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 and older 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).

• 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 of this medicine 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.
• Inhale 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 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.

How do I Administer Afrezza?

To administer Afrezza:

• Keep the inhaler level with the white mouthpiece on top and purple base on the bottom after acartridge has been inserted into the inhaler. Loss of drug effect can occur if the inhaler is turnedupside down, held with the mouthpiece pointing down, shaken, or dropped after the cartridge hasbeen inserted but before the dose has been administered. If any of the above occur, replace thecartridge before use.
• Hold the inhaler away from the mouth and fully exhale.
• After the inhaler is placed in the mouth and the lips form a seal, tilt the inhaler down towards thechin while keeping the head level.
• With the mouth closed around the mouthpiece, inhale deeply through the inhaler.
• Hold the breath for as long as comfortable and at the same time remove the inhaler from the mouth.
• After holding your breath, exhale and continue to breathe normally.

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 this medicine, your healthcare provider will give you a breathing test to check how your lungs are working.

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.

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.

Afrezza may cause serious side effects that can lead to death, including:See Important information

• 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 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 this medicine.
• 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 this medicine. 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 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).

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 it 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. If you would like more information, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information that is written for health professionals.

Recommended Starting Mealtime Dosage of Afrezza

Dose of Afrezza for Insulin Naïve Patients

• Initial dosage: 4 units inhaled at the beginning of each meal.
• Administer at the beginning of each meal.
• See the full prescribing information for the recommended starting mealtime dosage for insulin-naïve patients and patients who are using subcutaneous mealtime insulin or pre-mixed insulin.
• Modify the mealtime Afrezza dosage based on the patient's metabolic needs, blood glucose monitoring results, and glycemic control goal.
• If blood glucose control is not achieved with increased Afrezza dosages, consider discontinuing it.

Dose of Afrezza When Switching from Other Mealtime (Prandial) Insulin Regimens to Afrezza

When switching from another insulin to Afrezza, a different insulin dosage may be needed, and increased frequency of blood glucose monitoring and monitoring for signs and symptoms of hypoglycemia may be needed.

Subcutaneous, Mealtime (prandial) Insulin:

Follow the recommendations in Table 1 in the Afrezza Prescribing Information to convert each injected mealtime insulin dosage (or bolus dosage for patients using insulin pumps) to the recommended mealtime dosage of Afrezza.

Subcutaneous, Pre-Mixed Insulin:

• Refer to the prescribing information for the pre-mixed insulin to estimate the mealtime subcutaneous insulin dosage based on the product's pharmacokinetic and pharmacodynamic properties.
• Follow the recommendations in Table 1 to convert each estimated injected mealtime dosage to an Afrezza mealtime dose.
• If basal insulin is clinically indicated, refer to the prescribing information for the chosen basal insulin for dosage recommendations.

For Afrezza doses exceeding the contents of a single cartridge at mealtime, use more than one cartridge.

• To achieve the required total mealtime dosage, use a combination of 4-unit, 8-unit, and 12-unit cartridges.
• When titrating dosages above 16 units after the initial conversion dosage, use combinations of different cartridges.

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

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.

Active ingredient: human insulinInactive ingredients: fumaryl diketopiperazine, polysorbate 80

Read this Instructions for Use before you start using Afrezza and each time you get a new 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: 4 units (blue cartridge) 8 units (green cartridge) 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 cartridges. The Inhaler opens the cartridge automatically during use.
• Afrezza cartridges should only be used with the Afrezza Inhaler. Do not try to breathe in the insulin powder in any other way. Do not put cartridges in your mouth and do not swallow cartridges.
• Use only 1 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 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.How to take your dose of Afrezza:Always be sure you have the right number of cartridges for your dose available before you start. Afrezza cartridges must only be used with the Afrezza Inhaler.Step 1: Select the cartridges for your doseIf your prescribed dose is more than 12 units you will need to use more than 1 cartridge to get your right dose.Remove a blister card from the foil package. Tear along perforation to remove one strip. 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 inhaler after 15 days and get a new one.Step 2: Loading a cartridgeHold the inhaler level in one hand with the white mouthpiece on the top and purple base on the bottom.Open the inhaler by lifting the white mouthpiece to a vertical position.Before you put the cartridge in your inhaler, make sure it has been at room temperature for 10 minutes.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.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 AfrezzaRemove the Mouthpiece CoverImportant: Keep the inhaler level during and after removal of the purple mouthpiece cover.Hold the inhaler away from your mouth and fully blow out (exhale).Keeping your head level, place the mouthpiece in your mouth and tilt the inhaler down towards your chin.Close your lips around the mouthpiece to form a seal.Tilt the inhaler downward while keeping your head level.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 cartridgePlace the purple mouthpiece cover back onto the inhaler.Open the inhaler by lifting up the white mouthpiece.Remove the cartridge from the purple base.Throw away the used cartridge in your regular household trash.

How should I store Afrezza?

Not in Use: Refrigerated Storage 2-8ºC (36-46ºF)

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

In Use: Room Temperature Storage 25ºC (77ºF), excursions permitted 15-30ºC (59-86ºF)

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

Inhaler Storage:Store at 2-25ºC (36-77ºF); excursions permitted. Inhaler may be stored refrigerated, but should be at room temperature before use.

Handling:Before use, cartridges should be at room temperature for 10 minutes.