Insulin Human Inhalation

IMPORTANT WARNING:

Insulin inhalation may decrease lung function and can 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.

Your doctor or pharmacist will give you the manufacturer's patient information sheet (Medication Guide) when you begin treatment with insulin inhalation and each time you refill your prescription. Read the information carefully and ask your doctor or pharmacist if you have any questions. You can also visit the manufacturer's website to obtain the Medication Guide.

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

WHY is this medicine prescribed?

Insulin inhalation is used in combination with a long-acting insulin 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). It is also used in combination with other medications to treat people with type 2 diabetes (condition in which the body does not use insulin normally and, therefore, cannot control the amount of sugar in the blood) who need insulin to control their diabetes. Insulin inhalation is not used for the treatment diabetic ketoacidosis (a serious condition that may develop if high blood sugar is not treated). 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.

Over time, people who have diabetes and high blood sugar can develop serious or life-threatening complications, including heart disease, stroke, kidney problems, nerve damage, and eye problems. Using medication(s), making lifestyle changes (e.g., diet, exercise, quitting smoking), and regularly checking your blood sugar may help to manage your diabetes and improve your health. This therapy may also decrease your chances of having a heart attack, stroke, or other diabetes-related complications such as kidney failure, nerve damage (numb, cold legs or feet; decreased sexual ability in men and women), eye problems, including changes or loss of vision, or gum disease. Your doctor and other healthcare providers will talk to you about the best way to manage your diabetes.

Are there OTHER USES for this medicine?

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

HOW should this medicine be used?

Insulin inhalation comes as a powder to inhale by mouth using a special inhaler. It is usually used at the beginning of each meal. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Use insulin inhalation exactly as directed. Do not use more or less of it or use it more often than prescribed by your doctor.

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.

Before you use your insulin oral inhaler the first time, read the written instructions that come with it. Look at the diagrams carefully and be sure that you recognize all the parts of the inhaler. Ask your doctor or pharmacist to show you how to use it. Be sure to ask your pharmacist or doctor if you have any questions about how to inhale this medication.

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.

Before putting the cartidge in the inhaler, remove the cartridge(s) from the refrigerator and allow to sit at room temperature for 10 minutes.

After you insert a cartridge into the inhaler, keep the inhaler level with the white mouthpiece on top and purple base on the bottom. If the inhaler is held upside down, or if the mouthpiece is pointed down, shaken, or dropped, you may lose medication. If this happens, you will need to replace the cartridge with a new cartridge before using the inhaler.

Follow your doctor's instructions about how many insulin inhalation cartridges you should use each day. When you begin using insulin inhalation, your doctor may need to adjust the doses of your other diabetes medications, such as long-acting insulin and oral medications for diabetes. Your doctor may also need to adjust your dose of insulin inhalation during your treatment. Follow these directions carefully and ask your doctor if you have any questions. Do not change the dose of insulin inhalation or any other medication for diabetes without talking to your doctor.

What SPECIAL PRECAUTIONS should I follow?

Before using insulin inhalation,

• tell your doctor and pharmacist if you are allergic to insulin (Apidra, Humulin, Lantus, Levemir, Novolog, others), any other medications, or any of the inactive ingredients in insulin inhalation. Ask your pharmacist or check the Medication Guide for a list of the ingredients.

• 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. Be sure to let your doctor and pharmacist know that you are taking this medication before you start taking insulin inhalation. Do not start this medication 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 take insulin inhalation if you have this condition.

• 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, 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.

• 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 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.

• 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.

What SPECIAL DIETARY instructions should I follow?

Be sure to follow all exercise and dietary recommendations made by your doctor or dietitian. It is important to eat a healthy diet and to eat about the same amounts of the same kinds of food at about the same times each day. Skipping or delaying meals or changing the amount or kind of food you eat can cause problems with your blood sugar control.

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?

This medication may cause changes in your blood sugar. You should know the symptoms of low and high blood sugar and what to do if you have these symptoms.

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
• extreme drowsiness
• confusion
• dizziness

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 know about STORAGE and DISPOSAL of this medication?

Keep this medication in the refrigerator, in the container it came in, tightly closed, and out of reach of children. 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.

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

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 https://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 take too much insulin inhalation or if you take 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 OTHER INFORMATION should I know?

Your blood sugar and glycosylated hemoglobin (HbA1c) should be checked regularly to determine your response to insulin inhalation. Your doctor will also tell you how to check your response to insulin by measuring your blood or urine sugar levels at home. Follow these instructions carefully.

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

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.