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The FDA Approves An Update To Prescribing Information For MannKind's Afrezza (Insulin Human) Inhalation Powder, Revising Recommendations For Starting Mealtime Dosage When Patients Switch From Subcutaneous Mealtime Insulin Regimens

The updated labeling was supported by modeling data and in vivo results from the Dose Optimization study and the INHALE-3 trial that demonstrated improved postprandial glucose outcomes following conversion to inhaled insulin using the now-approved conversion dose.

The revised dosing recommendations, provided in the table below, include recommended dose conversions from injected mealtime insulin or insulin pump bolus dosing to the appropriate mealtime dosage of Afrezza and are intended to support a clinically appropriate and safe transition for adult patients initiating Afrezza. Please see the Full Prescribing Information for additional details.

Table 1: Recommended Starting Mealtime Dosage of Afrezza when Switching from Other Mealtime Insulin Regimens

Current Subcutaneous Mealtime Insulin DosageStarting Dosage of AFREZZA
Up to 3 units4 units
4 to 5 units8 units
6 to 7 units12 units
8 or more units16 units
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