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详细处方信息以本药内容附件PDF文件（201932717572713.pdf）的“原文Priscribing Information”为准
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部分中文LIBTAYO处方资料（仅供参考）

【英文名称】LIBTAYO

【适用证】

LIBTAYO是一种程序性死亡受体-1（PD-1）阻断抗体，用于治疗转移性皮肤鳞状细胞癌（CSCC）或局部晚期CSCC患者，这些患者不是治愈性手术或治愈性放射治疗的候选者。

【用法用量】

LIBTAYO的推荐剂量为每3周30分钟静脉输注350毫克。（2.1）

【注意事项】

严重和致命的免疫介导的不良反应：免疫介导的不良反应可能发生在任何器官系统或组织中，包括：免疫介导的肺炎，免疫介导的结肠炎，免疫介导的肝炎，免疫介导的内分泌病， 免疫介导的皮肤病学不良反应和免疫介导的肾炎和肾功能不全。 监测免疫介导的不良反应的症状和体征。 在基线和治疗期间定期评估临床化学，包括肝脏和甲状腺功能。 根据反应的严重程度，扣留或永久停用LIBTAYO并给予皮质类固醇。 （2.2,5.1）

输液相关反应：中断，根据反应的严重程度减慢输注速度或永久停药。 （2.2,5.2）

胚胎 - 胎儿毒性：可能导致胎儿伤害。 告知女性有可能对胎儿造成潜在风险并使用有效避孕措施。 （5.3,8.1,8.3）

【INDICATIONS AND USAGE】

LIBTAYO is a programmed death receptor-1 (PD-1) blocking antibody indicated for the treatment of patients with metastatic cutaneous squamous cell carcinoma (CSCC) or locally advanced CSCC who are not candidates for curative surgery or curative radiation. (1)

【DOSAGE AND ADMINISTRATION】

The recommended dosage of LIBTAYO is 350 mg as an intravenous infusion over 30 minutes every 3 weeks. (2.1)

【WARNINGS AND PRECAUTIONS】

Severe and Fatal Immune-Mediated Adverse Reactions: Immune-mediated adverse reactions can occur in any organ system or tissue, including the following: immune-mediated pneumonitis, immune-mediated colitis, immune-mediated hepatitis, immune-mediated endocrinopathies, immune-mediated dermatologic adverse reactions and immunemediated nephritis and renal dysfunction. Monitor for symptoms and signs of immune-mediated adverse reactions. Evaluate clinical chemistries, including liver and thyroid function, at baseline and periodically during treatment. Withhold or permanently discontinue LIBTAYO and administer corticosteroids based on the severity of reaction. (2.2, 5.1)

Infusion-Related Reactions: Interrupt, slow the rate of infusion or permanently discontinue based on severity of reaction. (2.2, 5.2)

Embryo-Fetal Toxicity: Can cause fetal harm. Advise females of reproductive potential of the potential risk to a fetus and use of effective contraception. (5.3, 8.1, 8.3)

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详细处方信息以本药内容附件PDF文件（201932717572713.pdf）的“原文Priscribing Information”为准
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