
Cisplatin
Oncology
TPMT
TPMTintermediateorpoormetabolizers
AdverseReactions
Citalopram(1)
Psychiatry
CYP2C19
CYP2C19poormetabolizers
ClinicalPharmacology,Warnings,DosageandAdministration
Citalopram(2)
Psychiatry
CYP2D6
CYP2D6poormetabolizers
ClinicalPharmacology
Clobazam
Neurology
CYP2C19
CYP2C19poormetabolizers
DosageandAdministration,UseinSpecificPopulations,ClinicalPharmacology
Clomipramine
Psychiatry
CYP2D6
CYP2D6poormetabolizers
Precautions
Clopidogrel
Cardiology
CYP2C19
CYP2C19intermediateorpoormetabolizers
BoxedWarning,DosageandAdministration,WarningsandPrecautions,ClinicalPharmacology
Clozapine
Psychiatry
CYP2D6
CYP2D6poormetabolizers
DosageandAdministration,UseinSpecificPopulations,ClinicalPharmacology
Cobimetinib
Oncology
BRAF
BRAFV600E/Kmutationpositive
IndicationsandUsage,DosageandAdministration,AdverseReactions,ClinicalPharmacology,ClinicalStudies
Codeine
Anesthesiology
CYP2D6
CYP2D6ultrarapidmetabolizers
BoxedWarning,WarningsandPrecautions,UseinSpecificPopulations,PatientCounselingInformation
Crizotinib
Oncology
ALK
ALKgenerearrangementpositive
IndicationsandUsage,DosageandAdministration,AdverseReactions,ClinicalPharmacology,ClinicalStudies
Dabrafenib(1)
Oncology
BRAF
BRAFV600E/Kmutationpositive
IndicationsandUsage,DosageandAdministration,WarningsandPrecautions,AdverseReactions,ClinicalPharmacology,ClinicalStudies,PatientCounselingInformation
Dabrafenib(2)
Oncology
G6PD
G6PDdeficient
WarningsandPrecautions,AdverseReactions,PatientCounselingInformation
Dapsone(1)
Dermatology
G6PD
G6PDdeficient
WarningsandPrecautions,UseinSpecificPopulations,PatientCounselingInformation
Dapsone(2)
InfectiousDiseases
G6PD
G6PDdeficient
Precautions,AdverseReactions,Overdosage
Dasatinib
Oncology
BCR-ABL1
Philadelphiachromosomepositive,T315Imutationpositive
IndicationsandUsage,DosageandAdministration,WarningsandPrecautions,AdverseReactions,ClinicalPharmacology,ClinicalStudies
DenileukinDiftitox
Oncology
IL2RA
CD25antigenpositive
IndicationsandUsage,WarningsandPrecautions,ClinicalStudies
Desipramine
Psychiatry
CYP2D6
CYP2D6poormetabolizers
Precautions
Dexlansoprazole
Gastroenterology
CYP2C19
CYP2C19poormetabolizers
DrugInteractions,ClinicalPharmacology
DextromethorphanandQuinidine
Neurology
CYP2D6
CYP2D6poormetabolizers
WarningsandPrecautions,ClinicalPharmacology
Diazepam
Neurology
CYP2C19
CYP2C19poormetabolizers
ClinicalPharmacology
Dinutuximab
Oncology
MYCN
MYCNamplificationpositive
ClinicalStudies
Dolutegravir
InfectiousDiseases
UGT1A1
UGT1A1poormetabolizers
ClinicalPharmacology
Doxepin(1)
Psychiatry
CYP2D6
CYP2D6poormetabolizers
ClinicalPharmacology
Doxepin(2)
Psychiatry
CYP2C19
CYP2C19poormetabolizers
ClinicalPharmacology
DrospirenoneandEthinylEstradiol
Gynecology
CYP2C19
CYP2C19intermediatemetabolizers
ClinicalPharmacology
Eliglustat
InbornErrorsofMetabolism
CYP2D6
CYP2D6ultrarapid,intermediateorpoormetabolizers
IndicationsandUsage,DosageandAdministration,Contraindications,WarningsandPrecautions,DrugInteractions,UseinSpecificPopulations,ClinicalPharmacology,ClinicalStudies
