ST LOUIS (MD Consult) - On July 15, 2009, Novo Nordisk US announced that the US Food and Drug Administration (FDA) has approved updated labeling for NovoLog (insulin aspart [rDNA origin] injection). NovoLog is a rapid-acting insulin analog used to control hyperglycemia in adults and children with diabetes mellitus.

 

The updated labeling allows for an extension of the time period in which Novolog can be stored in an insulin pump. The previous label allowed for the drug to be stored in the pump reservoir for 2 days, whereas the new labeling allows for storage up to 6 days. The label change was approved on the basis of the FDA's review of data from Novo Nordisk that showed the stability of NovoLog in the pump for this extended period.

 

The updated NovoLog label also states that patients using this drug in their pumps should change the pump's infusion set and the infusion set insertion site at least every 3 days—up from a change previously advised to occur every 48 hours. The revised label keeps the same recommendation that NovoLog should be discarded after exposure to temperatures that exceed 37°C (98.6°F).

 

According to a quote contained in the manufacturer's press release made by Richard R. Rubin, PhD, professor of medicine and pediatrics at The Johns Hopkins University, "The ability to go longer between changes of insulin in the pump allows people with diabetes to have more active and flexible lifestyles, which are integral to the success of long-term diabetes management."

 

圣路易斯(MD Consult)——2009年7月15日，美国诺和诺德制药有限公司宣布，Novolog(rDNA来源的门冬胰岛素注射液)的最新说明书已获得美国食品药品管理局(FDA)的批准。Novolog是一种速效胰岛素制剂，用于控制成人及儿童糖尿病患者的高血糖症。

最新的说明书允许延长Novolog于胰岛素泵内的储存时间。先前的说明书允许在泵内储存2d，而这个新说明书允许储存达6d。诺和诺德制药有限公司的试验数据表明，在此延长期内，泵中的Novolog仍可稳定存在，而FDA通过对此数据进行审查，批准了说明书中的这一更改。

最新的Novolog说明书也规定，通过胰岛素泵用药的患者应至少每3d更换(之前建议每48h更换)一次泵输注管和输注管插入部位。Novolog暴露于37°C (98.6°F)以上的环境中时应废弃不用，此建议在新的说明书中仍予以保留。

约翰霍普金斯大学的医学兼儿科教授Richard R. Rubin, PhD在厂商的新闻发布会上如是说道，“泵内胰岛素的更换间期能够延长，使得糖尿病患者可以拥有更为积极灵活的生活方式，而这也是长期糖尿病治疗成功的重要方面。”