纳武单抗注射剂(OPDIVO 10MG/ML 24ML SDV)

产地国家:美国

处方药:是

所属类别:10毫克/毫升 24毫升/瓶

包装规格:10毫克/毫升 24毫升/瓶

计价单位:瓶

生产厂家英文名:BRISTOL-MYERS SQUIBB COMPANY

原产地英文商品名:OPDIVO 10MG/ML 24ML SDV 1/EA

原产地英文药品名:nivolumab

中文参考商品译名:Opdivo注射液 10毫克/毫升 24毫升/瓶

中文参考药品译名:纳武单抗重组

简介:

近日,美国FDA批准Opdivo(nivolumab)新适应症;为治疗晚期黑色素瘤、小细胞肺癌、经典霍奇金淋巴瘤、肝细胞癌、头颈部鳞状细胞癌、晚期肾细胞癌、晚期或转移性尿路上皮癌的患者批准日期:2014年12月22日;公司:施贵宝公司OPDIVO(纳武单抗 nivolumab)注射液,用于静脉注射美国最初批准:2014年最近的重大变化适应症和用法:4/2018剂量和用法:4/2018警告和注意事项:4/2018作用机制PD-1配体PD-L1和PD-L2与T细胞上发现的PD-1受体的结合抑制T细胞增殖和细胞因子产生。在一些肿瘤中发生PD-1配体的上调,并且通过该途径的信号传导有助于抑制肿瘤的活性T细胞免疫监视。PD-L1和PD-L2,释放PD-1途径介导的免疫应答抑制,包括抗肿瘤免疫应答。在同系小鼠肿瘤模型中,阻断PD-1活性导致肿瘤生长减少。合并nivolumab(抗PD-1)和易普利姆玛(抗CTLA-4)介导的抑制的结果inenhanced T细胞功能比单独的任一种抗体的作用更大,并且结果inimproved在转移性黑色素瘤和晚期RCC抗肿瘤反应。在鼠类syngeneictumor模型中,PD-1和CTLA-4的双重阻断导致抗肿瘤活性增加。

作用机制:nibalma是一种对人体pde -1的抗体,它阻碍PD-1与pde – l1和pde – l2的结合,可以抑制癌抗原特异的T细胞的增殖,活性化以及细胞伤害活性的增强等,从而抑制肿瘤的增殖。

适应症:黑色素瘤不能切除并复发的非细胞肺癌切除根治或转移性肾细胞癌旧式霍奇金淋巴瘤有复发或远程转移的头颈癌癌症化疗后增加的无法治愈、复发的胃癌癌症化疗后增殖的无法切除的胸膜内皮肿。

用法与用量

1.黑素瘤通常,成人每隔两周打一次240mg的点滴,作为交换基因(基因)。不过,接受恶性黑色素瘤手术后的辅助治疗时,服药期限为12个月。对无法切除的恶性黑素瘤同时注射imp林(基因重组)的情况,通常成年人以3周的间隔打4次点滴,每次80毫克(基因重组)。然后作为nivor马(基因重组),每隔2周打240毫克点滴。

2.根治不能切除或转移性肾细胞癌通常,成人每隔两周打一次240mg的点滴,作为交换基因(基因)。如果对未接受化疗的根治或转移性肾细胞癌与林林(基因重组)一起使用,通常每隔3周打4次点滴作为对成人的nivor马(基因重组)。然后作为nivor马(基因重组),每隔2周打240毫克点滴。

3 .无法切除的非小细胞肺癌的进展、复发,复发或疑难性的古典的霍奇金淋巴瘤,复发或远程转移具有头颈癌,癌症化学疗法治愈后韩的无法切除的进展和复发的胃癌、癌化学疗法后韩的无法切除的进展和复发的恶性胸膜腔中皮瘤通常,成人每隔两周打一次240mg的点滴,作为交换基因(基因)。

不良反应:患者最常见的不良反应(20%)为:OPDIVO作为单一药剂:疲劳,皮疹,肌肉骨骼疼痛,瘙痒,腹泻,恶心,虚弱,咳嗽,呼吸困难,便秘,食欲不振,背痛,关节痛,上呼吸道感染,发热,头痛,和腹痛降低。OPDIVO与易普利姆玛黑色素瘤:乏力,皮疹,腹泻,恶心,发热,呕吐和呼吸困难。OPDIVO与易普利姆玛用于肾细胞癌:乏力,皮疹,腹泻,肌肉疼痛,皮肤瘙痒,恶心,咳嗽,发热,关节痛,食欲anddecreased。

用于特定人群:哺乳期,停止母乳喂养。

包装/存储:OPDIVO(nivolumab)注射剂如下:NDC40mg/4mL单剂量小瓶;100mg/10mL单剂量小瓶;240mg/24mL单剂量小瓶。OPDIVO储存在2°C至8°C(36°F至46°F)的冷藏温度下。保护OPDIVO不受光照影响不要冻结或摇晃。

英文版说明书:  

