硫酸长春新碱脂质体注射液(Marqibo injection Kit 1mg/ml 5ml)

药店国别：无 产地国家：美国 处方药：是 所属类别： 1毫克/毫升 5毫升/套件 包装规格： 1毫克/毫升 5毫升/套件 计价单位：套件 生产厂家中文参考译名： 无 生产厂家英文名：spectrum pharmaceuticals 原产地英文商品名：MARQIBO 1MG/ML 5ML KIT 1/EA 原产地英文药品名：vinCRIStine sulfate LIPOSOME 中文参考商品译名：MARQIBO注射液 1毫克/毫升 5毫升/套件 中文参考药品译名：硫酸长春新碱脂质体 曾用名：无

简介

近日，美国FDA批准抗癌新药Marqibo（vinCRIStine sulfate LIPOSOME）用于治疗复发两次或两次以上、或接受两种或两种以上抗白血病治疗方案仍继续恶化的费城染色体阴性（PH一）急性淋巴细胞白血病（ALL）罕见类型白血病成人患者。 ALL是一种血液和骨髓癌，发展迅速，临床诊断在儿童中比成年人中更为常见。该药主要成分为常用抗肿瘤药长春新碱，由一种类似细胞膜成分的脂质体包裹，每周注射一次。 批准日期：2012年8月9日 公司：SPECTRUM PHARMACEUTICALSMarqibo（硫酸长春新碱脂质体[vinCRIStine sulfate LIPOSOME]）注射液，用于静脉输注 美国最初批准：2012年 警告：查看完整的盒装警告的完整处方信息。 仅限静脉使用-如果由其他路线给出则致命鞘内使用会导致死亡Marqibo（vinCRIStine硫酸盐LIPOSOME注射液）与vinCRIStine硫酸盐注射剂有不同的剂量建议。 制备和给药前的Verifydrug名称和剂量，以避免药物过量。 最近的重大变化剂量和用量：11/2016 作用机制 Marqibo是一种鞘磷脂/胆固醇脂质体包裹的硫酸长春新碱制剂。非脂质体硫酸长春新碱与微管蛋白结合，改变微管蛋白聚合平衡，导致微管结构和功能改变。 非脂质体长春新碱硫酸盐稳定纺锤体装置，防止染色体分离，引发中期停滞和抑制有丝分裂。 适应症和用法 Marqibo是一种长春花生物碱，用于治疗成人患者，患有染色体阴性（Ph-）急性淋巴细胞白血病（ALL）的第二次或更多次复发，或者在两次或更多次抗白血病治疗后疾病进展。该指示基于总体响应率。尚未验证临床益处，例如总体存活率的改善。 剂量和给药 仅静脉使用。不要通过任何其他途径管理每7小时用1小时静脉注射剂量为2.25mg/m2的Marqibo。剂量形式和强度最终的药物产品是在马克琪工具包中的组件现场制备的。 制备后，每剂单剂量的Marqibo（vinCRIStine硫酸盐LIPOSOME注射液）含有5mg/31mL（0.16mg/mL）硫酸长春新碱。 禁忌症 Marqibo禁用于包括Charcot-Marie-Tooth综合征在内的脱髓鞘病症患者对于对硫酸长春新碱或Marqibo的任何其他成分（vinCRIStine硫酸盐LIPOSOME注射液）过敏的患者禁用MarqiboMarqibo禁用鞘内注射。 警告和注意事项 鞘内给药是致命的外渗会导致组织损伤神经毒性：监测患者的外周运动和感觉，中枢和自主神经病变，并减少，中断或停止使用。原先存在严重神经病变的患者应在经过仔细的风险 - 效益评估后才能用Marqibo治疗骨髓抑制：在每次服用Marqibo之前监测血细胞计数。 可能发生中性粒细胞减少，血小板减少或贫血;考虑减少或中断Marqibodose和支持性护理措施肿瘤溶解综合征：预测，监测和管理便秘，肠梗阻和/或麻痹性肠梗阻：研究预防性肠道方案，以防止潜在的便秘，肠梗阻和/或麻痹性肠梗阻疲劳：可能发生严重疲劳肝毒性：监测肝功能并修改或中断给药胚胎毒性：可引起胎儿伤害。建议女性对胎儿有潜在危险 不良反应 临床研究中最常见的不良反应（发生率≥30％）包括便秘，恶心，发热，疲劳，周围神经病变，发热性中性粒细胞减少，腹泻，贫血，食欲减退和失眠。 药物相互作用 预计Marqibo将与已知与非脂质体硫酸长春新碱相互作用的药物相互作用。 用于特定人群儿科用药：Marqibo在儿科患者中的安全性和有效性尚未确定。 包装提供/存储和处理 Marqibo Kit（NDC：20536-322-01）包含：•含有VinCRIStine硫酸盐注射液的小瓶，USP 5mg/5mL（1mg/mL）-NDC：20536-323-01•含有鞘磷脂/胆固醇脂质体注射液的小瓶103mg/mL-NDC：20536-324-01•含有磷酸钠注射液的小瓶355mg/25mL（14.2mg/mL）-NDC：20536-325-01•浮选环•过量标签磷酸钠注射瓶含有构成Marqibo（vinCRIStine硫酸盐LIPOSOME注射液），5mg/31mL（0.16mg/mL）•输液袋标签存储将Marqibo Kit存放在2°C至8°C的冰箱中 - 不要冷冻

