FDA,2013,药物的生物标志物及检测.xls

table of pharmacogenomic biomarkers in drug labels pharmacogenomics can play an important role in identifying responders and non-responders to medications, avoiding adverse events, and optimizing drug dose. drug labels 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 labels. some, but not all, of the labels include specific actions to be taken based on genetic information. relevant sections of the label with such information are noted in the last column of the table. biomarkers may include gene variants, functional deficiencies, expression changes, chromosomal abnormalities, and others. microbial variants that influence sensitivity to anti- infectives are not included in the table. please note that the table columns can be sorted. pharmacogenomic information can appear in different sections of the label. for more information on the relevance of information in various parts of the drug label (e.g. indications and usage, dosage and administration, boxed warning, etc.), please go to the relevant labeling guidance1. for information on the fdas initiative to improve prescription drug labels, visit the fda/cder learn website2. /drugs/scienceresearch/researchareas/pharmacogenetics/ucm083378.htm pharmacogenomic biomarkers in drug labels drugtherapeutic areabiomarker abacavirantiviralshla-b*5701 ado-trastuzumab emtansine oncologyerbb2 (her2) aripiprazolepsychiatrycyp2d6 arsenic trioxide oncologypml/rar atomoxetinepsychiatrycyp2d6 atorvastatinmetabolic and endocrinologyldl receptor azathioprinerheumatologytpmt boceprevirantiviralsil28b brentuximab vedotin oncologycd30 busulfanoncologyph chromosome capecitabineoncologydpd carbamazepineneurologyhla-b*1502 carisoprodolmusculoskeletalcyp2c19 carvedilolcardiovascularcyp2d6 celecoxibanalgesicscyp2c9 cetuximab (1)oncologyegfr cetuximab (2)oncologykras cevimelinedermatology and dentalcyp2d6 chlordiazepoxid e and amitriptyline psychiatrycyp2d6 chloroquineantiinfectivesg6pd cisplatinoncologytpmt citalopram (1)psychiatrycyp2c19 citalopram (2)psychiatrycyp2d6 clobazamneurologycyp2c19 clomipraminepsychiatrycyp2d6 clopidogrelcardiovascularcyp2c19 clozapinepsychiatrycyp2d6 codeineanalgesicscyp2d6 crizotiniboncologyalk dapsonedermatology and dentalg6pd dasatiniboncologyph chromosome denileukin diftitox oncologycd25 desipraminepsychiatrycyp2d6 dexlansoprazole (1) gastroenterologycyp2c19 dexlansoprazole (2) gastroenterologycyp1a2 dextromethorpha n and quinidine neurologycyp2d6 diazepampsychiatrycyp2c19 doxepinpsychiatrycyp2d6 drospirenone and ethinyl estradiol reproductivecyp2c19 eltrombopag (1) hematologyfactor v leiden (fv) eltrombopag (2) hematologyantithrombin iii deficiency (serpinc1) erlotiniboncologyegfr esomeprazolegastroenterologycyp2c19 everolimusoncologyerbb2 (her2) exemestaneoncologyer nat2 ivacaftorpulmonarycftr (g551d) lansoprazolegastroenterologycyp2c19 lapatiniboncologyerbb2 (her2) lenalidomidehematologychromosome 5q letrozoleoncologyer nat2 risperidonepsychiatrycyp2d6 sodium phenylacetate and sodium benzoate gastroenterologyucd (nags; cps; ass; otc; asl; arg) sodium phenylbutyrate gastroenterology ucd (nags; cps; ass; otc; asl; arg) tamoxifen (1)oncologyer tamoxifen (2)oncologyfactor v leiden (fv) tamoxifen (3)oncologyprothrombin mutations (f2) telaprevirantiviralsil28b terbinafineantifungalscyp2d6 tetrabenazineneurologycyp2d6 thioguanineoncologytpmt thioridazinepsychiatrycyp2d6 ticagrelorcardiovascularcyp2c19 tolterodinereproductive and urologiccyp2d6 tositumomaboncologycd20 antigen tramadol and acetaminophen