关于Enbrel(恩利)
Enbrel是一种批准用于治疗中度到重度类风湿性关节炎的药物,预计全美有150万人患有这种由于免疫系统紊乱造成的关节和软骨疼痛及膨胀的疾病。 该药物通过结合到特定蛋白使之失去活性而起到治疗作用,后者在正常的免疫功能和类风湿性关节炎及银屑病关节炎引起的反馈反应中都起关键性作用。Enbrel的副作用除注射部位皮肤有反馈作用外,对呼吸系统和其他部位也有潜在的感染性。 Immunex公司已在上个月已同意被其竞争对手Amgen公司(NasdaqNM:AMGN)用价值160亿美元的现金及股票收购,包括Enbrel。 UBS Warburg分析家Geoffrey Harris在一份报道中指出,“在今年第一季度获得的批准进一步巩固了对Enbrel销售额今年达到9.5亿美元,2005年将增加到27亿美元的估算。”他预计银屑病关节炎治疗申请的批准将为今年Enbrel销售额带来5600万美元,到2005年将每年达到4亿美元或者更多。 除了银屑病关节炎,FDA还批准Enbrel用于改善成年人类风湿性关节炎的征候及症状,以延缓其关节损害,以及儿童的多关节性幼态类风湿性关节炎。预计今后10年,扩充Enbrel的适应症使其能治疗银屑病关节炎可能是关节炎治疗医学进展的第一步。 在安慰剂对照的试验(n=349)中,最常见的副作用是注射部位反应(ISR)(37%)、感染(35%)和头痛(17%),只有ISR率高于安慰剂组;在氨甲喋呤对照的试验(n=415)中,最常见的副作用是感染(64%)、ISR (34%)和头痛(24%),只有ISR率高于氨甲喋呤组。 -重度感染:多见于易于感染者,如晚期或控制不良的糖尿病人;有些重度感染可致命;极少见结核菌感染。 -极少数时候致血液病症(有些可致命):如果持续发烧、瘀伤、出血或苍白要立即联系医生。 -对有JRA史的病人,头痛、腹痛、呕吐和恶心多于成人,但多较轻。其它很少报告的副作用包括重度感染(2%)和抑郁/人格障碍(1%)。 “我们很高兴委员会全体投票通过,并将同FDA密切合作尽快把Enbrel提供给强直性脊柱炎病人,目前他们的治疗选择很有限”,阿目金发展部副总裁塞登贝格(BethSeidenberg)说,“Enbrel能显著改善疼痛、脊柱的可动性和身体功能”。当前FDA除了批准非甾体抗炎药和类固醇治疗AS外几乎没有什么其它药,本病在美国约有35万名患者。 Enbrel是唯一批准来减少中重度活性RA症状体征、抑制结构性损害进展和减少银屑病关节炎患者活性关节炎症状体征的全人抗TNF受体,也是唯一批准治疗新诊断RA病人的生物制剂,可以单独使用。对缓解疾病的抗风湿性药无效的青少年类风湿性关节炎,其中重度活性多关节炎症状也可用Enbrel来减少。医生已开始熟悉Enbrel的优点,且证实它可长期耐受。5年前自从上市来全世界已有18万病人用过它。它的作用机理是吸附TNF,使炎症明显减少。每个人的效果差异很大,医学研究中对2/3的RA病人、3/4的JRA病人和1/2的银屑病关节炎病人有效。 该药从使用以来在病人中有下列报告: 严重感染:多在易感染者中出现,如晚期或控制不良的糖尿病患者;有些重度感染是致命的;罕见结核病人。 注意:如果有感染或对Enbrel及其成份过敏,不要使用;如果你容易感染的话要告诉医生;如果出现重度感染,停用Enbrel;如对Enbrel有什么疑问或出现感染与医生联系。 严重的神经系统病症,如多发性硬化症、癫痫或眼神经炎:如果你曾有这些疾病或如果用Enbrel后出现这些疾病要告诉医生。 也可能引起注射局部反应 日本批准依那西普用于类风湿治疗 惠氏日本公司和Takeda Pharmaceutical公司于2005年1月25日宣布,日本厚生省批准依那西普(etanercept,Enbrel)用于治疗对现有药物应答不足的类风湿性关节炎(RA)患者。 至此,本品已在全球70多个国家上市。 依那西普为一靶向肿瘤坏死因子(TNF)的完全人源化单克隆抗体药物,可缓解对传统抗关节炎药物应答不足的RA患者的体征和症状。其于1998年首次获得FDA批准用于治疗疼痛性关节疾病,长期安全性和疗效已在临床上得到了证明。依那西普可以单用治疗RA,以每周皮下注射2次的方式给药,在日本由惠氏公司和Takeda Pharmaceutical公司共同销售。本品最常见不良反应有注射部位反应、感染和头痛。 RA为一种可致残的慢性疾病。在日本大约有70万RA患者。严重的RA会引起机体免疫系统攻击关节内衬和结缔组织,致使关节疼痛和肿胀。如果不进行及时有效的治疗,还可能导致疲乏、残疾、畸形、器官损伤,甚至早死。在日本,畿患RA的女性患者人数是男性患者的4倍之多。RA可以在所有的年龄段包括儿童时期发病,其高发年龄段为25~50岁。 依那西普说明书 药品名:依那西普(Etanercept) 英文名:Infliximab、Enbrel@(Amgen Inc 生产)、Remicade@(Centacor.Inc生产). 来源: 英利昔是利用重组DNA和单克隆抗体技术制备的人源化的人鼠嵌合搞TNFα受体单抗. 依那西普是完全由人Ig生产的抗TNFα受体单抗. 作用机制: 本品为二聚体融合蛋白,由人类75kD肿瘤坏死因子(tumor necrosis factor, TNF)受体的细胞外配体结合部分和人类IgG1Fc段连接而成.本品Fc段含有GH2区、CH3区铰链区,但是不含有CH1区. 药代动力学: 适应证: 治疗低危/中危MDS、难治性贫血(RA)期伴有TNFa升高的病例. 单药有效率: 治疗MDS,有效率12.5%~30%. 剂型: 无菌白色不含防腐剂的冻干粉,每支含有Enbrel25mg,D-甘露醇40mg,蔗糖10mg,氨丁三醇1.2mg.依那西普为无菌冻干粉,每支含Remicade100mg. 剂量: 试验治疗MDS剂量(Remicade):3mg/kg静脉用药6次(第0、2、6、14、22、30周).Embrel,25mg皮下注射,每周2次,3个月为一疗程. 禁忌证: 不良反应: 临床应用规程: 注:以下产品是不同的规格和不同的价格,购买时请以电话咨询为准 -------------------------------------------------------------- About Enbrel® (etanercept)
How does ENBREL work? ENBREL is a type of protein called a tumor necrosis factor (TNF) blocker that blocks the action of a substance your body makes called TNF. Tumor necrosis factor is made by your body's immune system. People with immune diseases such as RA, JRA, AS, psoriatic arthritis, and plaque psoriasis have too much TNF in their bodies. About moderate to severe rheumatoid arthritis ENBREL can reduce the amount of TNF in the body. And while ENBREL can block the damage that too much TNF can cause, it can also lower the ability of your immune system to fight infections. So, taking ENBREL can make you more prone to getting infections or make any infection that you may have worse. To