英文版说明

Marqibo®(vinCRIStine sulfate LIPOSOME injection) for intravenous infusionInitial U.S. Approval: 2012MARQIBO Important Safety InformationImportant Safety InformationWARNINGFor Intravenous Use Only—Fatal if Given by Other RoutesDeath has occurred with intrathecal administration MARQIBO (vinCRIStine sulfate LIPOSOME injection) has different dosage recommendations than vincristine sulfate injection. Verify drug name and dose prior to preparation and administration to avoid overdosageContraindicationsMARQIBO is contraindicated in patients with demyelinating conditions, including Charcot-Marie-Tooth syndrome; in patients with hypersensitivity to vincristine sulfate or any of the other components of MARQIBO; and for intrathecal administrationWarnings and PrecautionsMARQIBO is for intravenous use only—fatal if given by other routes. Intrathecal use is fatalExtravasation causes tissue injury. If extravasation is suspected, discontinue infusion immediately and consider local treatment measuresSensory and motor neuropathy are common and cumulative. Monitor patients for peripheral motor and sensory, central and autonomic neuropathy and reduce, interrupt, or discontinue dosing. Patients with preexisting severe neuropathy should be treated with MARQIBO only after careful risk-benefit assessmentNeutropenia, thrombocytopenia, or anemia may occur. Monitor blood counts prior to each dose. Consider dose modification or reduction as well as supportive care measures if Grade 3 or 4 myelosuppression developsAnticipate, monitor for, and manage tumor lysis syndromeA prophylactic bowel regimen should be instituted with MARQIBO to prevent constipation, bowel obstruction, and/or paralytic ileusSevere fatigue can occur requiring dose delay, reduction, or discontinuation of MARQIBOFatal liver toxicity and elevated levels of aspartate aminotransferase have occurred. Monitor liver function and modify or interrupt dosing for hepatic toxicityMARQIBO can cause fetal harm. Advise women of potential risk to fetusAdverse EventsThe most commonly reported adverse reactions (incidence >30%) in clinical studies include constipation (57%), nausea (52%), pyrexia (43%), fatigue (41%), peripheral neuropathy (39%), febrile neutropenia (38%), diarrhea (37%), anemia (34%), decreased appetite (33%), and insomnia (32%)A total of 75.9% of patients experienced serious adverse events (SAEs) during the studies. The most commonly reported SAEs included febrile neutropenia (20.5%), pyrexia (13.3%), hypotension (7.2%), respiratory distress (6.0%), and cardiac arrest (6.0%)Twenty-eight percent of patients experienced adverse reactions leading to treatment discontinuation. The most common adverse reactions that caused treatment discontinuation were peripheral neuropathy (10%), leukemia-related (7%), and tumor lysis syndrome (2%)Deaths occurred in 23% of patients in study 1. The nonleukemia-related causes of death were brain infarct (1), intracerebral hemorrhage (2), liver failure (1), multisystem organ failure (2), pneumonia and septic shock(3), respiratory failure(4), pulmonary hemorrhage (1), and sudden cardiac death(1)Drug InteractionsMARQIBO is expected to interact with drugs known to interact with nonliposomal vincristine sulfate, therefore the concomitant use of strong CYP3A inhibitors or the use of potent P-glycoprotein inhibitors or inducers should be avoidedUse in Specific PopulationsThe safety and effectiveness of MARQIBO in pediatric patients have not been establishedIt is not known whether MARQIBO is excreted in human milkhttps://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid