Afrezza

Name: Afrezza

Afrezza Overview

Afrezza is a prescription medication used to control hyperglycemia (high blood sugar) in patients with type 1 and type 2 diabetes mellitus.

This medication comes in powder form to be inhaled. Afrezza is a man-made insulin that is breathed-in through your lungs (inhaled) and is used to control high blood sugar in adults with diabetes mellitus.

Afrezza helps move sugar from the blood into other tissues that use it for energy.

The dose and frequency of administration will depend on many factors, including diet, lifestyle, and other conditions you have. Afrezza is administered immediately before meals.

Common side effects of Afrezza include hypoglycemia (low blood sugar), cough, and throat pain or irritation.                          

Hypoglycemia related to Afrezza can also cause dizziness, drowsiness, and blurred vision. Do not drive or operate heavy machinery until you know how Afrezza affects you.

Manufacturer

  • Sanofi-Aventis U.S. LLC

Afrezza Usage

Use Afrezza exactly as prescribed. This medication comes in powder form to be inhaled.

  • Afrezza is administered immediately before meals.
  • Do not drink alcohol or use over-the-counter medicines that contain alcohol while using Afrezza.
  • Afrezza is not for use in place of long-acting insulin. Afrezza must be used with long-acting insulin in people who have type 1 diabetes mellitus.
  • Afrezza is not for use to treat diabetic ketoacidosis.
  • Do not smoke while using Afrezza. 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 18 years of age
 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 2 strengths:
  • 4 units (blue cartridge)
  • 8 units (green cartridge)
If your prescribed Afrezza dose is higher than 8 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 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 or 8 unit cartridges.
  • Throw away your Afrezza Inhaler after 15 days and get a new one.
  • After using Afrezza, powder residue in the mouthpiece is normal, this does not affect your dose.
 How to take your dose of Afrezza:Always be sure you have the right number of Afrezza cartridges for your dose available before you start. Afrezza cartridges mustonly be used with the Afrezza Inhaler. Step 1: Select the Afrezza cartridges for your dose
  • If your prescribed dose is 4 units, use 1 blue cartridge
  • If your prescribed dose is 8 units, use 1 green cartridge
  • If your prescribed Afrezza dose is higher than 8 units, you will need to use more than 1 cartridge.
  • If your prescribed dose is 12 units, use 1 blue cartridge and use 1 green cartridge
  • If your prescribed dose is 16 units, use 2 green cartridges
  • If your prescribed dose is 20 units, use 1 blue cartridge and use 2 green cartridges
  • If your prescribed dose is 24 units, use 3 green cartridges
 Step 2: Open PackagesA) Remove a blister card from the foil package.B) Tear along perforation to remove one strip. Step 3: Push Cartridges to RemoveA) Remove a cartridge from the strip by pressing on the clear side to push the cartridge out.B) Remove the right number of cartridges for your dose. Pushing on the cup will not damage the cartridge. (Afrezza cartridges left over in an opened strip must be used within 3 days)
Before Proceeding:Check that you have the right Afrezza cartridge(s) for your dose.Use only 1 inhaler for multiple cartridges.Throw away your Afrezza inhaler after 15 days and get a new one. Step 4: Loading a CartridgeA) Hold Inhaler: Hold the inhaler level in one (1) hand with the white mouthpiece on the top and purple base on the bottom.B) Open Inhaler: Open the inhaler by lifting the white mouthpiece to a vertical position. (Before you put the Afrezza cartridge in your inhaler, make sure it has been at room temperature for 10 minutes)C) Place Cartridgei) Hold the cartridge with the cup facing down.ii) Line up the cartridge with the opening in the inhaler.iii) The pointed end of the cartridge should line up with the pointed end in the inhaler.iv) Place the cartridge into the inhaler. Be sure that the cartridge lies flat in the inhaler.D) Close Inhaleri) Lower the mouthpiece to close the inhaler (this will open the drug cartridge).ii) You should feel a snap when the inhaler is closed. Step 5: Inhaling AfrezzaRemove the Mouthpiece Cover.Keep the inhaler level during and after removal of the purple mouthpiece cover.A) Exhale: Hold the inhaler away from your mouth and fully blow out (exhale).B) Position Inhaler in Mouth: Keeping your head level, place the mouthpiece in your mouth and tilt the inhaler down towards your chin, as shown. Close your lips around the mouthpiece to form a seal. Tilt the inhaler downward while keeping your head level.C) Inhale Deeply and Hold Breath: With your mouth closed around the mouthpiece, inhale deeply through the inhaler.
Hold your breath for as long as comfortable and at the same time remove the inhaler from your mouth. After holding your breath, exhale and continue to breathe normally. Step 6: Removing a Used CartridgeA) Replace Mouthpiece Cover: Place the purple mouthpiece cover back onto the inhaler.B) Open Inhaler: Open the inhaler by lifting up the white mouthpiece.C) Remove Cartridge: Remove the cartridge from the purple base.D) Throw away the Cartridge: Throw away the used cartridge in your regular household trash. Step 7: Repeat steps 4 through 6 for each Afrezza cartridge you need for your prescribed Afrezza dose.
  • Be careful not to mix NEW cartridges with USED cartridges. The white cup moves to the middle of the cartridge when it has been used.

