部分中文阿瓦斯汀处方资料（仅供参考） 阿瓦斯汀（Bevacizumab，Avastin）是重组的人源化单克隆抗体。2004年2月26日获得FDA的批准，是美国第一个获得批准上市的抑制肿瘤血管生成的药。通过体内、体外检测系统证实IgG1抗体能与人血管内皮生长因子（VEGF）结合并阻断其生物活性。而阿瓦斯汀包含了人源抗体的结构区和可结合VEGF的鼠源单抗的互补决定区。阿瓦斯汀是通过中国仓鼠卵巢细胞表达系统生产的，分子量大约为149,000道尔顿。阿瓦斯汀为无色透明、浅乳白色或灰棕色、pH值6.2的无菌液体。阿瓦斯汀有100mg和400mg两种规格，对应的体积为4ml和16ml（25mg/ml），不含防腐剂。 阿瓦斯汀（贝伐单抗） 为静脉滴注 美国首次批准：2004 警告：胃肠道穿孔，手术伤口愈合并发症，出血见完整的黑框警告完整的处方信息。 胃肠道穿孔：发生在高达阿瓦斯汀治疗的患者的3.2％。停止阿瓦斯汀用于胃肠道穿孔。 手术和伤口愈合并发症：请停止在患者伤口裂开。停止至少28天前，择期手术。手术后，直到手术伤口完全愈合时，不要启动阿瓦斯汀至少28天。 出血：严重或致命的出血，咯血，消化道出血，中枢神经系统出血，阴道出血Avastin-增加治疗的患者。不要给予阿瓦斯汀的患者有严重出血或近期咯血。 目前的主要变化 适应症和用法  08/2014 适应症和用法  08/2014 剂量和给药方法  08/2014 警告和注意事项，胃肠道穿孔和瘘管 08/2014 警告和注意事项，非消化道瘘  08/2014 警告和注意事项，出血  08/2014 警告和注意事项，静脉血栓栓塞事件  08/2014 警告和注意事项，后可逆脑病综合征（PRES）08/2014 警告和注意事项，胚胎，胎儿毒性（5.11）05/2015 适应症和用法 阿瓦斯汀是用于治疗指示的血管内皮生长因子特异性血管生成抑制剂： 转移性结直肠癌，与静脉注射5-氟尿嘧啶为基础的化疗一线还是二线治疗。 转移性结直肠癌，与fluoropyrimidine- irinotecan-或氟尿嘧啶，奥沙利铂为基础的化疗二线治疗的患者谁取得了进展在一线阿瓦斯丁含方案。 非鳞状非小细胞肺癌，与卡铂和紫杉醇的第一线治疗不能切除的，局部晚期，复发或转移性疾病。 胶质母细胞瘤，作为用于以下的现有治疗成年患者进行性疾病的单一试剂。 基于改进的客观缓解率有效性。在疾病相关症状或生存与贝伐单抗无数据表明改善。 转移性肾细胞癌与干扰素α 宫颈癌，与紫杉醇+顺铂或紫杉醇和拓扑替康的持续性，经常性，或转移性疾病的组合。 铂类耐药的复发性卵巢，输卵管或原发性腹膜癌，联合紫杉醇，聚乙二醇化脂质体阿霉素或托泊替康 使用限制：阿瓦斯汀未标明用于辅助治疗结肠癌。 用法用量 不要给予作为静脉推注或推注。 不要启动阿瓦斯汀28天以下的大手术，直到手术伤口完全愈合。 转移性结直肠癌 5mg/kg的IV每2周丸药-IFL 10毫克/千克IV每2周FOLFOX4 5毫克/公斤IV每2周或7.5毫克IV/kg，每3周在一线阿瓦斯丁含方案进展后氟尿嘧啶类药物，伊立替康和氟尿嘧啶，奥沙利铂为基础的化疗 非鳞状非小细胞肺癌 15毫克/千克IV，每3周用卡铂/紫杉醇 胶质母细胞瘤 10mg/kg的静脉，每2周 转移性肾细胞癌（MRCC） 10毫克/千克IV每2周，干扰素α 持续性，经常性，或宫颈转移癌 15毫克/千克IV，每3周用紫杉醇/顺铂或紫杉醇/托泊替康 铂类耐药的复发性卵巢，输卵管或原发性腹膜癌 10毫克/千克IV每2个星期用紫杉醇，聚乙二醇化脂质体多柔比星或每周托泊替 15毫克/千克IV，每3周用拓扑替康给予，每3周 剂型和规格 100毫克/毫升4，单次使用小瓶 400毫克/16毫升，单次使用小瓶 禁忌 无 警告和注意事项 穿孔或瘘：如果穿孔或瘘管时，请停止阿瓦斯汀。 动脉血栓栓塞事件（例如，心肌梗塞，脑梗塞）：请停止阿瓦斯汀用于严重ATE。 静脉血栓栓塞事件：请停止安维汀用于危及生命的静脉血栓栓塞 高血压：监测血压和治疗高血压。暂停阿瓦斯汀如果不是医学上的控制。停止安维汀用于高血压危象或高血压脑病。 后可逆脑病综合征（PRES）：请停止阿瓦斯汀。 蛋白尿：监测尿蛋白。停止阿瓦斯汀用于肾病综合征。暂停阿瓦斯汀用于中度蛋白尿。 输液反应：停止安维汀用于严重的输液反应。 胚胎 - 胎儿毒性：建议女性潜在风险的一个胎儿，以及需要使用有效的避孕。 卵巢早衰：建议女性的潜在风险。 不良反应 最常见的不良反应发生率（> 10％和至少两倍于控制臂速率）是鼻出血，头痛，高血压，鼻​​炎，蛋白尿，味觉改变，皮肤干燥，直肠出血，流泪症，腰痛和剥脱性皮炎。 要报告疑似不良反应，请联系Genentech公司在1-888-835-2555或FDA电话1-800-FDA-1088或www.fda.gov/medwatch。 特殊人群中使用 哺乳期：不推荐。 修订：5/2015 ------------------------------------------------------------- 温馨提示： 该药品土耳其版标签命名：ALTUZAN ( Avastin Equivalent) 美国、香港版标签命名：AVASTIN 均为罗氏生产的同款药品 ------------------------------------------------------------------- Important Safety Information What is Avastin approved for? Glioblastoma (GBM) Avastin is approved to treat glioblastoma (GBM) when taken alone in adult patients whose cancer has progressed after prior treatment (recurrent or rGBM). The effectiveness of Avastin in rGBM is based on tumor response. Currently, no data have shown whether or not Avastin improves disease-related symptoms or survival in people with