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, Bhaktawara Smaran A, Warren Matthew F, 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, 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.
Abatacept is a medication administered through intravenous infusion. It is supplied as a sterile, white, preservative-free, freeze-dried powder. Each vial of drug contains 250 mg abatacept, maltose, monobasic sodium phosphate, and sodium chloride for administration. Abatacept is a fusion protein consisting of the extracellular domain of CTLA-4 linked to the modified Fc portion of human immunoglobulin G1. It is produced using recombinant DNA technology. Abatacept is indicated for moderately to severely active rheumatoid arthritis in adults and polyarticular juvenile idiopathic arthritis in pediatric patients 6 years of age and older. It can be used as monotherapy or in combination with other disease-modifying antirheumatic drugs or methotrexate. Inter-lot variability was detected in a library of 132 vials spread across 34 lots of abatacept-maltose for injection by the University of Kentucky Drug Quality Task Force. A subcluster detection test was run on 13 vials that were shown to be an outlier group (r=0.9940, r=0.9551, r=0.9865, =0.02). Five of these vials individually appeared 4 or more standard deviations from the library cluster.
阿巴西普是一种通过静脉输注给药的药物。它以无菌、白色、无防腐剂的冻干粉末形式提供。每瓶药物含有250毫克阿巴西普、麦芽糖、磷酸二氢钠和用于给药的氯化钠。阿巴西普是一种融合蛋白，由与人类免疫球蛋白G1的修饰Fc部分相连的CTLA-4细胞外结构域组成。它采用重组DNA技术生产。阿巴西普适用于成人中度至重度活动性类风湿关节炎以及6岁及以上儿童患者的多关节型幼年特发性关节炎。它可以作为单一疗法使用，也可以与其他改善病情的抗风湿药物或甲氨蝶呤联合使用。肯塔基大学药物质量特别工作组在分布于34批注射用阿巴西普-麦芽糖的132个小瓶库中检测到批次间变异性。对13个小瓶进行了子聚类检测试验，这些小瓶被证明是一个异常值组（r = 0.9940，r = 0.9551，r = 0.9865，= 0.02）。其中5个小瓶各自显示出与库聚类相差4个或更多标准差。
