• 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).

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.

• 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.
• 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 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.

Usual Adult Dose for Diabetes Type 2:

Insulin-naive:
Initial dose: 4 units via oral inhalation at the beginning of each meal
Maintenance dose: Adjust dose based on individual's metabolic needs, glucose monitoring results, and glycemic goals

Switching from Subcutaneous Mealtime Insulin:
Dose conversion as follows:
4 units inhaled insulin replaces up to 4 units of subcutaneous mealtime insulin
8 units inhaled insulin replaces 5 to 8 units of subcutaneous mealtime insulin
12 units inhaled insulin replaces 9 to 12 units of subcutaneous mealtime insulin
16 units inhaled insulin replaces 13 to 16 units of subcutaneous mealtime insulin
20 units inhaled insulin replaces 17 to 20 units of subcutaneous mealtime insulin
24 units inhaled insulin replaces 21 to 24 units of subcutaneous mealtime insulin

Switching from Subcutaneous Pre-mixed insulin:
-Estimate mealtime injected dose by dividing the total daily injected pre-mixed insulin dose by one-half (half will be the total daily mealtime dose; half will be the daily basal dose)
-Divide the total daily mealtime dose equally among the 3 meals of the day; use dose conversion table above
-Give the other half the total daily injected dose as injected basal insulin

Comments:
-Dose adjustments may be needed with changes in physical activity, meal patterns, or during acute illness.
-Use a single inhalation per cartridge; doses exceeding 8 units will require multiple cartridges.
-Monitor blood glucose, especially in patients requiring high doses; if blood glucose control is not achieved with increasing doses, consider subcutaneous mealtime insulin.

Use: Inhaled insulin is a rapid acting insulin for use in adult patients with diabetes mellitus to improve glycemic control.

Usual Adult Dose for Diabetes Type 1:

Insulin-naive:
Initial dose: 4 units via oral inhalation at the beginning of each meal
Maintenance dose: Adjust dose based on individual's metabolic needs, glucose monitoring results, and glycemic goals

Switching from Subcutaneous Mealtime Insulin:
Dose conversion as follows:
4 units inhaled insulin replaces up to 4 units of subcutaneous mealtime insulin
8 units inhaled insulin replaces 5 to 8 units of subcutaneous mealtime insulin
12 units inhaled insulin replaces 9 to 12 units of subcutaneous mealtime insulin
16 units inhaled insulin replaces 13 to 16 units of subcutaneous mealtime insulin
20 units inhaled insulin replaces 17 to 20 units of subcutaneous mealtime insulin
24 units inhaled insulin replaces 21 to 24 units of subcutaneous mealtime insulin

Switching from Subcutaneous Pre-mixed insulin:
-Estimate mealtime injected dose by dividing the total daily injected pre-mixed insulin dose by one-half (half will be the total daily mealtime dose; half will be the daily basal dose)
-Divide the total daily mealtime dose equally among the 3 meals of the day; use dose conversion table above
-Give the other half the total daily injected dose as injected basal insulin

Comments:
-Dose adjustments may be needed with changes in physical activity, meal patterns, or during acute illness.
-Use a single inhalation per cartridge; doses exceeding 8 units will require multiple cartridges.
-Monitor blood glucose, especially in patients requiring high doses; if blood glucose control is not achieved with increasing doses, consider subcutaneous mealtime insulin.

Use: Inhaled insulin is a rapid acting insulin for use in adult patients with diabetes mellitus to improve glycemic control.

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 this medicine

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.

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

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).

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.