Drug Label Updated to Include Time Action Profile for Rapid-Acting Inhaled Insulin
The inhaler can be used for up to 15 days from the date of first use.
The prescribing information for Afrezza (insulin human inhalation powder; MannKind) has been updated to include new clinical data relating to treatment effect and dosing. Specifically, the key highlights of the label update include new study data that describe the time-action profile by dosage strength of Afrezza as well as clarity on "starting" and "adjusting" mealtime dose. Afrezza, a rapid-acting inhaled insulin, is indicated to improve glycemic control in adult patients with diabetes mellitus.
The Clinical Pharmacology section of the labeling has been updated based on data from a randomized, controlled, six-treatment, crossover dose-response study comparing Afrezza to insulin lispro in 30 type 1 diabetes patients. In this study, time to first measurable effect was ~12 minutes for both the Afrezza 4 unit and 12 unit cartridge. The time to peak effect was ~35 minutes for Afrezza 4 unit and ~45 minutes for Afrezza 12 unit; return to baseline occurred after approximately 1.5 to 3 hours for the 4 and 12 unit cartridges, respectively.
"These data articulate the rapid-acting nature of Afrezza to address post-prandial hyperglycemia, setting it apart from other mealtime options available to help patients maintain greater control over their blood glucose levels,” said Satish Garg, MD, MBBS, DM — Barbara Davis Center for Diabetes (BDC) – University of Colorado.
As for the Dosage and Administration, this section has been updated to include information on how patients on injected mealtime insulin should initially be dosed on Afrezza (see Mealtime Afrezza Starting Dose Conversion Table); mealtime dose adjustments may be required based on the patient's metabolic need and glycemic control goals.
Mealtime Afrezza starting dose conversion table (Source: MannKind)
Afrezza is available as 4 unit, 8 unit, and 12 unit single-use cartridges; the inhaler is individually packaged and is fully assembled with a removable mouthpiece cover. The inhaler can be used for up to 15 days from the date of first use; after 15 days the inhaler must be discarded and replaced with a new inhaler.
Afrezza® [package insert]. Westlake Village, California: MannKind Corporation; 2014..