FDA Approves NovoLog(R) Labeling Update - Increasing The Time Patients Can Use And Store NovoLog(R) In Their Pumps From Two Days To Six Days

Main Category: Diabetes
Also Included In: Regulatory Affairs / Drug Approvals
Article Date: 17 Jul 2009 - 1:00 PDT

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Diabetes patients taking NovoLog® (insulin aspart [rDNA origin] injection) can now use the insulin in their pump for up to six days following the U.S. Food and Drug Administration (FDA) approval of a labeling change, diabetes care company Novo Nordisk announced today.[i] The previous label allowed for NovoLog® to be stored in the pump reservoir for two days. This makes NovoLog® the first and only rapid-acting insulin with this extended in-use time.

An insulin pump is a small, battery powered device designed to constantly deliver insulin into the patient's body 24 hours a day according to a preset program. Approximately the size of a pager, the pump system is composed of a reservoir for the insulin, a small battery, the pump, and a thin plastic tube with a needle on the end that passes insulin into the body, called the infusion set.

The updated NovoLog® label also states that patients using NovoLog® in their pumps should change the infusion set and the infusion set insertion site at least every three days. The previous label stated that NovoLog® in the pump reservoir, infusion set and the infusion set insertion site be changed at least 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).

"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," said Richard R. Rubin, PhD, professor, medicine and pediatrics, The Johns Hopkins University School of Medicine.

The label change is based on the FDA's review of data from Novo Nordisk that showed the stability of NovoLog® in the pump for up to six days.

NovoLog® is a rapid-acting insulin analog, meaning it works faster and for a shorter period of time compared with regular human insulin. NovoLog® is also available in FlexPen®, the world's #1 selling prefilled insulin pen. Diabetes patients who take NovoLog® can eat within 5-10 minutes of use, rather than the typical 30 minutes required with regular human insulin.

NovoLog® was first approved by the FDA in 2000 and approved for use in pumps in 2001.

About NovoLog® (insulin aspart [rDNA origin] injection)

NovoLog® is a man-made insulin that is used to control high blood sugar in adults and children with diabetes mellitus.

[i] Revised NovoLog Prescribing Information. "Dosage and Administration." Section 2.3. "Continuous subcutaneous insulin infusion (CSII) by external pump."

NovoLog® is a registered trademark of Novo Nordisk A/S.

Source
Novo Nordisk

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