theragenomics: drug labels with annotated information

thasso provides the present information via PharmGKB which constantly annotates drug labels and or product monographs containing pharmacogenetic (i.e., theragenomic) information approved by the US Food and Drug Administration (FDA), the European Medicines Agency (EMA), the Pharmaceuticals and Medical Devices Agency, Japan (PMDA), and Health Canada (Santé Canada) (HCSC). PharmGKB annotations provide a brief summary of the pharmacogenetic information in the label, an excerpt from the label and a downloadable PDF file of the label in question with the respective  pharmacogenetic information highlighted.  A list of genes and phenotypes found within the label is mapped to label section headers and listed at the end of each annotation. PharmGKB also attempts to interpret the level of action implied in each label with the “PGx Level” tag. Unfortunately, similar information is not available from Swissmedic, the Swiss Agency of Therapeutic Products. Thus, for the time being, the according column in the Table below holds no information .

 

Pharmacogically active ingredient

FDA

EMA

PMDA

HCSC

Swissmedic

 

abacavir

Genetic testing recommended

Genetic testing required

Informative PGx

Genetic testing recommended

  

abiraterone

Informative PGx

     

acetaminophen

Actionable PGx

  

Actionable PGx

  

afatinib

Genetic testing required

Genetic testing required

 

Genetic testing required

  

afutuzumab

Informative PGx

     

aliskiren

 

Informative PGx

    

amitriptyline

Actionable PGx

     

anastrozole

Genetic testing required

  

Genetic testing required

  

arformoterol

Informative PGx

     

aripiprazole

Actionable PGx

Actionable PGx

 

Actionable PGx

  

arsenic trioxide

Genetic testing required

Genetic testing required

Genetic testing required

Genetic testing required

  

atazanavir

 

Genetic testing recommended

    

atomoxetine

Actionable PGx

 

Actionable PGx

Actionable PGx

  

atorvastatin

Actionable PGx

 

Actionable PGx

Actionable PGx

  

axitinib

 

Informative PGx

    

azathioprine

Genetic testing recommended

 

Actionable PGx

Actionable PGx

  

belimumab

Informative PGx

Informative PGx

    

boceprevir

Informative PGx

Informative PGx

 

Informative PGx

  

bosutinib

Genetic testing required

Genetic testing required

 

Genetic testing required

  

brentuximab vedotin

Informative PGx

Genetic testing required

    

busulfan

Actionable PGx

    

cabazitaxel

 

Informative PGx

    

capecitabine

Actionable PGx

Actionable PGx

Actionable PGx

Actionable PGx

  

carbamazepine

Genetic testing required

 

Informative PGx

Genetic testing recommended

  

carglumic acid

Genetic testing required

Genetic testing required

    

carisoprodol

Actionable PGx

     

carvedilol

Actionable PGx

  

Actionable PGx

  

celecoxib

Actionable PGx

 

Informative PGx

Actionable PGx

  

ceritinib

Genetic testing required

     

cetuximab

Genetic testing required

Genetic testing required

Genetic testing required

Genetic testing required

  

cevimeline

Actionable PGx

     

chloroquine

Actionable PGx

     

chlorpropamide

Actionable PGx

  

Actionable PGx

  

cisplatin

Actionable PGx

     

citalopram

Actionable PGx

  

Actionable PGx

  

clobazam

Actionable PGx

     

clomifene

     

clomipramine

Actionable PGx

     

clopidogrel

Genetic testing recommended

Actionable PGx

Actionable PGx

Actionable PGx

  

clozapine

Actionable PGx

     

codeine

Actionable PGx

  

Actionable PGx

  

crizotinib

Genetic testing required

Genetic testing required

Genetic testing required

Genetic testing required

  

dabrafenib

Actionable PGx

Genetic testing required

 

Genetic testing required

  

dapsone

Actionable PGx

  

Actionable PGx

  

darifenacin

Actionable PGx

Actionable PGx

 

Actionable PGx

  

darunavir

 

Informative PGx

    

dasatinib

Genetic testing required

Genetic testing required

Genetic testing required

Genetic testing required

  

denileukin diftitox

Genetic testing required

     

desflurane

   

Actionable PGx

  

desipramine

Actionable PGx

     

desloratadine

Informative PGx

    

dexlansoprazole

Actionable PGx

  

Actionable PGx

  

dextromethorphan

Genetic testing recommended

Actionable PGx

    

diazepam

Actionable PGx

     

divalproex sodium

Genetic testing required

  

Genetic testing required

  

doxepin

Actionable PGx

     

dronedarone

 

Informative PGx

    

drospirenone

Informative PGx

  

Actionable PGx

  

efavirenz

 

Actionable PGx

 