find out more about prescription ENBREL, talk with your doctor. Your doctor is the best source of information. You can also view the Important Safety Information. If you have additional questions, call 1-888-4ENBREL (1-888-436-2735). This line is open Monday through Friday, 8:00 am to 11:00 pm, Eastern Time. Administering ENBREL can be convenient. ENBREL is a protein and is injected (by you or someone else) just under the skin. Once you've filled your prescription, schedule a training session with your doctor's office to learn the proper techniques for self-injection. During this session, you may administer your first dose of ENBREL. You'll learn what you need to know at the doctor's office to inject ENBREL at home. ENBREL has more than 14 years of collective clinical experience. The first ENBREL clinical trials began in 1992. Since its approval for moderate to severe rheumatoid arthritis in 1998, ENBREL has also been approved for use in treating moderate to severe juvenile rheumatoid arthritis (JRA), psoriatic arthritis, ankylosing spondylitis (AS), and moderate to severe plaque psoriasis. The safety profile for ENBREL during clinical trials showed: Rates of serious adverse events were comparable to control patients in rheumatoid arthritis, psoriatic arthritis, and plaque psoriasis clinical trials. The most common adverse events reported were injection site reactions, infections, and headache. Routine laboratory monitoring specific for ENBREL therapy is not required; however, careful medical management and supervision of patients are recommended. Tell your doctor if you are prone to infection or have had hepatitis B. Learn More: rheumatoid arthritis juvenile rheumatoid arthritis psoriatic arthritis ankylosing spondylitis plaque psoriasis ENBREL is a type of protein called a tumor necrosis factor (TNF) blocker that blocks the action of a substance your body's immune system makes called TNF. People with an immune disease, such as rheumatoid arthritis, juvenile idiopathic arthritis, ankylosing spondylitis, psoriatic arthritis, or psoriasis, have too much TNF in their bodies. ENBREL can reduce the amount of active TNF in the body to normal levels, helping to treat your disease. But, in doing so, ENBREL can also lower the ability of your immune system to fight infections. Serious infections, including tuberculosis (TB), have happened in patients taking ENBREL. Some of these serious infections have been fatal. Many serious infections occurred in people prone to infection. Serious infections have also occurred in patients with advanced or poorly controlled diabetes. Do not start ENBREL if you have an infection or are allergic to ENBREL or its components. Once on ENBREL, if you get an infection or have any sign of an infection, including fever, cough, or flu-like symptoms, or have open sores, tell your doctor. Your doctor should test you for TB before starting ENBREL and should monitor you closely for signs and symptoms of TB. Serious nervous system disorders, such as multiple sclerosis, seizures, or inflammation of the nerves of the eyes have been reported. There have been rare reports of serious blood disorders (some fatal). In medical studies, more cases of lymphoma (a type of cancer) were seen in patients taking TNF blockers compared to similar patients who were not taking TNF blockers. The risk