analgesicscyp2d6 trastuzumaboncologyerbb2 (her2) tretinoindermatology and dentalpml/rar trimipraminepsychiatrycyp2d6 valproic acidpsychiatry ucd (nags; cps; ass; otc; asl; arg) vemurafeniboncologybraf venlafaxinepsychiatrycyp2d6 voriconazoleantifungalscyp2c19 warfarin (1)hematologycyp2c9 warfarin (2)hematologyvkorc1 label sections boxed warning, contraindications, warnings and precautions, patient counseling information indications and usage, warnings and precautions, adverse reactions, clinical pharmacology, clinical studies clinical pharmacology, dosage and administration boxed warning, clinical pharmacology, indications and usage, warnings dosage and administration, warnings and precautions, drug interactions, clinical pharmacology indications and usage, dosage and administration, warnings and precautions, clinical pharmacology, clinical studies dosage and administration, warnings and precautions, drug interactions, adverse reactions, clinical pharmacology clinical pharmacology indications and usage, description, clinical pharmacology clinical studies contraindications, precautions, patient information boxed warning, warnings and precautions clinical pharmacology, special populations drug interactions, clinical pharmacology dosage and administration, drug interactions, use in specific populations, clinical pharmacology indications and usage, warnings and precautions, description, clinical pharmacology, clinical studies indications and usage, dosage and administration, warnings and precautions, adverse reactions, clinical pharmacology, clinical studies drug interactions precautions precautions clinical pharmacology, warnings, precautions drug interactions, warnings drug interactions clinical pharmacology, dosage and administration, use in specific populations drug interactions boxed warning, dosage and administration, warnings and precautions, drug interactions, clinical pharmacology drug interactions, clinical pharmacology warnings and precautions, use in specific populations, clinical pharmacology indications and usage, warnings and precautions, adverse reactions, clinical pharmacology, clinical studies indications and usage, precautions, adverse reactions, patient counseling information indications and usage, clinical studies, patient counseling information indications and usage, warnings and precautions, clinical studies drug interactions clinical pharmacology, drug interactions pharmacogenomic biomarkers in drug labels clinical pharmacology clinical pharmacology, warnings and precautions drug interactions, clinical pharmacology precautions precautions, drug interactions warnings and precautions warnings and precautions clinical pharmacology drug interactions, clinical pharmacology indications and usage, boxed warning, adverse reactions, use in specific populations, clinical pharmacology, clinical studies indications and usage, dosage and administration, clinical studies, clinical pharmacology contraindications, warnings warnings, precautions, clinical pharmacology drug interactions, clinical pharmacology clinical pharmacology, special populations drug interactions indications and usage, patient counseling information special populations clinical pharmacology clinical pharmacology, dosage and administration, drug interactions, specific populations, warnings and precautions indications and usage, dosage and administration clinical pharmacology, clinical studies indications and usage, dosage and administration, clinical pharmacology, clinical studies indications and usage, dosage