培美曲塞,培美曲塞二钠冻干粉注射剂 アリムタ注射用(Alimta Injection 500mg)




所属类别: 500毫克/瓶

包装规格: 500毫克/瓶




原产地英文商品名:Alimta Injection(アリムタ注射用)500mg/Vial

原产地英文药品名:Pemetrexed Sodium Hydrate













生产厂家:Eli Lilly(礼来公司上市)




主要经尿清除。在肾功能正常的患者(肌苷清除率为90 ml/min),Alimta的系统清除率为91.8 ml/min。与顺铂、叶酸、维生素B12联合应用时不影响Alimta的药代动力学。






Alimta仅可静脉滴注,与顺铂联用,推荐剂量为500 mg/m2,第1天,滴注超过10分钟,21天为一个周期。顺铂推荐剂量为75 mg/m2,在Alimta滴注结束后30分钟开始滴注,时间超过2小时。肌苷清除率> 45 ml/min的患者不需调整剂量,肌苷清除率<45 ml/min的患者不建议使用Alimta。接受Alimta治疗的患者应同时应用叶酸和维生素B12,可减少治疗相关的血液学毒性和胃肠道毒性。任何疑问,请遵医嘱!





CANCERApproval Marks Third European Indication for ALIMTAINDIANAPOLIS, IND., USA, 11 April, 2008 – Eli Lilly and Company (NYSE: LLY) today announced that European health authorities have approved the use of ALIMTA® (pemetrexed for injection) for a histologically-based use in the first-line treatment of advanced non-small-cell lung cancer (NSCLC), the most common form of lung cancer. This approval – the third for pe-metrexed in Europe – follows an initial positive opinion issued by the European Medicines Agency’s (EMEA) Committee for Medicinal Products for Human Use (CHMP) on February 21, 2008.The EMEA specifically approved pemetrexed in combination with cisplatin as a first-line treat-ment for NSCLC patients with other than predominantly squamous cell histology. Histology is the microscopic study of tissue and NSCLC is classified by its histology. Previously, all histolo-gies were treated similarly.“This approval opens the door for a novel, tailored approach based on histology or tissue type,” said Richard Gaynor, M.D., vice president of cancer research and global oncology platform leader for Lilly. “Our hope is that this study provides physicians with a powerful tool for choos-ing the right drug for the right patient that leads to optimal treatment results.”The approval in first-line NSCLC is based on a Phase III randomized study that eva luated pemetrexed plus cisplatin versus GEMZAR® (gemcitabine HCl for injection) plus cisplatin. The 1,725-patient study, the largest Phase III clinical trial undertaken in the first-line setting of NSCLC, met its primary endpoint of non-inferiority relative to overall survival.However, when it came to survival by histology, the study found, in a pre-planned histological analysis, that patients with either adenocarcinoma or large-cell carcinoma had a clinically relevant improvement in overall survival when treated with the pemetrexed regimen in the first-line setting. In comparison, patients with squamous cell histology were found to have a more favorable overall survival when treated with the gemcitabine regimen.The lead investigator of the study, Giorgio Scagliotti, M.D., Department of Clinical and Biological Sciences Thoracic Oncology Unit, University of Torino, Orbassano, Italy, said the approval of pemetrexed plus cisplatin in a first-line setting marked an important step forward in treating the world’s leading cause of cancer deaths.“This study provides further evidence of the need to use a tailored approach to treating lung cancer patients, rather than simply using a particular medicine because of the treatment stage,” said Dr. Scagliotti.Data from the first-line NSCLC study was presented at the Presidential Symposium at the 12th World Conference on Lung Cancer (WCLC) in Seoul, Korea, on September 5, 2007, and at the Presidential Symposium III at the 14th Annual European Cancer Conference (ECCO) on September 24, 2007, in Barcelona, Spain.This regulatory approval paves the way for launches in Europe and applies to all 27 countries of the European Union, as well as Norway, Iceland, and Liechtenstein.Pemetrexed as Second-Line NSCLC TreatmentIn regard to the second-line indication for pemetrexed in NSCLC, the EMEA has approved a change in the indication to patients with other than predominantly squamous cell histology. This decision was based on a retrospective analysis of Phase III data in patients treated with either pemetrexed or docetaxel second-line that showed NSCLC patients with other than predominantly squamous cell histology had improved survival when treated with pemetrexed as compared to docetaxel, whereas patients with squamous cell histology treated with docetaxel had improved survival compared to pemetrexed. Data from this trial was presented at ECCO on September 25, 2007, in Barcelona.Notes to EditorAbout ALIMTA (pemetrexed for injection)Pemetrexed is currently indicated in combination with cisplatin in more than 85 countries for the treatment of patients with malignant pleural mesothelioma (MPM) whose disease is unresectable or who are otherwise not candidates for curative surgery. Pemetrexed is also approved as a sec-ond-line, single agent for the treatment of patients with locally advanced or metastatic NSCLC after prior chemotherapy. This latest approval is for pemetrexed in combination with cisplatin as a first-line treatment for NSCLC patients with other than predominantly squamous cell histology.About Non-Small-Cell Lung Cancer (NSCLC)NSCLC is the most common type of lung cancer and represents 85 to 90 percent of all lung can-cers. NSCLC has five-tier staging, starting at 0 and rising to the severity of stage IV. NSCLC can spread through the lymphatic system, penetrating the chest lining, ribs, and the nerves and blood vessels that lead to the arm. The liver, bones and brain are potential targets if the cancer-ous cells enter the bloodstream.According to the World Health Organization (WHO) Cancer Report, lung cancer is the world's most common cancer and the leading cause of cancer death for men and women. More than 1 million people die from lung cancer each year.NSCLC is defined as a group of histologies, that is, tumor types differentiated by cellular struc-ture. The most common NSCLC histology types are squamous (or epidermoid) carcinoma, ade-nocarcinoma, and large-cell carcinoma. These histologies are often classified together because to date, approaches to diagnosis, staging, prognosis, and treatment have been similar.About Lilly Oncology, a Division of Eli Lilly and CompanyFor more than four decades, Lilly Oncology has been collaborating with cancer researchers to deliver innovative treatment choices and valuable programs to patients and their physicians. Inspired by courageous patients living with cancer, Lilly Oncology is providing treatments that are considered global standards of care and developing a broad portfolio of novel targeted therapies to accelerate the pace and progress of cancer care.About Eli Lilly and CompanyLilly, a leading innovation-driven corporation, is developing a growing portfolio of first-in-class and best-in-class pharmaceutical products by applying the latest research from its own worldwide laboratories and from collaborations with eminent scientific organizations. Headquartered in Indianapolis, Ind., Lilly provides answers – through medicines and information – for some of the world's most urgent medical needs.


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