CIMZIA 制造商：脐血公司 药理分类：肿瘤坏死因子（TNF）阻断剂 活性成分（补）：Certolizumab pegol 200mg/vial;为SC已经来到重组后的密码，不含防腐剂。 指示（补）：在中度至重度的克罗恩病：减少症状和体征，以及维持成年患者的临床反应与反应不足常规治疗。 药理：TNFα的水平升高有牵连的克罗恩病的病理变化。 Certolizumab pegol是一种重组，人性化抗体Fab'片段，有一个供人肿瘤坏死因子，炎症细胞因子，一中起着关键作用，炎症过程的亲和力。肿瘤坏死因子刺激白细胞介素-1，前列腺素，血小板活化因子的生成，一氧化氮。经过与certolizumab pegol治疗，克罗恩病病患的C -反应蛋白减少。 临床试验：两个安慰剂对照试验进行中度至重度的克罗恩病的患者。在第一项研究，662例患者给予400毫克或certolizumab pegol周时0，2，4或安慰剂，然后每4个星期到24周。在第6周，在研究药物对患者的临床反应的比例为35％，而安慰剂为27％，临床缓解由于在22和17％，对于那些服用安慰剂的研究指出，药物的患者％。在患者的比例谁在临床反应6和26周时有显着性（23％对比16％），显示出不同的临床反应的维护。 法律分类：接收 成人：给由资深大律师在腹部或大腿已经来到。 400毫克（二交感200毫克）第1天，然后在2和4周，维修400毫克，每4个星期。 儿童：不推荐。 警告/注意事项：主动感染：不推荐。长期或反复感染史。条件，易患感染。试验肺结核，治疗肺结核第一。密切留意新的感染，如果严重感染停止开发。组织胞浆菌病，结核病史或接触。免疫功能低下。 B型肝炎感染;停止，如果重新发生。恶性肿瘤。中枢神经系统脱髓鞘疾病。血液异常。瑞士法郎。如果停止狼疮样综合征或严重的过敏反应发生。妊娠（Cat.B）。哺乳母亲：不推荐。 互动（补）：并行anakinra的，活疫苗或其他肿瘤坏死因子阻断剂：不推荐。免疫抑制剂的感染风险增加。可能会干扰凝血试验（例如，聘任）。 不良反应（补）：上呼吸道感染，尿路感染，关节痛，其他感染;罕见：肺结核，乙型肝炎病毒再活化，过敏反应，恶性肿瘤，抗体的形成。 如何提供：洁1（2单剂量小瓶瓦特注射器，针头，物资） 最后更新：2009年1月15日 部分中文赛妥珠单抗资料介绍 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. UCB公司的单克隆抗体Cimzia对克罗恩病有疗效 根据初步临床研究的结果,由优时比(UCB)公司研制的一种单隆抗体——Cimzia(certolizumab pegol,赛妥珠单抗)可以减轻采用常规治疗不能完全缓解病情的成年中、重度克罗恩病(Crohn′s disease,又称局限性回肠炎、局限性肠炎、节段性肠炎和肉芽肿性肠炎)活动期病人的临床症状,而且该药对于那些不能耐受英利昔单抗(infliximab, Centocor公司的产品,商品名为Remicade)或使用英利昔单抗无效的病人也有一定疗效。 Cimzia与英利昔单抗和雅培(Abbott)公司的阿达木单抗(adalimumab,商品名为Humira)一样,也是一种肿瘤坏死因子(TNF)抑制剂,可缓解克罗恩病症状。目前用于治疗克罗恩病的生物制剂常会在病人使用一段时间后失效,无法阻止病情的发展,而且病人还会对这些特殊的生物制剂产生免疫介导反应。因而此时医生通常需使用一系列的药物,并且在几种药物之间不断地进行更换。 此次名为“Welcome研究”的临床试验对象为539名曾对英利昔单抗产生应答、但现已不再产生应答或是因为急性或迟发性输液反应而对其不能耐受的病人,研究分为两期:一是开标记诱导期,即在试验开始、2周和4周时分别给予赛妥珠单抗400 mg；然后是双盲维持期,即连续6～24周使用赛妥珠单抗400 mg。试验的首个终点指标为:用药第6周时,病人的克罗恩病活动指数(Crohn′s disease activity index, CDAI)至少降低至100,若降低至150则可视为症状缓解。初步研究结果显示,用药6周后,有62.2%的病人对赛妥珠单抗产生了应答, 39.3%的病人症状减轻;而在用药第2周,产生应答的病人比例即达到33.2%,在第4周时,有43.8%的病人产生了应答。这一结果与另一项名为“Precise 2 试验”的结果(病人应答率为64%)相近。由于参加Precise 2 试验的病人在使用赛妥珠单抗前并未使用过英利昔单抗,故这两项研究的结果提示,赛妥珠单抗对使用过英利昔单抗的病人仍有较好疗效。 cimzia（赛妥珠单抗，CERTOLIZUMAB PEGOL）类风湿新药 比利时UCB公司宣布，已收到美国FDA关于新药Cimzia（certolizumab pegol）的生物制剂新药上市申请的回复函。该药为第一个用聚乙二醇修饰的抗肿瘤坏死因子药物，用于治疗类风湿性关节炎。 作为批准Cimzia上市的前提条件，FDA要求UCB公司提供更新的、可靠的临床研究资料，包括从申请生物制剂上市许可以来的最新数据。 UCB公司表示，Cimzia可适用于中到重度类风湿性关节炎患者及其他炎性疾病，UCB公司一定会尽力达到FDA的要求。2008年2月，UCB公司向FDA递交该药治疗类风湿性关节炎的生物制剂上市申请之前，已进行了包含超过2300名受试者的多中心对照Ⅲ期临床试验。 2008年4月，美国FDA已批准Cimzia用于治疗对传统治疗方法不敏感的克罗恩病中到重度患者。其治疗克罗恩病的效果在瑞士也得到了认可。目前，欧洲EMEA正在对Cimzia治疗类风湿性关节炎的效用进行积极审查 此药需冷藏。 