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Ofatumumab and rituximab抑制免疫药物重新激活HBV

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Ofatumumab and rituximab: reactivation of HBV infection United States of America — The Food and Drug Administration (FDA) has approved changes to the prescribing information for ofatumumab (Arzerra®) and rituximab (Rituxan®) to warn of the risk of reactivation of hepatitis B virus (HBV) infection. The revised labelling will also include additional recommendations for screening, monitoring and managing patients. Both ofatumumab and rituximab are used to treat certain cancers of the blood and lymph system. Rituximab is also approved to treat other medical conditions, including rheumatoid arthritis. Both drugs suppress the immune system.

 

In patients with prior HBV infection, HBV reactivation may occur when the body’s immune system is impaired. Infection can cause serious liver problems, including liver failure and death. The risk of HBV reactivation is already described in the labelling for both drugs; however, cases continue to occur, including deaths. Reference: FDA Drug Safety Communication, 25 August 2013 at

 

http://www.fda.gov/Drugs/ DrugSafety/ucm366406.htm

 

美国食品药品管理局(FDA)最新审批的新药全人源化靶向抗CD20单克隆抗体。
ofatumumab,中文名称:奥法木单抗[1]  ,系全人源化靶向抗CD20单克隆抗体,用于氟达拉滨和阿仑珠单抗治疗无效的顽固性慢性淋巴细胞白血病(CLL)[2]  。本品通过与小型和大型的CD20分子上的小环抗原靶向结合,促使细胞溶解,特异诱导CD20细胞凋亡,从而专一性地杀灭B淋巴瘤细胞[3]  ,而对其他正常组织无不良影响。
近日,美国食品与药物管理局(FDA)因病毒感染风险而被列入观察清单。FDA将对此问题继续加以评估以确定是否需要修改药物标签。列入观察清单并不意味着FDA已认定相关药物的确具有健康风险,FDA亦不建议临床医生体用此类药物
 
美罗华(利妥昔单抗注射液),适应症为本品适用于:复发或耐药的滤泡性中央型淋巴瘤(国际工作分类B、C 和D 亚型的B 细胞非霍奇金淋巴瘤)的治疗。先前未经治疗的CD20 阳性III-IV 期滤泡性非霍奇金淋巴瘤,患者应与标准CVP 化疗(环磷酰胺、长春新碱和强的松)8 个周期联合治疗。CD20 阳性弥漫大B 细胞性非霍奇金淋巴瘤(DLBCL)应与标准CHOP 化疗(环磷酰胺、阿霉素、长春新碱、强的松)8 个周期联合治疗。

Ofatumumab and rituximab抑制免疫药物重新激活HBV

原文:http://www.cnblogs.com/biopy/p/5213444.html

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