Opdivo (Nivolumab Injection)FULL INDICATIONSFor Previously Treated Patients With Advanced Non-Small Cell Lung Cancer (1 of 10)OPDIVO® (nivolumab) is a prescription medicine used to treat a type of advanced stage lung cancer (called non-small cell lung cancer) that has spread or grown and you have tried chemotherapy that contains platinum, and it did not work or is no longer working. If your tumor has an abnormal EGFR or ALK gene, you should have also tried an FDA-approved therapy for tumors with theseabnormal genes, and it did not work or is no longer working.For Patients With Metastatic Melanoma (2 of 10)OPDIVO® (nivolumab) is a prescription medicine used to treat a type of skin cancer called melanoma that has spread or cannot be removed by surgery (advanced melanoma). OPDIVO is approved for both BRAF+ and BRAF- patients. OPDIVO was approved for BRAF+ metastatic melanoma patients based on the amount of time patients lived without their tumors worsening. There is ongoing eva luation of clinical benefit of OPDIVO for this use.OPDIVO® (nivolumab) is a prescription medicine used in combination with YERVOY® (ipilimumab) to treat a type of skin cancer called melanoma that has spread or cannot be removed by surgery (advanced melanoma). OPDIVO in combination with YERVOY was approved based on the amount of time patients lived without their tumors worsening. There is ongoing eva luation of clinical benefit of OPDIVO in combination with YERVOY for this use.OPDIVO (10 mg/mL) and YERVOY (5 mg/mL) are injections for intravenous (IV) use.To Help Prevent a Skin Cancer Called Melanoma From Coming Back After It and the Affected Lymph Nodes Have Been Removed by Surgery (3 of 10)OPDIVO® (nivolumab) is a prescription medicine used to treat people with a type of skin cancer called melanoma to help prevent melanoma from coming back after it and lymph nodes that contain cancer have been removed by surgery.For Adults With Kidney Cancer (Renal Cell Carcinoma) That Has Spread (4 of 10)OPDIVO® (nivolumab) is a prescription medicine used in combination with YERVOY® (ipilimumab) to treat kidney cancer (renal cell carcinoma) in certain people when their cancer has spread.OPDIVO (10 mg/mL) and YERVOY (5 mg/mL) are injections for intravenous (IV) use.For Previously Treated Patients With Advanced Renal Cell Carcinoma (5 of 10)OPDIVO® (nivolumab) is a prescription medicine used to treat kidney cancer (renal cell carcinoma) when your cancer has spread or grown after treatment with other cancer medications.For Patients With Squamous Cell Carcinoma of the Head and Neck (SCCHN) That Has Returned or Spread After Previous Treatment (6 of 10)OPDIVO® (nivolumab) is a prescription medicine used to treat head and neck cancer (squamous cell carcinoma) that has come back or spread and you have tried chemotherapy that contains platinum and it did not work or is no longer working.For People With Liver Cancer (Hepatocellular Carcinoma) That Have Received Treatment With Nexavar® (sorafenib) (7 of 10)OPDIVO® (nivolumab) is a prescription medicine used to treat people with liver cancer (hepatocellular carcinoma) after you have received treatment with Nexavar® (sorafenib). OPDIVO was approved based on response rate and how long patients’ responses lasted. There is ongoing eva luation of clinical benefit of OPDIVO for this use.For Previously Treated Patients With Advanced Bladder Cancer (Urothelial Carcinoma) (8 of 10)OPDIVO® (nivolumab) is a prescription medicine used to treat bladder cancer (urothelial carcinoma) that has spread or grown and you have tried chemotherapy that contains platinum, and it did not work or is no longer working. OPDIVO was approved based on response rate and how long patients’ responses lasted. There is ongoing eva luation of clinical benefit of OPDIVO for this use.For People 12 Years of Age and Older Whose CRC Has Spread to Other Parts of the Body (Metastatic), Has Progressed After Treatment With a Fluoropyrimidine, Oxaliplatin, and Irinotecan, and Is dMMR or MSI-H (9 of 10)OPDIVO® (nivolumab) is a prescription medicine used to treat adults and children 12 years of age and older with a type of colon or rectal cancer (colorectal cancer) that has spread to other parts of the body (metastatic), is mismatch repair deficient (dMMR) or microsatellite instability-high (MSI-H), and you have tried chemotherapy with a fluoropyrimidine, oxaliplatin, and irinotecan, and it did not work or is no longer working. OPDIVO was approved based on response rate and how long patients’ responses lasted. There is ongoing eva luation of clinical benefit of OPDIVO for this use.For Adults With classical Hodgkin Lymphoma Whose Cancer has Come Back or Spread After an Autologous Stem Cell Transplant and Treatment With Adcetris® (brentuximab vedotin) or After 3 or More Kinds of Treatment Including an Autologous Stem Cell Transplant (10 of 10)OPDIVO® (nivolumab) is a prescription medicine used to treat adults with a type of blood cancer called classical Hodgkin lymphoma if your cancer has come back or spread after a type of stem cell transplant that uses your own stem cells (autologous), and you used the drug brentuximab vedotin (Adcetris®) before or after your stem cell transplant, or if you received at least 3 kinds of treatment including an autologous stem cell transplant. OPDIVO was approved based on response rate. There is ongoing eva luation of clinical benefit of OPDIVO for this use.It is not known if OPDIVO is safe and effective in children less than 18 years of age.It is not known if OPDIVO is safe and effective in children less than 12 years of age with MSI-H or dMMR metastatic colorectal cancer, or in children less than 18 years of age for the treatment of any other cancers.

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