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  药店国别: 德国药房
产地国家: 德国
所属类别: 抗癌药物->治疗扁平细胞癌药物
处方药:处方药
包装规格: 20毫克/毫升 10毫升/小瓶 1小瓶/盒
计价单位:
  点击放大  
生产厂家英文名:
Merck
该药品相关信息网址1:
https://www.bavencio.com/en_US/for-patients-and-caregivers/mcc-patients-and-caregivers/home.html?&source=GOOGLE&HBX_PK=s+bavencio&skwid=p30251903414
该药品相关信息网址2:
https://www.rxlist.com/bavencio-drug.htm
原产地英文商品名:
BAVENCIO 20mg/mL 10mL/vial 1vail/box
原产地英文药品名:
avelumab
中文参考商品译名:
BAVENCIO 20毫克/毫升 10毫升/小瓶 1小瓶/盒
中文参考药品译名:
AVELUMAB
原产地国家批准上市年份:
0000/00/00
英文适应病症1:
Adults and pediatric patients 12 years and older with metastatic Merkel cell carcinoma (MCC).
英文适应病症2:
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:
12岁及以上患有转移性Merkel细胞癌(MCC)的成人和儿科患者。
中文适应病症参考翻译2:
局部晚期或转移性尿路上皮癌(UC)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(201932717094636.pdf)的“原文Priscribing Information”为准
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部分中文BAVENCIO处方资料(仅供参考)


【英文名称】
BAVENCIO

【适用证】

BAVENCIO是一种程序性死亡配体-1(PD-L1)阻断抗体,适用于治疗

12岁及以上患有转移性Merkel细胞癌(MCC)的成人和儿科患者。 (1.1)根据肿瘤反应率和反应持续时间,在加速批准下批准该适应症。持续批准该适应症可能取决于确认试验中的临床益处的验证和描述。 (1.1,14.1)

局部晚期或转移性尿路上皮癌(UC)患者:

---在含铂化疗期间或之后有疾病进展(1.2)

---使用含铂化疗的新辅助或辅助治疗12个月内有疾病进展(1.2)

根据肿瘤反应率和反应持续时间,该指征在加速批准下获得批准。持续批准该适应症可能取决于确认试验中的临床益处的验证和描述。 (1.2,14.2)

【用法用量】

预先注射前4次注射,然后根据需要进行。(2.1)

每2周用60分钟静脉输注800毫克。(2.2)

【注意事项】

免疫介导的肺炎:预防中度肺炎;永久停止严重,生命危害或复发性中度肺炎。 (5.1)

免疫介导的肝炎:监测肝功能的变化。扣留中度肝炎;永久停止严重或危及生命的肝炎。 (5.2)

免疫介导的结肠炎:保留中度或重度结肠炎;永久停止危及生命或复发性严重结肠炎。 (5.3)

免疫介导的内分泌病:保留严重或危及生命的内分泌病(5.4)

免疫介导的肾炎和肾功能障碍:保留中度或重度肾炎和肾功能不全;永久停止危及生命的肾炎或肾功能不全。 (5.5)

输液相关反应:中度或减慢轻度或中度输液相关反应的输注速度。停止输液并永久停止BAVENCIO用于严重或危及生命的输液相关反应。 (5.7)

胚胎 - 胎儿毒性:BAVENCIO可导致胎儿伤害。建议对胎儿的潜在风险和使用有效的避孕措施。 (5.8,8.1,8.3)

【INDICATIONS AND USAGE】

BAVENCIO is a programmed death ligand-1 (PD-L1) blocking antibody indicated for the treatment of

Adults and pediatric patients 12 years and older with metastatic Merkel cell carcinoma (MCC). (1.1) This indication is approved under accelerated approval based on tumor response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. (1.1, 14.1)

Patients with locally advanced or metastatic urothelial carcinoma (UC) who:

---Have disease progression during or following platinum-containing chemotherapy (1.2)

---Have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy (1.2)

This indication is approved under accelerated approval based on tumor response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. (1.2, 14.2)

【DOSAGE AND ADMINISTRATION】

Premedicate for the first 4 infusions and subsequently as needed. (2.1)

Administer 800 mg as an intravenous infusion over 60 minutes every 2 weeks. (2.2)

【WARNINGS AND PRECAUTIONS】

Immune-mediated pneumonitis: Withhold for moderate pneumonitis; permanently discontinue for severe, lifethreatening, or recurrent moderate pneumonitis. (5.1)

Immune-mediated hepatitis: Monitor for changes in liver function. Withhold for moderate hepatitis; permanently discontinue for severe or life threatening hepatitis. (5.2)

Immune-mediated colitis: Withhold for moderate or severe colitis; permanently discontinue for life-threatening or recurrent severe colitis. (5.3)

Immune-mediated endocrinopathies: Withhold for severe or life-threatening endocrinopathies (5.4)

Immune-mediated nephritis and renal dysfunction: Withhold for moderate or severe nephritis and renal dysfunction; permanently discontinue for life-threatening nephritis or renal dysfunction. (5.5)

Infusion-related reactions: Interrupt or slow the rate of infusion for mild or moderate infusion-related reactions. Stop the infusion and permanently discontinue BAVENCIO for severe or life-threatening infusion-related reactions. (5.7)

Embryo-fetal toxicity: BAVENCIO can cause fetal harm. Advise of potential risk to a fetus and use of effective contraception. (5.8, 8.1, 8.3)

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详细处方信息以本药内容附件PDF文件(201932717094636.pdf)的“原文Priscribing Information”为准
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更新日期:  2019-3-27
附件:
201932717094636.pdf    

 
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