What’s New with the AFREZZA Prescribing Information?
The information below is for general reference only. If you have questions on the use of Afrezza and if it is appropriate for you, please speak to your healthcare provider.
On September 29, 2017 we announced that the U.S. Food & Drug Administration (FDA) approved an update to the Afrezza prescribing information. This includes new clinical data that was presented at the American Diabetes Association’s 76th Scientific Sessions in June 2016. Afrezza (insulin human) inhalation powder is approved by the FDA to improve glycemic control in adult patients with diabetes mellitus. It is the only inhaled rapid-acting mealtime insulin available in the United States. Afrezza is dosed at the beginning of a meal and begins to appear in the blood in approximately one minute¹.
Key highlights of the label update:
- Inclusion of study data that describe the time-action profile by dosage strength, showing first measurable effect starts in approximately 12 minutes, peak effects occur approximately 35 to 45 minutes after dosing and return to baseline after approximately 1.5 to 3 hours for the 4 and 12 unit cartridges respectively.
- Clarity on “Starting” and “Adjusting” mealtime dose.
- Updated pregnancy and lactation section to conform to current FDA label guidance.
Details of the label update:
1) Clinical Pharmacology (Section 12): The basis of this label change comes from a randomized, controlled, six-treatment, crossover dose-response study comparing Afrezza to the rapid-acting insulin analog, lispro, in 30 patients with type 1 diabetes. The data highlighted below demonstrates the importance of understanding the time to peak effect and time for effect to return to baseline.
|Parameter for Insulin Effect||AFREZZA 4 units||AFREZZA 12 units|
|Time to first measurable effect||~12 minutes||~12 minutes|
|Time to peak effect||~35 minutes||~45 minutes|
|Time for effect to return to baseline||~90 minutes||~180 minutes|
For the 48 unit dose, the time to first measurable effect is ~12 minutes, time to peak effect ~55 minutes, and time for effect to return to baseline is ~4.5 hours.
2) Dosage and Administration (Section 2): The Dosing Information section has been updated with “Step 1” to inform how patients on injected mealtime insulin should initially be dosed on Afrezza (Figure 1). Additionally, “Step 2” was added to highlight that mealtime dose adjustments may be required based on the individual metabolic needs and glycemic control goals.
Figure 1. Mealtime AFREZZA Starting Dose Conversion Table
3) Use in Specific Populations (Section 8): The Pregnancy and Lactation sections of the label have been updated to conform to the current FDA label guidance. These areas have been configured to provide healthcare providers with clearer risk benefit information for informed decision making in these populations.
(1) Data on file, MannKind Corporation