-
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
Drug
Therapeutic
Area*
Biomarker?
Referenced Subgroup?
Labeling Sections
Abacavir
Infectious
Diseases
HLA-B
HLA-B*5701 allele
carriers
Boxed Warning,
Contraindications,
Warnings
and
Precautions
Ado-
Trastuzumab
Emtansine
Oncology
ERBB2
HER2 protein
Indications
and
Usage,
overexpression or gene
Warnings and
Drug
Therapeutic
Area*
Biomarker?
Referenced Subgroup?
Labeling Sections
amplification positive
Precautions, Adverse
Reactions, Clinical
Pharmacology,
Clinical
Studies
Afatinib
Oncology
EGFR
EGFR
exon
19
deletion
or
Indications
and
Usage,
exon 21 substitution
Dosage and
(L858R) positive
Administration,
Adverse
Reactions,
Clinical
Pharmacology,
Clinical
Studies
ALK gene rearrangement
Indications
and
Usage,
positive
Adverse Reactions,
Clinical
Pharmacology,
Clinical
Studies
LDL receptor mutation
heterozygotes
Indications
and
Usage,
Adverse Reactions,
Clinical
Studies
Precautions
Alectinib
Oncology
ALK
Alirocumab
Endocrinology
LDLR
Amitriptyline
Psychiatry
CYP2D6
CYP2D6 poor
metabolizers
Hormone receptor
positive
Anastrozole
Oncology
ESR1, PGR
Indications
and
Usage,
Adverse Reactions,
Drug Interactions,
Clinical
Studies
Clinical Pharmacology
Arformoterol (1)
Pulmonary
UGT1A1
UGT1A1 poor
metabolizers
Arformoterol (2)
Pulmonary
CYP2D6
CYP2D6 intermediate or
Clinical Pharmacology
poor
metabolizers
CYP2D6 poor
metabolizers
Dosage and
Administration,
Use
in
Specific Populations,
Aripiprazole
Psychiatry
CYP2D6
Drug
Therapeutic
Area*
Biomarker?
Referenced Subgroup?
Labeling Sections
Drug
Interactions,
Clinical Pharmacology
Aripiprazole Lauroxil
Psychiatry
CYP2D6
CYP2D6 poor
metabolizers
Dosage and
Administration,
Use
in
Specific
Populations,
Clinical Pharmacology
Arsenic Trioxide
Oncology
PML-RARA
PML-RAR
α
translocation
Clinical
positive
Pharmacology,
Indications and Usage
CYP2D6
poor
metabolizers
Dosage and
Administration,
Warnings and
Precautions, Drug
Interactions,
Clinical
Pharmacology
Clinical
Pharmacology,
Warnings,
Precautions, Drug
Interactions, Adverse
Reactions, Dosage and
Administration
Dosage and
Administration,
Clinical
Pharmacology
Atomoxetine
Psychiatry
CYP2D6
Azathioprine
Rheumatology
TPMT
TPMT intermediate or
poor
metabolizers
Belinostat
Oncology
UGT1A1
UGT1A1*28 allele
homozygotes
Blinatumomab
Oncology
BCR-ABL1
Philadelphia
chromosome
Indications
and
Usage,
negative
Clinical Studies
IL28B
rs12979860 T
Clinical Pharmacology
allele
carriers
(C/T
and
T/T
genotype)
Philadelphia
chromosome
Indications
and
Usage,
positive
Adverse
Reactions,
Use
Boceprevir
Infectious
Diseases
IFNL3
Bosutinib
Oncology
BCR-ABL1
Drug
Therapeutic
Area*
Biomarker?
Referenced Subgroup?