and administration, clincal studies indications and usage, dosage and administration, clinical studies drug interactions clinical pharmacology dosage and administration, warnings, clinical pharmacology clinical pharmacology indications and usage, adverse reactions, use in specific populations, clinical pharmacology, clinical studies drug interactions, clinical pharmacology indications and usage, clinical pharmacology, patient counseling information boxed warning, indications and usage, clinical studies, patient counseling indications and usage, adverse reactions, clinical studies, clinical pharmacology indications and usage, warnings and precautions, clinical pharmacology, clinical studies, patient counseling information dosage and administration, contraindications, precautions, adverse reactions, clinical pharmacology precautions, clinical pharmacology drug interactions precautions drug interactions indications and usage, patient counseling information warnings and precautions, clinical pharmacology drug interactions dosage and administration, warnings and precautions, drug interactions indications and usage, warnings and precautions, clinical pharmacology, clinical studies indications and usage, clinical pharmacology, clinical studies clinical pharmacology, drug interactions, special populations clinical pharmacology, drug interactions clinical pharmacology clinical pharmacology, drug interactions indications and usage, warnings and precautions, adverse reactions, clinical studies, clinical pharmacology warnings warnings, precautions, contraindications, dosage and administration use in specific populations, clinical pharmacology, clinical studies clinical studies, use in specific populations clinical pharmacology precautions, drug interactions, clinical pharmacology precautions precautions drug interactions, clinical pharmacology boxed warning, contraindications adverse reactions, clinical pharmacology drug interactions, clinical pharmacology indications and usage, description, clinical pharmacology indications and usage, dosage and administration, nutritional management indications and usage, precautions, medication guide warnings warnings clinical pharmacology drug interactions dosage and administration, warnings, clinical pharmacology dosage and administration, precautions, warnings precautions, warnings, contraindications clinical studies clinical pharmacology, drug interactions, warnings and precautions indications and usage, clinical pharmacology clinical pharmacology indications and usage, precautions, clinical pharmacology boxed warning, dosage and administration, precautions drug interactions contraindications, precautions, adverse reactions indications and usage, warning and precautions, clinical pharmacology, clinical studies, patient counseling information drug interactions clinical pharmacology, drug interactions dosage and administration, precautions, clinical pharmacology dosage and administration, precautions, clinical pharmacology pharmacogenomic biomarkers in drug labels 2013-3-28版版本本 2013-2， drug list 2012-3,药药品品目目录录 abacavirabacavir3abacavir3阿巴卡韦 ado-trastuzumab emtansine ， 2013-3月添加 her-2靶向抗体-药物共轭物 t-dm1 aripiprazolearipiprazole4aripiprazole4阿立哌唑 arsenic trioxidearsenic trioxide5arsenic trioxide5三氧化二砷 atomoxetineatomoxetine6atomoxetine6托莫西汀 atorvastatinatorvastatin7atorvastatin7阿伐他汀 azathioprineazathioprine8azathioprine8硫唑嘌呤 boceprevirboceprevir9boceprevir9抗丙型肝炎 brentuximab vedotinbrentuximab vedotin10brentuximab vedotin10抗体药物偶联物 busulfanbusulfan11busulfan11马里兰 