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  药店国别: 瑞士药房
产地国家: 瑞士
所属类别: 抗癌药物->治疗皮肤癌药物
处方药:处方药
包装规格: 1200毫克/20毫升 1小瓶 20毫升
计价单位:
  点击放大  
生产厂家英文名:
Roche
该药品相关信息网址1:
https://www.tecentriq.com/
原产地英文商品名:
Tecentriq concentrate for solution for infusion 1200mg/20ml 1vial 20ml
原产地英文药品名:
atezolizumab
中文参考商品译名:
Tecentriq 浓缩液用于输液 1200毫克/20毫升 1小瓶 20毫升
中文参考药品译名:
atezolizumab
原产地国家批准上市年份:
0000/00/00
英文适应病症1:
dult patients with locally advanced or metastatic urothelial carcinoma (UC)
临床试验期:
完成
中文适应病症参考翻译1:
治疗局部晚期或转移性尿路上皮癌(UC)的成人患者
药品信息:

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详细处方信息以本药内容附件PDF文件(201932822400923.pdf)的“原文Priscribing Information”为准
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部分中文Tecentriq处方资料(仅供参考)


【英文名称】
Tecentriq

【适用证】

Tecentriq作为单药治疗适用于治疗局部晚期或转移性尿路上皮癌(UC)的成人患者:

•先前含铂化疗后,或

•被认为不合格的顺铂,其肿瘤的PD-L1表达≥5%(见5.1节)。

Tecentriq作为单药治疗适用于先前化疗后治疗局部晚期或转移性非小细胞肺癌(NSCLC)的成年患者。 EGFR激活突变或ALK阳性肿瘤突变的患者在接受Tecentriq之前也应接受靶向治疗(见5.1节)。

【用法用量】

Tecentriq必须由经历癌症治疗的医生发起和监督。

UC患者的PD-L1检测

根据经验证的试验证实的PD-L1的肿瘤表达,应选择先前未治疗的UC患者进行治疗(见5.1节)。

剂量学

Tecentriq的推荐剂量为每三周静脉内施用1,200mg。

治疗持续时间

建议患者接受Tecentriq治疗,直至失去临床获益(见5.1节)或无法控制的毒性。

延迟或错过剂量

如果错过计划剂量的Tecentriq,应尽快给予; 建议不要等到下一次计划的剂量。 必须调整给药方案以维持剂量间隔3周。

治疗期间的剂量修改

不建议减少Tecentriq的剂量。

【禁忌】

对活性物质或6.1节中列出的任何赋形剂过敏。

【Therapeutic indications】

Tecentriq as monotherapy is indicated for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma (UC):

• after prior platinum-containing chemotherapy, or

• who are considered cisplatin ineligible, and whose tumours have a PD-L1 expression ≥ 5% (see section 5.1).

Tecentriq as monotherapy is indicated for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) after prior chemotherapy. Patients with EGFR activating mutations or ALK-positive tumor mutations should also have received targeted therapy before receiving Tecentriq (see section 5.1).

【Posology and method of administration】

Tecentriq must be initiated and supervised by physicians experienced in the treatment of cancer.

PD-L1 testing for patients with UC

Patients with previously untreated UC should be selected for treatment based on the tumour expression of PD-L1 confirmed by a validated test (see section 5.1).

Posology

The recommended dose of Tecentriq is 1,200 mg administered intravenously every three weeks.

Duration of treatment

It is recommended that patients are treated with Tecentriq until loss of clinical benefit (see section 5.1) or unmanageable toxicity.

Delayed or missed doses

If a planned dose of Tecentriq is missed, it should be administered as soon as possible; it is recommended not to wait until the next planned dose. The schedule of administration must be adjusted to maintain a 3-week interval between doses.

Dose modifications during treatment

Dose reductions of Tecentriq are not recommended.

【Contraindications】

Hypersensitivity to atezolizumab or to any of the excipients listed in section 6.1.

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详细处方信息以本药内容附件PDF文件(201932822400923.pdf)的“原文Priscribing Information”为准
---------------------------------------------------------------

更新日期:  2019-3-28
附件:
201932822400923.pdf    

 
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