fda公布药品说明书中药物基因组学相关生物标志物列表.docVIP

Table of Pharmacogenomic Biomarkers in Drug Labeling Pharmacogenomics can play an important role in identifying responders and non-responders to medications, avoiding adverse events, and optimizing drug dose. Drug labeling may contain information on genomic biomarkers and can describe: Drug exposure and clinical response variability Risk for adverse events Genotype-specific dosing Mechanisms of drug action Polymorphic drug target and disposition genes The table below lists FDA-approved drugs with pharmacogenomic information in their labeling. The labeling for some, but not all, of the products includes specific actions to be taken based on the biomarker information. Pharmacogenomic information can appear in different sections of the labeling depending on the actions. For more information, please refer to the appropriate labeling guidance. Biomarkers in the table include but are not limited to germ-line or somatic gene variants, functional deficiencies, expression changes, and chromosomal abnormalities; selected protein biomarkers that are used to select patients for treatment are also included. This table does not include non-human genetic biomarkers (e.g., microbial variants that influence sensitivity to antibiotics), or biomarkers that are used solely for diagnostic purposes (e.g., for genetic diseases) unless they are linked to drug activity or used to identify a specific subset in whom prescribing information differs. For drugs that are available in multiple dosage forms, salts, or combinations, a single representative product is listed. In the case of combination products, the single agent associated with the biomarker is listed unless the agent is only approved as a combination product, in which case all agents are listed. Pharmacogenomic Biomarkers in Drug Labeling Drug Therapeutic Area* Biomarker? Referenced Subgroup? Labeling Sections HYPERLINK /scripts/cder/daf/index.cfm?event=cessvarApplNo=020977 Abacavir Infectious Diseases HLA-B HLA-B*5701 allele carri