capecitabinecapecitabine12capecitabine12卡培他滨 carbamazepinecarbamazepine13carbamazepine13卡马西平 carisoprodolcarisoprodol14carisoprodol14 卡立普多； 肌安宁 carvedilolcarvedilol15carvedilol15卡维地络 celecoxibcelecoxib16celecoxib16塞来昔布 cetuximab (1)cetuximab (1)17cetuximab (1)17西妥昔单抗 cetuximab (2)cetuximab (2)18cetuximab (2)18西妥昔单抗 cevimelinecevimeline19cevimeline19西维美林 chlordiazepoxide and amitriptyline chlordiazepoxide and amitriptyline20 chlordiazepoxide and amitriptyline20 氯氮卓 和 阿米替林 chloroquinechloroquine21chloroquine21氯喹 cisplatincisplatin22cisplatin22顺铂 citalopram (1)citalopram (1)23citalopram (1)23西酞普兰 citalopram (2)citalopram (2)24citalopram (2)24西酞普兰 clobazamclobazam25clobazam25 氯巴占； 氧异安定 clomipramineclomipramine27clomipramine27氯米帕明 clopidogrelclopidogrel28clopidogrel28氯吡格雷 clozapineclozapine29clozapine29氯氮平 codeinecodeine30codeine30可待因 crizotinibcrizotinib31crizotinib31克卓替尼 dapsonedapsone32dapsone32氨苯砜 dasatinibdasatinib33dasatinib33达沙替尼 denileukin diftitoxdenileukin diftitox342013-2月添加白介素ii-融合毒素 desipraminedesipramine35desipramine地昔帕明 dexlansoprazole (1)dexlansoprazole (1)36dexlansoprazole (1)36右旋兰索拉唑 dexlansoprazole (2)dexlansoprazole (2)37dexlansoprazole (2)37右旋兰索拉唑 dextromethorphan and quinidine dextromethorphan and quinidine38 dextromethorphan and quinidine38 右美沙芬和奎尼丁 diazepamdiazepam39diazepam39安定 doxepindoxepin40doxepin40多塞平 drospirenone and ethinyl estradiol drospirenone and ethinyl estradiol41 drospirenone and ethinyl estradiol41 屈螺酮 + 炔雌醇 eltrombopag (1)eltrombopag (1)42艾曲波帕 eltrombopag (2)eltrombopag (2)43艾曲波帕 erlotiniberlotinib44erlotinib42埃罗替尼 esomeprazoleesomeprazole45esomeprazole43左旋奥美拉唑 everolimuseverolimus46依维莫司 exemestaneexemestane47exemestane44依西美坦 fluorouracilfluorouracil48fluorouracil45五氟脲嘧啶，5-fu fluoxetine fluoxetine and olanzapine50 fluoxetine and olanzapine47 氟西汀 + 奥氮平 fluoxetine and olanzapinefluoxetine49fluoxetine46氟西汀 flurbiprofenflurbiprofen51flurbiprofen48氟比洛芬 fluvoxaminefluvoxamine 52fluvoxamine (1)49氟伏沙明 fulvestrantfulvestrant53fulvestrant52氟维司群 galantaminegalantamine54galantamine53加兰他敏 gefitinibgefitinib 55gefitinib (1)54吉非替尼 iloperidoneiloperidone56iloperidone56伊潘立酮 imatinib (1)imatinib (1)57imatinib (1)57伊马替尼 imatinib (2)imatinib (2)58imatinib (2)58伊马替尼 imatinib (3)imatinib (3)59imatinib (3)59伊马替尼 imatinib (4)imatinib (4)60imatinib (4)60伊马替尼 imipramineimipramine61imipramine61丙咪嗪 indacaterolindacaterol62indacaterol62茚达特罗粉雾剂(吸入) irinotecanirinotecan63irinotecan63伊立替康 isosorbide and hydralazine isosorbide and hydralazine64 isosorbide and hydralazine64 异山梨醇 和 氢氯噻嗪 ivacaftorivacaftor65ivacaftor65 lansoprazole， 2013-3月添 加 兰索拉唑 lapatiniblapatinib66lapatinib66拉帕替尼 lenalidomidelenalidomide67lenalidomide67来那度胺 letrozoleletrozole68letrozole68来曲唑 maravirocmaraviroc69maraviroc69马拉维诺 mercaptopurinemercaptopurine70mercaptopurine70巯基嘌呤 metoprololmetoprolol71metoprolol71美托洛尔 modafinilmodafinil 72modafinil (1)72莫达非尼 mycophenolic acidmycophenolic acid732013年2月添加骁悉，吗替麦考酚酯 nefazodonenefazodone74nefazodone74奈法唑酮 nilotinib (1)nilotinib (1)75nilotinib (1)76尼罗替尼 nilotinib (2)nilotinib (2)76nilotinib (2)77尼罗替尼 nortriptylinenortriptyline77nortriptyline78去甲替林 omeprazoleomeprazole78omeprazole79奥美拉唑 panitumumab (1)panitumumab (1)79panitumumab (1)80帕尼单抗 panitumumab (2)panitumumab (2)80panitumumab (2)81帕尼单抗 pantoprazolepantoprazole81pantoprazole82泮托拉唑 paroxetineparoxetine82paroxetine83帕罗西汀 peginterferon alfa-2bpeginterferon alfa-2b83peginterferon alfa-2b84长效a-2b干扰素 perphenazineperphenazine84perphenazine85奋乃静 pertuzumabpertuzumab85帕妥珠单抗 phenytoinphenytoin86phenytoin86苯妥英钠 pimozidepimozide87pimozide87匹莫齐特 