英文药名：ACTEMRA Injection（Tocilizumab[Genetical Recombination]） 中文药名：重组托西珠单抗注射剂 生产厂家：中外制药 アクテムラ点滴静注用80mg／アクテムラ点滴静注用200mg／アクテムラ点滴静注用400mg 治疗类别名称 人源化抗人IL-6受体的单克隆抗体 欧文商標名 ACTEMRA 一般名 トシリズマブ(遺伝子組換え) (Tocilizumab(Genetical Recombination))(JAN) 構造式 アミノ酸214個の軽鎖2分子とアミノ酸447、448(主成分)又は449個の重鎖2分子からなる糖蛋白質 分子式 軽鎖(C1033H1606N278O337S6) 重鎖(C2181H3398N582O672S15：主成分) 分子量 約148,000 药效药理 1.这种药物被抑制在体外，可溶性和膜结合的IL-6受体结合的对IL-6的生物学活性通过它们的表达。 2.这种药物抑制人IL-6给药于食蟹猴的活性的表达。 3.这种药物是在食蟹猴胶原诱导的关节炎，以及从一开始关节炎之前通过施用抑制关节肿胀的表达和关节炎发病后给药改善了关节的肿胀。 4.抗小鼠IL-6受体抗体，IL-6的贫血中的转基因小鼠，蛋白尿，抑制表达的研究结果如高γ球蛋白血症，延长存活天数。 适应病症 ○ 治疗变化的影响疾病不足 类风湿关节炎（包括预防关节结构破坏），幼年特发性关节炎关节活跃，全身发作幼年特发性关节炎 ○ 各种症状和Castleman病相关的实验室检查（C反应蛋白，纤维蛋白原增加，血沉增快，血红蛋白低价值，低白蛋白值，全身不适）改进。但是，仅限于患者切除淋巴结不指示。 用法用量 ○类风湿性关节炎，青少年特发性关节炎与活性铰接 推荐剂量每4周间隔：，静脉滴注一次为8mg/kg ○全身发作幼年特发性关节炎，Castleman病 推荐剂量每2周间隔，静脉内输注一次为8mg/kg。此外，可以通过症状缩短长达一周给药间隔。 包装规格 静脉滴注 200毫克/10毫升：1瓶 400毫克/20毫升：1瓶 80毫克/4毫升：1瓶 生产商：中外制药 中外公司的抗人白介素-6受体单克隆抗体Actemra（tocilizumab，MRA）获日本批准上市，用以治疗罕见的Castleman病。该产品不仅是第一个日本研发的单抗，也是第一个治疗这种少见的淋巴增生性疾病的商品化药物 以上部份处方资料仅供参考，使用时请阅读原文：http://www.info.pmda.go.jp/go/pack/6399421A1020_1_14/ ACTEMRA for Intravenous Infusion（Tocilizumab[genetical recombination]） ACTEMRA 200mg for Intravenous Infusion（アクテムラ点滴静注用200mg）  Brand name : ACTEMRA 200mg for Intravenous Infusion 　Active ingredient: Tocilizumab(genetical recombination) 　Dosage form: injection 　Print on wrapping: ACTEMRA 400mg for Intravenous Infusion（アクテムラ点滴静注用400mg）  Brand name : ACTEMRA 400mg for Intravenous Infusion 　Active ingredient: Tocilizumab(genetical recombination) 　Dosage form: injection 　Print on wrapping: ACTEMRA 80mg for Intravenous Infusion（アクテムラ点滴静注用80mg） Brand name : ACTEMRA 80mg for Intravenous Infusion 　Active ingredient: Tocilizumab(genetical recombination) 　Dosage form: injection 　Print on wrapping: Effects of this medicine This medicine improves joint pain/swelling and general symptoms accompanied by rheumatoid arthritis, polyarticular-course juvenile idiopathic arthritis (pJIA), systemic juvenile idiopathic arthritis (sJIA) and prevents progression of joint destruction in rheumatoid arthritis, by suppressing the actions of Interleukin-6 (IL-6). This medicine also improves conditions (e.g. general malaise) and laboratory findings (e.g. increased C-reactive protein, anemia) associated with Castleman's disease. It is usually used for treatment of rheumatoid arthritis, polyarticular-course juvenile idiopathic arthritis, systemic juvenile idiopathic arthritis and Castleman's disease. Before using this medicine, be sure to tell your doctor and pharmacist •If you have previously experienced any allergic reactions (itch, rash, etc.) to any medicines. If you have bacterial/viral infection. If you have tuberculosis or have a history of it. If anyone who has close contact with you (anyone in your household, etc.) has tuberculosis. If you have interstitial pneumonia or have a history of it. If you have a macrophage activation syndrome (MAS). If you have intestinal diverticulum. If you have leukopenia, neutropenia or thrombopenia. •If you are pregnant or breastfeeding. •If you are taking any other medicinal products. (Some medicines may interact to enhance or diminish medicinal effects. Beware of over-the-counter medicines and dietary supplements as well as other prescription medicines.) Dosing schedule (How to take this medicine) •Your dosing schedule prescribed by your doctor is <<to be written by a healthcare professional>> •In general, you are administered with intravenous infusion once every two weeks or four weeks. It will take about one hour for one intravenous infusion. •The treatment period with this medicine depends on your response to the treatment. •Blood test and/or ECG test may be performed before and during the treatment with this medicine. Precautions while taking this medicine •You should receive blood test, chest X-ray test, and ECG test regularly during the treatment with this medicine. Receive these tests according to instructions of your doctor. Possible adverse reactions to this medicine The most commonly reported adverse reactions include upper respiratory infection, rash, gastroenteritis and pneumonia. If any of these symptoms occur, consult with your doctor or pharmacist. The symptoms described below are rarely seen as initial symptoms of the adverse reactions indicated in brackets. If any of these symptoms occur, stop taking this medicine and see your doctor immediately. •general dullness, lightheadedness, decreased consciousness, impaired mind/judgment, glow, pale face, swelling around the eye/lip, hoarseness, breathing difficulty, shortness of breath, palpitation, hives [anaphylactic shock, anaphylaxis] •cold-like symptoms, general dullness, fever, vomiting, shortness of breath, cough, sore throat, rash with pain, joint pain, pain on urination [infections] •fever, dry cough, breathing difficulty, shortness of breath [interstitial pneumonia] •nausea, vomiting, severe abdominal pain [intestinal perforation] •fever, sore throat [agranulocytosis, leukopenia, neutropenia] •nose/gum bleeding, continuous bleeding, blue spot, subcutaneous bleeding [thrombopenia] •general dullness, body swelling, easy breathing in upright position than when lying down, breathing difficulty, shortness of breath, palpitation on exertion [cardiac failure] The above symptoms do not describe all the adverse reactions to this medicine. Consult with your doctor or pharmacist if you notice any symptoms of concern other than those listed above. Storage conditions and other information •Do not receive live vaccines during the treatment with this medicine. Chugai Pharmaceutical Co., Ltd.Injection Revised: 4/2016 The information on this sheet is based on approvals granted by the Japanese regulatory authority. Approval details may vary by country. Medicines have adverse reactions (risks) as well as efficacies (benefits). It is important to minimize adverse reactions and maximize efficacy. To obtain a better therapeutic response, patients should understand their medication and cooperate with the treatment.