英文药名：ACTEMRA Injection（Tocilizumab[Genetical Recombination]） 中文药名：重组托珠单抗皮下注射剂 生产厂家：中外制药 アクテムラ皮下注162mgシリンジ／アクテムラ皮下注162mgオートインジェクター 治疗类别名称 人源化抗人IL-6受体的单克隆抗体 商標名 ACTEMRA 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 操作注意事项 为了避免暴露于光，这种药物是能够保存，把外包装盒。此外，外包装盒开启后还可以节省挡住光线。 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，17与由施用从发病关节炎之前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。 适应证和用途： ACTEMRA(tocilizumab)是白介素-6(IL-6)受体抑制剂用于类风湿性关节炎治疗：适用于一种或更多TNF 拮抗剂治疗反应不佳的中度至严重-活动性类风湿性关节炎成年患者。 用法用量 成人，皮下注射一次在2周的时间间隔为162mg TOCILIZUMAB（遗传学重组）。 包装规格 皮下注射 162mg注射器：0.9毫升×1注射器 62mg自动进样器：0.9毫升×1自动进样器 制造厂商 中外制药有限公司 完整处方资料附件：http://www.info.pmda.go.jp/go/pack/6399421G1022_1_08/ 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 Brand name : ACTEMRA 162mg Syringe for SC Injection 　Active ingredient: Tocilizumab(genetical recombination) 　Dosage form: injectable preparation 　Print on wrapping: --------------------------------------- Brand name : ACTEMRA 162mg Auto-Injector for SC Injection 　Active ingredient: Tocilizumab(genetical recombination) 　Dosage form: injectable preparation 　Print on wrapping: --------------------------------------- Effects of this medicine This medicine improves joint pain/swelling and general symptoms accompanied by rheumatoid arthritis, and prevents progression of joint destruction, by suppressing actions of interleukin-6 (IL-6). It is usually used to treat rheumatoid arthritis. 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 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, for adults, inject 1 syringe subcutaneously at a time, at an interval of 2 weeks. Strictly follow the instructions. •Inject this medicine into the abdomen, thighs, or upper arms. Injection site should be rotated and changed every time you inject the medicine. Inject to the area at least 3 cm apart from the previously injected site. Avoid injecting this medicine into the skin with wound or rash. •Blood test and/or ECG test may be performed before and during the treatment with this medicine. •Only if you have received proper training at a medical facility and your doctor has judged you are capable of it, this medicine may be self-injected. Receive an explanation to fully understand how to self-inject and how to discard syringes and needles properly (used syringes and needles must never be re-used). Strictly follow the instructions. •If you missed an injection, consult with your doctor. You should never inject two doses at one time. •If you accidentally inject more than your prescribed dose, consult with your doctor or pharmacist. •Do not stop injecting this medicine or not adjust the dosage unless your doctor instructs you to do so. 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 injection site reaction and upper respiratory infection. 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. •lassitude, lightheadedness, decreased consciousness, impaired mind/judgment, glow, pale face, swelling around the eye/lip, hoarseness, breathlessness, shortness of breath, palpitation, urticaria [anaphylactic shock, anaphylactoid symptoms] •cold-like symptoms, lassitude, fever, vomiting, shortness of breath, cough, sore throat, rash with pain, joint pain, pain on urination [infections] •fever, dry cough, breathlessness, 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] •lassitude, body swelling, easy breathing in upright position than when lying down, breathlessness, 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 •Keep out of the reach of children. Store in a box, keep in the refrigerator (2 to 8℃) to avoid light and freezing. •Discard the remainder. Do not store them. Ask the pharmacist or healthcare facility how to discard them. •If any symptoms suspected adverse reactions appear at the time of self-injection, consult with your doctor or pharmacist immediately. If you feel you are not able to continue self-injections, consult with your doctor immediately. •Do not receive live vaccines during the treatment with this medicine.