FDA,2013,药物说明书,生物标志物,基因检测

Atomoxetine
Atomoxetine
托莫西汀
Atorvastatin
Atorvastatin
阿伐他汀
辉瑞
心血管 高脂血症
Homozygous familial hypercholesterolemia
LDL receptor
Azathioprine
Azathioprine
硫唑嘌呤 GSK， Benlysta 商品名 Victrelis
AБайду номын сангаасo-Trastuzumab 2013-3月添加 Emtansine
T-DM1
罗氏
肿瘤 HER2 protein HER2阳性晚期(转移 overexpression or gene amplification positive 性)乳腺癌 EGFR exon 19 deletion or 肿瘤 EGFR突变的非小细 exon 21 substitution (L858R) mutation positive 胞肺癌 抑郁症
肿瘤 Philadelphia chromosome 辉瑞,Bosulif 慢性髓细胞白血病 BCR/ABL1 (t(9;22)) positive CML 肿瘤 抗体—药物偶 西雅图遗传 霍杰金淋巴瘤(HL)； CD30 positive CD30 公司 联物 系统性间变性大细胞 淋巴瘤 Ph Chromosome negative 肿瘤 GSK (lack effectiveness with Ph Ph Chromosome 马里兰 慢性粒细胞性白血病 positive) 博舒替尼 卡培他滨 卡马西平 卡马西平 卡谷氨酸 卡立普多； 肌安宁 卡维地络 塞来昔布 辉瑞 罗氏 诺华 诺华 肿瘤 精神-神经，癫痫 精神-神经，癫痫 DPD deficient DPD
HLA-B*1502 allele carriers HLA-B*1502 HLA-A*3101 allele carriers HLA-A*3101 allele carriers
Orphan N-acetylglutamate synthase NAGS 高氨血症（罕见病） deficiency Europe公司 骨骼-肌肉，肌松 心血管 高血压 骨骼肌肉-NSAID 肿瘤 结直肠癌，头颈癌 肿瘤 结直肠癌，头颈癌 干燥综合征 抗感染，疟疾 糖尿病 肿瘤 CYP2C19 poor CYP2C19 metabolizers CYP2D6 poor metabolizers CYP2D6 CYP2C9 poor metabolizers CYP2C9 EGFR protein expression positive KRAS codon 12 and 13 mutation negative CYP2D6 poor metabolizers G6PD deficient G6PD deficient TPMT intermediate or poor metabolizers
骨骼-肌肉，风湿 肿瘤 系统性红斑狼疮 抗病毒-丙肝
TPMT intermediate or poor TPMT metabolizers CD257 positive IL28B rs12979860 T allele carriers
Belimumab Boceprevir
2013年11月添加 Boceprevir
Cetuximab (1)
Cetuximab (1)
西妥昔单抗
德国默克
EGFR
Cetuximab (2) Cevimeline Chloroquine Chlorpropamide Cisplatin
Cetuximab (2) Cevimeline Chloroquine 2013年11月添加 Cisplatin
西酞普兰 西酞普兰 氯巴占； 氧异安定 氯米帕明 氯吡格雷 氯氮平 可待因 赛诺菲
CYP2C19 poor 精神-神经，抑郁 metabolizers metabolizers CYP2D6 poor 精神-神经，抑郁 精神-神经，丹麦灵 北制药，严重类型 CYP2C19 poor Lennox-Gastaut综 metabolizers 合征的癫痫 CYP2D6 poor metabolizers 精神-神经 抑郁，三环类 心血管-抗凝 CYP2C19 intermediate or poor metabolizers
ERBB2 (HER2)
Afatinib Amitriptyline Anastrozole Aripiprazole Arsenic Trioxide
2013年11月添加 2013年11月添加 2013年11月添加 Aripiprazole Arsenic Trioxide
阿法替尼 阿米替林 阿那曲唑 阿立哌唑 三氧化二砷
CYP2C19 CYP2D6 CYP2C19 CYP2D6 CYP2C19
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, Dosage and Administration, Warnings and Precautions, Clinical Pharmacology, Clinical Studies, Patient Counseling Information Warnings and Precautions, Adverse Reactions, Patient Counseling Informationand Usage, Precautions, Indications Adverse Reactions, Patient Counseling Information; and Precautions, Adverse Reactions, Overdosage Precautions, Adverse Reactions, Overdosage Indications and Usage, Clinical Studies, Patient Counseling Information
贝利木单抗 博普瑞韦
BAFF/TNFSF13 Clinical Pharmacology, Clinical Studies B IL28B Clinical Pharmacology
Bosutinib
2013年11月添加
Brentuximab Vedotin
Brentuximab Vedotin
Busulfan Capecitabine Carbamazepine (1) Carbamazepine (2) Carglumic Acid Carisoprodol Carvedilol Celecoxib
Busulfan Capecitabine Carbamazepine 2013年11月添加 2013年11月添加 Carisoprodol Carvedilol Celecoxib
Pharmacogenomic Biomarkers in Drug Labels
2013-11版本 Abacavir 2013-10版本 Abacavir 中文药名 阿巴卡韦 制药公司 GSK 治疗领域 抗病毒 艾滋病 Referenced Subgroup 检测适用人群 生物标志物 Label Sections Boxed Warning, Contraindications, Warnings and Precautions, Patient Counseling Information Indications and Usage, Warnings and Precautions, Adverse Reactions, Clinical Pharmacology, Clinical Studies Indications and Usage, Dosage and Administration, Adverse Reactions, Clinical Pharmacology, Clinical Studies, Patient Counseling Information Precautions Indications and Usage, 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 HLA-B*5701 allele carriers HLA-B*5701
Indications and Usage, Adverse Reactions, Clinical Studies Indications and Usage, Description, Clinical Pharmacology
Clinical Studies Contraindications, Precautions, Patient Information Boxed Warning, Warnings and Precautions Boxed Warning, Warnings and Precautions Indications and Usage, Warnings and Precautions, Special Populations, Clinical Pharmacology, Clinical Studies 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
B-I
EGFR
CYP2D6 poor metabolizers CYP2D6 Hormone receptor positive ESR1, PGR
AZ，瑞宁得 乳腺癌
精神-神经 精神分裂 CYP2D6 poor metabolizers CYP2D6 症 肿瘤 PML/RARα (t(15;17)) gene PML/RARα 急性早幼粒细胞白血 expression positive 病 礼来 精神-神经，儿童多 动症 CYP2D6 poor metabolizers CYP2D6
西妥昔单抗 西维美林 氯喹 氯磺丙脲 顺铂
德国默克
KRAS CYP2D6 G6PD G6PD TPMT
Citalopram (1) Citalopram (2) Clobazam Clomipramine Clopidogrel Clozapine Codeine
Citalopram (1) Citalopram (2) Clobazam Clomipramine Clopidogrel Clozapine Codeine