通用名称TYSABRI
那他珠单抗300mg/15mL SOLN，稀释后静脉输液，不含防腐剂的。
法律分类：
接收
类药物TYSABRI
免疫调节剂（整合素受体拮抗剂）。
制造商TYSABRI
Biogen Idec公司，公司
【适应症】用于TYSABRI
在中度至重度活动性克罗恩病的诱导和维持临床反应和缓解的成年患者的炎症有反应不足或不能耐受常规治疗和肿瘤坏死因子-α抑制剂的证据。
成人剂量的TYSABRI
≥18yrs：给予静脉滴注1小时以上，期间和输注后1小时的监控。 300毫克，每4周。如果没有治疗反应的诱导治疗停止后12周，或如果无法在6 MOS开始治疗慢性随之而来的类固醇逐渐减少。愿继续与氨基水杨酸。
禁忌TYSABRI
进行性多灶性白质脑病（PML）。
注意事项TYSABRI
肾或肝功能不全。进行性多灶性白质脑病的症状和体征的监测;中止若发生。定期重新评估（在输注后3个月和6个月，那么以后每6个月）。免疫抑制。接种疫苗。老人。怀孕（Cat.C）。哺乳母亲：不推荐使用。
互作TYSABRI
伴随其他免疫抑制剂或TNF-α抑制剂：不推荐。
不良反应TYSABRI
感染，过敏性反应（停止，如果发生不重新启动），肝（监控，如果发生中断），恶心，胆石症，荨麻疹，头痛，乏力，关节痛，注射部位反应，抗体形成（如持久性，可显着降低疗效）血细胞计数的变化，肠阻塞或狭窄，腹腔粘连。
如何是TYSABRI提供的吗？
单次使用小瓶（300毫克）-1
Important Information about TYSABRI
TYSABRI increases the risk of progressive multifocal leukoencephalopathy (PML), an opportunistic viral infection of the brain, which usually leads to death or severe disability. Infection by the JC virus (JCV) is required for the development of PML and patients who are anti-JCV antibody positive have a higher risk of developing PML. Factors that increase the risk of PML are presence of anti-JCV antibodies, prior immunosuppressant use, and longer TYSABRI treatment duration. Patients who have all three risk factors have the highest risk of developing PML. Other serious adverse events that have occurred in TYSABRI-treated patients include hypersensitivity reactions (e.g., anaphylaxis) and infections, including opportunistic and other atypical infections. Clinically significant liver injury has also been reported in the post-marketing setting. A list of adverse events can be found in the full TYSABRI product labeling for each country where it is approved.
TYSABRI
Generic Name for TYSABRI
Natalizumab 300mg/15mL; soln; for IV infusion after dilution; preservative-free.
Legal Classification:
Rx
Pharmacological class for TYSABRI
Immunomodulator (integrin receptor antagonist).
Manufacturer of TYSABRI
Biogen Idec, Inc.
Indications for TYSABRI
In moderately-to-severely active Crohn's disease: to induce and maintain clinical response and remission in adult patients with evidence of inflammation who have had inadequate response to or are intolerant to conventional therapy and TNF-α inhibitors.
Adult dose for TYSABRI
≥18yrs: Give by IV infusion over 1 hour; monitor during and for 1 hour post-infusion. 300mg every 4 weeks. Discontinue after 12 weeks of induction therapy if no therapeutic response, or if unable to taper off chronic concomitant steroids within 6 mos of starting therapy. May continue with aminosalicylates.
Contraindications for TYSABRI
Progressive multifocal leukoencephalopathy (PML).
Precautions for TYSABRI
Renal or hepatic insufficiency. Monitor for signs and symptoms of progressive multifocal leukoencephalopathy; discontinue if occurs. Reevaluate periodically (at 3months and 6months post-infusion, then every 6months thereafter). Immunosuppression. Vaccinations. Elderly. Pregnancy (Cat.C). Nursing mothers: not recommended.
Interactions for TYSABRI
Concomitant other immunosuppressants or TNF-α inhibitors: not recommended.
Adverse Reactions for TYSABRI
Infections, allergic reactions (discontinue if occurs; do not restart), hepatotoxicity (monitor and discontinue if occurs), nausea, cholelithiasis, urticaria, headache, fatigue, arthralgia, inj site reactions; antibody formation (if persistent, may substantially reduce efficacy); changes in blood cell counts; intestinal obstruction or stenosis, abdominal adhesions.
How is TYSABRI supplied?
Single-use vial (300mg)—1
