药品信息:
--------------------------------------------------------------- 详细处方信息以本药内容附件PDF文件(201932822244126.pdf)的“原文Priscribing Information”为准 --------------------------------------------------------------- 部分中文Imfinzi处方资料(仅供参考)
【英文名称】Imfinzi
【适用证】
IMFINZI作为单药治疗适用于治疗局部晚期,不可切除的非小细胞肺癌(NSCLC)的成人,其肿瘤在≥1%的肿瘤细胞中表达PD-L1且其基于铂的疾病未发生进展 化放疗(见5.1节)。
【用法用量】
治疗必须由经验丰富的癌症治疗医生发起和监督。
PD-L1检测局部晚期NSCLC患者
应根据经验证的试验证实的PD-L1的肿瘤表达评估局部晚期NSCLC患者的治疗(第5.1节)。
剂量学
IMFINZI的推荐剂量为10 mg / kg,每2周静脉输注60分钟,直至疾病进展或不可接受的毒性,或最多12个月。
建议继续对临床稳定的患者进行治疗,初步证明疾病进展,直至疾病进展得到证实。
不建议剂量递增或减少。 根据个人的安全性和耐受性,可能需要停止或停用剂量。
【禁忌】
对活性物质或6.1节中列出的任何赋形剂过敏。
【Therapeutic indications】
IMFINZI as monotherapy is indicated for the treatment of locally advanced, unresectable non-small cell lung cancer (NSCLC) in adults whose tumours express PD-L1 on ≥ 1% of tumour cells and whose disease has not progressed following platinum-based chemoradiation therapy (see section 5.1).
【Posology and method of administration】
Treatment must be initiated and supervised by a physician experienced in the treatment of cancer.
PD-L1 testing for patients with locally advanced NSCLC
Patients with locally advanced NSCLC should be evaluated for treatment based on the tumour expression of PD-L1 confirmed by a validated test (section 5.1).
Posology
The recommended dose of IMFINZI is 10 mg/kg administered as an intravenous infusion over 60 minutes every 2 weeks, until disease progression or unacceptable toxicity, or a maximum of 12 months.
It is recommended to continue treatment for clinically stable patients with initial evidence of disease progression until disease progression is confirmed.
Dose escalation or reduction is not recommended. Dose withholding or discontinuation may be required based on individual safety and tolerability.
【Contraindications】
Hypersensitivity to the active substance(s) or to any of the excipients listed in section 6.1.
--------------------------------------------------------------- 详细处方信息以本药内容附件PDF文件(201932822244126.pdf)的“原文Priscribing Information”为准 --------------------------------------------------------------- |