【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】 注：以下产品不同的规格和不同的价格，购买时请以电话咨询为准！ ·CIMZIA 200毫克/毫升/填充注射器 2注射器/套 ·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 Generic Name for CIMZIA Certolizumab pegol 200mg/mL soln for SC inj; or per vial (pwd for SC inj after reconstitution); preservative-free. Legal Classification: Rx Pharmacological Class for CIMZIA Tumor necrosis factor blocker. Manufacturer of CIMZIA UCB Inc. Indications for CIMZIA In moderately to severely active Crohn's disease: to reduce signs and symptoms and to maintain clinical response in adult patients with inadequate response to conventional therapy. Adult dose for CIMZIA Rotate inj site. Give by SC inj in abdomen or thigh. 400mg (two 200mg inj at separate sites) on day 1, then at weeks 2 and 4; maintenance 400mg every 4 weeks. Children's dosing for CIMZIA Not recommended. Warnings/Precautions for CIMZIA Increased risk of serious or fatal infections (eg, TB, bacterial sepsis, invasive fungal). Active infections: not recommended. Chronic or history of recurring infections. Conditions that predispose to infection. Test for and treat latent tuberculosis prior to initiating therapy. Monitor closely for new infections, discontinue if serious infection or sepsis develops. History of TB or histoplasmosis exposure. Immunosuppressed. Monitor for hepatitis B infection; discontinue if reactivation occurs. Malignancies. Pre-existing or recent-onset demyelinating disorders (eg, multiple sclerosis, Guillain-Barré syndrome). Hematological abnormalities. CHF. Discontinue if lupus-like syndrome or serious hypersensitivity reaction occurs. Pregnancy (Cat.B). Nursing mothers: not recommended. Interactions for CIMZIA Concurrent anakinra, abatacept, rituximab, natalizumab, live or attenuated vaccines, or other TNF blockers: not recommended. Immunosuppressants increase risk of infection. May interfere with coagulation tests (eg, aPTT). Adverse Reactions for CIMZIA Upper respiratory infections, rash, UTI, arthralgia, other infections; rare: TB, HBV reactivation, hypertension, heart failure, back pain, hypersensitivity reactions, malignancies (eg, lymphoma; esp. children), neurological disorders (seizures, optic neuritis, peripheral neuropathy), antibody formation, lupus-like syndrome. How is CIMZIA supplied? Kit—1 (2 single-dose vials w. syringes, needles, supplies); Single-use prefilled syringes—2 (w. supplies)