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  药店国别: 以色列药房
产地国家: 以色列
所属类别: 抗癌药物->治疗骨髓瘤药物
处方药:处方药
包装规格: 3.5毫克/瓶
计价单位:
  点击放大  
生产厂家中文参考译名:
Janssen-Cilag GmbH
生产厂家英文名:
Janssen-Cilag GmbH
该药品相关信息网址1:
www.velcade.com/
该药品相关信息网址2:
www.chemocare.com/bio/velcade.asp
该药品相关信息网址3:
www.medilexicon.com/drugs/velcade.php
原产地英文商品名:
VELCADE POWDER FOR INFUSION SOLUTION 3.5mg/Vial
原产地英文药品名:
BORTEZOMIB
中文参考商品译名:
万珂注射用粉剂 3.5毫克/瓶
中文参考药品译名:
硼替佐米
原产地国家批准上市年份:
2003/05/13
英文适应病症1:
Multiple myeloma
英文适应病症2:
Myeloma
临床试验期:
完成
中文适应病症参考翻译1:
多发性骨髓瘤
中文适应病症参考翻译2:
骨髓瘤
药品信息:

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 详细处方信息以本药内容附件PDF文件(20081608005040.pdf)的“原文Priscribing Information”为准
---------------------------------------------------------------
 部分中文万珂处方资料(仅供参考)

通用名:注射用硼替佐米

商品名称:万珂TM(Velcade)

英文名:Bortezomib for Injection

汉浯拼音:Zhusheyong  Pengtizuomi

分子式:C19H25BN4O4

分子量:384。24
本品主要成份为硼替佐米,其化学名称为:[(1R)-3-甲基-1-[[(2S)-1-氧-3-苯基-2-[(吡嗪羧基)氨基]丙基]氨基]丁基]硼酸

性状
本品为白色或类白色块状物或粉末。

药理毒理
●药效学
硼替佐米是哺乳动物细胞中26S蛋白酶体糜蛋白酶样活性的可逆抑制剂。26S蛋白酶体是一种大的蛋白质复合体,可降解泛蛋白。泛蛋白酶体通道在调节特异蛋白在细胞内浓度中起到重要作用,以维持细胞内环境的稳定。蛋白水解会影响细胞内多级信号串联,这种对正常的细胞内环境的破坏会导致细胞的死亡。而对26S蛋白酶体的抑制可防止特异蛋白的水解。体外试验证明硼替佐米对多种类型的癌细胞具有细胞毒性。临床前肿瘤模型体内试验证明硼替佐米能够延迟包括多发性骨髓瘤在内的肿瘤生长。
●毒理学
尚未进行硼替佐米的致癌性研究。
用中国仓猝鼠卵巢细胞进行体外染色体畸变分析显示硼替佐米有诱裂活性(染色体结构畸变)。体外诱变性分析(埃姆斯试验)和小鼠体内小核分析结果显示硼替佐米没有基因毒性。
尚未对生育影响进行研究,但是在一般毒理学研究中对生殖组织进行了评价。6个月的大鼠毒理研究显示,剂量≥0.3mg/㎡(临床推荐剂量的1/4)时发现对卵巢有变性的作用,剂量为1.2mg/㎡时发现有变性的改变。本品可能对男性或女性的生育能力有潜在影响。

药代动力学
对8名多发性骨髓瘤患者静脉给予本品1.3mg/㎡,最大血药浓度中值为509ng/m1(范围109-1300ng/m1),肌酐清除率为3l-169ml/min。对晚期恶性肿瘤患者给予本品1.45-2.00mg/㎡,首剂量后的平均消除半衰期为9-15小时。作为单药,推荐剂量的硼替佐米在多发性骨髓瘤患者体内的药代动力学尚不完全明确。
●分布
尚未对推荐剂量的硼替佐米在多发性骨髓瘤患者体内的分布容积进行研究。浓度为100-1000ng/ml时,硼替佐米与人体血浆蛋白的平均结合率为83%。
●代谢
利用人体肝微粒体和互补脱氧核糖核酸(cDNA)表达的细胞色素P450同工酶进行的体外研究显示,硼替佐米主要通过细胞色素P450酶系的3A4、2D6、2C19、2C9和IA2酶氧化代谢。主要代谢途径是去硼酸化,形成2个去硼酸化代谢物,再通过羟基化形成几个代谢产物。去硼酸化的硼替佐米代谢产物无抑制26S蛋白酶体的活性。8名患者给药后10-30分钟的血浆数据显示,血浆中代谢产物的浓度比原形药物低。
●消除
尚未对硼替佐米在人体内的消除途径进行研究。
●特殊人群
年龄、性别和人种:尚未就年龄、性别和人种对硼替佐米药代动力学影响进行评价。
肝功能损害的患者:尚未进行对肝功能损害患者的药代动力学研究。
肾功能损害的患者:尚未进行对肾功能损害患者的药代动力学研究。临床研究中患者的肌酐清除率为13.8-220m1/min。
儿童:尚无儿童药代动力学资料。

