Allison Spitery Pharm.D., Mary J. Elder Pharm.D., Nada Farhat Pharm.D., Insaf Mohammad Pharm.D., Alison Lobkovich Pharm.D.
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引用次数: 0
摘要
近年来,以长效胰高血糖素为基础的疗法(如semaglutide)的使用有所增加,这是因为这些疗法在控制糖尿病血糖、降低心血管风险和控制体重方面具有优势。持续的药物短缺导致临床医生和患者寻求获得这些疗法的替代途径,包括使用非美国食品和药物管理局(FDA)批准的复方胰高血糖素疗法。本综述文件介绍了用于糖尿病和体重管理的复方注射用塞马鲁肽的法律、安全性和实际考虑因素。虽然本文针对的是注射用塞马鲁肽,但所述概念适用于所有基于增量素的复方注射疗法。虽然普遍建议不要使用未经 FDA 批准的复方增量素类似物,但如果临床医生选择使用复方增量素疗法,则必须考虑到对每位患者的潜在危害和益处,并且必须正确教育患者如何正确使用所接受的产品。
Legal, safety, and practical considerations of compounded injectable semaglutide
The use of long-acting incretin-based therapies, such as semaglutide, has increased in recent years due to their benefits for glycemic control in diabetes, cardiovascular risk reduction, and weight management. Ongoing drug shortages have led clinicians and patients to seek alternative routes for accessing these therapies, including the use of non-United States Food and Drug Administration (FDA)-approved compounded incretin-based therapy. This review paper describes the legal, safety, and practical considerations of compounded injectable semaglutide for diabetes and weight management. While this paper is specific to injectable semaglutide, the concepts described apply to all compounded injectable incretin-based therapies. While there is a general recommendation against the use of non–FDA-approved compounded incretin analogs, if clinicians elect to use compounded incretin-based therapy, the potential harms and benefits for each patient must be considered, and patients must be properly educated on the correct administration of the product they receive.