Exubera PowderGeneric Name:
Insulin (IN-su-lin)Brand Name:
Exubera Powder is used for:
Treating diabetes mellitus. Certain patients (type 1 and some type 2 diabetic patients) may need to use Exubera Powder with a longer-acting form of insulin or with other oral antidiabetic medicines.
Exubera Powder is a fast-acting form of hormone insulin. It works by helping your body to use sugar properly. This lowers the amount of glucose in the blood, which helps to treat diabetes.
Do NOT use Exubera Powder if:
- you are allergic to any ingredient in Exubera Powder
- you are having an episode of low blood sugar
- you have uncontrolled or poorly controlled lung or breathing problems
- you smoke or you stopped smoking less than 6 months ago
Contact your doctor or health care provider right away if any of these apply to you.
Before using Exubera Powder:
Some medical conditions may interact with Exubera Powder. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
- if you are pregnant, planning to become pregnant, or are breast-feeding
- if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
- if you have allergies to medicines, foods, or other substances
- if you drink alcoholic beverages, smoke, or are regularly exposed to secondhand smoke
- if you have adrenal, pituitary, or thyroid problems; diabetic ketoacidosis; kidney or liver problems; lung or breathing problems (eg, chronic obstructive pulmonary disease [COPD], asthma, bronchitis); nerve problems; respiratory infection; or runny or stuffy nose
- if you use 3 or more insulin injections per day
- if you are fasting, have high blood sodium levels, or are on a low-salt diet
Some MEDICINES MAY INTERACT with Exubera Powder. Tell your health care provider if you are taking any other medicines, especially any of the following:
- Beta-blockers (eg, propranolol), clonidine, guanethidine, lithium, or reserpine because they may increase the risk of high or low blood sugar or may hide the signs and symptoms of low blood sugar if it occurs
- Angiotensin-converting enzyme (ACE) inhibitors (eg, enalapril), disopyramide, fenfluramine, fibrates (eg, clofibrate, gemfibrozil), fluoxetine, monoamine oxidase inhibitors (MAOIs) (eg, phenelzine), oral medicine for diabetes (eg, glipizide, metformin, nateglinide), pentamidine, pentoxifylline, propoxyphene, salicylates (eg, aspirin), somatostatin analogs (eg, octreotide), or sulfonamide antibiotics (eg, sulfamethoxazole) because the risk of low blood sugar may be increased
- Atypical antipsychotics (eg, clozapine, olanzapine), corticosteroids (eg, prednisone), danazol, diazoxide, diuretics (eg, furosemide, hydrochlorothiazide), estrogen, glucagon, HIV protease inhibitors (eg, ritonavir), hormonal contraceptives (eg, birth control pills), isoniazid, niacin, phenothiazines (eg, chlorpromazine), progesterones (eg, medroxyprogesterone), somatropin, sympathomimetics (eg, albuterol, epinephrine, terbutaline), or thyroid hormones (eg, levothyroxine) because they may decrease Exubera Powder's effectiveness, resulting in high blood sugar
This may not be a complete list of all interactions that may occur. Ask your health care provider if Exubera Powder may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.
How to use Exubera Powder:
Use Exubera Powder as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- Exubera Powder comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Exubera Powder refilled.
- If you are using Exubera Powder with meals, use your dose within 10 minutes before the meal begins unless your doctor tells you otherwise.
- A health care provider will teach you how to use Exubera Powder. Be sure you understand how to use Exubera Powder. Follow the procedures you are taught when you use a dose. Contact your health care provider if you have any questions.
- Be sure that you have blisters that contain the correct amount of medicine that you need. Do NOT use three 1 mg blisters in place of one 3 mg blister. If you need a 3 mg blister and do not have one, use two 1 mg blisters unless your doctor tells you otherwise.
- Do NOT open the medicine blister or swallow Exubera Powder. Exubera Powder is a powder for inhalation into the lungs. Use it only with the inhaler device provided. Do not use it with any other type of inhaler device.
- To prepare the inhaler device - Hold it so that the words " Exubera Inhaler" face you. Pull the black ring at the bottom of the base to pull the base out of the chamber. You should hear a click when the inhaler device is fully extended. The bottom of the chamber must be above the gray button.
- To load the inhaler device - Hold a medicine blister with the printed side up and the notch pointed toward the inhaler. Insert it into the slot on the inhaler device. Push it in as far as it will go. Make sure the mouthpiece is closed. Pull the blue handle out from the bottom as far as it will go, and then squeeze the blue handle until it snaps shut.
- To use Exubera Powder - Stand or sit up straight. Hold the inhaler upright, with the blue button facing toward you. Push the blue button until it clicks and watch for the insulin cloud to fill the chamber.
- After the cloud appears, breathe out normally and turn the mouthpiece so that it is facing toward you. Place the mouthpiece fully in your mouth and form a seal around the mouthpiece with your lips. Do NOT blow into the mouthpiece. Do not block the opening with your tongue or teeth. Breathe in slowly and deeply through your mouth to inhale the insulin cloud and then take the inhaler device out of your mouth. Close your mouth and hold your breath for 5 seconds, and then breathe out normally.