Actionable PGx

  

eliglustat

Genetic testing required

Genetic testing required

    

eltrombopag

Actionable PGx

Actionable PGx

Actionable PGx

Actionable PGx

  

emtricitabine

 

Actionable PGx

    

erlotinib

Genetic testing required

Genetic testing required

 

Genetic testing required

  

erythromycin

Actionable PGx

  

Actionable PGx

  

esomeprazole

Actionable PGx

Informative PGx

 

Informative PGx

  

ethinyl estradiol

Informative PGx

Genetic testing required

 

Actionable PGx

  

everolimus

Genetic testing required

Actionable PGx

 

Genetic testing required

  

exemestane

Genetic testing required

  

Genetic testing required

  

fampridine

 

Informative PGx

    

fesoterodine

Actionable PGx

Actionable PGx

 

Actionable PGx

  

fluorouracil

Actionable PGx

 

Actionable PGx

Actionable PGx

  

fluoxetine

Informative PGx

     

flurbiprofen

Informative PGx

     

fluvoxamine

Informative PGx

     

fosamprenavir

 

Informative PGx

    

fulvestrant

Genetic testing required

Genetic testing required

Genetic testing required

   

galantamine

Informative PGx

  

Informative PGx

  

gefitinib

Informative PGx

Genetic testing required

Genetic testing required

Genetic testing required

  

glibenclamide

Actionable PGx

  

Actionable PGx

  

glimepiride

Actionable PGx

Actionable PGx

 

Actionable PGx

  

glipizide

Actionable PGx

     

homoharringtonine

Informative PGx

     

hydralazine

Informative PGx

     

ibritumomab

Informative PGx

Genetic testing required

    

ibrutinib

Genetic testing required

Genetic testing required

 

Genetic testing required

  

iloperidone

Actionable PGx

     

imatinib

Genetic testing required

Genetic testing required

Genetic testing required

Genetic testing required

  

imipramine

Actionable PGx

     

indacaterol

Informative PGx

Informative PGx

Informative PGx

   

indinavir

 

Informative PGx

    

irinotecan

Actionable PGx

 

Actionable PGx

Actionable PGx

  

isoflurane

   

Actionable PGx

  

isoniazid

Informative PGx

     

isosorbide dinitrate

Informative PGx

     

ivabradine

 

Informative PGx

    

ivacaftor

Genetic testing required

Genetic testing required

 

Genetic testing required

  

lansoprazole

Informative PGx

     

lapatinib

Genetic testing required

Genetic testing required

Genetic testing required

Genetic testing required

  

lenalidomide

Informative PGx

Informative PGx

Informative PGx

Informative PGx

  

letrozole

Genetic testing required

  

Genetic testing required

  

lomitapide

Informative PGx

Genetic testing required

 

Informative PGx

  

mafenide

Actionable PGx

     

maraviroc

Genetic testing required

Genetic testing required

 

Genetic testing required

  

mercaptopurine

Genetic testing recommended

Actionable PGx

 

Actionable PGx

  

methylene blue

Actionable PGx

Actionable PGx

    

metoclopramide

Actionable PGx

     

metoprolol

Informative PGx

  

Actionable PGx

  

mipomersen

Informative PGx

     

modafinil

Actionable PGx

     

mycophenolic acid

Actionable PGx

 

Actionable PGx

Actionable PGx

  

nalidixic acid

Actionable PGx

     

nefazodone

Informative PGx

     

nelfinavir

Informative PGx

Informative PGx

    

nilotinib

Genetic testing required

Genetic testing required

 

Genetic testing required

  

nitrofurantoin

Actionable PGx

  

Actionable PGx

  

norelgestromin

 

Genetic testing required

 

Actionable PGx

  

norfloxacin

Actionable PGx

  

Actionable PGx

  

nortriptyline

Actionable PGx

  

Actionable PGx

  

ofatumumab

Informative PGx

Informative PGx

    

olanzapine

Informative PGx

Informative PGx

    

omeprazole

Informative PGx

  

Informative PGx

  

panitumumab

Genetic testing required

Genetic testing required

Genetic testing required

Genetic testing required

  

pantoprazole

Actionable PGx

    

paroxetine

Informative PGx

     

pazopanib

Actionable PGx

Actionable PGx

    

peginterferon alfa-2b

Actionable PGx

    

pegloticase

Actionable PGx

Genetic testing required

    

perphenazine

Actionable PGx

     

pertuzumab

Genetic testing required

Genetic testing required

 

Genetic testing required

  

phenylacetic acid

Informative PGx

     

phenytoin

Actionable PGx

  

Genetic testing recommended

  

pimozide

Genetic testing required

     

ponatinib

Actionable PGx

Genetic testing required

    

posaconazole

 

