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Byetta No Longer Requires Refrigeration After First Use

Amylin Pharmaceuticals, Inc. and Eli Lilly and Company announced today that the FDA has approved more convenient patient storage instructions for BYETTA(R) (exenatide) injection. BYETTA Pens can now be kept at a room temperature not to exceed 77 degrees F (25 degrees C) after first use. Refrigeration is no longer required after first use.

Byetta No Longer Requires Refrigeration After First Use: Amylin Pharmaceuticals, Inc. and Eli Lilly and Company announced today that the FDA has approved more convenient patient storage instructions for BYETTA(R) (exenatide) injection. BYETTA Pens can now be kept at a room temperature not to exceed 77 degrees F (25 degrees C) after first use. Refrigeration is no longer required after first use.

Refrigeration No Longer Required After First Use

SAN DIEGO and INDIANAPOLIS, Feb. 20 /PRNewswire-FirstCall/ — Amylin Pharmaceuticals, Inc. (Nasdaq: AMLN) and Eli Lilly and Company (NYSE: LLY) announced today that the U.S. Food and Drug Administration (FDA) has approved more convenient patient storage instructions for BYETTA(R) (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."
For complete safety profile and other important prescribing considerations, visit www.BYETTA.com.