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 .
[table id=8 /]
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.