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Defeat Diabetes Foundation

Defeat Diabetes
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New Storage Instructions Approved For BYETTA®

Posted: Thursday, March 01, 2007

As reported in last week newsletter, it is no longer necessary to refrigerate the Byetta® pen after you begin to use it, which will increase compliance dramatically.

Amylin Pharmaceuticals, Inc.and Eli Lilly and Company announced that the U.S. Food and Drug Administration (FDA) has approved more convenient patient storage instructions for BYETTA® (exenatide) injection. BYETTA® Pens can now be kept at a room temperature not to exceed 77 degrees F (25 degrees C) after first use.

With the updated label, refrigeration of BYETTA® is no longer required after first use. Patients can now keep a BYETTA® Pen at a temperature anywhere from 36 degrees F (2 degrees C) to 77 degrees F (25 degrees C) after first use. Until first use, BYETTA Pens must continue to be stored in a refrigerator between 36 degrees F (2 degrees C) and 46 degrees F (8 degrees C). These new, more convenient storage instructions will be provided to patients and healthcare professionals during the next few weeks. Patients now using BYETTA® can immediately begin storing their current, in use BYETTA® Pen at a room temperature not to exceed 77 degrees F (25 degrees C). BYETTA Pens should be protected from light and never frozen.

This change further enhances the convenience of BYETTA® for patients. BYETTA® is available in a simple-to-use 5 microgram and 10 microgram fixed dose pen device. Unlike insulin, the dose of BYETTA does not need to be adjusted based on the size of meals or amount of exercise, and no additional blood glucose monitoring is required.

"My patients already find BYETTA® simple and easy to use," said Deborah Hinnen, RN, ARNP, CDE, BC-ADM, FAAN, Diabetes Nurse Specialist and Coordinator of Diabetes Education Services, Mid America Diabetes Associates, Wichita, Kansas. "The ability to store the BYETTA® Pen without the need for refrigeration after first use is an improved convenience that makes it even easier for people with type 2 diabetes to take advantage of the unique clinical benefits of BYETTA®."

Source: Diabetes In Control: http://www.BYETTA.com