产地国家：美国 处方药：是 所属类别：100毫克/片 30片/瓶 包装规格：100毫克/片 30片/瓶 计价单位：瓶 生产厂家英文名：Pfizer Inc 原产地英文商品名：Daurismo 100mg/Tablets 30Tablets/bottles 原产地英文药品名：glasdegib 中文参考商品译名：Daurismo 100毫克/片 30片/瓶 中文参考药品译名：格拉斯吉布

简介：

近日，美国食品和药物管理局(FDA)批准靶向抗癌药Daurismo(glasdegib)上市，联合低剂量阿糖胞苷(LD-AC)化疗，一线治疗新确诊的2类急性髓性白血病(AML)成人患者，具体为：(1)年龄在75岁及以上的老年AML患者;(2)因同时存在其他疾病而不适合进行强化诱导化疗的AML成人患者。此次批准，使Daurismo成为首个也是唯一一个获FDA批准治疗AML的Hedgehog信号通路抑制剂，将为因年龄或其他疾病无法接受强化化疗的难治性患者群体提供一个大幅改善总体生存的重要治疗选择。批准日期：2018年11月21日 开发公司:辉瑞DAURISMO(格拉斯吉布[glasdegib])片剂,供口服使用首次美国批准：2018警告：胚胎-胎儿毒性完全处方信息，完整的框警告。当给孕妇服用DAURISMO可导致胚胎-胎儿死亡或严重出生缺陷。DuriSimo是动物胚胎毒性、胎儿毒性和致畸性。在DAURISMO治疗开始前，对有生育潜力的女性进行妊娠测试。建议有生育潜力的女性在使用DAURISMO治疗期间和最后一剂量后至少30天内使用有效的避孕措施。建议男性在使用DAURISMO治疗期间以及在最后一次给药后至少30天内通过精液和避孕套与怀孕伴侣或具有生育潜力的女性伴侣接触避孕套的潜在风险，以避免潜在的药物接触。 作用机理：Glasdegib是Hedgehog通路的抑制剂。Glasdegib结合并抑制与刺猬信号转导有关的平滑的膜蛋白。在小鼠异种移植人AML模型中，glasdegib联合小剂量阿糖胞苷比单独应用glasdegib或小剂量阿糖胞苷更能抑制肿瘤的增大，降低骨髓中CD45+/CD33+细胞的百分率。 适应症及用法：DAURISMO是一种刺猬途径抑制剂，联合小剂量阿糖胞苷，用于治疗成人≥75岁的新诊断急性髓细胞白血病(AML)或具有不能使用强化诱导化疗的生态病症。 使用限制：DAURISMO尚未在伴有严重肾损害或中度至重度肝损害的患者中进行研究。 剂量与给药推荐剂量：口服100mg，每日1次。 剂型和强度：片剂，100mg，25mg。 禁忌症：没有。 警告和注意事项： 献血：建议患者在最后一次给药后至少30天内不要用DAURISMO进行献血或采血治疗。 QTc间期延长：监测心电图和电解质。IFQTc发生延长，中断治疗与DuriSimo。 不良反应：最常见的不良反应(发生率≥20%)是贫血、疲劳、出血、发热、中性粒细胞减少、肌肉骨骼疼痛、恶心、水肿、血小板减少、呼吸困难、食欲减退、吞咽困难、粘膜炎、便秘和皮疹。 药物相互作用： 强CYP3A4抑制剂：考虑非强CYP3A抑制剂的替代疗法，或监测不良反应风险增加，包括QTc间期延长。 强CYP3A4诱导剂：避免与DuriSo同时使用。 QTC延长用药：避免与达鲁司莫联合用药。如果联合用药是不可避免的，监测QT间期延长的风险增加。 在特定人群中的使用：哺乳期，建议妇女不要母乳喂养。 包装：DAURISMO薄膜包衣片，封装配置 剂型规格：片剂，30片/瓶，100毫克;60片/瓶，25毫克 存放：20o C至25o C (68o F至77o F)，允许在15度到30度之间(59度到86度)旅行。

英文版说明书：

Approves Daurismo (glasdegib) for Patients with Acute Myeloid LeukemiaU.S. Food and Drug Administration today approved Daurismo (glasdegib) tablets to be used in combination with low-dose cytarabine (LDAC), a type of chemotherapy, for the treatment of newly-diagnosed acute myeloid leukemia (AML) in adults who are 75 years of age or older or who have other chronic health conditions or diseases (comorbidities) that may preclude the use of intensive chemotherapy.“Intensive chemotherapy is usually used to control AML, but many adults with AML are unable to have intensive chemotherapy because of its toxicities. Today’s approval gives health care providers another tool to use in the treatment of AML patients with various, unique needs. Clinical trials showed that overall survival was improved using Daurismo in combination with LDAC compared to LDAC alone for patients who would not tolerate intensive chemotherapy,” 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.AML is a rapidly progressing cancer that forms in the bone marrow and results in an increased number of abnormal white blood cells in the bloodstream and bone marrow. The National Cancer Institute at the National Institutes of Health estimates that in 2018, approximately 19,520 people will be diagnosed with AML and approximately 10,670 patients with AML will die of the disease. Almost half of the adults diagnosed with AML are not treated with intensive chemotherapy because of comorbidities and chemotherapy related toxicities.The efficacy of Daurismo was studied in a randomized clinical trial in which 111 adult patients with newly diagnosed AML were treated with either Daurismo in combination with LDAC or LDAC alone. The trial measured overall survival (OS) from the date of randomization to death from any cause. Results demonstrated a significant improvement in OS in patients treated with Daurismo. The median OS was 8.3 months for patients treated with Daurismo plus LDAC compared with 4.3 months for patients treated with LDAC only.Common side effects reported by patients receiving Daurismo in clinical trials include low red blood cell count (anemia), tiredness (fatigue), bleeding (hemorrhage), fever with low white blood cell count (febrile neutropenia), muscle pain, nausea, swelling of the arms or legs (edema), low platelet counts (thrombocytopenia), shortness of breath (dyspnea), decreased appetite, distorted taste (dysgeusia), pain or sores in the mouth or throat (mucositis), constipation and rash.The prescribing information for Daurismo includes a Boxed Warning to advise health care professionals and patients about the risk of embryo-fetal death or severe birth defects. Daurismo should not be used during pregnancy or while breastfeeding. Pregnancy testing should be conducted in females of reproductive age prior to initiation of Daurismo treatment and effective contraception should be used during treatment and for at least 30 days after the last dose. The Boxed Warning also advises male patients of the potential risk of drug exposure through semen and to use condoms with a pregnant partner or a female partner that could become pregnant both during treatment and for at least 30 days after the last dose. Daurismo must be dispensed with a patient Medication Guide that describes important information about the drug’s uses and risks. Patients should also be advised not to donate blood or blood products during treatment. Health care providers should also monitor patients for changes in the electrical activity of the heart, called QT prolongation.The FDA granted this application Priority Review designation. Daurismo also received Orphan Drug designation, which provides incentives to assist and encourage the development of drugs for rare diseases.