FDA基因检测用药指南

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. 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 Labeling

Therapeutic Labeling

Drug Biomarker? Referenced Subgroup?

Area* Sections

Boxed Warning,

Infectious Contraindicati

Abacavir HLA-B HLA-B*5701 allele carriers

Diseases ons, Warnings

and

Precautions Indications

HER2 protein

Ado-Trastuzumand Usage,

Oncology ERBB2 overexpression or gene

ab Emtansine Warnings and

amplification positive

Precautions,

? ? ? ? ?

Labeling Drug

Therapeutic

Biomarker? Referenced Subgroup?

Afatinib Alectinib Alirocumab Amitriptyline Anastrozole Arformoterol (1) Area*

Oncology EGFR Oncology ALK

Endocrinology LDLR

Psychiatry CYP2D6 Oncology ESR1, PGR Pulmonary UGT1A1 Sections Adverse Reactions, Clinical

Pharmacology, Clinical Studies Indications and Usage, Dosage and EGFR exon 19 deletion or

Administratio

exon 21 substitution

n, Adverse

(L858R) positive

Reactions,

Clinical

Pharmacology, Clinical Studies Indications and Usage, Adverse

ALK gene rearrangement Reactions,

positive Clinical

Pharmacology, Clinical Studies Indications and Usage,

LDL receptor mutation Adverse

heterozygotes Reactions,

Clinical Studies

CYP2D6 poor metabolizers Precautions

Indications and Usage, Adverse Hormone receptor positive

Reactions,

Drug

Interactions, Clinical Studies

UGT1A1 poor metabolizers

Clinical

Pharmacology Therapeutic

Biomarker? Referenced Subgroup?

Area*

Arformoterol CYP2D6 intermediate or

Drug

Labeling

Sections Clinical

(2) Aripiprazole Aripiprazole

Lauroxil

Arsenic Trioxide AtomoxetineAzathioprine Pulmonary CYP2D6

poor metabolizers Pharmacology Dosage and Administration, Use in Specific

Psychiatry CYP2D6 CYP2D6 poor metabolizers Populations,

Drug

Interactions, Clinical

Pharmacology Dosage and Administration, Use in

Psychiatry CYP2D6 CYP2D6 poor metabolizers Specific

Populations, Clinical

Pharmacology Clinical

Oncology PML-RARA

PML-RARα translocation Pharmacology

positive

, Indications

and Usage Dosage and Administration, Warnings and

Psychiatry CYP2D6 CYP2D6 poor metabolizers Precautions,

Drug

Interactions, Clinical

Pharmacology Clinical

Pharmacology, Warnings, Precautions, RheumatologDrug

y TPMT TPMT intermediate or poor

metabolizers

Interactions,

Adverse Reactions, Dosage and Administration

Drug

Therapeutic

Biomarker? Referenced Subgroup?

Area* Oncology

Belinostat

Blinatumomab Oncology

Labeling Sections Dosage and

UGT1A1*28 allele Administratio

UGT1A1

homozygotes n, Clinical

Pharmacology Indications

Philadelphia chromosome and Usage,

BCR-ABL1

negative Clinical

Boceprevir

Infectious Diseases

Bosutinib Oncology

Brexpiprazole Psychiatry

Busulfan Oncology

Cabozantinib Oncology

Capecitabine Oncology

Carbamazepin

e (1)

NeurologyCarbamazepinNeurologyIFNL3 BCR-ABL1

CYP2D6 BCR-ABL1

RET DPYD HLA-B HLA-A Studies

IL28B rs12979860 T allele

carriers (C/T and T/T

Clinical

genotype)

Pharmacology

Indications and Usage, Adverse

Philadelphia chromosome Reactions,

positive Use in Specific

Populations, Clinical Studies Dosage and Administration, Drug

CYP2D6 poor metabolizers

Interactions,

Use in Specific Populations, Clinical

Pharmacology

Philadelphia chromosome Clinical

negative Studies

RET mutation positive

Clinical

Studies

Warnings and Precautions,

DPD deficient Patient

Counseling Information Boxed HLA-B*1502 allele carriers

Warning,

Warnings, Precautions

HLA-A*3101 allele carriers Warnings

Drug e (2)

Therapeutic

Biomarker? Referenced Subgroup?

Area* Labeling Sections

Inborn Errors

Carglumic Acid of NAGS

Indications and Usage, Warnings and Precautions,

N-acetylglutamate Use in Specific synthase deficient Populations,

Metabolism

Carisoprodol

Rheumatolog

y

CYP2C19

Carvedilol Cardiology CYP2D6

Celecoxib

Rheumatolog

y

CYP2C9

Ceritinib Oncology ALK

Cetuximab (1) Oncology EGFR

Clinical

Pharmacology, Clinical Studies

Use in Specific

CYP2C19 poor Populations, metabolizers Clinical

Pharmacology Drug

CYP2D6 poor metabolizers

Interactions,

Clinical

Pharmacology Dosage and Administration, Use in

CYP2C9 poor metabolizers Specific

Populations, Clinical

Pharmacology Indications and Usage, Adverse

ALK gene rearrangement Reactions, positive Clinical

Pharmacology, Clinical Studies Indications and Usage, EGFR protein expression

Dosage and

positive

Administratio

n, Warnings and

Precautions,

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