报道称,随着伊萨图西马布的使用,疹病毒的重新激活
Michelle Nadeau Nguyen1, Graça M Dores1, Afrouz Nayernama1
1Division of Pharmacovigilance, Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USA.
Journal of chemotherapy (Florence, Italy)
|October 6, 2023
概括
伊萨图克西马布治疗可能会增加多发性骨髓瘤患者中疹病毒 (VZV) 再激活的风险. 市场营销后的数据导致了更新的处方信息,推抗病毒预防.
科学领域:
- 药物监督 药物监督 药物监督
- 在瘤学瘤学.
- 免疫学 免疫学 免疫学
背景情况:
- 伊萨图キシ马布是一种用于多发性骨髓瘤的CD38定向抗体.
- 多发性骨髓瘤治疗可以增加机会性感染的风险.
- 疹病毒 (Varicella zoster virus,简称VZV) 的重新激活是免疫功能低下患者的已知风险.
研究的目的:
- 为了调查伊萨图西马布和VZV重新激活之间的潜在关联.
- 为了评估来自isatuximab营销后监测的安全信号.
主要方法:
- 对FAERS,PubMed和Embase的营销后病例报告的审查.
- 包括符合特定案例定义和因果关系标准的案件.
- 对患者人口统计,治疗和风险因素的分析.
主要成果:
- 十五个病例符合与伊萨图克西马布相关的VZV重新激活的标准.
- 患者接受伊萨图西马布治疗血液瘤,包括多发性骨髓瘤.
- 同时使用蛋白酶体抑制剂和/或免疫调节药物是常见的.
结论:
- 市场营销后的分析发现,伊萨图西马布对VZV重新激活的潜在风险.
- 美国ISATUXIMAB处方信息已更新以此安全信息.
- 建议在接受伊萨图西马布治疗的患者进行抗病毒预防.
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