适应症
本品用于多发性骨髓瘤患者的治疗,此患者在使用本品前至少接受过两种治疗,并在最近-次治疗中病情还在进展。
本品的有效性基于它的有效率。尚无临床对照试验证明其临床利益,如对存活率的改善
●成人
推荐剂量
本品的推荐剂量为单次注射1.3 mg/㎡,每周注射2次,连续注射2周(即在第1、4、日和11天注射)后停药10天(即从第12至第2l天)。3周为1个疗程,两次给药至少间隔72小时。
在临床研究中,被确认完全有效的患者再接受另外2个周期的注射用硼替佐米治疗。建议有效的患者接受8个周期的注射用硼替佐米治疗。
剂量调整以及重新开始治疗
当发生3级非血液学的或任何4级血液学的毒性(不包括下面讨论的神经病)时,应暂停本品治疗。一旦毒性症状得到缓解,可以重新开始本品的治疗,剂量减少25%(例如: 1.3mg/㎡降低到1.0mg/㎡;1.0mg/㎡降低到0.7mg/㎡)。如果患者发生与本品治疗有关的神经痛或周围感觉神经病,应按下表推荐的调整剂量进行治疗。如果患者本身患有严重的神经病,只有权衡利弊后方可使用本品。
表1:当发生与本品治疗有关的神经痛或者外周感觉神经病时推荐的剂量调整
外周神经病症状和体征的严重程度                            用法用量调整
1级(感觉异常或者反射丧失),不伴有疼痛或者功能丧失         不改变
1级,伴有疼痛或者2级(功能障碍,但不影响日常生活)       剂量降至1.0mg/㎡
2级,伴有疼痛或者3级(不影响日常生活)                   暂停本品的治疗直至毒性缓解后恢复本品的的治疗,剂量降至0.7mg/㎡,并且改为每周注射一次。
4级(永久的感觉丧失,功能障碍)                           停止本品的治疗。
NCI常见毒性标准

给药方法
本品须用3.5ml生理盐水完全溶解后在3-5秒内通过导管静脉注射,随后使用注射用0.9%氯化钠溶液冲洗。
不良反应
在两项临床研究中,228名多发性骨髓瘤患者接受本品治疗,剂量为1.3mg/m2,每周注射2次,连续注射2周后停药10天(即21天为1个疗程),最多持续8个疗程。
最常见的不良事件有虚弱(包括疲劳、不适和乏力)(65%)、恶心(64%)、腹泻(51%)、食欲下降(包括厌食)(43%)、便秘(43%)、血小板减少(43%)、周围神经''''''''''''''''病(包括周围感觉神经病和周围神经病加重)  (37%)、发热(36%)、呕吐(36%)和贫血(32%)。
14%的患者至少有过一次4级不良反应,最常见的不良反应为血小板减少(3%)和中性粒细胞减少症(3%)。

严重不良事件
严重不良事件的定义为,无论是否有因果关系任何导致死亡、危及生命、导致住院或延长住院时间、造成明显残疾或为重大的医疗事件。在研究过程中,228位患者中共有113位(50%)发生了严重不良事件。最常见的严重不良事件包括发热(7%)、肺炎(7%)、腹泻(6%)、呕吐(5%)、脱水(5%)和恶心(4%)。
18%的患者因研究者认为与药物相关的不良事件而导致停药,停药原因包括周围神经病(5%)、血小板减少(4%)、腹泻(2%)和疲劳(2%)。
在试验中有2例死亡的报告,研究者认为可能与研究的药物有关,1例为心跳呼吸停止,另1例为呼吸衰竭。
最常见的不良事件列干表4,发生率≥10%的不良事件均包括在内。单臂研究通常不能鉴别不良事件是由药物造成还是患者基础疾病所致。

规格
每瓶含有3.5mg硼替佐米的无菌冻干粉末。

贮藏:在25℃(15~30℃)避光处保存。

包装:玻璃药瓶包装。1瓶/盒。

有效期:24个月

About VELCADE
    VELCADE is being co-developed by Millennium Pharmaceuticals, Inc. and Johnson & Johnson Pharmaceutical Research & Development, L.L.C. Millennium is responsible for commercialization of VELCADE in the U.S., Janssen-Cilag is responsible for commercialization in Europe and the rest of the world. Janssen Pharmaceutical K.K. is responsible for commercialization in Japan. For a limited period of time, Millennium and Ortho Biotech Inc. are co-promoting VELCADE in the U.S. VELCADE is approved in 85 countries worldwide.

