Insulin inhalation powder

What is Insulin inhalation powder?

INSULIN INHALATION (Exubera®) is a human-made form of insulin. Insulin is a hormone produced naturally by the pancreas. Insulin lowers the amount of sugar in your blood. Keeping your blood sugar close to normal prevents or reduces long-term complications of diabetes including damage to the blood vessels, eyes, kidneys, or nerves. Insulin inhalation is a short-acting insulin that starts working faster than injected regular insulin. Because of the quicker onset of action, you should eat a meal within 10 minutes after inhaling your dose of insulin. This will help to reduce the risk of low blood sugar (hypoglycemia).The time-course of action of insulin may vary in different people and at different times in the same person. You need a prescription to buy inhaled insulin.

There are different types of insulin available. Each type has a different onset of action and a different duration of action in the body. You should learn which types you take and how you should administer them, and how each type acts in your body.

If you switch from injected insulin to inhaled insulin, your dose of insulin may change. Monitor your blood sugar more frequently. Take care to learn and recognize the symptoms of hypoglycemia (low blood sugar) and know how you should treat these reactions.

What should I tell my health care provider before I take this medicine?

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

• adrenal or pituitary gland problems

• asthma

• diarrhea

• fever or infection

• injury or trauma

• kidney disease

• liver disease

• lung diseases like COPD, chronic bronchitis, emphysema, or cystic fibrosis

• nausea, vomiting

• recent surgery

• thyroid disease

• currently smoke tobacco or quit smoking within the past 6 months

• an unusual reaction to Insulin, mannitol, medicines, foods, dyes, or preservatives

• pregnant or trying to get pregnant

• breast-feeding

How should this medicine be used?

This medicine is for inhalation by mouth. Use exactly as directed. Do not use more than prescribed. Do not use more or less often than prescribed. It is important to follow the directions given to you by your prescriber or health care professional. You will be taught how to use the inhaler. If you are using more than one blister pack for a dose, inhale each blister pack separately. If you use the 3 mg blister pack, and it becomes unavailable, do not substitute three 1 mg blister packs. Contact your health care provider for instructions.

Your health care provider will tell you how long to wait after you inhale your dose of insulin before eating a meal. Most of the time, you will wait for 10 minutes or less. You will also be taught how to adjust doses for activities and illness.

Clean the chamber and mouthpiece of the inhaler once a week with a damp cloth and mild soap. Rinse with warm water. Make sure the inhaler is fully dry before using it. For the base of the inhaler, wipe the outside with a damp soft cloth. Do not use soap or any other cleanser. Do not clean the Release Unit. It should be replaced every 2 weeks. The inhaler should be replaced once a year.

What if I miss a dose?

It is important not to miss a dose. Your health care professional or prescriber should discuss a plan for missed doses with you. If you do miss a dose, follow their plan. Do not take double doses. Know the signs of low and high blood sugar and make sure a close family member or friend can also recognize these signs. Contact your health care professional or prescriber at once if you have any problems.

What drug(s) may interact with Insulin Inhalation?

• other medicines for diabetes

• other medicines that are inhaled, especially those used for asthma like albuterol

Many medications may cause changes (increase or decrease) in blood sugar, these include:

• alcohol containing beverages

• angiotensin converting enzyme inhibitors (ACE inhibitors), often used for high blood pressure or heart problems (examples include captopril, enalapril, lisinopril)

• antiretroviral protease inhibitors (examples include indinavir, ritonavir, saquinavir)

• aspirin and aspirin-like drugs

• beta-blockers, often used for high blood pressure or heart problems (examples include atenolol, metoprolol, propranolol)

• certain medicines used for mental depression, emotional, or psychotic disturbances

• chromium

• cisapride

• clonidine

• cyclosporine

• danazol

• diazoxide

• disopyramide

• epinephrine

• female hormones, such as estrogens, progestins, or contraceptive pills

• fenofibrate

• gemfibrozil

• glucagon

• growth hormone (somatropin)

• guanethidine

• isoniazid

• lithium

• metoclopramide

• male hormones or anabolic steroids

• medications to suppress appetite or for weight loss

• medicines for allergies, asthma, cold, or cough

• niacin

• nicotine (including nicotine found in patches and gum)

• pentamidine

• pentoxifylline

• phenytoin

• propoxyphene

• quinolone antibiotics, medicines used for infections (examples include ciprofloxacin, levofloxacin, norfloxacin)

• some herbal dietary supplements

• steroid medicines such as prednisone or cortisone

• sulfonamides, medicines for infection ( examples include Azulfidine®, Bactrim®, Gantrisin® Septra®)

• tacrolimus

• thyroid hormones

• water pills (diuretics)

Some medications can hide the warning symptoms of low blood sugar (hypoglycemia). You may need to monitor your blood sugar more closely if you are taking one of these medications. These include:

• beta-blockers, often used for high blood pressure or heart problems (examples include atenolol, metoprolol, propranolol)

• clonidine

• guanethidine

• reserpine

Tell your prescriber or health care professional about all other medicines you are taking, including non-prescription medicines, nutritional supplements, or herbal products. Also tell your prescriber or health care professional if you are a frequent user of drinks with caffeine or alcohol, if you smoke, or if you use illegal drugs. These may affect the way your medicine works. Check with your health care professional before stopping or starting any of your medicines.

What should I watch for while taking Insulin Inhalation?

Visit your health care professional or prescriber for regular checks on your progress. To control your diabetes properly you must use insulin regularly and follow a regular diet and exercise schedule. Diabetes cannot be cured. Careful, daily control of blood sugar can postpone or prevent many of the long-term complications of diabetes.

Treatment with inhaled insulin has caused small declines in lung function. Because of this effect, your doctor will monitor your lung function before and during treatment with Exubera®.

Dangerously high or low blood sugar can occur when meals and insulin are not spaced properly. Checking and recording your blood glucose and urine ketone levels regularly is important. Sometimes it is hard to tell the difference between low and high blood sugar (see side effects). Use a glucometer (blood glucose or sugar measuring device), whenever possible, before you treat high or low blood sugar.

Always carry a quick-source of sugar with you in case you have symptoms of low blood sugar (hypoglycemia). Examples include hard sugar candy or glucose tablets.

Do not switch brands or types of insulin without consulting your health care professional or prescriber. Switching insulin brand or type can cause dangerously high or low blood sugar.

Always keep an extra supply of insulin on hand.

Wear a Medic Alert bracelet or necklace and/or carry an identification card with your name and address, condition, medication, and prescriber's name and address.

If you develop a cold, diarrhea, vomiting, or other infection or illness, you should contact your health care professional or prescriber. 'Sick-days' may require changes to your insulin dosage. Or your illness may need to be evaluated. Ask your health care professional or prescriber what you should do if you become ill. Do not stop taking your insulin; check with your health care professional or prescriber for advice.

Many nonprescription cough and cold products contain sugar or alcohol. These can affect diabetes control or can alter the results of tests used to monitor blood sugar. Avoid alcohol. Avoid products that contain alcohol or sugar.

If you are going to have surgery, make sure you tell the health care professionals that you take insulin.

What side effects may I notice from receiving Insulin Inhalation?

Learn how and when you should monitor your blood sugar, and what you should do if high or low blood sugar occurs. Side effects that you should report to your prescriber or health care professional as soon as possible:

Symptoms of hypoglycemia (low blood glucose):

• anxiety or nervousness, confusion, difficulty concentrating, hunger, pale skin, nausea, fatigue, sweating, headache, palpitations, numbness of the mouth, tingling in the fingers, tremors, muscle weakness, blurred vision, cold sensations, uncontrolled yawning, irritability, rapid heartbeat, shallow breathing, and loss of consciousness. You should learn to recognize your own symptoms of hypoglycemia. Your symptoms may be different than others. If you are uncertain about your symptoms of hypoglycemia, check your blood sugar often to help you learn to recognize the symptoms. Hypoglycemia may cause you to not be aware of your actions or surroundings if it is severe, so you should let others know what to do if you cannot help yourself in a severe reaction. Your prescriber or health care professional will teach you how to treat hypoglycemia. Always carry a quick source of sugar such as candies or glucose tablets with you.

Symptoms of high blood sugar (hyperglycemia):

• dizziness, dry mouth, flushed dry-skin, fruit-like breath odor, loss of appetite, nausea, stomach ache, unusual thirst, frequent passing of urine

Insulin also can cause rare but serious allergic reactions in some patients, including:

• severe skin rash and itching (hives)

• difficulty breathing

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

• cough

• bitter taste

Where can I keep my medicine?

Store the inhaled insulin blister packs at room temperature (15—30 degrees C or 59—86 degrees F). Once the foil overwrap is opened, use the blister packs within 3 months. Do not refrigerate or freeze the blister packs; throw away the blister packs if they freeze. Keep unused blister packs in the foil overwrap. Protect the blister packs from moisture; keep out of humid places like the bathroom. Store the inhaler and the release unit at room temperature.

Keep out of the reach of children in a container that small children cannot open.