雷莫芦单抗,雷莫芦单抗注射剂(CYRAMZA 10MG/ML 50ML PF SDV)

药店国别:

产地国家:美国

处方药:

所属类别: 0毫克/毫升 50毫克/瓶

包装规格: 0毫克/毫升 50毫克/瓶

计价单位:

生产厂家中文参考译名:

生产厂家英文名:ELI LILLY AND COMPANY

原产地英文商品名:CYRAMZA 10MG/ML 50ML PF SDV 1/EA

原产地英文药品名:RAMUCIRUMAB

中文参考商品译名:CYRAMZA注射剂 10毫克/毫升 50毫克/瓶

中文参考药品译名:雷莫芦单抗

曾用名:

简介

—美国FDA扩展Cyramza的批准使用治疗侵袭性非小细胞肺癌2014年12月12日,美国FDA批准Cyramza (ramucirumab)治疗转移性非小细胞癌(NSCLC)新适应症。

NSCLC是最常见形式的肺癌,当癌细胞在肺部组织形成时就会发生这种疾病。美国国家癌症研究所预测,2014年将有22.421万美国人被确诊患有肺癌,有15.926万人将死于这种疾病。Cyramza通过阻断帮助肿瘤增长的血液供应而发挥作用。

这款药物适用于以铂类为基础化疗治疗期间或治疗后肿瘤出现恶化的患者,它将与另一款化疗药物多西他赛合并用药。

“今天的批准是Cyramza在2014年获得的第三项适应症,

”FDA药物评价与研究中心血液及肿瘤产品办公室主任、医学博士Pazdur称。

“研究Cyramza用于各种恶化肿瘤的努力为患者提供了重要的治疗选择。

”4月21日,FDA批准Cyramza作为一种单一制剂用于治疗晚期胃癌或胃食管连接部腺癌,后者是位于食管与胃连接处的癌症。

11月5日,FDA批准Cyramza与另一款化疗药物紫杉醇合并用于晚期胃或GEJ腺癌。Cyramza加多西多赛用于转移性NSCLC的获批基于一项由1253名先前有过治疗并恶化肺癌患者参与的临床研究。研究受试者被随机配给Cyramza+多西多赛或安慰剂+多西多赛。当疾病出现恶化或发生无法耐受副作用时停止治疗。

这项试验旨在检测总生存期,即受试者死亡前的存活时间。结果显示,Cyramza+多西多赛治疗受试者中有一半的人从治疗开始存活了10.5个月,相比之下,安慰剂+多西多赛治疗受试者中一半的人从治疗开始存活了9.1个月。临床研究中观察到的与Cyramza+多西多赛相关的最常见副作用包括抗感染的白细胞水平下降(嗜中性白血球减少)、疲劳及口腔炎症。Cyramza可引起严重出血、血栓、血压升高及可能损伤创面愈合。

批准日期:2014年12月20日

公司:礼来公司

注射用CYRAMZA(雷莫芦单抗,ramucirumab)为静脉输注治疗非小细胞肺癌和晚期胃癌

美国初次批准:2014

适应证和用途

CYRAMZA®是一个人血管内皮升长因子受体2拮抗剂适用:⑴ 作为单药或与紫杉醇联用,为晚期胃或胃-食道连接腺癌,有用或氟嘧啶[fluoropyrimidine]-或含铂化疗后疾病进展的治疗。⑵ 与多烯紫杉醇联用,为治疗转移非小细胞肺癌用或基于铂化疗后疾病进展。有EGFR或ALK基因组肿瘤畸变患者用FDA-批准的治疗对这些畸变接受CYRAMZA治疗以前应有疾病进展。

剂量和给药方法

只为静脉输注。不要静脉推注或丸注给药。胃癌⑴ CYRAMZA的推荐剂量或作为单药或与每周紫杉醇联用是8 mg/kg每2周。非小细胞肺癌⑵ 在输注多烯紫杉醇前,在21天疗程在第1天静脉给予CYRAMZA 10 mg/kg。

剂型和规格注射:⑴ 单剂量小瓶,100 mg/10 mL(10 mg每mL)溶液(3)⑵ 单剂量小瓶,500 mg/50 mL(10 mg每mL)溶液(3)

