Patient information: uses, side effects, how to take - Afrezza

What is the most important information I should know about AFREZZA?

AFREZZA can cause serious side effects, including:

Sudden lung problems (bronchospasms). Do not use AFREZZA if you have long-term (chronic) lung problems such as asthma or chronic obstructive pulmonary disease (COPD). Before starting AFREZZA, your healthcare provider will give you a breathing test to check how your lungs are working.

What is AFREZZA?

AFREZZA is a man-made insulin that is breathed-in through your lungs (inhaled) and is used to control high blood sugar in adults and children 6 years of age and older, with diabetes mellitus.

AFREZZA is not for use to treat diabetic ketoacidosis. AFREZZA must be used with basal insulin in people who have type 1 diabetes mellitus.
It is not known if AFREZZA is safe and effective for use in people who smoke. AFREZZA is not for use in people who smoke or have recently stopped smoking (less than 6 months).

It is not known if AFREZZA is safe and effective in children under 6 years of age.

Who should not use AFREZZA?

Do not use AFREZZA if you:

Are having an episode of low blood sugar (hypoglycemia).
Have chronic lung problems such as asthma or COPD.

Are allergic to regular human insulin or any of the ingredients in AFREZZA. See the end of this Medication Guide for a complete list of ingredients in AFREZZA.

What should I tell my healthcare provider before using AFREZZA?

Before using AFREZZA, tell your healthcare provider about all your medical conditions, including if you:

Have lung problems such as asthma or COPD.
Have or have had lung cancer.
Are using any inhaled medications.
Smoke or have recently stopped smoking.
Have kidney or liver problems.
Are pregnant, planning to become pregnant, or are breastfeeding. AFREZZA may harm your unborn or breastfeeding baby.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins or herbal supplements.

Before you start using AFREZZA, talk to your healthcare provider about low blood sugar and how to manage it.

How should I use AFREZZA?

Read the detailed Instructions for Use that comes with your AFREZZA.
Take AFREZZA exactly as your healthcare provider tells you to. Your healthcare provider should tell you how much AFREZZA to use and when to use it.
Your healthcare provider will train you or your caregiver in how to use AFREZZA.
After training, you or your child (10 years of age or older) may self-administer AFREZZA.
Know the strength of AFREZZA you use. Do not change the amount of AFREZZA you use unless your healthcare provider tells you to.
Take AFREZZA at the beginning of your meal.
Check your blood sugar levels. Ask your healthcare provider what your blood sugar should be and when you should check your blood sugar levels.
Keep AFREZZA and all medicines out of the reach of children.

Your dose of AFREZZA may need to change because of:

Change in level of physical activity or exercise, weight gain or loss, increased stress, illness, change in diet, or because of other medicines you take.

What should I avoid while using AFREZZA?

While using AFREZZA do not:

Drive or operate heavy machinery, until you know how AFREZZA affects you.
Drink alcohol or use over-the-counter medicines that contain alcohol.
Smoke.

What are the possible side effects of AFREZZA?

AFREZZA may cause serious side effects that can lead to death, including:

See “What is the most important information I should know about AFREZZA?”

Low blood sugar (hypoglycemia). Signs and symptoms that may indicate low blood sugar include:

Dizziness or light-headedness, sweating, confusion, headache, blurred vision, slurred speech, shakiness, fast heartbeat, anxiety, irritability or mood change, hunger.

Decreased lung function. Your healthcare provider should check how your lungs are working before you start using AFREZZA, 6 months after you start using it and yearly after that.
Lung cancer. In studies of AFREZZA in people with diabetes, lung cancer occurred in a few more people who were taking AFREZZA than in people who were taking other diabetes medications. There were too few cases to know if lung cancer was related to AFREZZA. If you have lung cancer, you and your healthcare provider should decide if you should use AFREZZA.
Diabetic ketoacidosis. Talk to your healthcare provider if you have an illness. Your AFREZZA dose or how often you check your blood sugar may need to be changed.
Severe allergic reaction (whole body reaction). Get medical help right away if you have any of these signs or symptoms of a severe allergic reaction:

A rash over your whole body, trouble breathing, a fast heartbeat, or sweating.

Low potassium in your blood (hypokalemia).
- Heart failure. Taking certain diabetes pills called thiazolidinediones or “TZDs” with AFREZZA may cause heart failure in some people. This can happen even if you have never had heart failure or heart problems before. If you already have heart failure it may get worse while you take TZDs with AFREZZA. Your healthcare provider should monitor you closely while you are taking TZDs with AFREZZA. Tell your healthcare provider if you have any new or worse symptoms of heart failure including:

Shortness of breath, swelling of your ankles or feet, sudden weight gain.

