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You Can Stop Refrigerating Your Byetta

by  David Mendosa
Friday, February 16, 2007


One of the biggest problems that people had at first with Byetta  has just disappeared. Sure, it still makes some people nauseous, although that’s something that hasn’t bother me and there are good ways to deal with it.

But you no longer have to refrigerate Byetta. This updates my previous article here, “Refrigerating Insulin and Byetta”.

The need for us to keep Byetta cool has been a special problem for me and others when we fly. The Transportation Security Administration doesn’t like the gel packs in the Byetta carrying case that the manufacturer, Amylin Pharmaceuticals, provides.

Now, however, Amylin and the U.S. Food and Drug Administration have agreed that we don’t have to refrigerate our Byetta pens once we start using them. Before we open them, they say that we should keep them in the original carton in a refrigerator between 36 and 46 degrees Farenheit, which is a normal fridge operating temperature.

Amylin now says that once we start using the Byetta pens we can use them for the full 30 days as long as we keep them below 77 degrees Farenheit and protect them from light.

We still can’t let Byetta freeze. If it does get frozen, it’s useless and we need to throw it away.

This change has actually been in the works for at least half a year. Daniel Bradbury, who is now the company’s president and who is slated to become its chief executive officer, told analysts in Amylin’s “Quarterly Update Conference Call”  on July 24, 2006, that the company had “demonstrated the stability of  Byetta at room temperature for the full 30-day pen lifespan. We will provide this additional data and work with the FDA to obtain approval for a change in the storage instructions.”
 
Personally, I will still keep my Byetta in the fridge when I am at home. After all, that is one of the best places to keep it out of the light.