瑞博西尼片KISQALI 600MG DAILY TAB(RIBOCICLIB)

药店国别： 产地国家：美国 处方药：是 所属类别： 600毫克/片 63片/盒 包装规格： 600毫克/片 63片/盒 计价单位：盒 生产厂家中文参考译名： 生产厂家英文名：NOVARTIS 原产地英文商品名：KISQALI 600MG DAILY TAB 3X21 BLST 63/EA 原产地英文药品名：ribociclib 中文参考商品译名：Kisqali片 600毫克/片 63片/盒 中文参考药品译名：瑞博西尼 曾用名：以前名 LEE011

简介

新型抗癌口服药Kisqali(Ribociclib)于2017年03月13日获得美国食品和药物监督管理局(FDA)的批准，该药为一种片剂，批准规格为200mg，每日剂量为600mg;Kisqali是由诺华开发，继辉瑞Ibrance之后第二个CDK4/6抑制剂，与芳香酶抑制剂联用作为一线用药治疗HR阳性/ HER2阴性绝经后妇女晚期转移乳腺癌。 批准日期：2017年3月13日 公司：诺华制药公司KISQALI®(ribociclib)口服用片剂 美国初始批准：2017年 作用机理 Ribociclib是细胞周期蛋白依赖性激酶(CDK)抑制剂4和6，这些激酶在结合到D-细胞周期激活和信号传导途径从而导致细胞周期进展和细胞增殖中发挥至关重要的作用。的细胞周期蛋白D-CDK4/ 6复合物通过成视网膜细胞瘤蛋白(Rb蛋白)的磷酸化调控细胞周期进程。在体外，ribociclib降低pRb的磷酸化导致在细胞周期的G1期逮捕和在乳腺癌细胞系中降低细胞增殖。 在体内，在与导致肿瘤的人类肿瘤细胞异种移植小鼠模型单药治疗ribociclib减少册，其中Rb蛋白的抑制相关有了磷酸化。在使用来自患者的雌激素受体阳性乳腺癌异种移植模型中，增加肿瘤生长抑制导致ribociclib和抗雌激素(例如来曲唑)的组合相比，每个单独的药物研究。 适应症和用法 KISQALI是在组合指示芳香酶抑制剂激酶抑制剂使用的初始基于内分泌疗法用于治疗绝经后妇女的激素受体(HR)阳性，人表皮生长因子受体2(HER2)阴性晚期或转移性乳腺癌。 用法用量 KISQALI片剂口服食物伴或不伴来曲唑的组合。推荐起始剂量：600毫克口服(3×200mg片剂)，每日服用一次没有食物有或连续21天，随后7天假治疗。剂量中断，可以根据个人的安全性和耐受需要减少，和/或停止。 剂型和规格片剂： 200毫克 禁忌症 无。 警告和注意事 项QT间期延长：监控心电图(心电图)和电解质前治疗KISQALI开始。在大约第一个周期的第14天，并且在第二周期开始时重复心电图，并作为临床指征。监视在每个周期的开始电解质为6个周期，并作为临床指征。肝胆毒性：血清转氨酶水平越来越普遍。开始治疗前KISQALI进行肝功能检查(肝功能试验)。监测每2周肝功进行第2次循环，在每个随后的4个周期的开始，并且根据临床指征。中性粒细胞减少：开始治疗前进行全血球计数(CBC)随着KISQALI。 CBC监控每2周前两个周期，在每个随后的四个周期的开始，并作为临床指征。胚胎 - 胎儿毒性：可引起胎儿造成伤害。告知潜在风险的患者到胎儿，并使用有效的避孕方法在治疗期间。 不良反应 最常见的不良反应(发生率≥20%)是中性粒细胞减少，恶心，疲劳，腹泻，白细胞减少症，脱毛症，呕吐，便秘，头痛和背部疼痛。 药物相互作用 CYP3A4抑制剂：避免同时使用强CYP3A酶抑制剂随着KISQALI的。如果无法避免强抑制剂，降低KISQALI剂量。CYP3A4诱导剂：避免同时使用强CYP3A诱导随着KISQALI的。CYP3A的基板：具有窄治疗指数的敏感的CYP3A基板的剂量可能需要降低随着KISQALI当同时给予。药物延长已知QT间期：避免同时使用药物来延长QT间期被称为抗心律失常药这样的。 特殊人群中使用哺乳期： 建议不进行母乳喂养。

