艾尔巴韦片Elbasvir,エレルサ錠(ERELSA Tablets 50mg)说明书

产地国家:日本

处方药:是

所属类别: 50毫克/片 28片/盒

包装规格: 50毫克/片 28片/盒

计价单位:盒

生产厂家英文名:MSD K.K.

原产地英文商品名:ERELSA(エレルサ錠)50mg/Tablets 28Tablets/box

原产地英文药品名:Elbasvir

中文参考商品译名:ERELSA(エレルサ錠)50毫克/片 28片/盒

中文参考药品译名:艾尔巴韦

简介

新一代丙肝药品ERELSA Tablets(Elbasvir エレルサ錠)已获日本批准上市

治疗类别名称:抗病毒药物

商标名:ERELSA Tablets 50mg

一般名:エルバスビル(Elbasvir)

化学名

Dimethyl N,N’-([(6S)-6-phenyl-6H-indolo[1,2-c][1,3]benzoxazine-3,10-diyl]bis{1H-imidazole-5,2-diyl-(2S)-pyrrolidine-2,1-diyl[(2S)-3-methyl-1-oxobutane-1,2-diyl]})biscarbamate

分子式:C49H55N9O7

分子量:882.02

性状

白色粉末。非常易溶于丙酮或乙酸乙酯,乙醇(99.5),以极微溶,几乎不溶于水。操作注意事项为了避免潮湿,保存PTP板的遗体,从PTP板之前,为了给药取出。条件批准在建立药品风险管理计划的顶部,要正确实施。

药效药理

1. 作用机序Erubasubiru是用于HCV NS5A抑制剂。HCV NS5A是在病毒RNA复制和HCV的粒子形成的重要蛋白。

2.抗病毒活性在HCV复制子测定法中,Erubasubiru是基因型1a,1b中,示出了针对2,3,4和全长HCV复制子细胞和基因型6的嵌合HCV复制子细胞的5复制抑制活性,各EC 50值0.004的,0.003,0.003,0.14,0.0003,0.001,是0.009nM。此外,基因型1a从临床分离物衍生,1b中,(中位数EC 50值)的复制在2,3,4,5和6,分别0.005,0.009,1.85,0.02嵌合复制子细胞抑制Erubasubiru的活性,0.0007,0.0007,是0.016nM。

3.耐药性进行了检查Erubasubiru对已经纳入了NS5A抑制剂,NS5A区域的基因型1a M28A/T,Q30D/E/H/K/R,L31M/V看出已知突变HCV复制细胞的作用, H58D和Erubasubiru的Y93C/H/N活性的突变已被衰减到1/2000从1/634).基因型1b中L28M的NS5A区域,由L31F的突变和Y93H Erubasubiru的活性减弱从1/2到1/17。

Erubasubiru和更符合国内的II/III期试验的Gurazopurebiru,在NS5A区病人耐药突变管理的慢性丙型肝炎或C型代偿期肝硬化患者的基因型1b开始前组合检测,未检出它在患者SVR12率为93%,分别为(52/56例)和99%(N =二百六十〇分之二百五十七)。谁获得了治疗无反应和序列信息(7例)患者的耐药突变的分析。 7例患者全部治疗成了无应答检测在NS5A区域的耐药性突变。

谁成为治疗无应答患者的情况下基因1b型,观察所有Y93H(7例)和L31M(4例)作为NS5A区域的抗药性的变种。5名患者基因型1a的是,无论存在或不存在所检测的NS5A区的抗性突变的给药开始之前的,在所有情况下SVR12实现。与II/III期研究海外利巴韦林Erubasubiru和组合Gurazopurebiru,以及两种药物,未处理的和先前处理过的(三药物组合相结合的汇总分析,这是根据聚乙二醇化的干扰素和利巴韦林添加两药联合疗法,或HCV蛋白酶抑制剂在慢性丙型肝炎或C型代偿性肝硬化患者的治疗的基因型1a),在患者的突变)它已被检测到超过灵敏度降低五倍到电阻突变(Erubasubiru NS5A区的给药开始前SVR12速率55%,分别为(例如16/29)和50%(实施例13/26),分别为98%的患者在NS5A区域抗性突变未被检测到(例如四百三十九分之四百三十二)和99%(295分之291这是一个例子)。

在II / III期研究海外利巴韦林Erubasubiru和组合Gurazopurebiru,以及两种药物,治疗慢性丙型肝炎或C型代偿期肝硬化患者未经治疗基因1b型相结合的汇总分析,NS5A管理开始前患者被检测的面积电阻突变,患者SVR12速率未检测到的为97%,分别为(例如38/39)和99%(实施例242分之239)。在慢性丙型肝炎或C型代偿期肝硬化患者以前治疗基因1b型,患者的耐药突变已在NS5A区域的管理开始前分别检测,86%的患者SVR12率没有被检测到(它是31/36患者)和100%(N =223分之223)。

