FDA基因检测用药指南

1、FDA基因检测用药指南Table of Pharmacogenomic Biomarkers in Drug LabelingPharmacogenomics can play an important role in identifying responders andnon-responders to medications, avoiding adverse events, and optimizing drug dose. Drug labeling may contain information on genomic biomarkers and can describe:Drug

2、exposure and clinical response variability Risk for adverse events Genotype-specific dosing Mechanisms of drug actionPolymorphic drug target and disposition genesThe table below lists FDA-approved drugs with pharmacogenomic information in their labeling. The labeling for some, but not all, of the pr

3、oducts includes specific actions to be taken based on the biomarker information. Pharmacogenomicinformation 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 l

4、imited to germ-line or somatic gene variants, functional deficiencies, expression changes, and chromosomalabnormalities; 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 varian

5、ts that influence sensitivity to antibiotics), or biomarkers that are used solely fordiagnostic 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

6、 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

7、 LabelingTherapeutic LabelingDrug Biomarker? Referenced Subgroup?Area* SectionsBoxed Warning,Infectious ContraindicatiAbacavir HLA-B HLA-B*5701 allele carriersDiseases ons, Warnings andPrecautions IndicationsHER2 proteinAdo-Trastuzumand Usage,Oncology ERBB2 overexpression or geneab Emtansine Warning

8、s andamplification positivePrecautions, 9 9 9 9 9 Labeling DrugTherapeuticBiomarker? Referenced Subgroup?Afatinib Alectinib Alirocumab Amitriptyline Anastrozole Arformoterol (1) Area*Oncology EGFR Oncology ALKEndocrinology LDLRPsychiatry CYP2D6 Oncology ESRI, PGR Pulmonary UGT1A1 Sections Adverse Re

9、actions, ClinicalPharmacology, Clinical Studies Indications and Usage, Dosage and EGFR exon 19 deletion orAdministratioexon 21 substitutionn, Adverse(L858R) positiveReactions,ClinicalPharmacology, Clinical Studies Indications and Usage, AdverseALK gene rearrangement Reactions,positive ClinicalPharma

10、cology, Clinical Studies Indications and Usage,LDL receptor mutation Adverseheterozygotes Reactions,Clinical StudiesCYP2D6 poor metabolizers PrecautionsIndications and Usage, Adverse Hormone receptor positiveReactions,DrugInteractions, Clinical StudiesUGT1A1 poor metabolizersClinicalPharmacology The

11、rapeuticBiomarker? Referenced Subgroup?Area*Arformoterol CYP2D6 intermediate orDrugLabelingSections Clinical(2) Aripiprazole AripiprazoleLauroxilArsenic Trioxide At omox e t i neAz ath i opr i ne Pulmonary CYP2D6poor metabolizers Pharmacology Dosage and Administration, Use in Specific Psychiatry CYP

12、2D6 CYP2D6 poor metabolizers Populations,Drug Interactions, Clinical Pharmacology Dosage and Administration, Use in Psychiatry CYP2D6 CYP2D6 poor metabolizers Specific Populations, Clinical Pharmacology Clinical Oncology PML-RARA PML-RAR o translocation Pharmacology positive ,Indications and Usage D

13、osage and Administration, Warnings and Psychiatry CYP2D6 CYP2D6 poor metabolizers Precautions, Drug Interactions, Clinical Pharmacology ClinicalPharmacology, Warnings, Precautions, RheumatologDrugy TPMT TPMT intermediate or poormetabolizersInteractions,Adverse Reactions, Dosage and AdministrationDru

14、gTherapeuticBiomarker? Referenced Subgroup?Area* OncologyBelinostatBlinatumomab OncologyLabeling Sections Dosage andUGT1A1*28 allele AdministratioUGT1A1homozygotes n, ClinicalPharmacology IndicationsPhiladelphia chromosome and Usage,BCR-ABLlnegative ClinicalBoceprevirInfectious DiseasesBosutinib Onc

15、ologyBrexpiprazole PsychiatryBusulfan OncologyCabozantinib OncologyCapecitabine OncologyCarbamazepin e (1)NeurologyCarbamazepinNeurologyIFNL3 BCR-ABL1CYP2D6 BCR-ABL1RET DPYD HLA-B HLAN StudiesIL28B rsl2979860 T allelecarriers (C/T and T/TClinicalgenotype)PharmacologyIndications and Usage, AdversePhi

16、ladelphia chromosome Reactions,positive Use in SpecificPopulations, Clinical Studies Dosage and Administration, DrugCYP2D6 poor metabolizersInteractions,Use in Specific Populations, ClinicalPharmacologyPhiladelphia chromosome Clinicalnegative StudiesRET mutation positiveClinicalStudiesWarnings and P

17、recautions,DPD deficient PatientCeritinib Oncology ALKCounseling Information Boxed HLA-B*1502 allele carriersWarning, Warnings, PrecautionsHLA-A*3101 allele carriers WarningsDrug e (2)TherapeuticBiomarker? Referenced Subgroup?Area* Labeling SectionsInborn ErrorsCarglumic Acid of NAGSIndications and

18、Usage, Warnings and Precautions,N-acetylglutamate Use in Specific synthase deficient Populations, MetabolismCarisoprodolRheumatolog yCYP2C19Carvedilol Cardiology CYP2D6CelecoxibRheumatolog yCYP2C9Cetuximab (1) Oncology EGFRClinicalPharmacology, Clinical StudiesUse in SpecificCYP2C19 poor Populations, metabolizers ClinicalPharmacology DrugCYP2D6 poor metabolizersInteractions,ClinicalPharmacology Dosage and Administration, Use inCYP2C9