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当前位置:药品说明书与价格首页 >> 神经内科 >> 多发性硬化症 >> 药品推荐 >> Zinbryta Prefilled Syringe(达利珠单抗长效注射剂)

Zinbryta Prefilled Syringe(达利珠单抗长效注射剂)

2016-06-05 04:27:39  作者:新特药房  来源:互联网  浏览次数:1  文字大小:【】【】【
简介:长效注射剂Zinbryta(daclizumab)剂量预装注射器每月一次用于复发性多发性硬化成年患者治疗,其每月可由患者自行使用。FDA的药品评价和研究中心中神经学产品部主任说;Zinbryta 为可能需要一种新的治疗选择的患者 ...

长效注射剂Zinbryta(daclizumab)剂量预装注射器每月一次用于复发性多发性硬化成年患者治疗,其每月可由患者自行使用。FDA的药品评价和研究中心中神经学产品部主任说;Zinbryta 为可能需要一种新的治疗选择的患者提供了一种额外的选择.
批准日期:
2016年5月27日;公司:AbbVie,Inc.和Biogen
ZINBRYTA(达利珠单抗 daclizumab)注射液,为皮下使用
美国初次批准:2016
作用机制
daclizumab在多发性硬化症中发挥治疗效应的精确机制但被假设通过与CD25结合,高-亲和力IL-2受体的一个亚单位是涉及IL-2介导的淋巴细胞活化的调节。
适应证和用途
ZINBRYTA是一种白介素-2受体阻断抗体适用为有多发性硬化症(MS)的复发型成年患者的治疗。因为其安全性图形,ZINBRYTA的使用一般地应保留为对两种或更多适用为的治疗MS药物已有反应不佳的患者。
剂量和给药方法
⑴ 推荐剂量:150mg每月一次。
⑵仅为皮下使用
⑶ 训练患者自身给药适当技术。
⑷ 基线时和给药间隔时定期进行实验室测试监视潜在地严重不良反应的早期征象。
剂型和规格
注射液:150mg/mL溶液在单-剂量预装注射器。
禁忌证
⑴ 预先存在肝病和肝受损,包括ALT或AST至少ULN的2倍。
⑵ 自身免疫性肝炎病史或涉及肝脏其他自身免疫情况。
⑶ 对daclizumab或制剂的任何其他组分超敏病史。
警告和注意事项
⑴ 超敏性反应:过敏反应和血管水肿的风险。如发生过敏反应或其他过敏性反应终止和不要再开始ZINBRYTA。
⑵ 感染:增加感的风险染。如发生严重感染,考虑不给ZINBRYTA直至感染解决。
⑶ 抑郁和自杀:忠告患者立即报告抑郁和/或自杀意念的症状至他们的卫生保健提供者。如发生严重抑郁和/或自杀意念考虑终止。
不良反应
对ZINBRYTA报道的最常见不良反应(发生率≥5%和发生率比对比药较高≥2%)为与AVONEX比较鼻咽炎,上呼吸道感染,皮疹,流感,皮炎,口咽痛,支气管炎,湿疹和淋巴结肿大;和与安慰剂比较上呼吸道感染,抑郁,皮疹,咽炎,和谷丙转氨酶增加(ALT)。
药物相互作用
肝毒性药物:评价与同时使用肝毒性的风险增加的潜能。


US Food and Drug Administration (FDA) approved ZINBRYTA™ (daclizumab) as a new once-monthly injection for treating multiple sclerosis.
Daclizumab is a genetically engineered monoclonal antibody that binds to CD25, a receptor on T cells that is thought to become activated in response to MS. Daclizumab is believed to work by selectively targeting these activated T cells without causing general T-cell depletion. It is approved by the FDA for use in rheumatoid arthritis and other autoimmune diseases. Daclizumab high yield process (DAC HYP) is administered subcutaneously once every four weeks, rather than via intravenous infusion.
Participants in the Phase II CHOICE study had either RRMS or SPMS, with worsening disease activity while taking one of the approved interferon therapies. The study showed that DAC HYP was well tolerated when added to an interferon. A statistically-significant 72-percent reduction in the frequency of gadolinium-enhancing MRI lesions was seen in the high-dose group (300 mg every four weeks).
The Phase IIb SELECT trial, with 600 participants who have RRMS, was a one-year study of treatment with DAC HYP. This study was subsequently extended for a second year as the SELECTION trial. The study included three treatment arms, with two dose levels (at 150 mg and 300 mg) and a placebo group.
Results of the SELECT trial announced in August 2011 indicated that the annualized relapse rate was decreased by 54 percent in the 150-mg-dose group and by 50 percent in the 300-mg-dose group. It also met its secondary endpoints: the number of new gadolinium-enhancing lesions was reduced by 69 percent and 78 percent; the number of new or newly enlarging T2-hyperintense lesions was reduced by 70 percent and 79 percent; and the proportion of patients who relapsed was reduced by 50 percent and 51 percent. These results were all for the low- and high-dose groups respectively. Sustained disability progression at one year was reduced by 57 percent with the lower dose and 43 percent with the higher dose.
Participants who completed this trial were enrolled in an extended trial called SELECTION to evaluate long-term safety and efficacy. One-year results of the SELECTION trial were presented46 in 2012. Patients who were on placebo and began treatment with DAC HYP in the extension trial had a 59-percent reduction in annualized relapse rate compared to the year prior, while patients who continued on DAC HYP saw their low relapse rate from the prior year maintained.
In 2013, further data from this trial was presented;47 patients who received two years of treatment with DAC HYP in the SELECT trial and its one-year extension study, SELECTION, were evaluated to determine the rate of brain atrophy (brain-volume loss). During the second year of treatment, brain-volume loss was 27-percent lower in the treated groups compared with the placebo group at year one. The authors of the study note that this reduction in the rate of brain atrophy in people with MS may be consistent with neuroprotection.
DAC HYP was further studied in the DECIDE trial,48 a Phase III study of 1,841 participants with relapsing MS, comparing DAC HYP to Avonex. DAC HYP was admin-istered subcutaneously once every four weeks for 96 to 144 weeks in a dose of 150 mg. This was compared to a weekly 30-mcg intramuscular injection of Avonex. The study began in March 2010 and was completed in the spring of 2014. Outcome measures included relapse rate, functional decline, and disability progression, as well as quality of life.
Initial results of the DECIDE trial were presented in 2014.49 Treatment with daclizumab resulted in a 45-percent reduction in annualized relapse rate (ARR), a 54-percent reduction in new and newly enlarging T2 lesions, and a 65-percent reduction in new gadolinium-enhancing lesions in comparison to Avonex. Risks associated with daclizumab treatment included infections, rash dermatitis, and liver enzyme abnormalities, some of which were serious. More than a third of people on daclizumab reported cutaneous (skin) issues – twice as many as on Avonex – including some cases severe enough to warrant discontinuing the drug. One death in a daclizumab-treated patient from the Phase II study was due to complications of a muscle abscess, and a second death was due to autoimmune liver inflammation. The safety profile of this medication including the nature of the cutaneous side effects will be closely evaluated in further analyses of the Phase III trial.

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