    In the U.S., VELCADE is indicated for the treatment of patients with multiple myeloma who have received at least one prior therapy. VELCADE is indicated for the treatment of patients with mantle cell lymphoma who have received at least one prior therapy. VELCADE is contraindicated in patients with hypersensitivity to bortezomib, boron, or mannitol. VELCADE should be administered under the supervision of a physician experienced in the use of antineoplastic therapy. In the European Union and many other countries worldwide, VELCADE is approved for patients with multiple myeloma after first relapse.

    Risks associated with VELCADE therapy include new or worsening peripheral neuropathy, hypotension observed throughout therapy, cardiac and pulmonary disorders, gastrointestinal adverse events, thrombocytopenia, neutropenia and tumor lysis syndrome. Women of childbearing potential should avoid becoming pregnant while being treated with VELCADE.

    Cases of severe sensory and motor peripheral neuropathy have been reported. The long-term outcome of peripheral neuropathy has not been studied in mantle cell lymphoma. Acute development or exacerbation of congestive heart failure, and/or new onset of decreased left ventricular ejection fraction has been reported, including reports in patients with few or no risk factors for decreased left ventricular ejection fraction. There have been rare reports of acute diffuse infiltrative pulmonary disease of unknown etiology such as pneumonitis, interstitial pneumonia, lung infiltration and Acute Respiratory Distress Syndrome in patients receiving VELCADE. Some of these events have been fatal. A higher proportion of these events have been reported in Japan. There have been rare reports of Reversible Posterior Leukoencephalopathy Syndrome (RPLS) in patients receiving VELCADE. RPLS is a rare, reversible, neurological disorder which can present with seizure, hypertension, headache, lethargy, confusion, blindness, and other visual and neurological disturbances. VELCADE is associated with thrombocytopenia and neutropenia. There have been reports of gastrointestinal and intracerebral hemorrhage in association with VELCADE. Transfusions may be considered. Complete blood counts (CBC) should be frequently monitored during treatment with VELCADE. Rare cases of acute liver failure have been reported in patients receiving multiple concomitant medications and with serious underlying medical conditions.

    Integrated Safety Data: Safety data from phase 2 and 3 studies of single- agent VELCADE 1.3 mg/m2/dose twice weekly for 2 weeks followed by a 10-day rest period in 1163 patients with multiple myeloma (N=1008) and mantle cell lymphoma (N=155) were integrated and tabulated. In these studies, the safety profile of VELCADE was similar in patients with multiple myeloma and mantle cell lymphoma. In the integrated analysis, the most commonly reported adverse events were asthenic conditions (including fatigue, malaise, and weakness) (64%), nausea (55%), diarrhea (52%), constipation (41%), peripheral neuropathy NEC (including peripheral sensory neuropathy and peripheral neuropathy aggravated) (39%), thrombocytopenia and appetite decreased (including anorexia) (each 36%), pyrexia (34%), vomiting (33%), and anemia (29%). Twenty percent (20%) of patients experienced at least 1 episode of greater than or equal to Grade 4 toxicity, most commonly thrombocytopenia (5%) and neutropenia (3%). A total of 50% of patients experienced serious adverse events (SAEs) during the studies. The most commonly reported SAEs included pneumonia (7%), pyrexia (6%), diarrhea (5%), vomiting (4%), and nausea, dehydration, dyspnea and thrombocytopenia (each 3%). Adverse events thought by the investigator to be drug-related and leading to discontinuation occurred in 22% of patients. The reasons for discontinuation included peripheral neuropathy (8%), asthenic conditions (3%) and thrombocytopenia and diarrhea (each 2%). In total, 2% of the patients died and the cause of death was considered by the investigator to be possibly related to study drug: including reports of cardiac arrest, congestive heart failure, respiratory failure, renal failure, pneumonia and sepsis. This integrated analysis does not include the phase 3, VELCADE plus DOXIL study.

    For more information about VELCADE clinical trials, patients and physicians can contact the Millennium Medical Product Information Department at 1-866-VELCADE (1-866-835-2233).

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 详细处方信息以本药内容附件PDF文件(20081608005040.pdf)的“原文Priscribing Information”为准
---------------------------------------------------------------

更新日期: 2013-1-27
附件:
20081608005040.pdf    

 
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