fda基因检测.docx

fda基因检测.docx

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fda基因检测

PharmacogenomicBiomarkersinDrugLabeling

Abacavir

InfectiousDiseases

HLA-B

HLA-B*5701allelecarriers

BoxedWarning,Contraindications,WarningsandPrecautions

PharmacogenomicInformationonAdo-TrastuzumabEmtansine

Oncology

ERBB2

HER2proteinoverexpressionorgeneamplificationpositive

IndicationsandUsage,WarningsandPrecautions,AdverseReactions,ClinicalPharmacology,ClinicalStudies

PharmacogenomicInformationonAfatinib

Oncology

EGFR

EGFRexon19deletionorexon21substitution（L858R）positive

IndicationsandUsage,DosageandAdministration,AdverseReactions,ClinicalPharmacology,ClinicalStudies

Amitriptyline

Psychiatry

CYP2D6

CYP2D6poormetabolizers

Precautions

Anastrozole

Oncology

ESR1,PGR

Hormonereceptor-positive

IndicationsandUsage,AdverseReactions,DrugInteractions,ClinicalStudies

Arformoterol

（1）

Pulmonary

UGT1A1

UGT1A1poormetabolizers

ClinicalPharmacology

Arformoterol

（2）

Pulmonary

CYP2D6

CYP2D6intermediateorpoormetabolizers

ClinicalPharmacology

Aripiprazole

Psychiatry

CYP2D6

CYP2D6poormetabolizers

DosageandAdministration,ClinicalPharmacology

PharmacogenomicInformationonArsenicTrioxide

Oncology

PML-RARA

PML-RARαtranslocationpositive

ClinicalPharmacology,IndicationsandUsage

Atomoxetine

Psychiatry

CYP2D6

CYP2D6poormetabolizers

DosageandAdministration,WarningsandPrecautions,DrugInteractions,ClinicalPharmacology

Azathioprine

Rheumatology

TPMT

TPMTintermediateorpoormetabolizers

ClinicalPharmacology,Warnings,PrecautionsDrugInteractions,AdverseReactions,DosageandAdministration

Boceprevir

InfectiousDiseases

IFNL3

IL28Brs12979860Tallelecarriers（C/TandT/Tgenotype）

ClinicalPharmacology

Bosutinib

Oncology

BCR/ABL1

Philadelphiachromosomepositive

IndicationsandUsageAdverseReactions,UseinSpecificPopulations,ClinicalStudies

Busulfan

Oncology

BCR-ABL1

Philadelphiachromosomenegative

ClinicalStudies

Capecitabine

Oncology

DPYD

DPDdeficient

Contraindications,WarningsandPrecautions,PatientInformation

Carbamazepine

（1）

Neurology

HLA-B

HLA-B*1502allelecarriers

BoxedWarning,Warnings,Precautions

Carbamazepine

（2）

Neurology

HLA-A

HLA-A*3101allelecarriers

Warnings

PharmacogenomicInformationonCarglumicAcid

InbornErrorsofMetabolism

NAGS

N-acetylglutamatesynthasedeficient

IndicationsandUsage,WarningsandPrecautions,UseinSpecificPopulationsClinicalPharmacologyClinicalStudies

Carisoprodol

Rheumatology

CYP2C19

CYP2C19poormetabolizers

UseinSpecificPopulations,ClinicalPharmacology

Carvedilol

Cardiology

CYP2D6

CYP2D6poormetabolizers

DrugInteractions,ClinicalPharmacology

Celecoxib

Rheumatology

CYP2C9

CYP2C9poormetabolizers

DosageandAdministration,UseinSpecificPopulations,ClinicalPharmacology

PharmacogenomicInformationonCeritinib

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

Cisplatin

Oncology

TPMT

TPMTintermediateorpoormetabolizers

ClinicalPharmacology,Warnings,Precautions,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

Codeine

Anesthesiology

CYP2D6

CYP2D6ultra-rapidmetabolizers

BoxedWarnings,WarningsandPrecautions,UseinSpecificPopulations,PatientCounselingInformation

PharmacogenomicInformationonCrizotinib

Oncology

ALK

ALKgenerearrangementpositive

IndicationsandUsage,DosageandAdministration,AdverseReactions,ClinicalPharmacology,ClinicalStudies

Dabrafenib

（1）

Oncology

BRAF

BRAFV600E/Kmutationpositive

IndicationsandUsage,Dosage