雷莫芦单抗注射溶液Cyramza 500mg/50ml(Ramucirumab)说明书

药店国别： 产地国家：德国 处方药：是 所属类别： 500毫克/50毫升 50毫升/瓶 包装规格： 500毫克/50毫升 50毫升/瓶 计价单位：瓶 生产厂家中文参考译名： 生产厂家英文名：Lilly Deutschland GmbH 原产地英文商品名：Cyramza 500mg/50ml 50ML 原产地英文药品名：Ramucirumab 中文参考商品译名：CYRAMZA注射溶液 500毫克/50毫升 50毫升/瓶 中文参考药品译名：雷莫芦单抗 曾用名： 简介：注射用CYRAMZA(雷莫芦单抗，ramucirumab)，为静脉输注能显著改善胃癌生存期美国初次批准：2014 适应证和用途 CYRAMZATM是一种人血管内皮生长因子受体2(VEGFR2)拮抗剂适用为胃癌的治疗。⑴ 晚期胃癌或胃-食管结合部腺癌，作为单药既往氟嘧啶-或含铂化疗后。 剂量和给药方法 ⑴ 给予8 mg/kg静脉每2周。 ⑵ 只为静脉输注。不要静脉推注或丸注。 剂型和规格 ⑴ 100 mg/10 mL (10mg每mL)溶液，单次-剂量小瓶⑵ 500 mg/50 mL (10mg每mL)溶液，单次-剂量小瓶 禁忌证 无。 警告和注意事项 ⑴ 动脉血栓事件(ATEs)：在临床试验中曾报道严重，有时致命性ATEs。对严重ATEs终止CYRAMZA。⑵ 高血压：监视血压和治疗高血压。对严重高血压暂时不给CYRAMZA。对药物不能控制的高血压终止CYRAMZA。⑶ 输注相关反应：输注期间监视体征和症状。⑷ 胃肠道穿孔：终止CYRAMZA。⑸ 损害伤口愈合：手术前不给CYRAMZA。⑹ 有肝硬变患者中临床恶化：有Child-Pugh B或C肝硬化患者可能发生脑病，腹水，或肝肾综合征新发病或恶化。⑺ 可逆性后部白质脑病综合征: 终止CYRAMZA。不良反应CYRAMZA-治疗患者观察到发生率≥10%和高于安慰剂≥2%最常见不良反应为高血压和腹泻。报告怀疑不良反应，联系Eli Lilly和公司电话-800-LillyRx(1-800-545-5979)或FDA电话1-800-FDA-1088或www.fda.gov/medwatch.特殊人群中使用⑴ 妊娠：根据其作用机制，CYRAMZA可能致胎儿危害。⑵ 哺乳母亲：终止哺乳或终止 英文版说明书 CYRAMZA。Cyramza (ramucirumab) is a human monoclonal antibody indicated for the treatment of Gastric cancer. Cyramza molecule was originally discovered by ImClone Systems, which was later acquired by Eli Lilly and Company in 2008.Cyramza is the first FDA-approved treatment for gastric cancer after prior chemotherapy. Eli Lilly received approval for Cyramza from the US Food and Drug Administration (FDA) for as a single-agent treatment for patients with advanced or metastatic gastric cancer or adenocarcinoma of the gastroesophageal junction (GEJ) in April 2014. The US FDA also granted orphan designation to the drug.Gastric cancer treatment--------------------------------------------------------------------------------An oral anti-cancer agent that blocks cell proliferation and tumour angiogenesis.--------------------------------------------------------------------------------Also known as stomach cancer or adenocarcinoma, gastric cancer originates in the form of a malignant tumour in the lining of stomach. In its advanced stages, the disease travels through the bloodstream and reaches organs such as liver, lungs and bones. It is the fifth most common cancer and the third-leading cause of cancer death in the world.Around a million new gastric cancer cases were registered worldwide in 2012. The disease is preva lent outside the US and in the European Union (EU).Cyramza blocks VEGF receptor 2Cyramza is a human monoclonal antibody (IgG1) that binds and blocks the activation of vascular endothelial growth factor (VEGF) receptor 2. The drug also stops binding of VEGF receptor ligands VEGF-A, VEGF-C and VEGF-D.The drug is available in 500mg/50ml and 100mg/10ml dosed vials for injection.Clinical trials on CyramzaThe FDA approval for Cyramza was based on the results obtained from a phase III clinical trial known as REGARD study. The randomised, double-blinded and placebo-controlled study enrolled 355 patients across 29 countries. Patients enrolled in the study had locally advanced or metastatic gastric cancer, including gastroesophageal junction adenocarcinoma following progression after initial fluoropyrimidine or platinum-containing chemotherapy."Patients enrolled for the study had locally advanced or metastatic gastric cancer, including gastroesophageal junction adenocarcinoma following progression after initial fluoropyrimidine or platinum-containing chemotherapy."Patients were administered with Cyramza solution and best supportive care (BSC) compared with placebo plus BSC. The primary endpoint of the study was overall survival and the secondary outcome measure was progression-free survival.The results of the study demonstrated that patients given Cyramza 8mg/kg by infusion every two weeks and best supportive care (BSC), as compared with placebo and BSC, showed improved overall survival and progression-free survival. The Cyramza 8mg/kg by infusion plus best supportive care (BSC) group also witnessed an increase in the median overall survival of patients with advanced gastric cancer by 37%.The overall median survival in Cyramza 8mg/kg plus best supportive care (BSC) arm was 5.2 months compared with 3.8 months in placebo arm and 0.78 in hazard ratio group. The progression-free survival was 2.1 months in Cyramza 8mg/kg plus BSC patients compared with 1.3 months in placebo and 0.48 months in hazard ratio.The adverse reactions found in the Cyramza-administered patients during the clinical study included hypertension and diarrhoea.Marketing commentaryEli Lilly and Company, headquartered at Indianapolis, US, is engaged in the discovery, development and commercialisation of high-quality medicines. It has 13 manufacturing plants and around 38,000 employees across 55 countries, and markets products in more than 125 countries.InformationGeneric Name: ramucirumabTrade Name: CyramzaSynonym: IMC 1121BEntry Type: New molecular entityDevelopmental StatusUK: Pre-registration (Filed)EU: Pre-registration (Filed)US: Approved (Licensed)UK launch Plans: Available only to registered usersActual UK launch date:CommentsApril 14: Approved by US FDA to treat patients with advanced stomach cancer or gastroesophageal junction adenocarcinoma. [12]22/04/2014 08:18:54Oct 13: Filed in the EU as a single-agent treatment for advanced gastric cancer following disease progression after initial chemotherapy [11].07/01/2014 10:16:17On 4 July 2012, orphan designation (EU/3/12/1004) was granted in the EU for ramucirumab for the treatment of gastric cancer [11].24/10/2013 09:01:03Oct 13: The FDA has granted Priority Review to the regulatory submission for ramucirumab as a single-agent treatment for advanced gastric cancer following disease progression after initial chemotherapy. The filing is based on data from REGARD. A US decision on approval is expected 2Q 2014. It has also been filed in the EU [10].24/10/2013 08:43:26April 12: PIII trials in progress, anticipated EU filing date later than 201213/04/2012 08:52:45EU filing anticipiated 2012 (2)19/01/2010 16:28:09Trial or other dataOct 13: REGARD study published in The Lancet [9].04/10/2013 10:34:50Sep 13: Top line results reported from the global PIII RAINBOW trial of ramucirumab + paclitaxel vs paclitaxel + placebo in patients with advanced gastric cancer refractory to or progressive after initial chemotherapy. The study met its primary endpoint of improved overall survival and a secondary endpoint of improved progression-free survival. The most common (>5% incidence) Grade >3 adverse events occurring at a higher rate on the ramucirumab arm included neutropenia, leukopenia, hypertension, fatigue/asthenia and abdominal pain [8].26/09/2013 22:18:20Jan 13: Further results from REGARD study presented at ASCO. Ramucirumab met its primary goal of improving overall survival (5.2 months vs 3.8 months with placebo). PFS was 2.1 vs 1.3 months, respectively. The company may file in the US later this year [7].24/01/2013 15:45:33Oct 12: Company report that the PIII REGARD trial , in patients with metastatic gastric cancer, met its primary endpoint of improved overall survival and also showed prolonged progression-free survival. The REGARD trial compared ramucirumab and best supportive care vs placebo and best supportive care as a second-line treatment in patients with metastatic gastric and gastroesophageal junction cancers. The most frequent adverse reaction (any grade) occurring at a higher rate with ramucirumab was hypertension (12%); other AEs ( > 5%) occurring more often with ramucirumab were diarrhoea and headache. A second PIII study in gastric cancer. RAINBOW, of ramucirumab in combination with paclitaxel, completed patient enrollment Sep 12 [6].16/10/2012 09:15:52Feb 12: Phase III trial eva luating the overall survival of patients with metastatic gastric cancer (NCT00917384). The 355 patients enrolled have all experienced disease progression following first-line platinum- or fluoropyrimidine-containing combination chemotherapy. Comparisons will be made between ramucirumab + best supportive care (BSC) and placebo + BSC. [4]13/04/2012 08:46:50Oct 10: A PIII trial (NCT01170663) eva luating the safety & efficacy of ramucirumab in combination with paclitaxel as second-line therapy began recruitment of approx 663 pts with metastatic gastric or gastro-oesophageal junction adenocarcinoma. Trial sites include the US, Germany, Singapore, Spain & Taiwan. The primary outcome measure will be overall survival time [3].11/04/2011 11:26:03NCT00917384: Started in Jul 09, this PIII study will eva luate the overall survival (OS) of 615 patients with metastatic gastric cancer (and gastroesophageal junction) following disease progression on first-line platinum- or fluoropyrimidine-containing combination chemotherapy who undergo treatment with the IMC-1121B plus best supportive care (BSC) vs placebo plus BSC. IMC-112B will be administered by IV infusion every 2 weeks at a dose of 8 mg/kg. Estimated study completion date: November 2012 [1].18/07/2009 16:56:05Evidence Based eva luationsNHSC/NIHR https://www.hsc.nihr.ac.uk/topics/ramucirumab-monotherapy-for-advanced-gastric-cance/CategoryBNF Category: Other immunomodulating drugs (08.02.04)Pharmacology: Vascular endothelial growth factor receptor-2 antagonistEpidemiology: Gastric cancer is the second most common cause of cancer-related death in the world. It is a difficult disease to cure, mainly because most patients present with advanced disease. 50% involve the pylorus, 25% the lesser curve and 10% the cardia. 2-8% of gastric cancers are lymphomas. 95% of gastric cancers occur in those aged over 55 years. 4,923 new diagnoses of gastric cancer were made in the UK in 2008. [5]Indication: Gastric cancerAdditional Details: or gastro-oesophageal junction cancer, second-lineMethod(s) of AdministrationIntravenous infusionCompany InformationName: Eli LillyUS Name: Eli LillyNICE InformationIn timetable: NoWhen: