Afrezza contains insulin. It is a rapid-acting insulin, which is a class of medications that increase insulin levels to decrease blood sugar. Afrezza is commonly used to manage diabetes.

How should I use this medication?

This medication is for inhalation through the mouth. Take this medication at the beginning of a meal. It is important to follow the directions given to you by your care team. You will be taught how to use this medication and how to adjust doses for activities and illness. Make sure that you are using your inhaler correctly. Do not use more insulin than prescribed. Do not use more or less often than prescribed.

A special MedGuide will be given to you by the pharmacist with each prescription and refill. Be sure to read this information carefully each time.

This medication comes with INSTRUCTIONS FOR USE. Ask your pharmacist for directions on how to use this medication. Read the information carefully. Talk to your pharmacist or care team if you have questions.

Talk to your care team about the use of this medication in children. Special care may be needed.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

It is important to follow your insulin routine as directed. Talk to your care team if you miss a dose. They can help you adjust your dosing routine. Do not take double doses.

Where should I keep my medication?

Keep out of the reach of children and pets.

Throw away the inhaler device 15 days after opening and get a new one. Between uses, store in a refrigerator or at room temperature 25 degrees C (77 degrees F).

Store unopened foil packages in a refrigerator between 2 and 8 degrees C (36 and 46 degrees F). These may be used until the expiration date. If unopened foil packages are stored at room temperature 25 degrees C (77 degrees F), they must be used within 10 days.

Store unopened blister cards and strips in a refrigerator between 2 and 8 degrees C (36 and 46 degrees F). These must be used within 1 month. If unopened blister cards and strips are stored at room temperature 25 degrees C (77 degrees F), they must be used within 10 days.

Opened strips that are in use should be stored at room temperature 25 degrees C (77 degrees F). Open strips must be used within 3 days.

Before use, the inhaler and the cartridges should be at room temperature for 10 minutes.

To get rid of medications that are no longer needed or have expired:

• Take the medication to a medication take-back program. Check with your pharmacy or law enforcement to find a location.
• If you cannot return the medication, ask your pharmacist or care team how to get rid of this medication safely.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.

What side effects may I notice from receiving this medication?

Side effects that you should report to your care team as soon as possible:

• Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
• Diabetic ketoacidosis (DKA)—increased thirst or amount of urine, dry mouth, fatigue, fruity odor to breath, trouble breathing, stomach pain, nausea, vomiting
• Low blood sugar (hypoglycemia)—tremors or shaking, anxiety, sweating, cold or clammy skin, confusion, dizziness, rapid heartbeat
• Low potassium level—muscle pain or cramps, unusual weakness or fatigue, fast or irregular heartbeat, constipation
• Wheezing or trouble breathing that is worse after use

Side effects that usually do not require medical attention (report to your care team if they continue or are bothersome):

• Cough
• Sore throat

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

• Kidney disease
• Liver disease
• Lung cancer
• Lung or breathing disease, such as asthma or COPD
• Often have low blood sugar
• Tobacco use
• Use other inhaled medications
• An unusual or allergic reaction to insulin, other medications, foods, dyes, or preservatives
• Pregnant or trying to get pregnant
• Breastfeeding

What may interact with this medication?

Some medications may affect your blood sugar levels or hide the symptoms of low blood sugar (hypoglycemia). Talk with your care team about all of the medications you take. They may suggest changes to your insulin dose or checking your blood sugar levels more often.

Medications that may affect your blood sugar levels include:

• Alcohol
• Certain antibiotics, such as ciprofloxacin, levofloxacin, sulfamethoxazole; trimethoprim
• Certain medications for blood pressure or heart disease, such as benazepril, enalapril, lisinopril, losartan, valsartan
• Certain medications for mental health conditions, such as fluoxetine or olanzapine
• Diuretics, such as hydrochlorothiazide (HCTZ)
• Estrogen and progestin hormones
• Other medications for diabetes
• Steroid medications, such as prednisone or cortisone
• Testosterone
• Thyroid hormones

Medications that may mask symptoms of low blood sugar include:

• Beta blockers, such as atenolol, metoprolol, propranolol
• Clonidine
• Guanethidine
• Reserpine

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Visit your care team for regular health checks.

This medication may affect your coordination, reaction time, or judgment. Do not drive or operate machinery until you know how this medication affects you. Sit up or stand slowly to reduce the risk of dizzy or fainting spells. Drinking alcohol with this medication can increase the risk of these side effects.

You may need blood work done while you are taking this medication. Your care team will monitor your HbA1C (A1C). This test shows what your average blood sugar level was over the past 2 to 3 months.

Learn how to check your blood sugar. Know the symptoms of low and high blood sugar and how to manage them.

Know the symptoms of low blood sugar and know how to treat it. Always carry a source of quick sugar with you. Examples include hard sugar candy or glucose tablets. Make sure others know that you can choke if you eat or drink if your blood sugar is too low and you are unable to care for yourself. Get medical help at once.

Tell your care team if you have high blood sugar. Your medication dose may change if your body is under stress. Some types of stress that may affect your blood sugar include fever, infection, and surgery.

Do not skip meals. Ask your care team if you should avoid alcohol. Many cough and cold products contain sugar or alcohol. These can affect blood sugar levels.

Do not change the brand or type of insulin unless your care team tells you to. Switching insulin brand or type can affect your blood sugar enough to cause serious adverse effects.

Always keep an extra supply of insulin and related supplies on hand.

Wear a medical ID bracelet or chain. Carry a card that describes your condition. List the medications and doses you take on the card.

What are the most serious risks of this medication?

This medicine may cause narrowing of the airways that may cause difficulty with breathing.Tell your health care professional right away if you have breathing problems such as wheezing, shortness of breath, chest tightness, or cough following treatment.

You should not use this medicine if you have asthma. This medicine can worsen wheezing and cause breathing problems in people with asthma.

You should not use this medicine if you have chronic bronchitis or emphysema. This medicine can worsen wheezing and cause breathing problems in people with lung disease.