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达必妥警告和注意事项
2021-10-21 17:12:06
达必妥dupilumab的警告和注意事项
1. 超敏反应：达必妥后可能会发生过m反应，如出现荨麻疹，皮疹，结节性红斑，过m反应和血清病。在发生超敏反应时停用达必妥。
2. 结膜炎和角膜炎：接受达必妥治Liao的特应性皮-炎患-者更容易出现结膜炎和角膜炎。患-者应向其医务人员报告新出现的或恶化的眼部症状。
3. 嗜酸性粒细胞增多症：警惕血管炎性皮疹，肺部症状恶化和/或经病变，特别是减少口服皮质类固醇后。
4. 急性发作：达必妥不应用于治Liao的急性发作。
5. 降d皮质类固醇剂量：开始用达必妥治Liao后，不要突然停止全身，局部或吸入皮质类固醇。如果情况合适，可逐渐减少类固醇的使用量。
6. 寄s虫感ran：在开始使用达必妥治Liao之前，患-者需要治Liao预先存在的蠕虫感ran。如果患-者在接受达必妥治Liao时感ran并且对抗蠕虫治Liao没有反应，则停止使用达必妥治Liao直-感ran消退。
达必妥（dupilumab）药W过量
对达必妥用药过量没有具体的治Liao方法。如果用药过量，监测患-者的任-何不良反应迹象或症状，并立即采取适当的对症治Liao。
达必妥（dupilumab）禁忌症
对dupilumab或其任-何赋形剂过m的患-者，禁用达必妥。
达必妥（dupilumab）不良反应
1.特应性皮-炎治Liao中z常见的不良反应（≥1%）：部位反应，结膜炎，睑缘炎，口腔疱疹，角膜炎，眼睛瘙痒，其他单纯疱疹病毒感ran和干眼症。
2.治Liao中z常见的不良反应（≥1%）：部位反应，口咽疼痛和嗜酸性粒细胞增多。
3.慢性鼻-鼻窦炎伴鼻息肉治Liao中z常见的不良反应（≥1%）：部位反应，结膜炎，睑缘炎，嗜酸性粒细胞增多、，牙痛，胃炎和
达必妥（dupilumab）在特殊人群中使用
孕妇：避免在怀-孕期间使用达必妥
达必妥（dupilumab）一般描述
Dupilumab是一种白细胞介素-4受体α（IL-4Rα）拮抗剂，是一种结合IL-4Rα并抑制IL-4和IL-13信号传导的人单克隆抗体。Dupilumab的分子量约为147 kDa，通过重组DNA技术在中国仓鼠卵巢细胞系中生产。
达必妥为无菌、无防腐剂、透明-微乳白色、无色-浅黄色的皮下注-射溶液。达必妥是一种单剂量预充式注-射器，注-射器是溶剂为2.25mL的硅化I型透明玻璃注-射器并带有保护装置。帽不是用天然橡胶乳胶制成的。每个300mg/2mL的预装注-射器输中含有300mg dupilumab和左旋精氨酸盐酸盐(10.5mg)、左旋组氨酸(6.2mg)、聚山梨醇酯80 (4mg)、乙酸钠(2mg)、蔗糖(100mg)和注-射用水，pH=5.9。
达必妥（dupilumab）作用机制
Dupilumab是一种人单克隆IgG4抗体，通过特异性结合IL-4和IL-13受体复合物共有的IL-4Rα亚基来抑制白细胞介素-4（IL-4）和白细胞介素-13（IL-13）信号传导。Dupilumab通过I型受体抑制IL-4信号传导，通过II型受体抑制IL-4和IL-13信号传导。
炎症是和特应性皮-炎发病机理中的重要组成部分。多种表达IL-4Rα的细胞（例如肥大细胞，嗜酸性粒细胞，巨噬细胞，淋巴细胞，上皮细胞，杯状细胞）和炎症介质（例如组胺，类二十烷酸，白三烯，细胞因子，趋化因子）参与炎症反应的发生。用dupilumab可以阻断IL-4Rα抑制IL-4和IL-13细胞因子诱导的炎症反应通路，包括促炎细胞因子，趋化因子，一氧化氮和IgE的释放; 然而，中dupilumab作用的机制尚未确定。
患-者资讯资料
1. 忠告患-者出现以上任-何不良反应（警告和注意事项）的症状立即联系医护人员。
2. 达必妥不用于治Liao急性发作。
3. 对dupilumab或其任-何赋形剂过m的患-者，禁用达必妥。
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