Treatment with TZDs and AFREZZA may need to be changed or stopped by your healthcare provider if you have new or worse heart failure.

Get emergency medical help if you have:

Trouble breathing, shortness of breath, fast heartbeat, swelling of your face, tongue, or throat, sweating, extreme drowsiness, dizziness, confusion.

The most common side effects of AFREZZA include:

Low blood sugar (hypoglycemia), cough, sore throat.

These are not all the possible side effects of AFREZZA. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 (1-800-332-1088).

General information about the safe and effective use of AFREZZA.

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use AFREZZA for a condition for which it was not prescribed. Do not give AFREZZA to other people, even if they have the same symptoms that you have. It may harm them.

This Medication Guide summarizes the most important information about AFREZZA. If you would like more information, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information about AFREZZA that is written for health professionals.

What are the ingredients in AFREZZA?

Active ingredient: human insulin

Inactive ingredients: fumaryl diketopiperazine, polysorbate 80

AFREZZA is a registered trademark of MannKind Corporation

Patent: www.mannkindcorp.com/patent-notices

Manufactured by: MannKind Corporation, Danbury, CT 06810

US License No. #2190

For more information, go to www.AFREZZA.com or call MannKind Corporation at 1-877-323-8505.

This Medication Guide has been approved by the U.S. Food and Drug Administration Revised 05/2026

INSTRUCTIONS FOR USE

AFREZZA ^®(uh-FREZZ-uh)

(insulin human)

inhalation powder, for oral inhalation use

This Instructions for Use contains information on how to use AFREZZA ^®(insulin human) inhalation powder dry powder inhaler.

Read this Instructions for Use all the way through 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 or your child (10 years of age or older) how to use the AFREZZA Inhaler the right way before it is used for the first time. Contact your healthcare provider if you have any questions.

Important Information You Need to Know Before Inhaling AFREZZA:

AFREZZA starts acting fast, so take your medicine right before you eat a meal.
For oral inhalation only.
AFREZZA is a mealtime (short acting) insulin.
Contact your healthcare provider before switching insulins.
Do not put cartridges in your mouth.
Do not swallow cartridges.
Do not use AFREZZA cartridges if they are expired.
Only use AFREZZA cartridges with the AFREZZA Inhaler. Do not breathe in the AFREZZA powder any other way.
Do not open the cartridges. The inhaler opens the cartridge automatically during use.
Do not reuse cartridges. Cartridges are single use and should only be used 1 time.
You can tell a cartridge has been used when the cartridge cup has moved from the front to the middle position in the cartridge base.
If your prescribed AFREZZA dose is higher than 12 units, you will need to use more than 1 cartridge.
If using more than 1 cartridge for a dose, the cartridges can be used in any order, regardless of cartridge strength.
Do not insert more than 1 cartridge into the inhaler at a time. Always remove the used cartridge from the inhaler before inserting a new one.
Only use 1 inhaler at a time. The same inhaler should be used for the 4 unit, 8 unit or 12 unit cartridges. The same inhaler should be used even when needing to use more than 1 cartridge for your dose.
Do not share the AFREZZA Inhaler with anyone else.
The inhaler lasts for 15 days. After 15 days of use, throw away your used inhaler and get a new one.

Warning:

After a cartridge is loaded into the inhaler, keep the inhaler level until the inhaler mouthpiece is in your mouth to avoid spilling the AFREZZA powder. Do not flip or rotate inhaler.
If any AFREZZA powder spills, throw away the cartridge into regular household trash, and wash your hands. Then restart the procedure with a new cartridge.

AFREZZA Inhaler Parts (Figure A):

AFREZZA Cartridge Parts and Strengths (Figure B):

Storage Information (Figure C)

Additional Storage Information

Important: Before use, cartridges and inhaler should be left out at room temperature for at least 10 minutes.
Do not put blister cards or blister strips back into the refrigerator after being opened or stored at room temperature.
Keep AFREZZA and all medicines out of reach of children.
Do not let cartridge or inhaler get wet.
Do not leave or store cartridges in the inhaler.
Use 1 inhaler at a time. The same inhaler should be used to take 4 unit, 8 unit or 12 unit cartridges.
Always store the inhaler with the mouthpiece cover on.

