部分中文赛妥珠单抗处方资料（仅供参考）

Certolizumab Pegol (Cimzia)批准用于治疗风湿性关节炎

FDA批准certolizumab pegol针剂(Cimzia; UCB, Inc)用于一种新的适应症，允许它用于治疗成人中度到重度的活动性风湿关节炎（RA）

美国RA的流行率估计达到1300万，其中女性受到的影响可能是男性的3倍。虽然，这种疾病可以影响各个年龄段人群，它的首发通常是在35-55岁之间。

“RA患者，关节僵硬、易疲劳，有疼痛和肿胀感。这使他们难以执行很多日常生活的活动，有时起床也会是场奋斗，”Roy Fleischmann医学博士在一家公司的新闻发布会上表示，并补充到certolizumab代表一种简便易行的治疗选择，它提高生活质量并抑制结构损伤。

Fleischmann医生是德克萨斯州大学达拉斯分校西南医学中心国际医学部的临床教授。

RA的聚乙二醇肿瘤坏死因子抑制剂获批是基于公司临床试验项目的数据。它包括超过2300名患者及超过4000病人年经验的4个多中心安慰剂控制对照第三期研究。

研究结果显示Certolizumab（200mg每隔一周）和甲氨喋呤（MTX）合用比单用MTX缓解RA症状、提高机体功能效果要显著。减少疼痛方面，第一周就有起色，到24周维持作用，可持续达1年。

数据也显示联合治疗显著地抑制关节损伤的等级，正如修订版Sharp总分及其分项、Erosion得分和关节间距狭窄得分，分别在24和52周评估的。（P<.001）。

接受certolizumab治疗的患者报告的严重副作用包括肺结核（包括潜伏期疾病复发）和恶性疾病，比如淋巴瘤。最常见报告的反应包括上呼吸道疾病、皮疹和尿路感染。药物安全数据的汇集分析显示注射部位疼痛的发生率低（<2%）且由于副反应退出治疗人数少（5%）。

Certolizumab的推荐剂量最初为400mg（给予两次200mg皮下注射），同时在第2和第4周，每隔一周注射200mg。维持剂量，我们认为certolizumab 400mg每四周是合适的。

在开始治疗慢性或周期性感染患者之前，人们应该仔细考虑Certolizumb治疗的风险/收益。由于细菌、分枝杆菌、侵入性霉菌或其他机会致病菌，严重和有时致命的感染一直在患者接受肿瘤坏死因子抑制剂中，在联用免疫抑制剂；比如MTX或皮质类固醇中有报导。用certolizumab治疗期间及之后，患者应该严密监控感染情况，包括基线水平测试为阴性的人的肺结核发展情况。出现严重感染或脓毒症应该中断治疗。

因为新的和恶化的充血性心力衰竭的案例已经在certolizumab治疗中有报导，所以心力衰竭的患者应该小心治疗、细心监视。

Certolizumab以包含200mg用于再构成的瓶装和新的200mg/mL单剂预填充针剂的形式销售。这项产品先前得到批准用于减少克罗恩式疾病的征象，保持中到重度对常规治疗反应不足的活动性疾病成人患者的临床反应。

此药需冷藏。

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CIMZIA（赛妥珠单抗/阿达单抗）

美国首次批准：2008

适应症及用法
CIMZIA是表示为一种肿瘤坏死因子（TNF）受体阻滞剂：
减少克罗恩病的症状和体征，并维持临床反应在成人中度至重度活动性疾病，谁也进行了常规治疗反应不足
治疗成人中度至重度活动性类风湿关节炎
 
【用法用量】
通过皮下注射给药CIMZIA。 CIMZIA初始剂量是400毫克（作为两个皮下注射200毫克给出）。

克罗恩病

最初和在第2周和第4周400毫克。如果响应时，按照400毫克每四个星期
类风湿关节炎

400毫克400毫克最初和在周2和4，然后由200 mg，隔周的维持剂量，每4周，可以考虑
 
剂型和优势
200毫克冻干粉末配制用1mL注射用的无菌水，USP
200在单次使用预装玻璃注射器（3毫克/毫升）
 
禁忌
无
 
警告和注意事项
严重感染 - 不启动CIMZIA在一个活跃的感染。如果感染发展，认真监督，并停止CIMZIA如果变得严重感染.
例淋巴瘤和其他恶性肿瘤已发现的患者接受肿瘤坏死因子阻断剂.
心脏衰竭，恶化或新发，可能会出现.
可能发生过敏性反应或严重的过敏反应.
肝炎乙肝病毒再激活 - 监视乙肝病毒携带者在治疗数月后。如果再活化发生，停止CIMZIA“，并开始抗病毒治疗.
脱髓鞘疾病，加重或新发，可能会出现.
血细胞减少，全血细胞减少症 - 建议患者立即就医，如果症状发展，并考虑：停止CIMZIA.
狼疮样综合征 - 停止CIMZIA综合征进展.
 
不良反应
最常见的不良反应（发生率≥7％，高于安慰剂）：上呼吸道感染，皮疹，泌尿道感染.

