The Use of Genetics in Guiding Therapy

PGx Biomarkers in Drug Labels

June 2012

Pharmacogenomics can play an important role in identifying responders and non-responders to medications, avoiding adverse events, and optimizing drug dose. Drug labels may contain information on genomic biomarkers and can describe for example: drug exposure and clinical response variability, risk for adverse events, genotype-specific dosing, mechanisms of drug action and polymorphic drug target and disposition genes.

< Previous Slide

PGx Biomarkers in Drug Labels

Next Slide >

 

Jump to section:

• Introduction
• Pharmacogenomics
• PGx Biomarkers in Drug Labels
• FDA-Approved Drugs with PGx-Related Label Information
• FDA-Approved Drugs with PGx-Related Label Information
• The FDA and PGx-Related Drug Label Updates
• Clopidogrel (Plavix)
• CYP2C19 and Response to Clopidogrel
• CYP2C19 and Response to Clopidogrel (cont)
• CYP2C19 PGx Testing for Clopidogrel
• Mayo CYP2C19 Test
• The FDA and PGx-Related Drug Label Updates
• Warfarin
• Warfarin PGx
• Allele Frequencies
• Medco-Mayo Warfarin Effectiveness Study
• Mayo Test for Warfarin Sensitivity
• FDA-Approved Drugs with PGx-Related Label Information
• Most Psychotropic Medications Are Metabolized by CYPs
• CYP450 Testing — Psychotherapeutics
• CYP2D6
• Mayo Test for CYP2D6
• Mayo Tests for CYP2D6
• Additional Mayo Tests for Psychiatric Applications
• The FDA and PGx-Related Drug Label Updates
• UGT1A1
• Irinotecan Metabolism
• UGT1A1 Genetic Variants
• Mayo Tests for UGT1A1
• The FDA and PGx-Related Drug Label Updates
• Human Leukocyte Antigens and Drug Hypersensitivity
• HLA-B*1502
• Mayo Test for HLA-B*1502
• HLA-B*5701
• Mayo Test for HLA-B*5701
• Summary
• Questions