FDA基因检测用药指南.docx

FDA基因检测用药指南.docx

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FDA基因检测用药指南

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

InbornErrorsofMet