If you are having problems with your Afrezza inhaler or if it breaks and you need a new one, call 1-800-633-1610.

Other Requirements

Not in Use: Refrigerated Storage

  • Unopened sealed foil packages of Afrezza for inhalation should be stored in the refrigerator: 36-46°F (2-8°C).
  • Sealed unopened foil packages kept in the refrigerator, may be used until the expiration date. (If a foil package is not refrigerated, the contents must be used within 10 days)

In Use: Room Temperature Storage

  • Sealed (unopened) blister cards and/or strips can be kept at room temperature but must be used within 10 days.
  • Opened strips of Afrezza can be kept at room temperature but must be used within 3 days.

Storage Instructions:

  • Once you have taken your full dose, make sure the purple mouthpiece cover has been replaced and the inhaler is closed.
  • Keep the inhaler in a clean, dry place until the mouthpiece cover on until your next dose.
  • May be stored refrigerated, but must be at room temperature before use.
  • Never leave or store cartridges in the inhaler.
  • Keep out of reach of children.

Care Instructions:

  • Use one inhaler at a time. The same inhaler should be used to take 4 unit or 8 unit cartridges.
  • Replace the inhaler every 15 days to maintain drug delivery.
  • The outside of the inhaler can be wiped with a clean, dry cloth if needed. Never wash the inhaler. Keep it dry.

Commonly used brand name(s)

In the U.S.

  • Afrezza

Available Dosage Forms:

  • Aerosol Powder

Therapeutic Class: Antidiabetic

Pharmacologic Class: Insulin, Rapid Acting

Before Using Afrezza

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of insulin human inhaled in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of insulin human inhaled in the elderly.

Pregnancy

Pregnancy Category Explanation
All Trimesters C Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Balofloxacin
  • Besifloxacin
  • Ciprofloxacin
  • Enoxacin
  • Fleroxacin
  • Flumequine
  • Gatifloxacin
  • Gemifloxacin
  • Lanreotide
  • Levofloxacin
  • Liraglutide
  • Lomefloxacin
  • Metreleptin
  • Moxifloxacin
  • Nadifloxacin
  • Norfloxacin
  • Octreotide
  • Ofloxacin
  • Pasireotide
  • Pazufloxacin
  • Pefloxacin
  • Pioglitazone
  • Pramlintide
  • Prulifloxacin
  • Rosiglitazone
  • Rufloxacin
  • Sparfloxacin
  • Thioctic Acid
  • Tosufloxacin

