Class Name(s):

• 68:20.08.08 Short-acting Insulins

Pronunciation:

• (in' su lin)

Brand Name(s):

• Afrezza^®

IMPORTANT WARNING:

Insulin inhalation may cause bronchospasms (breathing difficulties). Tell your doctor if you have or have ever had asthma or chronic obstructive pulmonary disease (COPD; a group of diseases that affect the lungs and airways). Your doctor will tell you not to use insulin inhalation if you have asthma or COPD. Your doctor will order certain tests to check how well your lungs are working before therapy, 6 months after starting therapy, and annually while using insulin inhalation treatment. Tell your doctor if you have any of the following symptoms: wheezing or difficulty breathing.

Keep all appointments with your doctor and the laboratory.

You will be given the Medication Guide. Read the information carefully and ask your doctor or pharmacist if you have any questions.

Talk to your doctor about the risks of using insulin inhalation.

WHY is this medicine prescribed?

Insulin inhalation is to treat type 1 diabetes (condition in which the body does not produce insulin and therefore cannot control the amount of sugar in the blood) and type 2 diabetes (condition in which the body does not use insulin normally and, therefore, cannot control the amount of sugar in the blood). Insulin inhalation is a short-acting, man-made version of human insulin. Insulin inhalation works by replacing the insulin that is normally produced by the body and by helping to move sugar from the blood into other body tissues where it is used for energy. It also stops the liver from producing more sugar.

HOW should this medicine be used?

Insulin inhalation comes as a powder to inhale by mouth using a special inhaler. Use it at the beginning of each meal.

Use insulin inhalation exactly as directed. Do not use more or less of it or use it more often than prescribed by your doctor.

Your doctor will may adjust your dose of insulin inhalation during your treatment.

You or a caregiver will be shown how to use the medicine before your first dose. You will also be given the instructions for use. Read these carefully. Talk to your doctor or pharmacist if you have any questions on how to use the medicine.

Insulin inhalation controls diabetes, but does not cure it. Continue to use insulin inhalation even if you feel well. Do not stop using insulin inhalation without talking to your doctor. Do not switch to another type of insulin without talking to your doctor.

Insulin inhalation powder comes as a single-use cartridge. The cartridges should only be used with the inhaler that comes with your prescription. Do not try to open the cartridge, swallow the cartridge, or inhale the contents without the inhaler that comes with your prescription.

To use the insulin inhalation powder, follow these steps:

1. Open the blister foil package. Tear off the blister strip containing the needed cartridges.
2. Remove the cartridge from the blister strip. Allow refrigerated cartridges to sit at room temperature for 10 minutes.
3. Load the cartridge into the inhaler by laying the inhaler on a flat surface and opening it by lifting the mouthpiece to an upright vertical position. Hold the cartridge with the white cup facing down. Line up the pointed end of the cartridge with the pointed end in the inhaler, and insert it flat. Snap the inhaler closed.
4. Keep the inhaler level at all times to avoid spilling the powder.
5. Pull off the mouthpiece cover. Sit upright with your head level. Carefully pick up the inhaler, and hold it level away from the mouth.
6. Fully breathe out, without blowing into the inhaler. Place the mouthpiece in the mouth and close the lips around it to form a seal. Tilt the inhaler slightly downward toward the chin and inhale quickly and deeply through the mouthpiece.
7. Remove the inhaler from the mouth. Hold the breath as long as is comfortable, then breathe out normally.
8. Place the mouthpiece cover back on the inhaler. Lift the mouthpiece to an upright position to open the inhaler. Remove the used cartridge. Throw it away in the regular trash. Do not reuse cartridges.

Are there OTHER USES for this medication?

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

What SPECIAL PRECAUTIONS should I follow?