Informative PGx

    

prasugrel

Informative PGx

Informative PGx

    

pravastatin

Informative PGx

    

primaquine

Actionable PGx

  

Actionable PGx

  

probenecid

Actionable PGx

     

propafenone

Actionable PGx

  

Actionable PGx

  

propranolol

Informative PGx

Informative PGx

    

protriptyline

Actionable PGx

     

pyrazinamide

Informative PGx

     

quinidine

Genetic testing recommended

Actionable PGx

    

quinine

Actionable PGx

  

Actionable PGx

  

rabeprazole

Informative PGx

  

Actionable PGx

  

ranolazine

 

Actionable PGx

    

rasburicase

Genetic testing required

Actionable PGx

Genetic testing required

Genetic testing recommended

  

regorafenib

Informative PGx

Informative PGx

    

rifampin

Informative PGx

     

risperidone

Informative PGx

  

Informative PGx

  

ritonavir

 

Informative PGx

    

rituximab

Informative PGx

Genetic testing required

    

rosuvastatin

Informative PGx

  

Actionable PGx

  

ruxolitinib

 

Informative PGx

    

sevoflurane

   

Actionable PGx

  

sildenafil

 

Informative PGx

    

simeprevir

Informative PGx

  

Informative PGx

  

sirolimus

 

Informative PGx

    

sodium benzoate

Informative PGx

     

sodium nitrite

Actionable PGx

     

sodium phenylbutyrate

Informative PGx

Informative PGx

 

Genetic testing required

  

sofosbuvir

Informative PGx

     

succimer

Informative PGx

     

succinylcholine

   

Actionable PGx

  

sulfadiazine

Actionable PGx

  

Actionable PGx

  

sulfamethoxazole

Actionable PGx

  

Actionable PGx

  

sulfasalazine

Actionable PGx

  

Actionable PGx

  

sulfisoxazole

Actionable PGx

  

Actionable PGx

  

sunitinib

 

Informative PGx

    

tamoxifen

Actionable PGx

  

Genetic testing required

  

telaprevir

Actionable PGx

Actionable PGx

    

telithromycin

 

Informative PGx

    

tenofovir

 

Actionable PGx

    

terbinafine

Informative PGx

     

tetrabenazine

Genetic testing required

  

Actionable PGx

  

thioguanine

Actionable PGx

  

Actionable PGx

  

thioridazine

Actionable PGx

     

ticagrelor

Informative PGx

Actionable PGx

    

timolol

Informative PGx

    

tiotropium

Informative PGx

     

tipranavir

 

Informative PGx

    

tolterodine

Actionable PGx

 

Informative PGx

Informative PGx

  

tositumomab

Informative PGx

     

tramadol

Actionable PGx

  

Actionable PGx

  

trametinib

Genetic testing required

Genetic testing required

 

Genetic testing required

  

trastuzumab

Genetic testing required

Genetic testing required

Genetic testing required

Genetic testing required

  

trastuzumab emtansine

Genetic testing required

Genetic testing required

 

Genetic testing required

  

tretinoin

Genetic testing required

 

Informative PGx

Genetic testing required

  

trimethoprim

Actionable PGx

  

Actionable PGx

  

trimipramine

Actionable PGx

     

valproic acid

Genetic testing required

 

Actionable PGx

Actionable PGx

  

vandetanib

 

Genetic testing recommended

    

vardenafil

 

Informative PGx

    

velaglucerase alfa

Genetic testing required

Genetic testing required

 

Genetic testing required

  

vemurafenib

Genetic testing required

Genetic testing required

 

Genetic testing required

  

venlafaxine

Informative PGx

     

vitamin c

Actionable PGx

  

Actionable PGx

  

voriconazole

Actionable PGx

Informative PGx

 

Actionable PGx

  

vortioxetine

Actionable PGx

Actionable PGx

 

Actionable PGx

  

warfarin

Actionable PGx

  

Actionable PGx

  

zonisamide

 

Informative PGx

    
       
       
 

Legend (how to read);

  • Genetic testing required:  The label states or implies that some sort of gene, protein or chromosomal testing, including genetic testing, functional protein assays, cytogenetic studies, etc., should be conducted before using this drug. 
  • Genetic testing recommended: The label states or implies that some sort of gene, protein or chromosomal testing, including genetic testing, functional protein assays, cytogenetic studies, etc., is recommended before using this drug. 
  • Actionable PGx: The label does not discuss genetic or other testing for gene/protein/chromosomal variants, but does contain information about changes in efficacy, dosage or toxicity due to such variants. 
  • Informative PGx: The label mentions a gene or protein is involved in the metabolism or pharmacodynamics of the drug, but there is no information to suggest that variation in these genes/proteins leads to different response.
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