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  药店国别: 美国药房
产地国家: 美国
所属类别: 抗癌药物->治疗肠癌药物
处方药:处方药
包装规格: 100毫克/10毫升 1x10毫升
计价单位:
  点击放大  
生产厂家中文参考译名:
BMS
生产厂家英文名:
BRISTOL MYERS SQUIBB
该药品相关信息网址1:
https://www.opdivo.com/
该药品相关信息网址2:
https://www.rxlist.com/opdivo-drug.htm
原产地英文商品名:
Opdivo 100mg/10 ml, 1x10 ml IV vial (Storage: 2-8°C)
原产地英文药品名:
nivolumab
中文参考商品译名:
欧狄沃 100毫克/10毫升 1x10毫升 (储存:2-8°C)
中文参考药品译名:
纳武利尤单抗
原产地国家批准上市年份:
0000/00/00
英文适应病症1:
patients with BRAF V600 wild-type unresectable or metastatic melanoma, as a single agent.
英文适应病症2:
patients with melanoma with lymph node involvement or metastatic disease who have undergone complete resection, in the adjuvant setting.
英文适应病症3:
patients with metastatic small cell lung cancer with progression after platinumbased chemotherapy and at least one other line of therapy.
英文适应病症4:
adult patients with classical Hodgkin lymphoma that has relapsed or progressed after
临床试验期:
完成
中文适应病症参考翻译1:
患有BRAF V600野生型不可切除或转移性黑色素瘤的患者,作为单一药物
中文适应病症参考翻译2:
患有淋巴结转移或转移性疾病的黑色素瘤患者,在辅助治疗中已经完全切除
中文适应病症参考翻译3:
患有转移性小细胞肺癌的患者,在接受铂类化疗和至少一种其他治疗后进展
中文适应病症参考翻译4:
经典霍奇金淋巴瘤的成人患者在复发或进展后
药品信息:

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 详细处方信息以本药内容附件PDF文件(201912720202333.pdf)的“原文Priscribing Information”为准
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 部分中文欧狄沃处方资料(仅供参考)


【英文名称】
Opdivo


【中文名称】
欧狄沃

【适应症和用途】

OPDIVO是一种程序性死亡受体-1(PD-1)阻断抗体,适用于治疗:

•患有BRAF V600野生型不可切除或转移性黑色素瘤的患者,作为单一药物。 (1.1)

•患有BRAF V600突变阳性的不可切除或转移性黑色素瘤的患者,作为单一药物。(1.1)

•无法切除或转移性黑色素瘤的患者,联合ipilimumab。(1.1)

•患有淋巴结转移或转移性疾病的黑色素瘤患者,在辅助治疗中已经完全切除。 (1.2)

•转移性非小细胞肺癌患者及铂类化疗后或之后的进展。患有EGFR或ALK基因组肿瘤畸变的患者在接受OPDIVO之前应该在FDA批准的治疗这些畸变的疾病进展。 (1.3)

•患有转移性小细胞肺癌的患者,在接受铂类化疗和至少一种其他治疗后进展。 (1.4)

•先前接受抗血管生成治疗的晚期肾细胞癌患者。 (1.5)

•患有中度或低风险的患者,既往未治疗的晚期肾细胞癌,与ipilimumab联合使用。 (1.5)

•经典霍奇金淋巴瘤的成人患者在复发或进展后:(1.6)

•自体造血干细胞移植(HSCT)和brentuximab vedotin,或

•3个或更多系列全身治疗,包括自体HSCT。

•患有头部和颈部复发或转移性鳞状细胞癌的患者,在铂类治疗之后或之后患有疾病进展。 (1.7)

•局部晚期或转移性尿路上皮癌患者:

•在含铂化疗期间或之后疾病进展

•在使用含铂化疗的新辅助治疗或辅助治疗后12个月内出现疾病进展。 (1.8)

•患有微卫星不稳定性高(MSI-H)或错配修复缺陷(dMMR)转移性结直肠癌的成人和儿科(12岁及以上)患者,其在用氟嘧啶,奥沙利铂和伊立替康治疗后进展,单药或与ipilimumab联合使用。(1.9)

•先前接受过索拉非尼治疗的肝细胞癌患者。 (1.10)

【剂量和用量】

在30分钟内静脉输注OPDIVO。

•无法切除或转移性黑色素瘤

•OPDIVO每2周240毫克,或每4周480毫克。(2.1)

•OPDIVO 1 mg / kg,然后在同一天使用ipilimumab,每3周一次,共4剂,然后OPDIVO每2周240 mg或每4周480 mg。(2.1)

•黑色素瘤的辅助治疗

•OPDIVO每2周240毫克,或每4周480毫克。(2.2)

•转移性非小细胞肺癌

•OPDIVO每2周240毫克,或每4周480毫克。(2.3)

