Insulin Human (rDNA Origin) Inhalation (patient information)

# Why this medication is 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 alone or 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 a short-acting, man-made version of human insulin that starts to work within 10 to 20 minutes after it is inhaled and continues to work for about 6 hours. It helps control blood sugar levels by moving sugar from the blood into other body tissues where it is used for energy. It also stops the liver from producing more sugar.

# How this medication should be used
Insulin inhalation comes as a powder to inhale by mouth using a specially designed inhaler. It is usually taken immediately before meals (within 10 minutes before eating). 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 brand or type of insulin without talking to your doctor.
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.
Insulin inhalation powder comes in small foil dose packets called blisters. Do not open or puncture the blisters. The blisters will open after they are put in the inhaler. Do not swallow the contents of the blister or inhale them without the proper inhaler. After you use a blister, throw it away in a garbage can that is out of the reach of children and pets. Do not try to reuse a blister.
Do not use three 1-mg blisters in place of one 3-mg blister. You may get too much insulin. If needed, you can use two 1-mg blisters in place of one 3-mg blister. Then check your blood sugar level and get a new supply of 3-mg blisters as soon as possible.
Call your doctor if you develop a cold or a cough or if you become congested at any time during your treatment. You will still be able to use insulin inhalation, but your doctor may adjust your dose or tell you to check your blood sugar level more often.
Ask your pharmacist or doctor for a copy of the manufacturer's Medication Guide. Carefully read the instructions on how to use the insulin inhaler, how to clean the insulin inhaler, and how often to replace the parts of the inhaler.

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

# Special precautions
Before using insulin inhalation:
- tell your doctor and pharmacist if you are allergic to insulin (Humulin, Iletin, Novolin, Velosulin, 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 mention any of the following: albuterol (Proventil, Ventolin); angiotensin-converting enzyme (ACE) inhibitors such as benazepril (Lotensin), enalapril (Vasotec), fosinopril (Monopril), lisinopril (Prinivil, Zestril), quinapril (Accupril), and ramipril (Altace); antihistamines; beta blockers such as atenolol (Tenormin), labetalol (Normodyne), metoprolol (Lopressor, Toprol XL), nadolol (Corgard), and propranolol (Inderal); clonidine (Catapres, Catapres-TTS); clozapine (Clozaril); danazol (Danocrine); diazoxide (Proglycem); disopyramide (Norpace, Norpace CR); diuretics ('water pills'); epinephrine; fenofibrate (Lofibra, TriCor); fluoxetine (Prozac, Sarafem); gemfibrozil (Lopid); guanethidine (Ismelin); HIV protease inhibitors including atazanavir (Reyataz), indinavir (Crixivan), lopinavir (in Kaletra), nelfinavir (Viracept), ritonavir (Norvir, in Kaletra), and saquinavir (Fortovase, Invirase); hormone replacement therapy; hormonal contraceptives (birth control pills, patches, rings, and injections); isoniazid (Laniazid, Nydrazid); lithium (Eskalith, Lithobid, Lithotabs); medications for asthma, colds, mental illness, and nausea; monoamine oxidase (MAO) inhibitors, including isocarboxazid (Marplan), phenelzine (Nardil), tranylcypromine (Parnate), and selegiline (Eldepryl); oral contraceptives (birth control pills); oral medications for diabetes; oral steroids such as dexamethasone (Decadron, Dexone), methylprednisolone (Medrol), and prednisone (Deltasone); other inhaled medications; olanzapine (Zyprexa); pentamidine (NebuPent, Pentam 300); pentoxifylline (Pentoxil, Trental); propoxyphene; reserpine (Serpalan, Serpasil); salicylate pain relievers such as aspirin; somatropin (Humatrope, Serostim, Zorbtive); sulfa antibiotics; terbutaline (Brethine); and thyroid medications. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
- tell your doctor if you smoke or have stopped smoking within the past 6 months, or if you have asthma, chronic obstructive pulmonary disease (COPD; a group of lung diseases including chronic bronchitis and emphysema), or other lung disease. Your doctor may tell you not to use insulin inhalation.
- do not smoke during your treatment with insulin inhalation. If you do start smoking, stop using insulin inhalation and call your doctor right away.
- tell your doctor if you have or have ever had nerve damage caused by your diabetes; or kidney or liver disease.
- tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. 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 what to do if you get sick, experience unusual stress, plan to travel across more than two time zones, or change your exercise or activity schedule. These changes can affect your dosing schedule and the amount of insulin you will need.
- 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.
- you should know that insulin inhalation may decrease lung function Your doctor will order certain tests to check how well your lungs are working before and during insulin inhalation treatment.

# Special dietary instructions
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.
Alcohol may cause a decrease in blood sugar. Ask your doctor about the safe use of alcoholic beverages while you are using insulin inhalation.

# What to do if you forget a dose
Skip the missed dose and continue your regular dosing schedule. Do not inhale a dose at a later time or inhale a double dose to make up for a missed one. When you realize that you have missed a dose, check your blood sugar and call your doctor if it is too high.

# Side effects

## minor side effects
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.
You may experience hypoglycemia (low blood sugar) while you are taking this medication. Your doctor will tell you what you should do if you develop hypoglycemia. He or she may tell you to check your blood sugar, eat or drink a food or beverage that contains sugar, such as hard candy or fruit juice, or get medical care. Follow these directions carefully if you have any of the following symptoms of hypoglycemia:
- shakiness
- dizziness or lightheadedness
- sweating
- nervousness or irritability
- sudden changes in behavior or mood
- headache
- numbness or tingling around the mouth
- weakness
- pale skin
- hunger
- clumsy or jerky movements
- nightmares
- difficulty falling asleep or staying asleep
- blurred vision
- slurred speech
- fast heartbeat
If hypoglycemia is not treated, severe symptoms may develop. Be sure that your family, friends, and other people who spend time with you know that if you have any of the following symptoms, they should get medical treatment for you immediately.
- confusion
- seizures
- loss of consciousness
Call your doctor immediately if you have any of the following symptoms of hyperglycemia (high blood sugar):
- extreme thirst
- frequent urination
- extreme hunger
- weakness
- blurred vision
If high blood sugar is not treated, a serious, life-threatening condition called diabetic ketoacidosis could develop. Get medical care immediately if you have any of these symptoms:
- dry mouth
- nausea and vomiting
- loss of appetite
- pain in the stomach
- fast heartbeat
- fast, deep breathing
- breath that smells fruity
- decreased consciousness
Insulin inhalation may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:
- chest pain
- cough
- coughing up mucus
- mild shortness of breath
- sore throat
- hoarse, changed, or lost voice
- runny nose
- nosebleed

## Severe side effects
Some side effects can be serious. If you experience any of these symptoms, call your doctor immediately:
- rash and/or itching over the whole body
- hives
- wheezing
Insulin inhalation may cause other side effects. Call your doctor if you have any unusual problems while using this medication.

# Storage conditions needed for this medication
Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and keep the unit dose blisters away from excess heat and moisture (not in the bathroom). Do not refrigerate. Do not freeze. Throw away any blister that has been exposed to moisture or excessive heat or that has been frozen. Throw away any medication that is outdated or no longer needed. Talk to your pharmacist about the proper disposal of your medication.

# In case of emergency/overdose
In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local 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 listed above, follow your doctor's instructions for what you should do if you develop hypoglycemia.

# Other information
Keep all appointments with your doctor and the laboratory. 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.
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.

# Brand names
- Exubera