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EXUBERA

Generic Name: insulin (inhalation) (IN soo lin IN ha LAY tion)
Brand Name: Afrezza

What is insulin inhalation?

Insulin inhalation is a rapid-acting form of human insulin that is inhaled through the mouth.

Insulin inhalation is used to treat type 1 (insulin dependent) or type 2 (non-insulin dependent) diabetes in adults.

If you have type 1 diabetes, you will also need to use a long-acting injectable insulin.

If you have type 2 diabetes, insulin inhalation may be the only medicine you need to control your blood sugar. However, your doctor may prescribe a long-acting injection insulin or a diabetes medicine you take by mouth.

Insulin inhalation may also be used for purposes not listed in this medication guide.

What is the most important information I should know about insulin inhalation?

Insulin inhalation can cause sudden or serious lung problems. You should not use this medicine if you smoke or have recently quit, or if you have chronic lung disease such as COPD or asthma.

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Do not use insulin inhalation if you are having an episode of low blood sugar, or if you are in a state of diabetic ketoacidosis (call your doctor for treatment with insulin).

What should I discuss with my healthcare provider before taking insulin inhalation?

Do not use insulin inhalation if you are having an episode of low blood sugar, or if you are in a state of diabetic ketoacidosis (call your doctor for treatment with insulin).

Insulin inhalation can cause sudden or serious lung problems.

You should not use insulin inhalation if you are allergic to it, or if you have:

  • a history of lung cancer; or

  • chronic lung disease, such as asthma or chronic obstructive pulmonary disease (COPD).

Do not use insulin inhalation if you smoke or have recently quit smoking (within the past 6 months).

To make sure insulin inhalation is safe for you, tell your doctor if you have:

  • liver or kidney disease;

  • an electrolyte imbalance (such as low levels of potassium in your blood);

  • heart disease, congestive heart failure; or

  • if you take an oral diabetes medicine such as pioglitazone or rosiglitazone.

In studies with insulin inhalation, lung cancer occurred in a small number of people. It is not clear whether this medicine was the actual cause of lung cancer. Ask your doctor about your specific risk. Your doctor will perform lung function tests to make sure you do not have conditions that would prevent you from safely using insulin inhalation.

It is not known whether insulin inhalation will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

It is not known whether insulin inhalation passes into breast milk or if it could harm a nursing baby. You should not breast-feed while using this medicine.

Insulin inhalation is not approved for use by anyone younger than 18 years old.

How should I take insulin inhalation?

Follow all directions on your prescription label. Your doctor may occasionally change your dose to make sure you get the best results. Do not use this medicine in larger or smaller amounts or for longer than recommended.

Read all patient information, medication guides, and instruction sheets provided to you. Ask your doctor or pharmacist if you have any questions.

Use insulin inhalation at the beginning of a meal.

Insulin inhalation is a powder contained inside a plastic cartridge that fits into the inhaler device supplied with this medicine. Only one cartridge can be placed in the inhaler device at one time. You may use each inhaler device for up to 15 days before replacing it with a new one.

Each blue cartridge of insulin inhalation powder is equal to 4 units of injectable insulin. Each green cartridge is equal to 8 units of injectable insulin. If your dose is more than 8 units, you will need to use more than one cartridge. Always use the least number of cartridges possible to get your correct dose. For example, if your dose is 12 units, use one 4-unit cartridge and one 8-unit cartridge to equal 12 units. For a dose of 16 units, use two 8-unit cartridges. Follow the dosing chart provided with this medicine to learn about combining cartridges to get the correct dose.

Insulin inhalation cartridges are packaged in a plastic blister card that is sealed inside a foil package. Store each unopened foil package in a refrigerator. An unopened foil package that is not refrigerated must be used within 10 days.

When you open the foil package, remove only the number of cartridges needed for your dose, put the rest of the blister card back into the foil package and return it to the refrigerator. Leave the cartridges needed for your dose at room temperature for 10 minutes before using them.

Once you have opened a foil package, you may store it at room temperature. After tearing open an individual blister-card strip, you must use the cartridges in that strip within 3 days.

While using insulin inhalation, your blood sugar will need to be checked often. You may also need to have lung function tests every 6 to 12 months.

Low blood sugar (hypoglycemia) can happen to everyone who has diabetes. Symptoms include headache, hunger, sweating, confusion, irritability, dizziness, or feeling shaky. Always keep a source of sugar with you in case you have low blood sugar. Sugar sources include fruit juice, hard candy, crackers, raisins, and non-diet soda. Be sure your family and close friends know how to help you in an emergency.

If you have severe hypoglycemia and cannot eat or drink, use a glucagon injection. Your doctor can prescribe a glucagon emergency injection kit and tell you how to use it.

Also watch for signs of high blood sugar (hyperglycemia) such as increased thirst, increased urination, hunger, dry mouth, fruity breath odor, drowsiness, dry skin, blurred vision, and weight loss.

Check your blood sugar carefully during times of stress, travel, illness, surgery or medical emergency, vigorous exercise, or if you drink alcohol or skip meals. These things can affect your glucose levels and your dose needs may also change. Do not change your medication dose or schedule without your doctor's advice.

Insulin inhalation is only part of a treatment program that may also include diet, exercise, weight control, regular blood sugar testing, and special medical care. Follow your doctor's instructions very closely.

What happens if I miss a dose?

If you forget to use your dose at the beginning of a meal, use the medicine as soon as you remember. Do not use extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An insulin overdose can cause life-threatening hypoglycemia.

Symptoms of severe hypoglycemia include extreme weakness, blurred vision, sweating, trouble speaking, tremors, stomach pain, confusion, and seizure (convulsions).

What should I avoid while taking insulin inhalation?

Do not smoke while using insulin inhalation. If you start smoking, you will have to stop using insulin inhalation and switch to another form of insulin to control your blood sugar.

Insulin inhalation may impair your thinking or reactions. Avoid driving or operating machinery until you know how this medicine will affect you.

Avoid drinking alcohol or taking medicines that contain alcohol.

Insulin inhalation side effects

Get emergency medical help if you have signs of insulin allergy: itching skin rash over the entire body, wheezing, trouble breathing, fast heart rate, sweating, or feeling like you might pass out.

Call your doctor at once if you have:

  • shortness of breath (even with mild exertion), swelling in your feet, rapid weight gain;

  • bronchospasm (wheezing, chest tightness, trouble breathing); or

  • low potassium--confusion, uneven heart rate, extreme thirst, increased urination, leg discomfort, muscle weakness or limp feeling.

Common side effects may include:

  • low blood sugar;

  • cough; or

  • throat pain or irritation.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

See also: Side effects (in more detail)

What other drugs will affect insulin inhalation?

There are many other medicines that can increase or decrease the effects of insulin on lowering your blood sugar. Other drugs may also interact with insulin, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using. Not all possible interactions are listed in this medication guide.

More about Exubera (insulin inhalation, rapid acting)

Consumer resources

Professional resources

Where can I get more information?

  • Your pharmacist can provide more information about insulin inhalation.
  • Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
  • Disclaimer: Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2012 Cerner Multum, Inc. Version: 1.01. Revision Date: 2015-03-19, 9:43:22 AM.

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