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AstraZeneca's injectable medication to improve glycemic control among adults with type 2 diabetes is now widely available across US pharmacies.
AstraZeneca’s injectable exenatide extended-release (Bydureon Pen 2 mg), a prescription medication indicated to improve glycemic control among adults with type 2 diabetes, is now widely available in pharmacies across the United States.
“Bydureon is the first once-weekly treatment option for adults with type 2 diabetes, and Bydureon Pen now offers the same continuous release of exenatide in a pre-filled device,” said John Yee, MD, MPH, vice president and US head medical officer at AstraZeneca, in a statement. “Bydureon has been shown to provide significant HbA1C reduction and, although not a weight-loss medicine, the additional benefit of weight loss.”
The pre-filled pen injector received FDA approval on February 28, 2014, for use in combination with proper diet and exercise. The device is designed for single use, which eliminates the process of transferring the drug between a vial and syringe, and it can be administered at any time of the day, with or without food.
Through its SteadyStart program, in which a “clinical educator teaches office staff how to prepare and administer Bydureon Pen,” AstraZeneca is working to make the device available at more health care facilities. The company encourages health care professionals to train patients on how to use the pen injector prior to prescribing the drug, and it also offers a support line and face-to-face training session for patients.
According to AstraZeneca, Bydureon is “not recommended as first-line therapy for patients who have inadequate glycemic control on diet and exercise and should not be used for treatment of patients with type 1 diabetes or diabetic ketoacidosis.” Additionally, exenatide extended-release is not a substitute for insulin.
The pen’s prescribing information details the risk of thyroid C-cell tumors, including medullary thyroid carcinoma, with the use of exenatide extended-release. However, it remains unknown whether the treatment causes those types of tumors, as human relevance could not be determined through clinical or non-clinical studies.