Preparing to Inhale AFREZZA
Step 1: Choose cartridges for dose 1.1 Figure out what AFREZZA cartridges are needed for your dose. Use the dosage chart below (Figure D) to determine the number of AFREZZA cartridges you can use for your dose. Note: If your prescribed AFREZZA dose is higher than 12 units, you will need to use more than 1 cartridge. If using more than 1 cartridge for a dose, the cartridges can be used in any order, regardless of cartridge strength.

Step 2: Get and check blister strip(s)
2.1 Open Foil package and remove blister card(s) needed for your dose (Figure E).
2.2 Get the blister strip(s) with the cartridges you need for your dose If needed, tear blister strip from the blister card (Figure F).
2.3 Check the expiration date printed on the blister strip(s) (Figure G).
Step 3: Remove cartridge(s) from blister strip(s)
3.1 Remove cartridge(s) from the strip by pressing on the clear plastic to push the cartridge out (Figure H). Note: Pushing on the clear plastic will not damage the cartridge.
3.2 If stored in the refrigerator, cartridge(s) and inhaler should be left out at room temperature for 10 minutes before use (Figure I).
3.3 Check that you have the correct cartridge(s) for your dose (Figure J).
Step 4: Load a cartridge
4.1 Open the inhaler by lifting the mouthpiece to an upright (vertical) position (Figure K).
4.2 Place Inhaler on a flat surface (Figure L)
4.3 Place Cartridge in the inhaler (Figure L) Hold the cartridge with the white 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 so that it sits flat.

4.4 Close the inhaler. You should feel a snap when the inhaler is closed (Figure N). Note: Closing the inhaler automatically opens the cartridge inside. Tilting or flipping your inhaler before dosing may spill AFREZZA powder. Keep the inhaler level until the inhaler mouthpiece is in your mouth.
Inhaling AFREZZA
Step 5: Remove cover and get ready
5.1 Pull off the mouthpiece cover (Figure O).
5.2 Sit upright, looking straight with your head level (Figure P)
5.3 While keeping the inhaler level, carefully pick up the inhaler and hold it away from your mouth (Figure P).
Step 6: Inhale AFREZZA
6.1 Hold the inhaler away from your mouth or next to the side of your head and fully breathe out (exhale) (Figure Q).
6.2 Place the inhaler into your mouth and close your lips around the mouthpiece (Figure R). 6.3 Tilt the inhaler slightly downward. This helps prevent the powder from being blocked by your tongue (Figure S).
6.4 Breathe in (inhale) quickly and deeply through the mouthpiece (Figure S).
6.5 Remove the inhaler from your mouth. Hold your breath for as long as comfortable (Figure T). Then breathe out normally.
After Inhaling AFREZZA
Step 7: Remove and throw away cartridge
7.1 Put the mouthpiece cover back onto the inhaler (Figure U). This keeps your fingers off the exposed mouthpiece.
7.2 Open the inhaler by lifting up the mouthpiece to an upright (vertical) position (Figure V).
7.3 Remove cartridge. Remove the used cartridge from the purple base (Figure W). The white cup should now be in the middle of the used cartridge (Figure W).
7.4 Throw away the used cartridge in your regular household trash (Figure X). Also, the used cartridge (composed of HDPE, assigned recycling number 2) can be recycled.
Step 8: Dosing with more cartridges
8.1 If your dose requires you to inhale more cartridges repeat Steps 4 to 7 for each AFREZZA cartridge needed to finish your required dose (Figure Y).

Caring for Your AFREZZA Inhaler
Cleaning AFREZZA Inhalers After taking your dose, powder residue inside the mouthpiece is normal; this will not affect your dose. The outside of the inhaler can be wiped with a clean, dry cloth only, if needed . Do not wash the inhaler or let the inhaler get wet. Always keep the inhaler dry.
Storing AFREZZA Inhalers Store AFREZZA Inhalers with the mouthpiece cover on, in a clean dry place at room temperature. Do not leave or store cartridges in the inhaler. Refer to the Storage Information section for more information.
Disposing of your AFREZZA Inhaler after 15 days. Only use 1 inhaler at a time. The same inhaler should be used to take 4 unit, 8 unit or 12 unit cartridges. Replace the inhaler 15 days after first use. Keep track of 15 days from when you start using the inhaler with a calendar (Figure AA) or use the chart on the box. Throw away (dispose of) used inhaler into household trash 15 days after first use.
If you are having problems with your AFREZZA Inhaler, have an adverse event, or if your AFREZZA Inhaler breaks and you need a new one, please call 1-877-323-8505.