RT Book, Section
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.
SR Print(0)
ID 1102698389
T1 Pharmacogenomic Information in Drug Labeling
T2 Clinical Genomics: Practical Applications in Adult Patient Care
YR 2014
FD 2014
PB McGraw-Hill Education
PP New York, NY
SN 9780071622448
LK accessmedicine.mhmedical.com/content.aspx?aid=1102698389
RD 2024/04/20
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.