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Acebutolol
  • Albiglutide
  • Atenolol
  • Betaxolol
  • Bisoprolol
  • Bitter Melon
  • Carteolol
  • Carvedilol
  • Celiprolol
  • Dulaglutide
  • Esmolol
  • Exenatide
  • Fenugreek
  • Furazolidone
  • Glucomannan
  • Guar Gum
  • Iproniazid
  • Isocarboxazid
  • Labetalol
  • Levobunolol
  • Linezolid
  • Lixisenatide
  • Methylene Blue
  • Metipranolol
  • Metoprolol
  • Moclobemide
  • Nadolol
  • Nebivolol
  • Nialamide
  • Oxprenolol
  • Penbutolol
  • Phenelzine
  • Pindolol
  • Practolol
  • Procarbazine
  • Propranolol
  • Psyllium
  • Rasagiline
  • Safinamide
  • Saxagliptin
  • Selegiline
  • Sotalol
  • Timolol
  • Tranylcypromine

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

  • Ethanol

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

  • Asthma, severe or
  • Chronic obstructive pulmonary disease (COPD)—Should not be used in patients with these conditions.
  • Emotional disturbances or
  • Fever or
  • Illness or
  • Infection or
  • Stress—These conditions increase blood sugar and may increase the amount of insulin you need.
  • Hypoglycemia (low blood sugar)—Should not be used in patients with this condition. If you have low blood sugar and take insulin, your blood sugar may reach dangerously low levels.
  • Hypokalemia (low potassium in the blood)—May make this condition worse and increase your chance of having serious side effects.
  • Kidney disease or
  • Liver disease—The effects of insulin human inhaled may be increased because of the slower removal of the medicine from the body.
  • Lung cancer, active or history of or at risk or
  • Lung disease—Use with caution. May make these conditions worse.

What are some things I need to know or do while I take Afrezza?

  • Tell all of your health care providers that you take Afrezza. This includes your doctors, nurses, pharmacists, and dentists.
  • Allergic reactions have happened with this medicine. Rarely, some reactions can be very bad or life-threatening. Talk with the doctor.
  • Low blood sugar may happen with Afrezza. Very low blood sugar can lead to seizures, passing out, long lasting brain damage, and sometimes death. Talk with the doctor.
  • Low blood potassium may happen with this medicine. If not treated, this can lead to a heartbeat that is not normal, very bad breathing problems, and sometimes death. Talk with the doctor.
  • Avoid driving and doing other tasks or actions that call for you to be alert until you see how Afrezza affects you.
  • Some diabetes drugs like pioglitazone or rosiglitazone may cause heart failure or make it worse in people who already have it. Using insulin with these drugs may increase this risk. If you also take one of these drugs, talk with the doctor.
  • Do not switch between different forms of this medicine without first talking with the doctor.
  • It may be harder to control your blood sugar during times of stress like when you have a fever, an infection, an injury, or surgery. A change in level of physical activity or exercise and a change in diet may also affect your blood sugar. Talk with your doctor.
  • Wear disease medical alert ID (identification).
  • Do not drive if your blood sugar has been low. There is a greater chance of you having a crash.
  • Check your blood sugar as you have been told by your doctor.
  • Have blood work checked as you have been told by the doctor. Talk with the doctor.
  • Avoid drinking alcohol or taking products that have alcohol in them while taking Afrezza.
  • Do not smoke while using this medicine.
  • If you are 65 or older, use Afrezza (insulin (oral inhalation)) with care. You could have more side effects.
  • Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using this medicine while you are pregnant.

Medication Guide Afrezza® (uh-FREZZ-uh) (insulin human) inhalation powder

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 with diabetes mellitus.
  • Afrezza is not for use in place of long-acting insulin. Afrezza must be used with long-acting insulin in people who have type 1 diabetes mellitus.
  • Afrezza is not for use to treat diabetic ketoacidosis.
  • 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 18 years of age.

