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
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