Before using insulin inhalation,

• tell your doctor and pharmacist if you are allergic to this medication, any part of this medication, or any other medications, foods or substances. Tell your doctor or pharmacist about the allergy and what symptoms you had.
• tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to let your doctor and pharmacist know if you are taking any other inhaled medications. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
• the following nonprescription or herbal products may interact with insulin inhalation: aspirin, niacin, and liquid medications that contain alcohol. Be sure to let your doctor and pharmacist know that you are taking these medications before you start taking insulin inhalation. Do not start these medications while taking insulin inhalation without discussing it with your healthcare provider.
• tell your doctor if you have symptoms of hypoglycemia (low blood sugar). Your doctor will probably tell you not to use insulin inhalation.
• tell your doctor if you have an infection or if you smoke or if you stopped smoking within the past 6 months. Also, tell your doctor if you have or have ever had low blood levels of potassium, diabetic ketoacidosis, lung cancer, nerve damage caused by your diabetes, heart failure, or kidney or liver disease.
• tell your doctor if you are pregnant, plan to become pregnant, or are breastfeeding. If you become pregnant while using insulin inhalation, call your doctor.
• if you are having surgery, including dental surgery, tell the doctor or dentist that you are using insulin inhalation.
• ask your doctor how often you should check your blood sugar. Be aware that low blood sugar may affect your ability to perform tasks such as driving and ask your doctor if you need to check your blood sugar before driving or operating machinery.
• alcohol may cause a change in blood sugar. Ask your doctor about the safe use of alcoholic beverages while you are using insulin inhalation.
• ask your doctor what to do if you get sick, gain or lose weight, experience unusual stress, plan to travel across time zones, or change your exercise or activity schedule. These changes can affect your dosing schedule and the amount of insulin you will need.
• you should know this medication may cause low blood sugar events especially if it is being used in combination with certain other blood sugar lowering medications. You should know the symptoms of low blood sugar (shakiness, nervousness, sweating, chills irritability, confusion, fast heart beat, feeling lightheaded or dizzy, hunger, headaches, nausea, blurred vision, or feeling weak). If you have these symptoms, consume about 15 grams of carbs [ex. half cup of juice or regular soda] every 15 minutes until your blood sugar has returned to normal.

What SPECIAL DIETARY instructions should I follow?

Be sure to follow all exercise and dietary recommendations made by your doctor or dietitian.

What should I do IF I FORGET to take a dose?

When you first start using insulin inhalation, ask your doctor what to do if you forget to inhale a dose at the correct time. Write down these directions so that you can refer to them later.

What SIDE EFFECTS can this medicine cause?

Insulin inhalation may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• cough
• sore throat or irritation
• tiredness
• diarrhea
• nausea
• headache
• painful, burning urination
• weight gain

Some side effects can be serious. If you experience any of these symptoms or those listed in the IMPORTANT WARNINGS section, call your doctor immediately or get emergency medical treatment:

• rash or itching, hives, fast heartbeat, sweating, difficulty breathing or swallowing
• shortness of breath; swelling of the arms, hands, feet, ankles, or lower legs; sudden weight gain
• shakiness, nervousness, sweating, chills, irritability, confusion, fast heartbeat, feeling lightheaded or dizzy, hunger, headaches, nausea, blurred vision, or feeling weak
• extreme confusion, loss of consciousness, seizures

Insulin inhalation may increase the risk that you will develop lung cancer. Talk with your doctor about the risks of using insulin inhalation.

Insulin inhalation may cause other side effects. Call your doctor if you have any unusual problems while using this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

What should I do in case of OVERDOSE?

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at http://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

Insulin inhalation overdose can occur if you use too much insulin inhalation or if you use the right amount of insulin inhalation but eat or exercise less than usual. Insulin inhalation overdose can cause hypoglycemia. If you have any of the symptoms of hypoglycemia, follow your doctor's instructions for what you should do if you develop hypoglycemia. Other symptoms of overdose:

• loss of consciousness
• seizures

What should I know about STORAGE and DISPOSAL of this medication?

Keep this medication in the container it came in and out of reach of children. Store this medication in the refrigerator. Unopened medication can be stored at room temperature for up to 10 days. Once opened, use the cartridge blister strips within 3 days when stored at room temperature. Use the inhaler for up to 15 days from the first day of use, then discard and replace it with a new inhaler. Never wash the inhaler; keep it dry.

Keep all medication out of sight and reach of children as many containers are not child-resistant. Always lock safety caps. Place the medication in a safe location - one that is up and away and out of their sight and reach. http://www.upandaway.org

Dispose of unneeded medications in a way so that pets, children, and other people cannot take them. Do not flush this medication down the toilet. Use a medicine take-back program. Talk to your pharmacist about take-back programs in your community. Visit the FDA's Safe Disposal of Medicines website http://goo.gl/c4Rm4p for more information.

What OTHER INFORMATION should I know?

Keep all appointments with your doctor and the laboratory.

Before having any laboratory test, tell your doctor and the laboratory personnel that you are using insulin inhalation.

You should always wear a diabetic identification bracelet to be sure you get proper treatment in an emergency.

Do not let anyone else use your medication. Ask your pharmacist any questions you have about refilling your prescription.

Keep a written list of all of the prescription and nonprescription (over-the-counter) medicines, vitamins, minerals, and dietary supplements you are taking. Bring this list with you each time you visit a doctor or if you are admitted to the hospital. You should carry the list with you in case of emergencies.

This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.

The American Society of Health-System Pharmacists, Inc. represents that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. makes no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. does not endorse or recommend the use of any drug. The information is not a substitute for medical care.

AHFS^® Patient Medication Information™ Copyright, 2026. The American Society of Health-System Pharmacists^®, 4500 East-West Highway, Suite 900, Bethesda, Maryland. All Rights Reserved. Duplication for commercial use must be authorized by ASHP.

Selected Revisions: October 15, 2026.