FDA APPROVES NEW STORAGE INSTRUCTIONS FOR BYETTA
With its newly approved label, Eli Lilly and Amylin Pharmaceuticals' Byetta no longer requires refrigeration after the first use. Type 2 diabetes patients can now keep a Byetta pen at a temperature anywhere from 36 to 77 degrees Fahrenheit after the first use. Until first use, Byetta pens must continue to be stored in a refrigerator between 36 and 46 degrees Fahrenheit.
The new storage instructions will be provided to patients and healthcare professionals during the next few weeks. Patients currently using Byetta (exenatide) can immediately begin storing Byetta pen at a room temperature not to exceed 77 degrees Fahrenheit.
This change further enhances the convenience of Byetta, according to the companies. Byetta is available in a simple-to-use 5- and 10-microgram fixed-dose pen. 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, the companies said.
Byetta helps control blood sugar through five unique actions in one therapy, including the stimulation of insulin secretion only when blood sugar is high. The drug restores the first-phase insulin response, decreases glucose output from the liver, regulates gastric emptying and decreases food intake.