Short answer: Keep sealed Afrezza foil packages in the fridge at 36°F to 46°F (2°C to 8°C) until the expiration date. In the fridge, sealed blister cards and strips must be used within 1 month. At room temperature, sealed cards and strips must be used within 10 days and opened strips within 3 days. Do not put a card or strip back in the fridge. Replace the inhaler 15 days after first use.
Afrezza is inhaled insulin powder in single-use cartridges. Three cartridges sit in each cavity of a blister strip, five strips make a card, and two cards come sealed in a foil package (30 cartridges). The cartridges are blue for 4 units, green for 8 units and yellow for 12 units (section 16).
| Where it is kept | Pack | Time limit |
|---|---|---|
| Not in use: refrigerated, 2°C to 8°C (36°F to 46°F) | Sealed (unopened) foil package | May be stored until the expiration date* |
| Not in use: refrigerated, 2°C to 8°C (36°F to 46°F) | Sealed (unopened) blister cards and strips | Must be used within 1 month* |
| In use: room temperature, 25°C (77°F), excursions permitted 15°C to 30°C (59°F to 86°F) | Sealed (unopened) blister cards and strips | Must be used within 10 days |
| In use: room temperature, 25°C (77°F), excursions permitted 15°C to 30°C (59°F to 86°F) | Opened strips | Must be used within 3 days |
The footnote on the refrigerated rows: “If a foil package, blister card or strip is not refrigerated, the contents must be used within 10 days.” Under the table: “Do not put a blister card or strip back into the refrigerator after being stored at room temperature.” The label does not say when the 1 month for refrigerated cards and strips starts counting.
3 days at room temperature, per the section 16 table. A sealed card or strip at room temperature gets 10 days. The Instructions for Use add that an opened strip does not go back in the fridge either: “Do not put blister cards or blister strips back into the refrigerator after being opened or stored at room temperature.” Section 16 names only storage at room temperature, not opening.
The Instructions for Use print their own storage chart as a picture (Figure C), so it is not quoted here. The Medication Guide has no storage section.
Section 16: “Store refrigerated or at room temperature 2°C to 25°C (36°F to 77°F); excursions permitted. Inhaler may be stored refrigerated, but should be at room temperature before use.” No excursion range is given. The Instructions for Use say: “Store AFREZZA Inhalers with the mouthpiece cover on, in a clean dry place at room temperature.”
The inhaler lasts 15 days from first use. Section 16: “After 15 days of use, the inhaler must be discarded and replaced with a new inhaler.” Do not wash it or let it get wet; wipe the outside with a clean, dry cloth only if needed. One inhaler is used for all three cartridge strengths.
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The label gives no travel instructions. Its numbers still set the limits: once a sealed card or strip leaves the fridge it must be used within 10 days, an opened strip within 3 days, and neither goes back in the fridge. Room temperature on the label is 77°F (25°C) with excursions to 59°F to 86°F (15°C to 30°C). Bring only what you will use in that time, keep the inhaler capped and dry, and do not leave cartridges in it.