Who should not use Afrezza?

Do not use Afrezza if you:

  • 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.
  • 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. For more information, go to www.Afrezza.com or call MannKind Corp. 1-877-323-8505.

What are the ingredients in Afrezza?

Active ingredient: human insulin

Inactive ingredients: fumaryl diketopiperazine, polysorbate 80

This Medication Guide has been approved by the U.S. Food and Drug Administration.

Afrezza® is a registered trademark owned by MannKind Corporation

Patented: http://www.mannkindcorp.com/research-development/patent-notices

MannKind Corporation
Danbury, CT 06810

Revised 03/2017

Instructions for Use Afrezza® (uh-FREZZ-uh) (insulin human) 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):
    • 4 units (blue cartridge)
    • 8 units (green cartridge)
    • 12 units (yellow cartridge)
     (Figure A)
  • 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.

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:

How to take your dose of Afrezza:

Always be sure you have the right number of Afrezza cartridges for your dose available before you start. 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.


Use the dosage chart below to determine the least number of Afrezza® cartridges you can use for your dose. Other cartridge combinations can be used.

(Figure B)

Example:

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.

Push Cartridges to Remove

Remove a cartridge from the strip by pressing on the clear side to push the cartridge out. Remove the right number of cartridges for your dose. Pushing on the cup will not damage the cartridge.

Afrezza cartridges left over in an opened strip must be used within 3 days.

Before Proceeding:

Check that you have the right Afrezza cartridge(s) for your dose.

Use only 1 inhaler for multiple cartridges. Throw away your Afrezza inhaler after 15 days and get a new one.

Step 2: Loading a cartridge

Hold Inhaler

Hold the inhaler level in one (1) hand with the white mouthpiece on the top and purple base on the bottom.

Open Inhaler

Open the inhaler by lifting the white mouthpiece to a vertical position.

Before you put the Afrezza cartridge in your inhaler, make sure it has been at room temperature for 10 minutes.

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.

Close Inhaler

Lower the mouthpiece to close the inhaler (this will open the drug cartridge).

You should feel a snap when the inhaler is closed.

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.

Close your lips around the mouthpiece to form a seal.

Tilt the inhaler downward while keeping your head level.

Inhale Deeply and Hold Breath

With your mouth closed around the mouthpiece, inhale deeply through the inhaler.

Hold your breath for as long as comfortable and at the same time remove the inhaler from your mouth. After holding your breath, exhale and continue to breathe normally.

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 the Cartridge

Throw away the used cartridge in your regular household trash.

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.

How should I store Afrezza?

*If a foil package, blister card or strip is not refrigerated, the contents must be used within 10 days

Do not put a blister card or strip back into the refrigerator after being stored at room temperature

Caring for your Afrezza inhaler:

Care Instructions

  • Use one inhaler at a time. The same inhaler should be used to take 4 unit, 8 unit or 12 unit cartridges. Replace the inhaler every 15 days to maintain drug delivery.

Keep track of 15 days from when you start using the inhaler with a calendar, or use the chart on the back of the inhaler box.

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®.

This Instructions for Use has been approved by the U.S. Food and Drug Administration.

Afrezza® is a registered trademark owned by MannKind Corporation

Patented: See http://www.mannkindcorp.com/research-development/patent-notices

MannKind Corporation
Danbury, CT 06810

Revised: 03/2017

PRINCIPAL DISPLAY PANEL - 90 -12 Unit KitCarton

NDC 47918-891-90
Rx ONLY

For FPO Only

Afrezza®
(insulin human)
Inhalation Powder

Each yellow cartridge
approximates 12 units
of injected insulin

MannKind Corporation

12
units per
cartridge

90 cartridges

FOR ORAL INHALATION ONLY

Carton Contains:
90 – 12 unit Cartridges + 2 Inhalers

Dispense the enclosed Medication Guide
to each patient

(web3)