奥英妥珠单抗冻干粉注射剂Besponsa Injection 0.9mg vial

药店国别： 产地国家：美国 处方药：是 所属类别： 0.9毫克/瓶 包装规格： 0.9毫克/瓶 计价单位：瓶 生产厂家中文参考译名： 生产厂家英文名：Pfizer 原产地英文商品名：Besponsa Injection 0.9mg/vial 原产地英文药品名：Inotuzumab Ozogamicin 中文参考商品译名：Besponsa冻干粉注射剂 0.9毫克/瓶 中文参考药品译名：奥英妥珠单抗 曾用名： 简介： 近日，美国FDA加速批准新药BESPONSA(inotuzumab ozogamicin)上市，治疗成人复发或难治性B细胞前体急性淋巴性白血病(B-cell precursor acute lymphoblastic leukemia)。值得一提的是，这是首款获得美国FDA批准的靶向CD22的抗体药物偶联物(ADC)。批准日期：2017年8月17日：公司：辉瑞(Pfizer)BESPONSA(奥英妥珠单抗[inotuzumab ozogamicin])注射用，用于静脉注射美国最初批准：2017年警告：肝毒性，包括肝脏VENO-OCCLUSIVE疾病(VOD)(也称为正常的阻塞性综合征，并且增加了造血后干细胞移植(HSCT)非复发性死亡的风险查看完整的盒装警告的完整处方信息。接受BESPONSA的患者发生肝毒性，包括致命和危及生命的VOD。接受BESPONSA的患者发生HSCT后非复发死亡率较高。 作用机制 Inotuzumab ozogamicin是CD22指导的抗体 - 药物偶联物(ADC)。 Inotuzumab识别人CD22。 小分子N-乙酰基-γ-加利车霉素是一种细胞毒性剂，通过接头与抗体共价连接。 非临床数据表明，inotuzumab ozogamicin的抗癌活性是由于ADC与表达CD22的肿瘤细胞的结合，然后是ADC-CD22复合物的内化，以及通过水解细胞内释放的N-乙酰基-γ-加利车霉素二甲基酰肼 连接子的切割。 N-乙酰基-γ-加利车霉素二甲基酰肼的活化诱导双链DNA断裂，随后诱导细胞周期停滞和凋亡细胞死亡。 适应症和用法 BESPONSA是CD22指导的抗体-药物偶联物(ADC)，用于治疗患有复发或难治性B细胞前体急性淋巴细胞白血病(ALL)的成人。 剂量和给药 在所有输注前使用皮质类固醇，退热药和抗组胺药预先给药。第1周期和随后的周期的给药方案，取决于对治疗的反应，如下所示。有关剂量详细信息，请参阅完整的处方信息。 第1天 第8天 第15天第1周期的给药方案所有患者：剂量 0.8毫克/平方米 0.5毫克/平方米 0.8毫克/平方米周期长度 21天根据对治疗的反应，给药后续周期的给药方案已达到CR或CRi的患者：剂量 0.5毫克/平方米 0.5毫克/平方米 0.5毫克/平方米周期长度 28天未达到CR或CRi的患者：剂量 0.8毫克/平方米 0.5毫克/平方米 0.5毫克/平方米周期长度 28天对于达到CR或CRi和/或允许从毒性恢复的患者，周期长度可延长至28天(即，从第21天开始的7天无治疗间隔)。有关重建冻干粉末，重组药物的制备和给药的说明，请参阅完整的处方信息。 剂量形式和强度 用于注射：在单剂量小瓶中0.9mg冻干粉末用于重构和进一步稀释。禁忌症没有警告和注意事项骨髓抑制：监测全血细胞计数;感染的体征和症状;出血/出血;或治疗期间骨髓抑制的其他影响;妥善管理。输注相关反应：在输注结束期间和输注结束后至少1小时监测输注相关反应。QT间期延长：在基线时获取心电图(ECG)和电解质，并在治疗期间进行监测。使用已知可延长QT间期的伴随中介时，更频繁地监测。胚胎 - 胎儿毒性：可导致胎儿伤害。告知女性有可能对胎儿造成潜在风险的生殖潜力并使用有效的避孕措施。 不良反应 最常见(≥20%)的不良反应是血小板减少，中性粒细胞减少，感染，贫血，白细胞减少，疲劳，出血，发热，恶心，头痛，发热性中性粒细胞减少，转氨酶增加，腹痛，γ-谷氨酰转移酶增加和高胆红素血症。 用于特定人群 哺乳期：建议不要母乳喂养。 包装提供/存储和处理如何提供 注射用BESPONSA(inotuzumab ozogamicin)以单剂量小瓶中的白色至灰白色冻干粉末形式提供，用于重构和进一步稀释。 每个小瓶提供0.9毫克inotuzumab ozogamicin。 每个纸箱(NDC 0008-0100-01)包含一个单剂量小瓶。存储和处理冷藏(2-8°C; 36-46°F)BESPONSA样品瓶并存放在原装纸箱中以防光照。 不要冻结。BESPONSA是一种细胞毒性药物。 遵循适用的特殊处理和处理程序。 奥英妥珠单抗英文版说明书 INOTUZUMAB OZOGAMICIN PFIZER INC 00008-0100-0FDA Approves BesponsaFDA Approves Besponsa (inotuzumab ozogamicin) for Relapsed or Refractory Acute Lymphoblastic LeukemiaU.S. Food and Drug Administration today approved Besponsa (inotuzumab ozogamicin) for the treatment of adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL).“For adult patients with B-cell ALL whose cancer has not responded to initial treatment or has returned after treatment, life expectancy is typically low,” said Richard Pazdur, M.D., director of the FDA’s Oncology Center of Excellence and acting director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug eva luation and Research. “These patients have few treatments available and today’s approval provides a new, targeted treatment option.”B-cell precursor ALL