FDA
FDA OKs new dosing guidance for patients switching to Afrezza inhaled insulin
FDA has approved an update to the Prescribing Information for Afrezza (insulin human) inhalation powder, revising recommendations for the starting mealtime dosage when patients switch from SC mealtime insulin regimens.
The revised dosing recommendations apply to conversions from injected mealtime insulin or insulin pump bolus dosing and are intended to support a clinically appropriate and safe transition for adult patients initiating Afrezza, according to a manufacturer press release.
The recommended starting mealtime dosages of Afrezza based on current SC mealtime insulin dosage are as follows:
The updated labeling was supported by modeling data and in vivo results from a dose optimization study (NCT04849845) and the phase 4 INHALE-3 trial (NCT05904743) that showed improved postprandial glucose outcomes following conversion to inhaled insulin using the new conversion doses.
Sources:
MannKind announces FDA approval of updated Afrezza® label providing starting dose guidance when switching from multiple daily injections (MDI) or insulin pump mealtime therapy. [News release]. 2025. https://investors.mannkindcorp.com/news-releases/news-release-details/mannkind-announces-fda-approval-updated-afrezzar-label-providing
Afrezza (insulin human) [package insert]. Food and Drug Administration. https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/022472s027lbl.pdf Revised January 2026. Accessed January 28, 2026.