报告疑似不良反应，联系UCB公司在1-866-822-0068或FDA在1-800-FDA-1088或www.fda.gov / medwatch。
 
药物相互作用
使用生物DMARDs治疗 - 增加严重感染的风险
活疫苗 - 不给CIMZIA
实验室测试 - 可能干扰与APTT测试

日期：10/2010
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GENERIC NAME: certolizumab

BRAND NAME: Cimzia

DRUG CLASS AND MECHANISM: Certolizumab is an injectable synthetic (man-made) protein antibody that binds to tumor necrosis factor alpha (TNFα) in the body and blocks the effects of TNFα in patients with rheumatoid arthritis and Crohn's disease. Adalimumab (Humira) and etanercept (Enbrel) are two other injectable drugs that block TNFα. Inflammation is the body's reaction to injury and is a necessary process for the repair of injury. TNF is a protein that the body produces when there is inflammation. TNF promotes inflammation and the signs of inflammation, which, in the case of arthritis, include fever as well as pain, tenderness, and swelling of joints. In the case of Crohn's disease, the signs of inflammation include fever, abdominal pain, and diarrhea. The unchecked inflammation of rheumatoid arthritis eventually leads to destruction of the joints. The inflammation in Crohn's disease can lead to strictures (narrowing) of the intestine or intestinal perforation. Certolizumab binds to TNF in the body and thereby blocks the effects of TNF. As a result, inflammation and its consequences in the joints and intestine are reduced. In arthritis, the progressive destruction of the joints is slowed or prevented. The FDA approved Certolizumab in April 2008.

GENERIC AVAILABLE: No

PRESCRIPTION: Yes

PREPARATIONS: Injection (powder): 200 mg. Injection (prefilled syringe): 200 mg

STORAGE: Certolizumab should be stored refrigerated at 2 to 8 C (36 to 46 F). Reconstituted certolizumab should be used within two hours if kept at room temperature or within 24 hours if refrigerated.

PRESCRIBED FOR: Certolizumab is used for treating signs and symptoms of moderate to severe Crohn's disease and maintaining response in adults unresponsive to usual treatment. It is also used for treating rheumatoid arthritis. It may be used alone or combined with methotrexate (Rheumatrex, Trexall) or other drugs used for treating rheumatoid arthritis.

DOSING: Certolizumab is injected under the skin (thigh or abdomen). Injection sites should be rotated. The recommended dose for treating Crohn‘s disease is 400 mg initially (2 injections of 200 mg), followed by 400 mg at weeks 2 and 4. For those who respond, the recommended maintenance dose is 400 mg every 4 weeks. The recommended dose for treating rheumatoid arthritis is 400 mg (2 injections of 200 mg) initially and at weeks 2 and 4, followed by 200 mg every other week.

DRUG INTERACTIONS: Combining anakinra (Kineret), abatacept (Orencia), rituximab (Rituxan) or natalizumab (Tysabri) with certolizumab may result in reduced white blood cells in the blood (neutropenia), serious infections and no additional benefit.

Certolizumab may interfere with the effectiveness of vaccines. Live vaccines, including attenuated vaccines, should not be used while patients are being treated with certolizumab. Certolizumab may interfere with tests of coagulation in patients receiving blood thinners.

PREGNANCY: There are no adequate studies of certolizumab in pregnant women.

NURSING MOTHERS: It is not known whether certolizumab is excreted in breast milk.
SIDE EFFECTS: The most common adverse effects in clinical studies were respiratory tract infections, urinary tract infections, and arthralgia (pain in the joints). Abdominal pain, diarrhea, and intestinal obstruction also may occur. Certolizumab may cause swelling, redness, pain and itching at the site of injection. Like other drugs that block TNFα, use of certolizumab has been associated with serious infections such as tuberculosis, sepsis (bacteria in the blood) and fungal infections. Individuals with active infections should not be treated with certolizumab. Certolizumab may worsen or cause new diseases of the nervous system. Certolizumab also may cause or worsen congestive heart failure. In studies, some patients who used certolizumab or other TNFα blocking drugs developed cancer. Since patients with Crohn's disease have a higher risk of cancers than the general population, the connection between cancer and use of certolizumab is unclear. Other side effects of certolizumab include hypersensitivity (allergic) reactions (including anaphylaxis) and reduced levels in the blood of platelets and red blood cells (aplastic anemia). Certolizumab may increase the risk of reactivating hepatitis B virus in chronic careers of the virus.
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原产地英文商品名:
CIMZIA STARTER KIT 200MG/ML/SYRINGE/KIT
原产地英文药品名:
CERTOLIZUMAB PEGOL
中文参考商品译名:
CIMZIA起始套装 200毫克/毫升/注射器/套
中文参考药品译名:
赛妥珠单抗
生产厂家中文参考译名:
UCB INC
生产厂家英文名:
UCB INC

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原产地英文商品名:
CIMZIA 200MG/ML/FILLED SYRINGE 2SYRINGES/KIT
原产地英文药品名:
CERTOLIZUMAB PEGOL
中文参考商品译名:
CIMZIA 200毫克/毫升/填充注射器 2注射器/套
中文参考药品译名:
赛妥珠单抗
生产厂家中文参考译名:
UCB INC
生产厂家英文名:
UCB INC