Lack of Content Uniformity in Azacitidine Vials.

Abstract

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.