阿瓦斯汀AVASTIN(BEVACIZUMAB)[400mg/Vial]

药店国别:

产地国家:德国

处方药:是

所属类别: 400毫克/支

包装规格: 400毫克/支

计价单位:

生产厂家中文参考译名:

生产厂家英文名:Roche(Genetech Inc., South San Francisco, CA, USA)

原产地英文商品名:AVASTIN 400mg/Vial

原产地英文药品名:BEVACIZUMAB

中文参考商品译名:阿瓦斯汀 400毫克/16毫升/瓶

中文参考药品译名:贝伐单抗

曾用名:阿瓦斯汀,阿瓦司汀

简介

部分中文阿瓦斯汀处方资料(仅供参考)

阿瓦斯汀Bevacizumab(商品名Avastin)中文说明书

【性状】

剂型:水剂。剂量:两种,100mg/4ml或400mg/16ml。

【作用机制】

Bevacizumab(商品名Avastin)是一种重组的人类单克隆IgG1抗体,通过抑制人类血管内皮生长因子的生物学活性而起作用。

【药理毒理】

药物代谢动力学特性:静脉给药后,平均清除半衰期为20天(范围11-50天),预测达到稳态的时间为100天。特殊人群:根据人群用药资料,没有发现稳态血药浓度与患者的年龄、性别之间有相关性。 与处方者有关的临床前安全资料在兔子中使用超过两倍Avastin人类推荐剂量,出现致畸性。目前无Avastin在人类和动物致癌性资料。

【适应症】

Avastin适用于联合以5-FU为基础的化疗方案一线治疗转移性结直肠癌。

【禁忌症】

目前不知Avastin的禁忌症。

【用法与用量】

推荐剂量为5mg/kg,每2周静脉注射1次直至疾病进展。Avastin应在术后28天以后使用,且伤口完全愈合。Avastin 需用100ml0.9%的生理盐水稀释,不能用葡萄糖溶解。Avastin不能静脉推注,第一次静脉滴注应在化疗后,滴注时间应超过90分钟。第一次滴注耐受性好,第二次静脉滴注时间应超过60分钟,仍然耐受好,以后滴注时间超过30分钟即可。

【不良反应】

最严重的不良反应为胃肠穿孔/伤口并发症、出血、高血压危象、肾病综合症、充血性心力衰竭。最常见的严重不良反应(NCI-CTC 3-4级 )为:无力、疼痛、高血压、腹泻、白细胞减少。最常见不良反应为:无力、疼痛、腹痛、头痛、高血压、腹泻、恶心、呕吐、食欲下降、口腔炎、便秘、上呼吸道感染、鼻衄、呼吸困难、剥脱性皮炎、蛋白尿。

【贮藏】

Avastin必须储存在原包装内,冷藏于2~8℃ ,避光保存。不能冷冻,不能摇动。阿瓦斯丁是一种基因工程单克隆抗体药物,通过抑制血管内皮生长因子,刺激新血管形成作用,使肿瘤组织无法获得所需的血液、氧和其他养分而致肿瘤细胞死亡,达到抗癌功效。我科2005年12月1日收治了1例乳腺癌术后肝转移的患者。使用阿瓦斯丁全身化疗。

英文版说明书

Indications and UsageMetastatic Colorectal CancerAVASTIN, in combination with intravenous 5-fluorouracil-based chemotherapy, is indicated for first- or second-line treatment ofpatients with metastatic carcinoma of the colon or rectum.Non-Small Cell Lung Cancer AVASTIN®, in combination with carboplatin and paclitaxel, is indicated for first line treatment of patients with unresectable, locally advanced, recurrent or metastatic non-squamous, non-small cell lung cancer. Boxed WARNINGS and Additional Important Safety InformationGastrointestinal (GI) perforation: Avastin administration can result in the development of GI perforation, in some cases resulting in fatality. GI perforation, sometimes associated with intra-abdominal abscess, occurred throughout treatment with Avastin.Permanently discontinue Avastin therapy in patients with GI perforation.Wound healing complication: Avastin administration can result in the development of wound dehiscence, in some instances resulting infatality.Permanently discontinue Avastin therapy in patients with wound dehiscence requiring medical intervention. The appropriate interval between termination of Avastin and subsequent elective surgery has not been determined.Hemorrhage: Severe, and in some cases fatal, pulmonary hemorrhage can occur in patients with NSCLC treated with chemotherapy and Avastin. Do not administer Avastin to patients with recent hemoptysis (≥1/2 tsp of red blood). Permanently discontinue Avastin in patients with serious hemorrhage and initiate aggressive medical management.Additional serious adverse events included non-GI fistula formation, arterial thromboembolic events, hypertensive crisis, reversible posterior leukoencephalopathy syndrome, neutropenia and infection, nephrotic syndrome, and congestive heart failure.The most common adverse events seen in patients receiving Avastin across all studies were asthenia, pain, abdominal pain, headache, hypertension, diarrhea, nausea, vomiting, anorexia, stomatitis, constipation, upper respiratory infection, epistaxis, dyspnea, exfoliative dermatitis,

用药温馨提示:当您服用此药物时,需定期接受医疗专业人士的检查,以便随时针对其药效、副作用等情况进行监测。本网站所包含的信息旨在为患者提供帮助,不能代替医学建议和治疗。
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