英文版说明

HIGHLIGHTS OF PRESCRIBING INFORMATIONThese highlights do not include all the information needed to use CYRAMZA safely and effectively. See full prescribing information for CYRAMZA.CYRAMZA(ramucirumab) injection, for intravenous useInitial U.S. Approval: 2014WARNING: HEMORRHAGE See full prescribing information for complete boxed warning.CYRAMZA increased the risk of hemorrhage, including severe and sometimes fatal hemorrhagic events. Permanently discontinue CYRAMZA in patients who experience severe bleeding [see Dosage and Administration (2.3), Warnings and Precautions (5.1)].RECENT MAJOR CHANGESINDICATIONS AND USAGECYRAMZA® is a human vascular endothelial growth factor receptor 2 antagonist indicatedas a single agent or in combination with paclitaxel, for treatment of advanced gastric or gastro-esophageal junction adenocarcinoma, with disease progression on or after prior fluoropyrimidine- or platinum-containing chemotherapy. (1.1)in combination with docetaxel, for treatment of metastatic non-small cell lung cancer with disease progression on or after platinum-based chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving CYRAMZA. (1.2)DOSAGE AND ADMINISTRATIONFor intravenous infusion only. Do not administer as an intravenous push or bolus. (2)Gastric CancerThe recommended dose of CYRAMZA either as a single agent or in combination with weekly paclitaxel is 8 mg/kg every 2 weeks. (2.1, 2.2, 2.3)Non-Small Cell Lung CancerAdminister CYRAMZA at 10 mg/kg intravenously on day 1 of a 21-day cycle prior to docetaxel infusion. (2.1, 2.2, 2.3)DOSAGE FORMS AND STRENGTHSInjection:100 mg/10 mL (10 mg per mL) solution, single-dose vial (3)500 mg/50 mL (10 mg per mL) solution, single-dose vial (3)CONTRAINDICATIONSNone (4)WARNINGS AND PRECAUTIONSArterial Thromboembolic Events (ATEs): Serious, sometimes fatal ATEs have been reported in clinical trials. Discontinue CYRAMZA for severe ATEs. (5.2)Hypertension: Monitor blood pressure and treat hypertension. Temporarily suspend CYRAMZA for severe hypertension. Discontinue CYRAMZA for hypertension that cannot be medically controlled. (5.3)Infusion-Related Reactions: Monitor for signs and symptoms during infusion. (5.4)Gastrointestinal Perforation: Discontinue CYRAMZA. (5.5)Impaired Wound Healing: Withhold CYRAMZA prior to surgery. (5.6)Clinical Deterioration in Patients with Cirrhosis: New onset or worsening encephalopathy, ascites, or hepatorenal syndrome can occur in patients with Child-Pugh B or C cirrhosis. (5.7)Reversible Posterior Leukoencephalopathy Syndrome: Discontinue CYRAMZA. (5.8)ADVERSE REACTIONSThe most common adverse reactions observed in single-agent CYRAMZA-treated patients at a rate of ≥10% and ≥2% higher than placebo were hypertension and diarrhea. (6.1)The most common adverse reactions observed in patients treated with CYRAMZA plus paclitaxel at a rate of ≥30% and ≥2% higher than placebo plus paclitaxel were fatigue, neutropenia, diarrhea, and epistaxis. (6.1)The most common adverse reactions observed in patients treated with CYRAMZA plus docetaxel at a rate of ≥30% and ≥2% higher than placebo plus docetaxel were neutropenia, fatigue/asthenia, and stomatitis/mucosal inflammation. (6.1)To report SUSPECTED ADVERSE REACTIONS, contact Eli Lilly and Company at 1-800-LillyRx (1-800-545-5979) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.USE IN SPECIFIC POPULATIONSPregnancy: Based on its mechanism of action, CYRAMZA may cause fetal harm. (8.1)Nursing Mothers: Discontinue nursing or discontinue CYRAMZA. (8.3)See 17 for PATIENT COUNSELING INFORMATION.Revised: 12/2014

 

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