Labeling Sections
in
Specific
Populations, Clinical
Studies
Brexpiprazole
Psychiatry
CYP2D6
CYP2D6 poor
metabolizers
Dosage and
Administration,
Drug
Interactions, Use in
Specific Populations,
Clinical Pharmacology
Busulfan
Oncology
BCR-ABL1
Philadelphia
chromosome
Clinical Studies
negative
RET mutation
positive
DPD deficient
Clinical Studies
Warnings
and
Precautions, Patient
Counseling
Information
Boxed Warning,
Warnings,
Precautions
Warnings
Cabozantinib
Capecitabine
Oncology
Oncology
RET
DPYD
Carbamazepine (1)
Neurology
HLA-B
HLA-B*1502 allele
carriers
HLA-A*3101 allele
carriers
N-acetylglutamate
synthase
deficient
Carbamazepine (2)
Neurology
HLA-A
Carglumic Acid
Inborn Errors
of Metabolism
NAGS
Indications
and
Usage,
Warnings and
Precautions,
Use in
Specific Populations,
Clinical
Pharmacology,
Clinical Studies
Use in
Specific
Populations, Clinical
Pharmacology
Drug
Interactions,
Clinical Pharmacology
Carisoprodol
Rheumatology
CYP2C19
CYP2C19 poor
metabolizers
Carvedilol
Cardiology
CYP2D6
CYP2D6 poor
metabolizers
Drug
Therapeutic
Area*
Biomarker?
Referenced Subgroup?
Labeling Sections
Celecoxib
Rheumatology
CYP2C9
CYP2C9 poor
metabolizers
Dosage and
Administration,
Use
in
Specific
Populations,
Clinical Pharmacology
Ceritinib
Oncology
ALK
ALK
gene rearrangement
Indications
and
Usage,
positive
Adverse Reactions,
Clinical
Pharmacology,
Clinical Studies
EGFR
protein expression
Indications
and
Usage,
positive
Dosage and
Administration,
Warnings and
Precautions, Adverse
Reactions, Clinical
Pharmacology,
Clinical
Studies
KRAS codon 12 and 13
mutation negative
Indications
and
Usage,
Dosage and
Administration,
Warnings and
Precautions, Adverse
Reactions, Clinical
Pharmacology,
Clinical
Studies
Precautions
Cetuximab (1)
Oncology
EGFR
Cetuximab (2)
Oncology
KRAS
Cevimeline
Dental
CYP2D6
CYP2D6 poor
metabolizers
G6PD deficient
Chloroquine
Infectious
Diseases
Endocrinology
Inborn Errors
of Metabolism
G6PD
Precautions
Chlorpropamide
Cholic Acid
G6PD
AKR1D1,
HSD3B7,
G6PD deficient
Bile acid
synthesis
enzyme deficient
Precautions
Indications
and
Usage,
Warnings and
Drug
Therapeutic
Area*
Biomarker?
Referenced Subgroup?
Labeling Sections
CYP27A1,
AMACR,
CYP7A1
Precautions, Adverse
Reactions, Use in
Specific
Populations,
Clinical
Pharmacology,
Clinical
Studies
TPMT intermediate or
poor metabolizers
CYP2C19
poor
metabolizers
Adverse
Reactions
Cisplatin
Oncology
TPMT
Citalopram (1)
Psychiatry
CYP2C19
Clinical
Pharmacology,
Warnings, Dosage and
Administration
Clinical
Pharmacology
Citalopram (2)
Psychiatry
CYP2D6
CYP2D6 poor
metabolizers
CYP2C19 poor
metabolizers
Clobazam
Neurology
CYP2C19
Dosage and
Administration,
Use
in
Specific
Populations,
Clinical Pharmacology
Precautions
Clomipramine
Psychiatry
CYP2D6
CYP2D6 poor
metabolizers
Clopidogrel
Cardiology
CYP2C19
CYP2C19 intermediate or
Boxed Warning, Dosage
poor
metabolizers
and Administration,
Warnings and
Precautions,
Clinical
Pharmacology
CYP2D6
poor
metabolizers
Dosage and
Administration,
Use
in
Specific Populations,
Clinical Pharmacology
Indications
and
Usage,
Dosage and
Administration,
Clozapine
Psychiatry
CYP2D6
Cobimetinib
Oncology
BRAF
BRAF V600E/K mutation
positive
Drug
Therapeutic
Area*
Biomarker?
Referenced Subgroup?
