对达拉图穆马布 (daratumumab) 氨酸酶注射的门诊使用的评估
Noah Vannarat1, David J Hermel2, Anne M Spengler2
1Pharmacy, Scripps Memorial Hospital, La Jolla, USA.
概括
皮下注射达拉图穆马布 (Dara SC) 在多发性骨髓瘤患者中表现出轻微的输液和注射反应. 减少的监测协议可能是安全的门诊治疗这种CD38向治疗.
科学领域:
- 在瘤学瘤学.
- 药理学 药理学是指药理学的学科.
- 临床药房 临床药房
背景情况:
- 达拉图穆马布针对多发性骨髓瘤治疗的血细胞上的CD38.
- 皮下达拉图穆马布 (Dara SC) 提供非劣质的疗效,输液反应比静脉注射更少.
- 药物标签中没有明确定义达拉SC安全性的最佳注射后观察时间.
研究的目的:
- 评估输液和注射相关反应的发生率和特征与皮下达拉图穆马布 (Dara SC).
- 评估Dara SC在门诊输液环境中的安全性.
- 确定是否需要对Dara SC进行当前的机构监测协议.
主要方法:
- 对接受达拉SC治疗的多发性骨髓瘤或轻链氨基粉症的成年患者的回顾性分析.
- 在前三个剂量内对输液和注射相关反应的评估.
- 分析反应严重程度,发病时间,并比较Dara-naïve和经验丰富的患者.
主要成果:
- 在前三个剂量内观察到与输液相关 (7.2%) 和注射相关 (2.1%) 反应的低发病率.
- 反应主要是轻微的 (1级) 有一个2级事件;注射反应发生在剂量1时,注射反应发生在剂量2和3时.
- 在以前用达拉图巴治疗的患者中没有观察到任何反应.
结论:
- 皮下daratumumab (Dara SC) 具有良好的安全性,具有轻度,可逆的输液和注射反应.
- 观察到的低发病率和轻度反应表明,可能不需要广泛的监测协议.
- 临床经验支持Dara SC在门诊输液环境中的安全性,这可能允许缩短观察时间.
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