英文药名：HUMIRA for S.C.Injection（Adalimumab(genetical recombination)） 中文药名：重组阿达木单抗注射溶液/预装注射剂 生产厂家：Eisai Co./AbbVie GK ヒュミラ皮下注20mgシリンジ0.4mL／ヒュミラ皮下注40mgシリンジ0.8mL／ヒュミラ皮下注40mgシリンジ0.4mL／ヒュミラ皮下注80mgシリンジ0.8mL 治疗类别名称 人抗TNFα单克隆抗体制剂 欧文商標名 HUMIRA 一般名： アダリムマブ (遺伝子組換え)（JAN） Adalimumab (Genetical Recombination) 本質： 抗体的人抗人TNFα单克隆重链（.gamma.1链）是IgG1和轻（κ链）进行编码的cDNA的表达在中国仓鼠卵巢细胞中产生的（C2197H3396N584O678S15 451个氨基酸残基;分子量：49,318.95 ，C2191H3384N582O677S15在C末端的那些赖氨酸残基缺失;分子量：49,190.78组成的，包括的）的重链2分子和214氨基酸残基（C1027H1606N282O332S6;分子量：23,407.82）由轻链的2分子组成的糖蛋白质 分子量： 約 148000 批准条件 在建立药品风险管理计划的顶部，要正确实施。 风湿性关节炎 进行了大规模的上市后监测，以充分考虑这种药物的安全性，在长期服用的安全性时，要考虑这种感染的表达。 肠型白塞氏病 由于在日本试验病人是非常有限，上市后，直至有关一定数量的案件数据积累，通过开展对一切案件的表现使用调查，药物这使得能够早期识别患者的背景信息，数据收集这些药物的安全性和有效性，采取必要的措施在正确使用这种药物。 药效药理 1. 阿达木单抗在体外试验中显示出选择性结合于TNFα的以下的效果。 ・ 表现出对人TNFα具有高亲和力。 ・ TNFα受体（TNF RI和TNF RII）对于TNFα的抑制的结合（IC 50值：1.26〜1.47×10-9mol/ L）。 ・ 在人TNFα诱导的细胞毒性对L929细胞以中和细胞死亡（IC 50值：1.4〜3.5×10-11mol/ L）。 适应病症 HUMIRA皮下注射20毫克0.4毫升注射器 HUMIRA皮下注射40毫克0.8ml的注射器 HUMIRA皮下注射40毫克0.4毫升注射器 治疗效果以下疾病不足 幼年特发性关节炎 HUMIRA皮下注射40毫克0.8ml的注射器 HUMIRA皮下注射40毫克0.4毫升注射器 HUMIRA皮下注射80毫克0.8ml的注射器 类风湿关节炎（包括预防关节结构破坏） 治疗效果以下疾病不足 寻常型银屑病，关节病型银屑病 强直性脊柱炎 肠型白塞氏病 部分非感染性，或泛葡萄膜炎的中间 在克罗恩病的中度或重度活动期诱导缓解并维持治疗的（限定于常规治疗是不够有效的情况下） 中度或重度溃疡性结肠炎的治疗（限的情况，即常规治疗是不够有效） 用法用量 HUMIRA皮下注射20毫克0.4毫升注射器 HUMIRA皮下注射40毫克0.8ml的注射器 HUMIRA皮下注射40毫克0.4毫升注射器 * 幼年特发性关节炎 一次20mg，如果小于或多个体重15千克30公斤，在上述的重30千克1次40毫克在两周内，和皮下注射的情况。 HUMIRA皮下注射40毫克0.8ml的注射器 HUMIRA皮下注射40毫克0.4毫升注射器 HUMIRA皮下注射80毫克0.8ml的注射器 * 风湿性关节炎 每两个星期一次的40毫克为阿达木单抗（基因重组）的成人和皮下注射。此外，如果效果不充分，可能会增加至80毫克一次。 * 斑块型银屑病，关节病型银屑病 成年人的80毫克皮下注射，第一次作为阿达木单抗（基因重组），一旦在随后的两周内，40毫克的皮下注射。此外，如果效果不充分，可以以一次80毫克增加到。 * 强直性脊柱炎 每两个星期一次的40毫克为阿达木单抗（基因重组）的成人和皮下注射。此外，如果效果不充分，可能会增加至80毫克一次。 * 肠型白塞氏病 成人首次皮下注射160mg，80毫克的皮下注射第2周后。初始给药和4周后以后，一旦在两周40毫克。 * 克罗恩病 成人首次皮下注射160mg，80毫克的皮下注射第2周后。初始给药和4周后以后，一旦在两周40毫克，和皮下注射。此外，如果减弱的效果可提高到一次80毫克。 * 溃疡性结肠炎 成人首次皮下注射160mg，80毫克的皮下注射第2周后。初始给药和4周后以后，在两周皮下注射40毫克。 * 部分非感染性，后部或泛葡萄膜炎的中间 成人首次皮下注射80毫克，在一周的第一剂量后皮下注射40毫克的。最初给药后三周后，一旦在两周的40毫克，和皮下注射。 包装规格 HUMIRA皮下注射 20毫克0.4毫升注射器：20毫克×1注射器 40毫克注射0.8毫升：40毫克×1注射器 40毫克0.4毫升注射器：40毫克×1注射器 80毫克注射0.8毫升：80毫克×1注射器 生产和销售（进口） Eisai Co./AbbVie GK 完整处方资料附件：http://www.info.pmda.go.jp/go/pack/3999426G1024_2_10/ HUMIRA for S.C. Injection Syringe（Adalimumab (genetical recombination)） HUMIRA 20mg for S.C. Injection Syringe 0.4mL（ヒュミラ皮下注20mgシリンジ0.4mL/Eisai Co., Ltd.） Brand name : HUMIRA 20mg for S.C. Injection Syringe 0.4mL 　Active ingredient: Adalimumab (genetical recombination) 　Dosage form: colorless limpid or slightly opalescent injectable solution in prefilled syringe 　Print on wrapping:  HUMIRA 20mg for S.C. Injection Syringe 0.4mL（ヒュミラ皮下注20mgシリンジ0.4mL/AbbVie GK） Brand name : HUMIRA 20mg for S.C. Injection Syringe 0.4mL 　Active ingredient: Adalimumab (genetical recombination)  　Dosage form: colorless limpid or slightly opalescent injectable solution in prefilled syringe  　Print on wrapping:  HUMIRA 40mg for S.C. Injection Syringe 0.8mL（ヒュミラ皮下注40mgシリンジ0.8mL/Eisai Co., Ltd.） Brand name : HUMIRA 40mg for S.C. Injection Syringe 0.8mL 　Active ingredient: Adalimumab (genetical recombination) 　Dosage form: colorless limpid or slightly opalescent injectable solution in prefilled syringe 　Print on wrapping:  HUMIRA 40mg for S.C. Injection Syringe 