英文药名：OPDIVO intravenous infusion(Nivolumab[Genetical Recombination]) 中文药名：纳武单抗重组注射剂 生产厂家：小野制药 オプジーボ点滴静注20mg／オプジーボ点滴静注100mg 治疗类别名称 - 抗肿瘤药 - 人抗PD-1单克隆抗体 商標名 OPDIVO 一般名 ニボルマブ（遺伝子組換え） Nivolumab（Genetical Recombination） 分子量 約145,000 本質 重组人IgG4单克隆抗体对人的PD-1，重链221的氨基酸残基被替换为临。它是由与光链中的两个选自由重链中的两个和214组成的由中国仓鼠卵巢细胞中产生的440个氨基酸残基的氨基酸残基的糖蛋白。 条件批准 1.建立药品风险管理计划的顶部，要正确实施。 2.由于试验病人在日本是非常有限的，上市后，直至有关一定数量的病例数据集成，通过实现对一切案件的使用，结果调查显示，这使得它能够及早发现这种药物的使用患者的背景资料，数据收集这种药物的安全性和有效性，采取必要的措施，正确使用此药。 作用机制 Nivolumab是针对人的PD-1的抗体，或其PD-1和PD-L1和PD-L2的抑制结合是一种配体，癌抗原特异性T细胞的增殖，活化和细胞毒性的样活性的增强，被认为抑制肿瘤的生长。 适应病症 1.不可切除恶性黑色素瘤 2.不能手术切除的晚期或复发的非小细胞肺癌 用法用量 1.不能切除的根治恶性黑色素瘤 在不能切除的恶性黑色素瘤患者的情况下，与化疗未处理 成人：静脉内输注一次为3mg/kg体重在两周的时间间隔。 在不能切除的恶性黑色素瘤患者的情况下，化疗过治疗 成人：静脉内输注一次为3mg/ kg的期间2周（体重）或者一旦为2mg /kg体重在3周的时间间隔。 2.不能手术切除的晚期或复发的非小细胞肺癌 成人：静脉内输注一次为3mg/ kg体重在两周的时间间隔。 禁忌 无。 警告和注意事项 免疫介导的不良反应：管理基于反应的严重程度皮质类固醇。 •免疫介导性肺炎：暂停对中度和永久性停止对严重或危及生命的肺炎。 •免疫介导的结肠炎：暂停为中度或重度，并永久停止对危及生命的结肠炎。 •免疫介导的肝炎：用于监测肝功能变化。扣压对中度和永久性停止对严重或危及生命的转氨酶和总胆红素升高。 •免疫介导的肾炎和肾功能不全：监视对肾功能的变化。扣压为中度或重度，并永久停止对危及生命的血肌酐升高。 •免疫介导的甲状腺功能减退症和甲状腺功能亢进症：监视的变化甲状腺功能。根据需要启动甲状腺激素替代。 •胚胎-胎仔毒性：可引起胎儿危害。提醒潜在风险胎儿和使用有效的避孕措施。 不良反应 最常见的不良反应（≥20％）患者的黑色素瘤是皮疹。 最常见的不良反应（≥20％），在晚期鳞状非小细胞肺癌患者有乏力，呼吸困难，肌肉骨骼疼痛，食欲下降，咳嗽，恶心，便秘等。 特殊人群中使用 •哺乳期：哺乳请停止。 包装规格 静脉滴注 20毫克/2毫升：  1瓶 100毫克/10毫升：1瓶 制造和销售 小野制药有限公司 完整处方附件：http://meds.qlifepro.com/detail/622364801/ OPDIVO intravenous infusion 20mg[unresectable advanced and/or recurrent non-small cell lung cancer/unresectable malignant melanoma]（オプジーボ点滴静注20mg［切除的晚期和/或复发性非小细胞肺癌/不能手术切除的恶性黑色素瘤］）  Brand name : OPDIVO intravenous infusion 20mg[unresectable advanced and/or recurrent non-small cell lung cancer/unresectable malignant melanoma] 　Active ingredient: Nivolumab(Genetical Recombination) 　Dosage form: injection 　Print on wrapping: OPDIVO intravenous infusion 100mg[unresectable advanced and/or recurrent non-small cell lung cancer/unresectable malignant melanoma]（オプジーボ点滴静注100mg［切除的晚期和/或复发性非小细胞肺癌/不能手术切除的恶性黑色素瘤］）  Brand name : OPDIVO intravenous infusion 100mg [unresectable malignant melanoma/unresectable advanced and/or recurrent non-small cell lung cancer] 　Active ingredient: Nivolumab(Genetical Recombination) 　Dosage form: injection 　Print on wrapping: Effects of this medicine This medicine inhibits binding of cancer cell to T-cell (immune cell) via PD-1 receptor and promotes T-cell activation. It consequently enhances immune response to cancer and shows antitumor effect. It is usually used to treat unresectable malignant melanoma. 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 autoimmune disorder or its history, or interstitial pulmonary disease or its history. •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>> •Chemotherapy-naive patients:In general, for adults administer by intravenous infusion once every 2 weeks. Chemotherapy-treated patients:In general, for adults administer by intravenous infusion once every 2 weeks or 3 weeks. •In general, administer by intravenous infusion for at least 1 hour at a time. •Ask your doctor about your dosing schedule. Precautions while taking this medicine • Possible adverse reactions to this medicine The most commonly reported adverse reactions include itch, leukoderma, hypothyroidism, fatigue and malaise. 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. •fever, dry cough, respiratory distress [interstitial pulmonary disease] •muscle weakness, droopy eyelid, respiratory distress, swallowing disorder [myasthenia gravis, myositis] •persistent diarrhea, abdominal pain, bloody stool [colitis, severe diarrhea] •dry mouth, nausea, vomiting, general malaise, polyuria [type 1 diabetes] •general malaise, loss of appetite, yellowing of the skin and the white of eyes [liver dysfunction, hepatitis] •general malaise, edema, sweating, decreased body weight [disturbed thyroid function] •paralysis, paralysis of the lower part of the body, numbness of limbs, pain in limbs [nervous disorder] •decreased urine output, facial edema, swelling in the eyelid, headache [renal disorder] •general malaise, decreased consciousness, vomiting, loss of appetite, hypotension [adrenal disorder] •fever, headache, vomiting [encephalitis] •generalized red spot and breakable blister, red rash, red spot with swelling in the center, fever [severe skin disorder] •edema, feeling hot, local pain [venous thromboembolism] •respiratory distress, consciousness disorder, swelling of eyelids/lips/tongue, fever [infusion reaction] 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. Ono Pharmaceutical Co., Ltd.Injection Revised: 2/2016 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.