Refrigerating Insulin and Byetta

Like everyone with type 1 diabetes and almost half of the people with type 2, my wife uses insulin to control her diabetes. When we vacation, we always used to make sure that our room has a refrigerator or at least had ice that we could use to keep the insulin cold, but not freezing.

Several years ago I wrote about a trip that we took to the Russian River area of Northern California. “My wife insisted that we get a kitchenette so she could refrigerate the insulin,” I wrote. “The kitchenette with its refrigerator wasn’t necessary, as we later realized. We could have used an insulin carrying case that included a cold pack.”

In that article I mentioned the Frio Cooling Wallet. It’s rated to keep insulin safe for 45 hours even when it is 100 degrees Farenheit.

We never bought a Frio. And now we know that we usually don’t need a refrigerator, ice, or a Frio for my wife’s insulin.

A little item about “Insulin and Refrigeration” in the summer 2006 issue of BD Update set us straight. BD is Becton, Dickinson and Company, the high quality – and high cost – manufacturer of insulin needles. You can to register to receive BD Update by calling the BD Consumer Services Department toll free at 1-888-232-2737, Monday through Friday from 9 a.m. to 5 p.m.

My wife uses only BD needles for the Lantus and Humalog that she takes. I use only their needles for my Byetta.

BD says that it isn’t always necessary for us to refrigerate insulin. We can store vials of insulin at room temperature – from 59 degrees Farhenheit to 85 degrees Fahrenheit (15 degrees Celsius to 30 degrees Celsius) – for up to 28 days. This applies to either opened or unopened vials.

This surprised us so much that I checked the prescribing information for several of the most common insulins. My wife uses Lantus, a basal insulin that has quickly become the most prescribed insulin in the U.S. Its site confirms what BD says.

The other insulin that my wife uses is Humalog, a fast acting insulin taken with meals. Its prescribing information shows the same temperature range.

Levemir, the other very long acting insulin, has similar requirements. Its prescribing information says that may be used for up to 42 days if it is kept below 86 degrees Fahrenheit.

Likewise for the older Humulin R insulin. If you can’t refrigerate it, you just need to keep it below 86 degrees Fahrenheit and away from heat and light.

But these are hardly the only types of insulin that people with diabetes use. I list and link the different types in “Insulin Web Sites, Part 12 of my On-line Diabetes Resources pages.

Be careful to follow the requirements of the insulin that you are using. For example, the prescribing information for the newest insulin, Apidra, says that opened or unopened vials or cartridges of Apidra should not get warmer than 77 degrees Fahrenheit (25 degrees Celsius).

And the temperature requirement for Byetta is even more stringent than that for Apidra. Byetta pens need to be kept at the narrow temperature range of 36 to 46 degrees Fahrenheit (2 to 8 degrees Celsius).

When travelling, Byetta will remain safe when not cooled for a maximum of 144 hours (total cumulative time) over the 30 day life of the pen up to just 77 degrees Fahrenheit. Maybe I should get a Frio Cooling Wallet after all.

Update to this Blog (8-31-06)

The manufacturer of Byetta, Amylin Pharmaceuticals, announced in its second quarter conference call that the company has new stability data for Byetta. They have determined that it is stable at room temperature for a full 30 days. They will soon submit this to the FDA for a label change.

This article is based on an earlier version of my article published by HealthCentral.