of lymphoma may be several-fold higher in people with rheumatoid arthritis and psoriasis; the role of TNF blockers in the development of malignancies is unknown. Tell your doctor if you: Think you have, are being treated for, have signs of, or are prone to infection In a medical study of patients with JIA, infection, headache, abdominal pain, vomiting, and nausea occurred more frequently than in adults. The kinds of infections reported were generally mild and similar to those usually seen in children. Other serious adverse reactions were reported, including serious infection and depression/personality disorder. If you have any questions about this information, be sure to discuss them with your doctor. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088. If you have any questions about this information, be sure to discuss them with your doctor. Please see full Prescribing Information. INDICATIONS Moderate to Severe Rheumatoid Arthritis (RA) ENBREL is indicated for reducing signs and symptoms, keeping joint damage from getting worse, and improving physical function in patients with moderate to severe rheumatoid arthritis. ENBREL can be taken with methotrexate or used alone. In medical studies, ENBREL was shown to be effective in about 2 out of 3 adults with RA who used it, and has been shown to begin working in as few as 2 weeks, with most patients receiving benefit within 3 months. In an RA medical study, 55% of patients had no progression of joint damage. ENBREL is indicated for reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis (JIA) in children ages 2 years and older. In medical studies, ENBREL was shown to be effective in about 3 out of 4 children with JIA who used it. For these JIA patients, ENBREL has been shown to begin working in approximately 2 to 4 weeks. Psoriatic Arthritis ENBREL is indicated for reducing signs and symptoms, keeping joint damage from getting worse, and improving physical function in patients with psoriatic arthritis. ENBREL can be used in combination with methotrexate in patients who do not respond adequately to methotrexate alone. In medical studies, ENBREL was shown to be effective in about 50% of psoriatic arthritis patients who used it. Clinical responses were apparent at the time of the first visit (4 weeks) and were maintained through 6 months of therapy. ENBREL is indicated for reducing signs and symptoms in patients with active ankylosing spondylitis. In a medical study, ENBREL was shown to be effective in about 3 out of 5 adults with AS who used it. Clinical responses were seen at 2 weeks in 46% of patients, with 59% of patients receiving benefit within 8 weeks. ENBREL is indicated for the treatment of adult patients (18 years or older) with chronic moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy. In medical studies, nearly half of patients saw a significant improvement in their plaque psoriasis within 3 months of using ENBREL. Overall, 3 out of 4 patients saw improvement. ENBREL can work fast; many patients saw improvement within 2 months. ENBREL has been shown to be effective through 12 months of therapy. |
恩利(依那西普注射剂)|Enbrel (Etanercept Injection Vials)简介:关于Enbrel(恩利)由美国惠氏专有,英文原名Entanercept(依那西普),商品名为恩利(Enbrel),是一种治疗类风湿关节炎的可溶性TNFa受体融合蛋白。它是由TNFa受体蛋白的膜外区与人IgG1的Fc段融合蛋白 ... 责任编辑:admin |
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