rGBM. Metastatic Colorectal Cancer (mCRC) Avastin is approved to treat metastatic colorectal cancer (mCRC) for: •First- or second-line treatment in combination with intravenous 5-fluorouracil–based chemotherapy •Second-line treatment when used with fluoropyrimidine-based (combined with irinotecan or oxaliplatin) chemotherapy after cancer progresses following a first-line treatment that includes Avastin Avastin is not approved for use after the primary treatment of colon cancer that has not spread to other parts of the body. Non–Small Cell Lung Cancer (NSCLC) Avastin, in combination with carboplatin and paclitaxel, is approved to treat advanced nonsquamous non–small cell lung cancer (NSCLC) in people who have not received chemotherapy for their advanced disease. Metastatic Kidney Cancer (mRCC) Avastin, used with interferon alfa, is approved to treat metastatic kidney cancer (mRCC). Advanced Cervical Cancer (CC) Avastin, in combination with paclitaxel and cisplatin or paclitaxel and topotecan, is approved to treat persistent, recurrent, or metastatic cancer of the cervix. Platinum-Resistant Ovarian Cancer (prOC) Avastin, in combination with paclitaxel, pegylated liposomal doxorubicin or topotecan, is approved to treat platinum-resistant recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer in women who received no more than two prior chemotherapy treatments. Possible serious side effects Everyone reacts differently to Avastin therapy. So it's important to know what the side effects are. Although some people may have a life-threatening side effect, most do not. Your doctor will stop treatment if any serious side effects occur. Be sure to contact your health care team if there are any signs of these side effects. Most serious side effects (not common, but sometimes fatal): •GI perforation. A hole that develops in your stomach or intestine. Symptoms include pain in your abdomen, nausea, vomiting, constipation, or fever •Wounds that don't heal. A cut made during surgery can be slow to heal or may not fully heal. Avastin should not be used for at least 28 days before or after surgery and until surgical wounds are fully healed •Serious bleeding. This includes vomiting or coughing up blood; bleeding in the stomach, brain, or spinal cord; nosebleeds; and vaginal bleeding. If you recently coughed up blood or had serious bleeding, be sure to tell your doctor Other possible serious side effects •Abnormal passage in the body. This type of passage—known as a fistula—is an irregular connection from one part of the body to another and can sometimes be fatal •Severe high blood pressure. Blood pressure that severely spikes or shows signs of affecting the brain. Blood pressure should be monitored every 2 to 3 weeks while on Avastin and after stopping treatment •Kidney problems. These may be caused by too much protein in the urine and can sometimes be fatal •Infusion reactions. These were uncommon with the first dose (less than 3% of patients). 