0.8mL（ヒュミラ皮下注40mgシリンジ0.8mL/AbbVie GK）  Brand name : HUMIRA 40mg for S.C. Injection Syringe 0.8mL 　Active ingredient: Adalimumab(genetical recombination) 　Dosage form: colorless limpid or slightly opalescent injectable solution in prefilled syringe 　Print on wrapping:  Effects of this medicine This medicine suppresses function of TNF-α which is the major causative substance of juvenile idiopathic arthritis. TNF (tumor necrosis factor) is one of cytokines existing inside of the body even in a healthy one, and involved in activities of immunity and development of inflammation or pain. It is usually used in the treatment of patients with active, polyarticular-course juvenile idiopathic arthritis who had insufficient response to conventional therapy. 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: infections such as sepsis or suspected of them, tuberculosis or a history of it, demyelinating disease such as multiple sclerosis or a personal/family history of it, hematologic disease or a history of it, a history of hepatitis B virus infection, congestive heart failure. If you are a hepatitis B virus carrier. If you have just received live vaccine. •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, if the patient weight is 15 kg to less than 30 kg, inject 1 syringe (20 mg of the active ingredient) subcutaneously at a time, every two weeks. Strictly follow the instructions. •Injection site should be changed every time you inject the medicine. Do not inject to sensitive area of skin, wound site, skin rash or a psoriasis lesion. Do not massage the subcutaneous injection site. •You need to inject in the area of at least 3 cm apart from the last injection site. •If you miss an injection, consult with your doctor. •If you accidentally inject more than your prescribed dose, consult with your doctor or pharmacist. •Do not stop injecting this medicine unless your doctor instructs you to do so. Precautions while taking this medicine • Possible adverse reactions to this medicine The most commonly reported adverse reactions include nasopharyngitis, rash, injection site reaction (erythema, itch, rash, bleeding, swelling) and upper respiratory tract 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. •chill, sudden high fever with shivering, cough, sputum  [severe infections such as sepsis or pneumonia] •prolonged slight fever or cough (2 weeks or over), general malaise, weight loss  [tuberculosis] •joint pain, muscular pain, skin eruption  [lupus-like syndrome] •reduced vision, double vision, numbness, pain, paralysis  [demyelinating disease] •breathing difficulty, hives, swelling around the eye or lip  [severe allergic reaction] •malaise, loss of appetite, yellowness in the skin and/or the white of the eye  [fulminant hepatitis, hepatic dysfunction, jaundice, hepatic insufficiency] 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 the medicine out of the reach of children. Store it away from light and freeze, at temperature of 2 to 8 ℃. •Discard the remainder. Do not store them. Ask the pharmacist or medical institution how to discard. Eisai Co., Ltd.Self-injection Revised: 9/2014 AbbVie GKSelf-injection Published: 3/2014 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.