Exubera

Insulin inhalation was withdrawn from the U.S. market in 2007 due to lack of consumer demand for the product. No drug safety concerns were cited in this withdrawal.

Exubera is a rapid-acting form of human insulin that is inhaled through the mouth. It works by lowering levels of glucose (sugar) in the blood.

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

Use Exubera exactly as it was prescribed for you. Do not use it in larger doses or for longer than recommended by your doctor.

Your doctor may occasionally change your dose to make sure you get the best results from Exubera.

If you use Exubera as a meal-time insulin, use it no more than 10 minutes before eating the meal.

To be sure Exubera is not causing certain side effects, your lung function will need to be tested on a regular basis. It is important that you not miss any scheduled visits to your doctor.

Continue using Exubera if you have a cold or flu virus that causes upper respiratory symptoms (cough, sore throat, nasal congestion). Check your blood sugar carefully during a time of stress or illness, since this can also affect your glucose levels.

Exubera is a powder that is supplied in "dose blisters" on cards that are packaged in a clear plastic tray. This tray is sealed inside a foil pouch that also contains a moisture-absorbing preservative packet. The 1-milligram (mg) dose blisters are supplied on a card printed with green ink. The 3-mg dose blisters are supplied on a card printed with blue ink.

Each 1-milligram dose blister of Exubera powder is equal to 3 units of injectable insulin and each 3-milligram dose blister is equal to 8 units of injectable insulin. Using three of the 1-mg dose blisters will not give you the same amount of medicine as one 3-mg dose blister. You may receive too much insulin when using three 1-mg dose blisters together, which could result in hypoglycemia.

The inhaler unit supplied with Exubera includes a base, a chamber, and a release unit. Each release unit may be used for up to 2 weeks before replacing. You may use the inhaler for up to 1 year before replacing it.

Once you have opened the foil pouch, keep the unused dose blisters in the pouch and use them within 3 months after opening the pouch. Keep the moisture-absorbing preservative packet contained in the foil pouch and do not open the packet or use its contents.

Do not use this medicine if you have chronic lung problems such as asthma or COPD. Before using this medicine, tell your doctor if you have kidney disease, liver disease, or if you have or have had lung cancer.

There are many other drugs that can potentially interfere with the glucose-lowering effects of Exubera. It is extremely important that you tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

If there are any changes in the brand, strength, or type of insulin you use, your dosage needs may change. Always check your medicine when it is refilled to make sure you have received the correct brand and type as prescribed by your doctor. Ask the pharmacist if you have any questions about the medicine given to you at the pharmacy.

If you use Exubera as a meal-time insulin, use it no more than 10 minutes before eating the meal.

Exubera is only part of a complete program of treatment that may also include diet, exercise, weight control, and testing your blood sugar. Follow your diet, medication, and exercise routines very closely. Changing any of these factors can affect your blood sugar levels.

Take care to keep your blood sugar from getting too low, causing hypoglycemia. Know the signs and symptoms of hypoglycemia, which include headache, confusion, drowsiness, weakness, dizziness, fast heartbeat, sweating, tremor, and nausea. Carry a piece of non-dietetic hard candy or glucose tablets with you in case you have low blood sugar.

Do not use this medicine if you have chronic lung problems such as asthma or COPD. Before using this medicine, tell your doctor if you have kidney disease, liver disease, or if you have or have had lung cancer.

If you have type 1 diabetes, you should use Exubera in addition to another long-acting type of insulin.

If you have type 2 diabetes, this may be the only medication you use to control your blood sugar, or your doctor may prescribe another long-acting insulin or diabetes medicine you take by mouth.

Exubera is only part of a complete program of treatment that may also include diet, exercise, weight control, and testing your blood sugar. Follow your diet, medication, and exercise routines very closely. Changing any of these factors can affect your blood sugar levels.

If there are any changes in the brand, strength, or type of insulin you use, your dosage needs may change. Always check your medicine when it is refilled to make sure you have received the correct brand and type as prescribed by your doctor. Ask the pharmacist if you have any questions about the medicine given to you at the pharmacy.

Hypoglycemia (low blood sugar) is the most common side effect of Exubera. Watch for signs of low blood sugar, which include headache, confusion, drowsiness, weakness, dizziness, fast heartbeat, sweating, tremor, and nausea. Carry a piece of non-dietetic hard candy or glucose tablets with you in case you have low blood sugar.

Serious side effects may include decreased lung function, lung cancer, and low potassium in your blood (hypokalemia). Your doctor should check your lung function before and during treatment.

Other less serious side effects are more likely to occur, such as:

• cough, sore throat;
• runny or stuffy nose;
• dry mouth; or
• ear pain.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.

Use the medication as soon as you remember. If it is almost time for the next dose, skip the missed dose and wait until your next regularly scheduled dose. Do not use extra medicine to make up the missed dose.

If you use Exubera as meal-time insulin and you forget to use your dose before a meal, use the insulin when you remember and wait 10 minutes before eating.

Symptoms of an Exubera overdose may be the same as signs of low blood sugar: confusion, drowsiness, weakness, fast heartbeat, sweating, tremor, and nausea.

Avoid letting your blood sugar get too low, causing hypoglycemia. Know the signs and symptoms of hypoglycemia, which include headache, confusion, drowsiness, weakness, dizziness, fast heartbeat, sweating, tremor, and nausea. Carry a piece of non-dietetic hard candy or glucose tablets with you in case you have low blood sugar.

There are many other drugs that can potentially interfere with the glucose-lowering effects of this medicine. Taking certain diabetes pills called thiazolidinediones (TZDs) with this medicine may cause or worsen heart failure. It is extremely important that you tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

If you use other inhaled medications, use them before using Exubera.