Isaacs James T, Almeter Philip J, Hunter Aaron N, Lyman Thomas A, Zapata Stephanie P, Henderson Bradley S, Larkin Seth A, Long Lindsey M, Bossle Megan N, Lozier Austin M, Melson Joshua D, Fraley Savannah R, Relucio Eunice Hazzel L, Felix Margaret A, Reynolds Jeffrey W, Naseman Ryan W, Platt Thomas L, Meador Kaylee N, Grahovic Sanda, Rajcan Jessica T, Shon Hyungjoo, Carlson Anna M, Fuson Taylor M, Haney Lian Z, Lodder Robert A
Department of Pharmacy Services, University of Kentucky HealthCare, Lexington, KY 40536.
Pharmacy Practice & Sciences, College of Pharmacy, University of Kentucky, Lexington, KY 40536.
Contact Context. 2024;2024. doi: 10.6084/m9.figshare.26828245. Epub 2024 Aug 27.
Azacitidine injections are used to treat specific types of blood cancers. They work by interfering with the growth of cancer cells. Azacitidine for injection is a nucleoside metabolic inhibitor indicated for the treatment of (a) Adult patients with the following FAB myelodysplastic syndrome (MDS) subtypes: Refractory anemia (RA) or refractory anemia with ringed sideroblasts (RARS) (if accompanied by neutropenia or thrombocytopenia or requiring transfusions), refractory anemia with excess blasts (RAEB), refractory anemia with excess blasts in transformation (RAEB-T), and chronic myelomonocytic leukemia (CMMoL), and (b) Pediatric patients aged 1 month and older with newly diagnosed Juvenile Myelomonocytic Leukemia (JMML). Intra-lot variability was initially detected in one lot of azacitidine for injection in which 17% of the samples scanned in the lot were more than 5 multidimensional SDs from the center of the lot cluster. After the intra-lot variability was detected, inter-lot variability was measured in a spectral library comprising 8 lots of azacitidine for injection.
阿扎胞苷注射液用于治疗特定类型的血癌。其作用机制是干扰癌细胞的生长。注射用阿扎胞苷是一种核苷代谢抑制剂，适用于治疗：(a) 患有以下FAB骨髓增生异常综合征（MDS）亚型的成年患者：难治性贫血（RA）或伴有环形铁粒幼细胞的难治性贫血（RARS）（如果伴有中性粒细胞减少或血小板减少或需要输血）、难治性贫血伴原始细胞增多（RAEB）、转化中的难治性贫血伴原始细胞增多（RAEB-T）以及慢性粒-单核细胞白血病（CMMoL）；(b) 年龄在1个月及以上的新诊断为幼年型粒-单核细胞白血病（JMML）的儿科患者。最初在一批注射用阿扎胞苷中检测到批内变异性，其中该批次中扫描的17%的样品距离批次聚类中心超过5个多维标准差。在检测到批内变异性后，在一个包含8批注射用阿扎胞苷的光谱库中测量了批间变异性。
