New storage instructions for exenatide (Byetta, Amylin/Lilly) injection have been approved that allows the pen to be kept at room temperature following its first use. The updated label states that refrigeration is no longer a requirement for exenatide once it has been used. Prior to first use, however, refrigeration of the pen is still required and its temperature should be maintained between 36°F and 46°F. According to the FDA, patients currently using exenatide can begin storing their pen at room temperature, but should continue to protect the product from light and temperatures below freezing. Exenatide is an incretin mimetic approved for use by Type 2 diabetes patients who have not been able to control their blood sugar levels with metformin, a sulfonylurea, or a thiazolidinedione.
To see more Hot off the Press news articles, click here.
To go to the Drug Topics homepage, click here.
FDA’s Recent Exemptions: What Do They Mean as We Finalize DSCSA Implementation?
October 31st 2024Kala Shankle, Vice President of Regulatory Affairs with the Healthcare Distribution Alliance, and Ilisa Bernstein, President of Bernstein Rx Solutions, LLC, discussed recent developments regarding the Drug Supply Chain Security Act.