prasugrelprasugrel88prasugrel88普拉格雷，抗凝 pravastatinpravastatin89pravastatin89普伐他汀 propafenonepropafenone90propafenone90普罗帕酮 propranololpropranolol91propranolol91普萘洛尔 protriptylineprotriptyline92protriptyline92普罗替林 quinidinequinidine93quinidine93奎尼丁 rabeprazolerabeprazole94rabeprazole94雷贝拉唑 rasburicaserasburicase95rasburicase95拉布立酶 rifampin, isoniazid, and pyrazinamide rifampin, isoniazid, and pyrazinamide96 rifampin, isoniazid, and pyrazinamide96 雷米封,异烟肼,吡嗪酰胺 risperidonerisperidone97risperidone97利培酮 sodium phenylacetate and sodium benzoate sodium phenylacetate and sodium benzoate98 sodium phenylacetate and sodium benzoate98 乙酸钠和苯甲酸钠 sodium phenylbutyratesodium phenylbutyrate99sodium phenylbutyrate99苯丁酸钠 tamoxifen (1)tamoxifen (1)100tamoxifen100他莫昔芬 tamoxifen (2)tamoxifen (2)101他莫昔芬 tamoxifen (3)tamoxifen (3)102他莫昔芬 telaprevirtelaprevir103telaprevir101特拉匹韦 terbinafineterbinafine104terbinafine102盐酸特比萘芬片 tetrabenazinetetrabenazine105丁苯那嗪 thioguaninethioguanine106thioguanine104硫代鸟嘌呤 thioridazinethioridazine107thioridazine105硫代鸟嘌呤 ticagrelorticagrelor108ticagrelor106替卡格雷 tolterodinetolterodine109tolterodine109托特罗定 tositumomabtositumomab110tositumomab110托西莫单抗 tramadol and acetaminophen tramadol and acetaminophen111 tramadol and acetaminophen111 曲马多 和 对乙氨基酚 trastuzumabtrastuzumab112trastuzumab112曲妥珠单抗 tretinointretinoin113tretinoin113维甲酸 trimipraminetrimipramine114trimipramine114曲米帕明（三甲丙咪嗪） valproic acidvalproic acid115valproic acid115丙戊酸 vemurafenibvemurafenib116vemurafenib116维罗非尼 venlafaxinevenlafaxine117venlafaxine117文拉法辛 voriconazolevoriconazole118voriconazole118伏立康唑 warfarin (1)warfarin (1)119warfarin (1)119华法林 warfarin (2)warfarin (2)120warfarin (2)120华法林 公公司司therapeutic areabiomarker 抗病毒 艾滋病antiviralshla-b*5701 罗氏 肿瘤 her2阳性晚期(转移性)乳腺 癌 oncologyerbb2 (her2) 精神-神经 精神分裂症psychiatrycyp2d6 肿瘤 急性早幼粒细胞白血病 oncologypml/rar 礼来精神-神经，儿童多动症psychiatrycyp2d6 辉瑞心血管 高脂血症 metabolic and endocrinology ldl receptor 骨骼-肌肉，风湿 肿瘤 rheumatologytpmt 抗病毒-丙肝antiviralsil28b 肿瘤 霍杰金淋巴瘤(hl)；系统性间 变性大细胞淋巴瘤 oncologycd30 肿瘤 慢性粒细胞性白血病 oncologyph chromosome 罗氏肿瘤oncologydpd 诺华精神-神经，癫痫neurologyhla-b*1502 骨骼-肌肉，肌松musculoskeletalcyp2c19 心血管 高血压cardiovascularcyp2d6 辉瑞骨骼肌肉-nsaidanalgesicscyp2c9 德国默克 肿瘤（爱必妥，德国默克） 结直肠癌，头颈癌 oncologyegfr 德国默克 肿瘤（爱必妥，德国默克） 结直肠癌，头颈癌 oncologykras 干燥综合征dermatology and dentalcyp2d6 精神-神经，抑郁psychiatrycyp2d6 抗感染，疟疾antiinfectivesg6pd 肿瘤oncologytpmt 精神-神经，抑郁psychiatrycyp2c19 精神-神经，抑郁psychiatrycyp2d6 精神-神经，丹麦灵北制药， 严重类型lennox-gastaut综合 征的癫痫 neurologycyp2c19 精神-神经 抑郁，三环类psychiatrycyp2d6 赛诺菲心血管-抗凝cardiovascularcyp2c19 精神-神经，精神分裂症psychiatrycyp2d6 骨骼肌肉-镇痛analgesicscyp2d6 辉瑞 肿瘤- 肺癌（alk阳性的非小细胞肺 癌） oncologyalk 抗感染，麻风病dermatology and dentalg6pd bms 肿瘤 bms公司,对伊马替尼治疗耐 药或不耐受,费城染色体阳性 (ph+)de 慢性髓细胞白血病 oncologyph chromosome ligand公司 肿瘤 ligand公司，治疗皮肤t淋巴 瘤(ctcl) oncologycd25 精神-神经，内源性,更年期、 反应性及神经性抑郁症 psychiatrycyp2d6 胃肠gastroenterologycyp2c19 胃肠gastroenterologycyp1a2 精神-神经 avanir 公司2011年上市，假性 球麻痹症状适应症 neurologycyp2d6 精神-神经psychiatrycyp2c19 精神-神经 精神分裂症psychiatrycyp2d6 泌尿生殖reproductivecyp2c19 血液 血小板减少症hematology factor v leiden (fv) 血液 血小板减少症hematology antithrombin iii deficiency (serpinc1) 罗氏 肿瘤 罗氏，特罗凯，egfr突变的 非小细胞肺癌，胰腺癌 oncologyegfr 胃肠gastroenterologycyp2c19 肿瘤 （西罗莫司的衍生物），胰腺 癌和肾细胞癌；激素阳性、 her2标志物阴性的晚期乳腺癌 oncologyher2/neu 肿瘤 （他莫苷芬治疗后病情进展的 绝经后晚期乳腺癌） oncologyer nat2 vertex公司，呼吸-治疗罕见型囊性纤维化pulmonarycftr (g551d) 武田gastroenterologycyp2c19 肿瘤 联合卡培他滨治疗her-2过度 表达的,既往接受过包括蒽环 类,紫杉醇,曲妥珠单抗(赫赛汀 )治疗的晚期或转移性乳腺癌 oncologyher2/neu 肿瘤 多发性骨髓瘤；具有5q缺失细 胞遗传学异常的骨髓增生异常 综合征所致的输血依赖性贫血 患者 oncologychromosome 5q 诺华 肿瘤 乳腺癌,激素治疗 oncologyer nat2 精神