TY - CHAP M1 - Book, Section TI - Pharmacogenomic Information in Drug Labeling A1 - Rogers, Hobart L. A1 - Pacanowski, Michael A2 - Murray, Michael F. A2 - Babyatsky, Mark W. A2 - Giovanni, Monica A. A2 - Alkuraya, Fowzan S. A2 - Stewart, Douglas R. Y1 - 2014 N1 - T2 - Clinical Genomics: Practical Applications in Adult Patient Care AB - Drug summary:Pharmacogenomic information is contained in the labeling of many drugs; the type of data available determine whether the results of a test are clinically actionable or useful.Pharmacogenomic tests can be used to select patients for therapy based on their ability to identify responders, predict adverse events, or guide drug dosing.Most pharmacogenomic labeling has focused on drugs thatHave a narrow therapeutic indexExhibit highly variable pharmacokinetics or responsesAre used to treat morbid or mortal conditionsHave serious toxicitiesSeveral examples exist where knowledge of a patient’s genotype can significantly influence the benefit-risk profile of a drug product and aid therapeutic decision making. Some examples of this includeWarfarin—CYP2C9 and VKORC1 genotypes predict stable warfarin doses and risk for severe bleeding.Clopidogrel—CYP2C19 genotype identifies individuals with low active metabolite exposure and diminished responses who may benefit from drugs not metabolized by CYP2C19.Abacavir—HLA-B*5701 genotype identifies patients at risk for severe hypersensitivity reactions that should not receive the drug.For a comprehensive list of all drugs with pharmacogenomic information appearing in their labels see http://www.fda.gov/Drugs/ScienceResearch/ResearchAreas/Pharmacogenetics/ucm083378.htm. SN - PB - McGraw-Hill Education CY - New York, NY Y2 - 2024/03/29 UR - accessmedicine.mhmedical.com/content.aspx?aid=1102698389 ER -