fda基因检测.docx

1、fda基因检测Pharmacogenomic Biomarkers in Drug LabelingAbacavirInfectious DiseasesHLA-BHLA-B*5701 allele carriersBoxed Warning, Contraindications, Warnings and PrecautionsPharmacogenomic Information on Ado-Trastuzumab EmtansineOncologyERBB2HER2 protein overexpression or gene amplification positiveIndicat

2、ions and Usage, Warnings and Precautions, Adverse Reactions, Clinical Pharmacology, Clinical StudiesPharmacogenomic Information on AfatinibOncologyEGFREGFR exon 19 deletion or exon 21 substitution (L858R)positiveIndications and Usage, Dosage and Administration, Adverse Reactions, Clinical Pharmacolo

3、gy, Clinical StudiesAmitriptylinePsychiatryCYP2D6CYP2D6 poor metabolizersPrecautionsAnastrozoleOncologyESR1, PGRHormone receptor-positiveIndications and Usage, Adverse Reactions, Drug Interactions, Clinical StudiesArformoterol (1)PulmonaryUGT1A1UGT1A1 poor metabolizersClinical PharmacologyArformoter

4、ol (2)PulmonaryCYP2D6CYP2D6 intermediate or poor metabolizersClinical PharmacologyAripiprazolePsychiatryCYP2D6CYP2D6 poor metabolizersDosage and Administration, Clinical PharmacologyPharmacogenomic Information on Arsenic TrioxideOncologyPML-RARAPML-RAR translocation positiveClinical Pharmacology, In

5、dications and UsageAtomoxetinePsychiatryCYP2D6CYP2D6 poor metabolizersDosage and Administration, Warnings and Precautions, Drug Interactions, Clinical PharmacologyAzathioprineRheumatologyTPMTTPMT intermediate or poor metabolizersClinical Pharmacology, Warnings, Precautions Drug Interactions, Adverse

6、 Reactions, Dosage and AdministrationBoceprevirInfectious DiseasesIFNL3IL28B rs12979860 T allele carriers (C/T and T/T genotype)Clinical PharmacologyBosutinibOncologyBCR/ABL1Philadelphia chromosome positiveIndications and Usage Adverse Reactions, Use in Specific Populations, Clinical StudiesBusulfan

7、OncologyBCR-ABL1Philadelphia chromosome negativeClinical StudiesCapecitabineOncologyDPYDDPD deficientContraindications, Warnings and Precautions, Patient InformationCarbamazepine (1)NeurologyHLA-BHLA-B*1502 allele carriersBoxed Warning, Warnings, PrecautionsCarbamazepine (2)NeurologyHLA-AHLA-A*3101

8、allele carriersWarningsPharmacogenomic Information on Carglumic AcidInborn Errors of MetabolismNAGSN-acetylglutamate synthase deficientIndications and Usage, Warnings and Precautions, Use in Specific Populations Clinical Pharmacology Clinical StudiesCarisoprodolRheumatologyCYP2C19CYP2C19 poor metabo

9、lizersUse in Specific Populations, Clinical PharmacologyCarvedilolCardiologyCYP2D6CYP2D6 poor metabolizersDrug Interactions, Clinical PharmacologyCelecoxibRheumatologyCYP2C9CYP2C9 poor metabolizersDosage and Administration, Use in Specific Populations, Clinical PharmacologyPharmacogenomic Informatio

10、n on CeritinibOncologyALKALK gene rearrangement positiveIndications and Usage, Adverse Reactions, Clinical Pharmacology, Clinical StudiesCetuximab (1)OncologyEGFREGFR protein expression positiveIndications and Usage, Dosage and Administration, Warnings and Precautions, Adverse Reactions, Clinical Ph

11、armacology, Clinical StudiesCetuximab (2)OncologyKRASKRAS codon 12 and 13 mutation negativeIndications and Usage, Dosage and Administration, Warnings and Precautions, Adverse Reactions, Clinical Pharmacology, Clinical StudiesCevimelineDentalCYP2D6CYP2D6 poor metabolizersPrecautionsChloroquineInfecti

12、ous DiseasesG6PDG6PD deficientPrecautionsChlorpropamideEndocrinologyG6PDG6PD deficientPrecautionsCisplatinOncologyTPMTTPMT intermediate or poor metabolizersClinical Pharmacology, Warnings, Precautions, Adverse ReactionsCitalopram (1)PsychiatryCYP2C19CYP2C19 poor metabolizersClinical Pharmacology, Wa

13、rnings, Dosage and AdministrationCitalopram (2)PsychiatryCYP2D6CYP2D6 poor metabolizersClinical PharmacologyClobazamNeurologyCYP2C19CYP2C19 poor metabolizersDosage and Administration, Use in Specific Populations, Clinical PharmacologyClomipraminePsychiatryCYP2D6CYP2D6 poor metabolizersPrecautionsClo

14、pidogrelCardiologyCYP2C19CYP2C19 intermediate or poor metabolizersBoxed Warning, Dosage and Administration, Warnings and Precautions, Clinical PharmacologyClozapinePsychiatryCYP2D6CYP2D6 poor metabolizersDosage and Administration, Use in Specific Populations, Clinical PharmacologyCodeineAnesthesiolo

15、gyCYP2D6CYP2D6 ultra-rapid metabolizersBoxed Warnings, Warnings and Precautions, Use in Specific Populations, Patient Counseling InformationPharmacogenomic Information on CrizotinibOncologyALKALK gene rearrangement positiveIndications and Usage, Dosage and Administration, Adverse Reactions, Clinical Pharmacology, Clinical StudiesDabrafenib (1)OncologyBRAFBRAF V600E/K mutation positiveIndications and Usage, Dosage