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MannKind AFREZZA Instructions For Use Manual

MannKind AFREZZA Instructions For Use Manual

Insulin human inhalation powder, for oral inhalation use
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This "Instructions for Use" contains information on how to use AFREZZA
Inhalation Powder.
Read this Instructions for Use before you start using AFREZZA and each time you get a new
AFREZZA Inhaler. There may be new information. This information does not take the place of
talking to your healthcare provider about your medical condition or your treatment.
Your healthcare provider should show you how to use your AFREZZA Inhaler the right
way before you use it for the first time.
Important information about AFREZZA:
AFREZZA comes in 3 strengths (see Figure A):
o 4 units (blue cartridge)
o 8 units (green cartridge)
o 12 units (yellow cartridge)
If your prescribed AFREZZA dose is higher than 12 units, you will need to use more than 1
cartridge.
If you need to use more than 1 cartridge for your dose, throw away the used cartridge
before getting a new one. You can tell when a cartridge has been used, because the cup
has moved to the center.
Do not try to open the AFREZZA cartridges. The AFREZZA Inhaler opens the cartridge
automatically during use.
AFREZZA cartridges should only be used with the AFREZZA Inhaler. Do not try to
breathe in the AFREZZA insulin powder in any other way. Do not put cartridges in your
mouth and do not swallow cartridges.
Use only 1 AFREZZA Inhaler at a time. The same inhaler should be used for the 4 unit, 8
unit or 12 unit cartridges.
Store the inhaler in a clean, dry place with the mouthpiece cover on until your next dose.
Throw away your AFREZZA Inhaler after 15 days and get a new one.
INSTRUCTIONS FOR USE
AFREZZA® (uh-FREZZ-uh)
(insulin human)
inhalation powder, for oral inhalation use
Figure A
1
(insulin human)
®

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Summary of Contents for MannKind AFREZZA

  • Page 1 AFREZZA insulin powder in any other way. Do not put cartridges in your mouth and do not swallow cartridges. Use only 1 AFREZZA Inhaler at a time. The same inhaler should be used for the 4 unit, 8 •...
  • Page 2 If you are having problems with your AFREZZA Inhaler or if it breaks and you need a new one, call 1-877-323-8505. Know your AFREZZA Inhaler: Know your AFREZZA cartridges:...
  • Page 3 AFREZZA cartridges must only be used with the AFREZZA Inhaler. Step 1: Select the AFREZZA cartridges for your dose If your prescribed AFREZZA dose is more than 12 units you will need to use more than 1 cartridge to get your right dose.
  • Page 4 Select Cartridges Important: Use the AFREZZA dose chart above (see Figure B) to help you choose the right number of AFREZZA cartridges needed for your dose. Open Packages Remove a blister card from the foil package. Tear along perforation to remove one strip.
  • Page 5 Place Cartridge Hold the cartridge with the cup facing down. Line up the cartridge with the opening in the inhaler. The pointed end of the cartridge should line up with the pointed end in the inhaler. Place the cartridge into the inhaler. Be sure that the cartridge lies flat in the inhaler.
  • Page 6 Step 3: Inhaling AFREZZA Remove the Mouthpiece Cover Important: Keep the inhaler level during and after removal of the purple mouthpiece cover. Exhale Hold the inhaler away from your mouth and fully blow out (exhale). Position Inhaler in Mouth Keeping your head level, place the mouthpiece in your mouth and tilt the inhaler down towards your chin, as shown.
  • Page 7 Step 4: Removing a used cartridge Replace Mouthpiece Cover Place the purple mouthpiece cover back onto the inhaler. Open Inhaler Open the inhaler by lifting up the white mouthpiece. Remove Cartridge Remove the cartridge from the purple base. Throw away (or recycle) the Cartridge Throw away the used cartridge in your regular household trash.
  • Page 8 Multiple cartridge dosing If you need more than one (1) AFREZZA cartridge for your dose, see the AFREZZA dosage chart above (Figure B). Repeat steps 2 through 4 for each AFREZZA cartridge you need for your prescribed AFREZZA dose.
  • Page 9 How should I store AFREZZA?
  • Page 10 Caring for your AFREZZA Inhaler:...
  • Page 11 Switching between AFREZZA and injected insulin: Contact your healthcare provider before switching insulins. AFREZZA is a mealtime insulin. Do not switch from AFREZZA to a long acting insulin. Do not switch from a long acting insulin to AFREZZA.
  • Page 12 Manufactured by: MannKind Corporation Danbury, CT 06810 US License No. #2190 © 2016 – 2023 MannKind Corporation This Instructions for Use has been approved by the U.S. Food and Drug Administration. Revised: 02/2023 AFREZZA is a registered trademark of MannKind Corporation Patent: www.mannkindcorp.com/patent-notices...

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