0.2% of patients had severe reactions. Infusion reactions include high blood pressure or severe high blood pressure that may lead to stroke, trouble breathing, decreased oxygen in red blood cells, a serious allergic reaction, chest pain, headache, tremors, and excessive sweating. Your doctor or nurse will monitor you for signs of infusion reactions •Severe stroke or heart problems. These may include blood clots, mini-stroke, heart attack, and chest pain. These can sometimes be fatal •Nervous system and vision problems. Signs include headache, seizure, high blood pressure, sluggishness, confusion, and blindness Side effects seen most often In clinical studies across different types of cancer, some patients experienced the following side effects: •High blood pressure •Too much protein in the urine •Nosebleeds •Rectal bleeding •Back pain •Headache •Taste change •Dry skin •Inflammation of the skin •Inflammation of the nose •Watery eyes Avastin is not for everyone Talk to your doctor if you are: •Undergoing surgery. Avastin should not be used for 28 days before or after surgery and until surgical wounds are fully healed •Pregnant. Data have shown that Avastin may harm your unborn baby. Use birth control while on Avastin. If you stop Avastin, you should keep using birth control for 6 months before trying to become pregnant •Planning to become pregnant. Taking Avastin could cause a woman's ovaries to stop working and may impair her ability to have children •Breastfeeding. Breastfeeding while on Avastin may harm your baby and is therefore not recommended If you have any questions about your condition or treatment, talk to your doctor. You may report side effects to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. You may also report side effects to Genentech at 1-888-835-2555. ------------------------------------------------------------- 产地国家：美国 所属类别：抗癌药物 ->治疗肠癌药物 原产地英文药品名： BEVACIZUMAB 中文参考药品译名： 贝伐单抗 原产地英文商品名： ALTUZAN (Avastin Equivalent)100mg/4mL/Vial 中文参考商品译名： 土耳其阿瓦斯汀 100毫克/4 毫升 生产厂家英文名： Roche in Switzerland 生产厂家中文参考译名： 罗氏(瑞士） 曾用名： 阿瓦斯汀，阿瓦司汀 -------------------------------------------------------- 产地国家：美国 所属类别：抗癌药物 ->治疗肠癌药物 原产地英文药品名： BEVACIZUMAB 中文参考药品译名： 贝伐单抗 原产地英文商品名： ALTUZAN(Avastin Equivalent)400mg/16mL/Vial 中文参考商品译名： 土耳其阿瓦斯汀 400毫克/16 毫升 生产厂家英文名： Roche in Switzerland 生产厂家中文参考译名： 罗氏(瑞士） 曾用名： 阿瓦斯汀，阿瓦司汀 该药品相关信息网址1： http://www.avastin.com/avastin/