n 2006, Exubera entered and had a short life on the market, as it lasted 13 months. Pfizer withdrew the first generation inhaled insulin, for several reasons – lack of support among practitioners and patients, large device, confusing dosing regimen, and high cost. In June 2014, the Food and Drug Administration approved Afrezza for use as a bolus insulin, in conjunction with basal insulin, for patients with type 1 and type 2 diabetes mellitus. Unlike injectable bolus insulin, Afrezza cannot be used for the management of diabetic ketoacidosis.
Afrezza is different than Exubera, particularly with its delivery device. Afrezza is a technosphere insulin technology within a device, smaller than an albuterol metered dose inhaler. As an alternative for post-prandial control, Afrezza will have an onset within 15 to 30 minutes, when used prior to meals. It would be reasonable to consider Afrezza among patients needing better post-prandial control, rather than patients who are controlled with an injectable bolus regimen.
While this evidence indicates a better safety profile for glycemic control, there are other concerns with Afrezza. The most common adverse events include cough and throat pain.
Among clinical trials, Afrezza had similar efficacy endpoints (i.e. A1c reduction), when compared to injectable bolus insulin. However, Afrezza had lower hypoglycemic events among patients with type 1 and type 2 diabetes – again, in comparison to injectable bolus insulin. While this evidence indicates a better safety profile for glycemic control, there are other concerns with Afrezza. The most common adverse events include cough and throat pain. Afrezza cannot be used among patients with a history of chronic obstructive pulmonary disease or asthma. Patients who currently smoke or quit within the previous 6 months should not be prescribed the second generation inhaled insulin. It is important to monitor pulmonary function tests at baseline and every 6 months with Afrezza. There is controversial data regarding the development of lung cancer. Long-term studies are needed to determine the risk of this adverse event with Afrezza.
With Afrezza, there are other educational points to remember, such as storage of the cartridges. Sealed cartridges can be stored in the refrigerator until its expiration date or at room temperature for 10 days. Unsealed cartridges should be used within 3 days. The delivery device should be changed every 15 days. Unlike Exubera, Afrezza has a better dosing regimen with 4 (blue), 8 (green), or 12 (yellow) unit cartridges. However, it can become expensive for the patient if different cartridges have to be used prior to a meal. For example, if the patient requires 16 units prior to dinner, then two 8-unit cartridges should be used. The average wholesale price is approximately $325.
Afrezza has been available longer than Exubera. While Afrezza may be an improvement since the first general inhaled insulin, it is still like any other approved medication in which there are advantages and disadvantages for its use. I would like to ask the AADE membership – are you recommending Afrezza for patients? If so, what characteristics or criteria do you follow when recommending the new inhaler? Share your thoughts with the membership, so we can learn from each other.
About the Author
Jennifer Clements received her Doctorate of Pharmacy from Campbell University in 2006 and completed a primary care residency at a Veterans Affairs Medical Center in 2007. She is also a certified diabetes educator and board certified in pharmacotherapy. Currently, she is the Interim Chair and Associate Professor in the Department of Pharmacy Practice at Presbyterian College School of Pharmacy.