•小细胞肺癌

•OPDIVO每2周240毫克。(2.4)

•晚期肾细胞癌

•OPDIVO每2周240毫克,或每4周480毫克。(2.5)

•OPDIVO 3 mg / kg,然后ipilimumab 1 mg / kg,每3周一次,共4剂,然后OPDIVO每2周240 mg或每4周480 mg。(2.5)

【警告和注意事项】

•免疫介导的肺炎:对于严重或危及生命的肺炎,中度和永久性停用。(5.1)

•免疫介导的结肠炎:当作为中度或重度的单一药物给予时,扣留OPDIVO,并且对于危及生命的结肠炎持续停止。 ipilimumab给予OPDIVO用于中度和永久性停用严重或危及生命的结肠炎。(5.2)

•免疫介导的肝炎:监测肝功能的变化。 对于严重或危及生命的转氨酶或总胆红素升高的中度和永久性停用。(5.3)

【INDICATIONS AND USAGE】

OPDIVO is a programmed death receptor-1 (PD-1) blocking antibody indicated for the treatment of:

• patients with BRAF V600 wild-type unresectable or metastatic melanoma, as a single agent. (1.1)

• patients with BRAF V600 mutation-positive unresectable or metastatic melanoma, as a single agent.(1.1)

• patients with unresectable or metastatic melanoma, in combination with ipilimumab.(1.1)

• patients with melanoma with lymph node involvement or metastatic disease who have undergone complete resection, in the adjuvant setting. (1.2)

• patients with metastatic non-small cell lung cancer and progression on or after platinum-based chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving OPDIVO. (1.3)

• patients with metastatic small cell lung cancer with progression after platinumbased chemotherapy and at least one other line of therapy. (1.4)

• patients with advanced renal cell carcinoma who have received prior antiangiogenic therapy. (1.5)

• patients with intermediate or poor risk, previously untreated advanced renal cell carcinoma, in combination with ipilimumab. (1.5)

• adult patients with classical Hodgkin lymphoma that has relapsed or progressed after: (1.6)

• autologous hematopoietic stem cell transplantation (HSCT) and brentuximab vedotin, or

• 3 or more lines of systemic therapy that includes autologous HSCT.

• patients with recurrent or metastatic squamous cell carcinoma of the head and neck with disease progression on or after a platinum-based therapy. (1.7)

• patients with locally advanced or metastatic urothelial carcinoma who:

• have disease progression during or following platinum-containing chemotherapy

• have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy. (1.8)

• adult and pediatric (12 years and older) patients with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan, as a single agent or in combination with ipilimumab.(1.9)

• patients with hepatocellular carcinoma who have been previously treated with sorafenib. (1.10)
 

【DOSAGE AND ADMINISTRATION】

Administer OPDIVO as an intravenous infusion over 30 minutes.

• Unresectable or metastatic melanoma

• OPDIVO 240 mg every 2 weeks or 480 mg every 4 weeks.(2.1)

• OPDIVO 1 mg/kg, followed by ipilimumab on the same day, every 3 weeks for 4 doses, then OPDIVO 240 mg every 2 weeks or 480 mg every 4 weeks. (2.1)

• Adjuvant treatment of melanoma

• OPDIVO 240 mg every 2 weeks or 480 mg every 4 weeks. (2.2)

• Metastatic non-small cell lung cancer

• OPDIVO 240 mg every 2 weeks or 480 mg every 4 weeks. (2.3)

• Small cell lung cancer

• OPDIVO 240 mg every 2 weeks. (2.4)

• Advanced renal cell carcinoma

• OPDIVO 240 mg every 2 weeks or 480 mg every 4 weeks.(2.5)

• OPDIVO 3 mg/kg followed by ipilimumab 1 mg/kg on the same day every 3 weeks for 4 doses, then OPDIVO 240 mg every 2 weeks or 480 mg every 4 weeks. (2.5)
 

【WARNINGS AND PRECAUTIONS】

• Immune-mediated pneumonitis: Withhold for moderate and permanently discontinue for severe or life-threatening pneumonitis. (5.1)

• Immune-mediated colitis: Withhold OPDIVO when given as a single agent for moderate or severe and permanently discontinue for life-threatening colitis. Withhold OPDIVO when given with ipilimumab for moderate and permanently discontinue for severe or life-threatening colitis. (5.2)

• Immune-mediated hepatitis: Monitor for changes in liver function. Withhold for moderate and permanently discontinue for severe or life-threatening transaminase or total bilirubin elevation. (5.3)
 

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 详细处方信息以本药内容附件PDF文件(201912720202333.pdf)的“原文Priscribing Information”为准
---------------------------------------------------------------

更新日期: 2019-1-28
附件:
201912720202333.pdf    

 
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