恩利(商品名),英文名为Enbrel,通用名为注射用依那西普(Etanercept ),是美国辉瑞公司(Pfizer)经生物工艺生产的、由人p75肿瘤坏死因子受体与人免疫球蛋白G1的Fc端连接组成二聚体融合蛋白。它是全球首个全人源化的、第一个用于治疗类风湿关节炎和强直性脊柱炎的可溶性肿瘤坏死因子拮抗剂。迄今为止,国外已上市17年,已有超过200万患者年的使用经验,除治疗类风湿关节炎和强直性脊柱炎外,还已批准治疗银屑病性关节炎、幼年慢性关节炎和银屑病,而在中国,数个月前正式批准上市治疗类风湿性关节炎和强直性脊柱炎。
研究证实,恩利能同时能够阻断炎性介质TNF-α和TNFβ,可使62%的类风湿关节炎患者达功能缓解;57%达临床缓解;90%达结构缓解,阻断疾病进程,阻止骨质破坏,改善关节功能,提高生活质量。还能缓解强直性脊柱炎的腰痛、外周关节炎和肌腱端炎。另外,恩利很少产生中和抗体,很少诱发严重感染和恶性肿瘤。 恩利规格为25mg/支, 50毫克,25毫克/25毫升/瓶 4瓶/盒。正规使用剂量为每周2支,即50mg/周,分2次或1次使用,但也可根据患者的年龄、病情和医生的经验来调整,一般来说,疗程至少3~6个月。适合于经济条件比较好的患者。 【药品名称】依那西普(Etanercept) 【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. 【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. 给药途径: 皮下注射或者静脉点滴. 配伍: 本品不宜与其他药品混合使用并且不应使用注射用水以外的溶媒溶药. 【禁忌证】败血症患者、已知对Embrel和Remicade或者制剂中其他成分过敏的患者禁用.心衰患者、老年患者、孕妇、哺乳期妇女慎用. 【不良反应】 【临床应用规程】 【贮存】 【原产地英文商品名】ENBREL 25mg/0.5ml/syringe 4syringes/Box
About Enbrel® (etanercept) About moderate to severe rheumatoid arthritis 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 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: 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: 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. If you have any questions about this information, be sure to discuss them with your doctor. Please see full Prescribing Information. INDICATIONS 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 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. 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. 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. |
依那西普注射剂(ETANERCEPT,ENBREL)简介:恩利(商品名),英文名为Enbrel,通用名为注射用依那西普(Etanercept ),是美国辉瑞公司(Pfizer)经生物工艺生产的、由人p75肿瘤坏死因子受体与人免疫球蛋白G1的Fc端连接组成二聚体融合蛋白。它是全球 ... 责任编辑:admin |
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