Labeling Sections
Adverse
Reactions,
Clinical
Pharmacology,
Clinical
Studies
Codeine
Anesthesiolog
y
CYP2D6
CYP2D6 ultrarapid
metabolizers
Boxed Warning,
Warnings and
Precautions,
Use in
Specific Populations,
Patient Counseling
Information
Crizotinib
Oncology
ALK
ALK
gene rearrangement
Indications
and
Usage,
positive
Dosage and
Administration,
Adverse
Reactions,
Clinical
Pharmacology,
Clinical
Studies
BRAF V600E/K mutation
positive
Indications
and
Usage,
Dosage
and
Administration,
Warnings
and
Precautions, Adverse
Reactions, Clinical
Pharmacology,
Clinical
Studies,
Patient Counseling
Information
Warnings and
Precautions, Adverse
Reactions, Patient
Counseling
Information
Warnings and
Precautions,
Use in
Dabrafenib (1)
Oncology
BRAF
Dabrafenib (2)
Oncology
G6PD
G6PD deficient
Dapsone
(1)
Dermatology
G6PD
G6PD deficient
Drug
Therapeutic
Area*
Biomarker?
Referenced Subgroup?
Labeling Sections
Specific
Populations,
Patient Counseling
Information
Dapsone
(2)
Infectious
Diseases
Oncology
G6PD
G6PD deficient
Precautions, Adverse
Reactions, Overdosage
Dasatinib
BCR-
ABL1
Philadelphia
chromosome
Indications
and
Usage,
positive, T315I
Dosage and
mutation positive
Administration,
Warnings and
Precautions, Adverse
Reactions, Clinical
Pharmacology,
Clinical
Studies
CD25 antigen positive
Indications
and
Usage,
Warnings and
Precautions, Clinical
Studies
Precautions
Denileukin Diftitox
Oncology
IL2RA
Desipramine
Psychiatry
CYP2D6
CYP2D6 poor
metabolizers
CYP2C19 poor
metabolizers
CYP2D6 poor
metabolizers
Dexlansoprazole
Gastroenterol
ogy
Neurology
CYP2C19
Drug Interactions,
Clinical
Pharmacology
Warnings and
Precautions, Clinical
Pharmacology
Clinical
Pharmacology
Dextromethorphan and
Quinidine
CYP2D6
Diazepam
Neurology
CYP2C19
CYP2C19 poor
metabolizers
MYCN amplification
positive
UGT1A1 poor
metabolizers
Dinutuximab
Oncology
MYCN
Clinical Studies
Dolutegravir
Infectious
Diseases
UGT1A1
Clinical Pharmacology
Drug
Therapeutic
Area*
Biomarker?
Referenced Subgroup?
Labeling Sections
Doxepin
(1)
Psychiatry
CYP2D6
CYP2D6 poor
metabolizers
CYP2C19 poor
metabolizers
CYP2C19
intermediate
metabolizers
CYP2D6 ultrarapid,
intermediate or poor
metabolizers
Clinical
Pharmacology
Doxepin (2)
Psychiatry
CYP2C19
Clinical Pharmacology
Drospirenone
and
Ethinyl
Gynecology
Estradiol
Eliglustat
Inborn
Errors
of Metabolism
CYP2C19
Clinical Pharmacology
CYP2D6
Indications
and
Usage,
Dosage and
Administration,
Contraindications,
Warnings
and
Precautions, Drug
Interactions, Use in
Specific Populations,
Clinical
Pharmacology,
Clinical Studies
Indications
and
Usage,
Warnings and
Precautions,
Use in
Specific Populations,
Clinical
Pharmacology,
Clinical Studies
Elosulfase
Inborn
Errors
of Metabolism
GALNS <
/p>
N-acetylgalactosamine-
6-sulfa
tase deficient
Eltrombopag
(1)
Hematology
F5
Factor
V
Leiden
carriers
Warnings and
Precautions
Antithrombin III
deficient
Warnings and
Precautions
Eltrombopag
(2)
Hematology
SERPINC1
Erlotinib
(1)
Oncology
EGFR
EGFR protein expression
Clinical Studies
positive
EGFR
exon
19
deletion
or
Indications
and
Usage,
exon 21 substitution
Dosage and
Erlotinib
(2)
Oncology
EGFR
Drug
Therapeutic
Area*
Biomarker?
Referenced Subgroup?