is a rapidly progressing type of cancer in which the bone marrow makes too many B-cell lymphocytes, an immature type of white blood cell. The National Cancer Institute estimates that approximately 5,970 people in the United States will be diagnosed with ALL this year and approximately 1,440 will die from the disease.Besponsa is a targeted therapy that is thought to work by binding to B-cell ALL cancer cells that express the CD22 antigen, blocking the growth of cancerous cells.The safety and efficacy of Besponsa were studied in a randomized trial of 326 patients with relapsed or refractory B-cell ALL who had received one or two prior treatments. Patients were randomized to receive treatment with Besponsa or an alternative chemotherapy regimen. The trial measured the percentage of patients with no evidence of disease and full recovery of blood counts after treatment (complete remission or CR). Of the 218 eva luated patients, 35.8 percent who received Besponsa experienced CR for a median 8.0 months; of the patients who received alternative chemotherapy, 17.4 percent experienced CR for a median 4.9 months.Common side effects of Besponsa include low levels of platelets (thrombocytopenia), low levels of certain white blood cells (neutropenia, leukopenia), infection, low levels of red blood cells (anemia), fatigue, severe bleeding (hemorrhage), fever (pyrexia), nausea, headache, low levels of white blood cells with fever (febrile neutropenia), liver damage (transaminases and/or gamma-glutamyltransferase increased), abdominal pain and high levels of bilirubin in the blood (hyperbilirubinemia).The prescribing information for Besponsa includes a boxed warning that severe liver damage (hepatotoxicity), including blockage of veins in the liver (veno-occlusive disease [VOD] or sinusoidal obstruction syndrome), occurred in some patients who took Besponsa. If hepatotoxicity occurs, doctors should pause treatment or reduce the dose of Besponsa. If VOD occurs, patients should stop taking Besponsa and be given standard VOD treatment, if severe.The boxed warning also includes an increased risk of death for patients who take Besponsa after receiving a certain type of stem cell transplant.Other serious side effects of Besponsa include a decrease in blood cell and platelet production (myelosuppression), infusion-related reactions and problems with the heart’s electrical pulses (QT interval prolongation). Women who are pregnant or breastfeeding should not take Besponsa because it may cause harm to a developing fetus or a newborn baby.The FDA granted this application Priority Review and Breakthrough Therapy designations. Besponsa also received Orphan Drug designation, which provides incentives to assist and encourage the development of drugs for rare diseases.