TYSABRI（那他珠单抗 natalizumab）注射剂获美国(FDA)批准为治疗多发性硬化症、克罗恩病
美国首次批准：2004 公司：Biogen Idec公司
警告：多灶性脑白质病
TYSABRI会增加进行性多灶性白质脑病（PML）的风险，这通常会导致死亡或重度残疾的大脑的机会性病毒感染.
危险因素的PML的发展包括持续时间的治疗，在先使用免疫抑制剂，以及抗JCV抗体的存在。发起和继续治疗与TYSABRI时，这些因素都要考虑的预期收益的情况下
监测患者，并在第一个迹象，立即扣留TYSABRI或症状PML的提示
PML的风险，因为，TYSABRI只能通过所谓的TOUCH®处方计划限制分配方案
目前的主要变化
警告和注意事项 05/2015
适应症和用法
TYSABRI是治疗所指示的整合素受体拮抗剂：
多发性硬化症（MS）
TYSABRI被表示为单一疗法用于治疗患有复发性多发性硬化的形式的治疗。 TYSABRI增加PML的风险。当启动并继续与TYSABRI治疗，医师应考虑使用TYSABRI的预期收益是否足以抵消这种风险。请参阅有关PML的使用TYSABRI风险的重要信息。
克罗恩病（CD）
TYSABRI被指示用于诱导和维持与中度至重度活动克罗恩病与炎症的证据谁不得不响应不足，或不能耐受常规的CD疗法和TNF-α的抑制剂临床反应和缓解的成年患者。
重要的限制：
在CD，TYSABRI应不与免疫抑制剂或TNF-α的抑制剂组合使用。
【用法用量】
300毫克静脉输注在一小时内，每四周。不要给作为静脉推或推。
TYSABRI的解决方案必须8小时编制内管理。
在输液过程中观察患者和一小时后，输注完成。
在CD，停止在没有12周诱导治疗经验丰富的治疗效果的患者，在患者不能开始治疗后六个月内停止慢性伴随类固醇。
剂型和规格
溶液[300毫克每15毫升小瓶]用于稀释之前输注。
禁忌
谁拥有或有过患者的PML。
谁曾过敏反应到TYSABRI的患者。
警告和注意事项
疱疹性脑炎和脑膜炎：危及生命或死亡病例时有发生。停止使用TYSABRI如果发生这种情况，并适当处理
肝：肝脏明显损伤，包括肝功能衰竭需要移植，已经发生。停止TYSABRI患者肝损伤的证据。
过敏反应：严重的过敏反应（如过敏症）时有发生。永久中止TYSABRI如果这样的反应发生。
免疫/感染：TYSABRI可能会增加对某些感染的风险。监测患者感染的发展，由于风险与使用TYSABRI的增加。
不良反应
最常见的不良反应（发生率≥10％）
MS - 头痛，乏力，关节痛，尿路感染，下呼吸道感染，肠胃炎，阴道炎，抑郁症，疼痛下肢，腹部不适，腹泻NOS和皮疹
头痛，上呼吸道感染，恶心和疲劳
特殊人群中使用
妊娠：根据动物实验数据，可能会对胎儿造成伤害。
美国上市包装
Tysabri (natalizumab) is an injectable disease-modifying treatment, delivered by intravenous infusion every four weeks, approved by the FDA for the treatment of relapsing forms of MS to delay progression of disability and reduce frequency of exacerbations and is produced by Biogen Idec and Elan Pharmaceuticals. Tysabri is generally recommended for use in people who have had an inadequate response to, or who have not tolerated, other disease-modifying treatments.
How does Tysabri work?
Tysabri is a humanized monoclonal antibody that serves as a receptor antagonist against the alpha 4 integrin cell adhesion molecule present on the surface of all leukocytes (a type of white blood cell that plays an important role in the immune system). Tysabri attaches to alpha 4 integrin and, by doing so, inhibits the leukocyte from carrying out its function as a part of the immune response. Although we don’t understand exactly how Tysabri works to reduce exacerbations and slow progression of disability in MS, by inhibiting the function of leukocytes, it appears to interfere with the abnormal immune response thought to be involved in MS.
How is Tysabri taken?
Tysabri is taken as an intravenous (IV) infusion given over 1 hour every 4 weeks. The recommended dose of Tysabri is 300 mg. Tysabri is only available in the US through doctors who are enrolled in the TOUCH Prescribing Program (TYSABRI Outreach: Unified Commitment to Health). The TOUCH Program ensures that Tysabri is prescribed and infused in a safe manner.
What evidence do we have that Tysabri works?
Tysabri was tested in people with MS in two randomized, double-blind, placebo-controlled studies. The studies included people with MS who had had at least 1 exacerbation during the year before the study and a certain level of disability as measured by the Kurtzke Expanded Disability Status Scale (EDSS).
Participants in Study 1 were randomly assigned to receive Tysabri 300 mg (n=627) or placebo (n=315) every four weeks for up to 28 months (30 infusions). Study 2 included people who had had 1 or more exacerbations while taking Avonex (interferon beta-1a) during the year before the study. Participants in Study 2 continued to receive Avonex weekly and were randomly assigned to receive Tysabri (n=589) or placebo (n=582) every four weeks for 28 months.
In both studies, the groups that received Tysabri (in Study 1, Tysabri alone, and in Study 2, Tysabri + Avonex) had significantly longer periods of time to sustained increase in disability and fewer exacerbations compared with the placebo groups (in Study 1, placebo alone, and in Study 2, Avonex + placebo).
Is there a generic form of Tysabri?
A generic form of Tysabri is not available.
Last updated: January 23, 2013