Elosulfase
InbornErrorsofMetabolism
GALNS
N-acetylgalactosamine-6-sulfatasedeficient
IndicationsandUsage,WarningsandPrecautions,UseinSpecificPopulations,ClinicalPharmacology,ClinicalStudies
Eltrombopag(1)
Hematology
F5
FactorVLeidencarriers
WarningsandPrecautions
Eltrombopag(2)
Hematology
SERPINC1
AntithrombinIIIdeficient
WarningsandPrecautions
Erlotinib(1)
Oncology
EGFR
EGFRproteinexpressionpositive
ClinicalStudies
Erlotinib(2)
Oncology
EGFR
EGFRexon19deletionorexon21substitution(L858R)positive
IndicationsandUsage,DosageandAdministration,AdverseReactions,ClinicalPharmacology,ClinicalStudies
Escitalopram(1)
Psychiatry
CYP2D6
CYP2D6poormetabolizers
DrugInteractions
Escitalopram(2)
Psychiatry
CYP2C19
CYP2C19poormetabolizers
AdverseReactions
Esomeprazole
Gastroenterology
CYP2C19
CYP2C19poormetabolizers
DrugInteractions,ClinicalPharmacology
Everolimus(1)
Oncology
ERBB2
HER2proteinoverexpressionnegative
IndicationsandUsage,DosageandAdministration,WarningsandPrecautions,AdverseReactions,DrugInteractions,UseinSpecificPopulations,ClinicalPharmacology,ClinicalStudies
Everolimus(2)
Oncology
ESR1
Estrogenreceptorpositive
ClinicalStudies
Evolocumab
Endocrinology
LDLR
LDLreceptormutationheterozygotesandhomozygotes
IndicationsandUsage,DosageandAdministration,AdverseReactions,UseinSpecificPopulations,ClinicalStudies
Exemestane(1)
Oncology
ESR1
Estrogenreceptorpositive
IndicationsandUsage,DosageandAdministration,ClinicalStudies
Exemestane(2)
Oncology
PGR
Progesteronereceptorpositive
ClinicalStudies
Fesoterodine
Urology
CYP2D6
CYP2D6poormetabolizers
DrugInteractions,ClinicalPharmacology
Fluorouracil(1)
Dermatology
DPYD
DPDdeficient
Contraindications,Warnings
Fluorouracil(2)
Oncology
DPYD
DPDdeficient
Warnings
Fluoxetine
Psychiatry
CYP2D6
CYP2D6poormetabolizers
WarningsandPrecautions,DrugInteractions,ClinicalPharmacology
Flurbiprofen
Rheumatology
CYP2C9
CYP2C9poormetabolizers
ClinicalPharmacology
Fluvoxamine
Psychiatry
CYP2D6
CYP2D6poormetabolizers
DrugInteractions
Fulvestrant
Oncology
ESR1,PGR
Hormonereceptorpositive
IndicationsandUsage,ClinicalPharmacology,ClinicalStudies
Galantamine
Neurology
CYP2D6
CYP2D6poormetabolizers
ClinicalPharmacology
Gefitinib
Oncology
EGFR
EGFRexon19deletionsorexon21substitution(L858R)mutationpositive
IndicationsandUsage,DosageandAdministration,ClinicalPharmacology,ClinicalStudies
Glimepiride
Endocrinology
G6PD
G6PDdeficient
WarningsandPrecautions,AdverseReactions
Glipizide
Endocrinology
G6PD
G6PDdeficient
Precautions
Glyburide
Endocrinology
G6PD
G6PDdeficient
Precautions
Hydralazine
Cardiology
NAT1-2
NAT1-2slowacetylators
ClinicalPharmacology
Ibrutinib
Oncology
del(17p)
Chromosome17pdeletionpositive
IndicationsandUsage,ClinicalStudies
Iloperidone
Psychiatry
CYP2D6
CYP2D6poormetabolizers
DosageandAdministration,WarningsandPrecautions,DrugInteractions,ClinicalPharmacology
Imatinib(1)
Oncology
KIT
KITproteinexpressionpositive,c-KITD816Vmutatio
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