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The European Commission has approved an extended room temperature in-use period storage instruction for Byetta® (exenatide) injections.
Patients can now keep a Byetta Pen at temperatures anywhere between two and 25 degrees Celsius for up to 30 days after first use.
But before they are opened, the prefilled devices must continue to be stored in a refrigerator between two and eight degrees Celsius.
Byetta is the first in a class of medicines for treating type 2 diabetes called incretin mimetics.
It exhibits many of the same effects as the human incretin hormone glucagon like peptide-1, which improves blood sugar levels after food intake by acting on the stomach, liver, pancreas and brain.
The new storage instructions will be provided to patients and healthcare professionals during the next few weeks. The pens should still be protected from light and must never be frozen.
Dr James Malone, global medical director at manufacturer Eli Lilly, said: “We are pleased with the approval of the updated label in Europe.
“The ability to store the pen, after first use, without the need for refrigeration, makes it convenient for people with type 2 diabetes who use Byetta.”
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Eli Lilly: www.lilly.com