Labeling Sections
(L858R)
positive
Administration,
Adverse Reactions,
Clinical
Pharmacology,
Clinical
Studies
Drug Interactions
Escitalopram (1)
Psychiatry
CYP2D6
CYP2D6 poor
metabolizers
CYP2C19 poor
metabolizers
CYP2C19 poor
metabolizers
Escitalopram (2)
Psychiatry
CYP2C19
Adverse Reactions
Esomeprazole
Gastroenterol
ogy
Oncology
CYP2C19
Drug Interactions,
Clinical
Pharmacology
Everolimus (1)
ERBB2
HER2 protein
Indications
and
Usage,
overexpression
negative
Dosage and
Administration,
Warnings and
Precautions, Adverse
Reactions, Drug
Interactions, Use in
Specific Populations,
Clinical
Pharmacology,
Clinical Studies
Estrogen
receptor
positive
LDL
receptor mutation
heterozygotes and
homozygotes
Clinical Studies
Everolimus (2)
Oncology
ESR1
Evolocumab
Endocrinology
LDLR
Indications
and
Usage,
Dosage and
Administration,
Adverse
Reactions,
Use
in
Specific
Populations, Clinical
Studies
Indications
and
Usage,
Exemestane (1)
Oncology
ESR1
Estrogen receptor
Drug
Therapeutic
Area*
Biomarker?
Referenced Subgroup?
Labeling Sections
positive
Dosage and
Administration,
Clinical Studies
Clinical
Studies
Exemestane (2)
Oncology
PGR
Progesterone receptor
positive
CYP2D6 poor
metabolizers
DPD deficient
Fesoterodine
Urology
CYP2D6
Drug Interactions,
Clinical
Pharmacology
Contraindications,
Warnings
Warnings
Warnings and
Precautions,
Drug
Interactions,
Clinical
Pharmacology
Clinical Pharmacology
Fluorouracil (1)
Dermatology
DPYD
Fluorouracil (2)
Fluoxetine
Oncology
Psychiatry
DPYD
CYP2D6
DPD
deficient
CYP2D6 poor
metabolizers
Flurbiprofen
Rheumatology
CYP2C9
CYP2C9 poor
metabolizers
CYP2D6 poor
metabolizers
Hormone receptor
positive
Fluvoxamine
Psychiatry
CYP2D6
Drug Interactions
Fulvestrant
Oncology
ESR1, PGR
Indications
and
Usage,
Clinical
Pharmacology,
Clinical
Studies
Clinical Pharmacology
Galantamine
Neurology
CYP2D6
CYP2D6 poor
metabolizers
EGFR exon 19 deletions
or
exon 21 substitution
(L858R) mutation
positive
Gefitinib
Oncology
EGFR
Indications
and
Usage,
Dosage and
Administration,
Clinical
Pharmacology,
Clinical
Studies
Drug
Therapeutic
Area*
Biomarker?
Referenced Subgroup?
Labeling Sections
Glimepiride
Endocrinology
G6PD
G6PD deficient
Warnings and
Precautions, Adverse
Reactions
Precautions
Precautions
Glipizide
Glyburide
Hydralazine
Ibrutinib
Endocrinology
Endocrinology
Cardiology
Oncology
G6PD
G6PD
NAT1-2
del (17p)
G6PD deficient
G6PD deficient
NAT
1-2
slow
acetylators
Clinical
Pharmacology
Chromosome 17p deletion
Indications
and
Usage,
positive
Clinical Studies
CYP2D6 poor
metabolizers
Dosage and
Administration,
Warnings and
Precautions, Drug
Interactions,
Clinical
Pharmacology
Iloperidone
Psychiatry
CYP2D6
Imatinib (1)
Oncology
KIT
KIT
protein expression
Indications
and
Usage,
positive, c-KIT D816V
Dosage
and
mutation negative
Administration,
Warnings and
Precautions, Adverse
Reactions, Use in
Specific
Populations,
Clinical
Pharmacology,
Clinical
Studies
Philadelphia
chromosome
Indications
and
Usage,
positive
Dosage and
Administration,
Warnings and
Precautions, Adverse
Reactions, Use in
Specific
Populations,
Clinical
Imatinib (2)
Oncology
BCR-ABL1