4.交叉耐药性在HCV基因型1复制子细胞在体外交叉耐药性测试,M28V和Q30L在基因型1a是其他NS5A抑制剂耐药,在基因1b型L28M/V,R30Q,L31V和Y93C NS5A区对于突变,观察Erubasubiru的活性。在一般情况下,在NS5A抑制剂发现抗性突变其他NS5A区域可能会减少Erubasubiru的活性。另外,在NS5A区域耐药突变衰减Erubasubiru的活性可能会减少其他NS5A抑制剂的活性。对于一个串联在NS3/4A抑制剂看到抗性突变,影响观察Erubasubiru的抑制活性。

适应症

在慢性丙型肝炎或C病毒血症的改善补偿血清1肝硬化型(基因型1)

用法与用量

成年人,每天给药一次,每次50毫克口服。该药物是与Gurazopurebiru组合使用时,使用期是12周。

包装规格

片50毫克:28片(PTP4粒×7)

制造厂商MSD有限公司注:以上中文资料仅参考,使用以原处方为准

英文版说明书

ERELSA Tablets 50 mg(エレルサ錠50mg)Brand name : ERELSA Tablets 50 mg Active ingredient: Elbasvir Dosage form: pink oval tablet, major axis: 14.54 mm, minor axis: 8.18 mm, thickness: 5.14 mm Print on wrapping: (Face)ERELSA 50mg, 220, エレルサ 50mg(Back)エレルサ 50mgEffects of this medicineThis medicine inhibits proteins involved in hepatitis C virus replication, thereby suppressing hepatitis C virus multiplication (antiviral action). It is used with grazoprevir.It is usually used to treat chronic hepatitis C or compensated cirrhosis type C.Before using this medicine, be sure to tell your doctor and pharmacist•If you have previously experienced any allergic reactions (itch, rash, etc.) to any medicines.If you have ever diagnosed as hepatitis B.•If you are pregnant or breastfeeding.•If you are taking any other medicinal products. (Some medicines may interact to enhance or diminish medicinal effects. Beware of over-the-counter medicines and dietary supplements as well as other prescription medicines.)Dosing schedule (How to take this medicine)•Your dosing schedule prescribed by your doctor is ((to be written by a healthcare professional))•In general, for adults, take 1 tablet (50 mg of the active ingredient) at a time, once a day, for 12 weeks. Strictly follow the instructions.•This medicine is used concomitantly with grazoprevir. Follow the instruction about grazoprevir.•Remove the medicine from a press-through package (PTP) immediately before use.•If you miss a dose, consult with your doctor or pharmacist. You should never take two doses at one time.•If you accidentally take more than your prescribed dose, consult with your doctor or pharmacist.•Do not stop taking this medicine unless your doctor instructs you to do so.Precautions while taking this medicine•Avoid taking any food containing St. John’s wort, since it may decrease the blood level of the medicine and diminish medicinal effects.Possible adverse reactions to this medicineThe most commonly reported adverse reactions include headache, general malaise, diarrhea, constipation and rash. If any of these symptoms occur, consult with your doctor or pharmacist.The symptoms described below are rarely seen as initial symptoms of the adverse reactions indicated in brackets. If any of these symptoms occur, stop taking this medicine and see your doctor immediately.•general malaise, loss of appetite, nausea/vomiting [liver dysfunction]The above symptoms do not describe all the adverse reactions to this medicine. Consult with your doctor or pharmacist if you notice any symptoms of concern other than those listed above.Storage conditions and other information•Keep out of reach of children. Store away from direct sunlight, heat and moisture.•Do not take the tablets out of the PTP sheet to avoid moisture.•Discard the remainder. Do not store them.MSD K.K.InternalPublished: 11/2016The information on this sheet is based on approvals granted by the Japanese regulatory authority. Approval details may vary by country. Medicines have adverse reactions (risks) as well as efficacies (benefits). It is important to minimize adverse reactions and maximize efficacy. To obtain a better therapeutic response, patients should understand their medication and cooperate with the treatment.November 21, 2016, MSD K.K. companies listed in Japan elbasvir and grazoprevir two new drugsMerck has been listed in Japan for two oral hepatitis C drugs, 50 mg of Erelsa (elbasvir) tablets and 50 mg of Grazyna (grazoprevir hydrate) tablets, respectively. NS5A inhibitors Erelsa and NS3 / 4A protease inhibitors and Grazyna were developed by Merck & Co for the treatment of viremia in patients with genotype 1 chronic hepatitis C or compensatory cirrhosis, one dose per day for 12 weeks The Erelsa and Grazyna showed a history of patients with different backgrounds (different treatment history, gender, IL28B genotype, presence or absence of resistance, etc.) in clinical trials of genotype 1 chronic hepatitis C patients in Japan Effectiveness and safety, including moderate to severe renal impairment in patients.

 

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