英文版说明书

FDA Approves Kisqali (ribociclib) for HR+/HER2- Metastatic Breast CancerUS Food and Drug Administration (FDA) has approved Kisqali (ribociclib, formerly known as LEE011) in combination with an aromatase inhibitor as initial endocrine-based therapy for treatment of postmenopausal women with hormone receptor positive, human epidermal growth factor receptor-2 negative (HR+/HER2-) advanced or metastatic breast cancer.Kisqali is a CDK4/6 inhibitor approved based on a first-line Phase III trial that met its primary endpoint early, demonstrating statistically significant improvement in progression-free survival (PFS) compared to letrozole alone at the first pre-planned interim analysis.Kisqali was reviewed and approved under the FDA Breakthrough Therapy designation and Priority Review programs."Kisqali is emblematic of the innovation that Novartis continues to bring forward for people with HR+/HER2- metastatic breast cancer," said Bruno Strigini, CEO, Novartis Oncology. "We at Novartis are proud of the comprehensive clinical program for Kisqali that has led to today's approval and the new hope this medicine represents for patients and their families."The FDA approval is based on the superior efficacy and demonstrated safety of Kisqali plus letrozole versus letrozole alone in the pivotal Phase III MONALEESA-2 trial.The trial, which enrolled 668 postmenopausal women with HR+/HER2- advanced or metastatic breast cancer who received no prior systemic therapy for their advanced breast cancer, showed that Kisqali plus an aromatase inhibitor, letrozole, reduced the risk of progression or death by 44 percent over letrozole alone (median PFS not reached (95% CI: 19.3 months-not reached) vs. 14.7 months (95% CI: 13.0-16.5 months); HR=0.556 (95% CI: 0.429-0.720); p<0.0001)[1].More than half of patients taking Kisqali plus letrozole remained alive and progression free at the time of interim analysis, therefore median PFS could not be determined. At a subsequent analysis with additional 11-month follow-up and progression events, a median PFS of 25.3 months for Kisqali plus letrozole and 16.0months for letrozole alone was observed. Overall survival data is not yet mature and will be available at a later date."In the MONALEESA-2 trial, ribociclib plus letrozole reduced the risk of disease progression or death by 44 percent over letrozole alone, and more than half of patients (53%) with measurable disease taking ribociclib plus letrozole experienced a tumor burden reduction of at least 30 percent.This is a significant result for women with this serious form of breast cancer," said Gabriel N.Hortobagyi, MD, Professor of Medicine, Department of Breast Medical Oncology, The University of Texas MD Anderson Cancer Center and MONALEESA-2 Principal Investigator. "These results affirm that combination therapy with a CDK4/6 inhibitor like ribociclib and an aromatase inhibitor should be a new standard of care for initial treatment of HR+ advanced breast cancer."Kisqali is taken with or without food as a once-daily oral dose of 600 mg (three 200 mg tablets) for three weeks, followed by one week off treatment. Kisqali is taken in combination with four weeks of any aromatase inhibitor.Breast cancer is the second most common cancer in American women[3]. The American Cancer Society estimates more than 250,000 women will be diagnosed with invasive breast cancer in 2017. Up to one-third of patients with early-stage breast cancer will subsequently develop metastatic disease.Novartis is committed to providing patients with access to medicines, as well as resources and support to address a range of needs.The Kisqali patient support program is available to help guide eligible patients through the various aspects of getting started on treatment, from providing educational information to helping them understand their insurance coverage and identify potential financial assistance options.About Kisqali (ribociclib)Kisqali (ribociclib) is a selective cyclin-dependent kinase inhibitor, a class of drugs that help slow the progression of cancer by inhibiting two proteins called cyclin-dependent kinase 4 and 6 (CDK4/6). These proteins, when over-activated, can enable cancer cells to grow and divide too quickly. Targeting CDK4/6 with enhanced precision may play a role in ensuring that cancer cells do not continue to replicate uncontrollably.Kisqali was developed by the Novartis Institutes for BioMedical Research (NIBR) under a research collaboration with Astex Pharmaceuticals.About the MONALEESA Clinical Trial ProgramNovartis is continuing to assess Kisqali through the robust MONALEESA clinical trial program, which includes two additional Phase III trials, MONALEESA-3 and MONALEESA-7, that are eva luating Kisqali in multiple endocrine therapy combinations across a broad range of patients, including premenopausal women.MONALEESA-3 is eva luating Kisqali in combination with fulvestrant cohttps