- Turn the mouthpiece to the closed position. Press the gray button, pull out the used medicine blister, and throw it away. Do not reuse a medicine blister. If you need to inhale another blister to complete your dose, repeat the steps above. Inhale only one blister at a time.
- To store the inhaler device - Squeeze the 2 chamber release buttons on the side of the base at the same time. Push the base back into the chamber.
- Carefully follow the instructions for cleaning and caring for the inhaler device. Replace the Exubera release unit every 2 weeks to ensure that the inhaler device will work properly.
- Exubera Powder begins to lower blood sugar about 10 to 20 minutes after you use a dose. The peak effect occurs about 2 hours after you use a dose. The effect of Exubera Powder lasts for up to 6 hours.
- If you also use bronchodilators or other inhaled products, they may increase the risk of high or low blood sugar. It is important to time your doses consistently with regard to Exubera Powder. Ask your doctor how to use bronchodilators or other inhaled products with Exubera Powder.
- It is very important to follow your insulin regimen exactly. Do NOT miss any doses. Ask your doctor for specific instructions to follow in case you ever miss a dose of insulin.
Ask your health care provider any questions you may have about how to use Exubera Powder.
Important safety information:
- Exubera Powder may cause drowsiness, dizziness, lightheadedness, or blurred vision. These effects may be worse if you take it with alcohol or certain medicines. Use Exubera Powder with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
- Do not drink alcohol without discussing it with your doctor. Drinking alcohol may increase your risk of developing high or low blood sugar.
- Do not smoke while you use Exubera Powder. Smoking may increase your risk of developing low blood sugar. If you start smoking while you are using Exubera Powder, contact your doctor right away.
- Do not use more than the recommended dose of Exubera Powder, use it more often than prescribed, or change the type or dose of insulin you are using without checking with your doctor.
- Any change of insulin should be made cautiously and only under medical supervision. Changes in purity, strength, brand (manufacturer), type (regular, NPH, lente), species (beef, pork, beef-pork, human), and/or method of manufacture may require a change in dose.
- Illness, especially with nausea and vomiting, may cause your insulin requirements to change. Even if you are not eating, you still require insulin. You and your doctor should establish a sick-day plan to use in case of illness. When you are sick, test your blood/urine often and call your doctor as instructed.
- Tell your doctor or dentist that you take Exubera Powder before you receive any medical or dental care, emergency care, or surgery.
- If you will be traveling across time zones, consult your doctor concerning adjustments in your insulin schedule.
- Carry an ID card at all times that says you have diabetes.
- An insulin reaction resulting from low blood sugar levels (hypoglycemia) may occur if you take too much insulin, skip a meal, or exercise too much. Low blood sugar may make you anxious, sweaty, weak, dizzy, drowsy, or faint. It may also make your heart beat faster; make your vision change; give you a headache, chills, or tremors; or make you more hungry. It is a good idea to carry a reliable source of glucose (eg, tablets or gel) to treat low blood sugar. If this is not available, you should eat or drink a quick source of sugar like table sugar, honey, candy, orange juice, or non-diet soda. This will raise your blood sugar level quickly. Tell your doctor right away if this happens. To prevent low blood sugar, eat meals at the same time each day and do not skip meals.
- Developing a fever or infection, eating significantly more than prescribed, or missing your dose of insulin may cause high blood sugar (hyperglycemia). High blood sugar may make you feel confused, drowsy, or thirsty. It can also make you flush, breathe faster, or have a fruit-like breath odor. If these symptoms occur, tell your doctor right away.
- Proper diet, regular exercise, and regular testing of blood sugar are important for best results when using Exubera Powder.
- Some people using Exubera Powder have developed lung cancer. The people who have developed lung cancer used to smoke cigarettes. It is not known if the lung cancer was related to Exubera Powder. Check with your doctor if you have any questions or concerns.
- Lab tests, including fasting blood glucose levels, hemoglobin A1c levels, and lung function, may be performed while you use Exubera Powder. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
- Use Exubera Powder with caution in the ELDERLY; if low blood sugar occurs, it may be more difficult to recognize in these patients.
- Exubera Powder should not be used in CHILDREN younger than 18 years old; safety and effectiveness in these children have not been confirmed.
- PREGNANCY and BREAST-FEEDING: It is not known if Exubera Powder can cause harm to the fetus. If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Exubera Powder while you are pregnant. It is not known if Exubera Powder is found in breast milk. If you are or will be breast-feeding while you use Exubera Powder, check with your doctor. Discuss any possible risks to your baby.
Possible side effects of Exubera Powder:
All medicines may cause side effects, but many people have no, or minor side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:
Cough; dry mouth; increased sputum production; runny or stuffy nose; sore throat.Seek medical attention right away if any of these SEVERE side effects occur:
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; wheezing; muscle pain); changes in vision; chest pain or discomfort; chills; confusion; dizziness; drowsiness; fainting; fast or irregular heartbeat; headache; loss of consciousness; mood changes; seizures; shortness of breath; slurred speech; swelling; tremor; trouble breathing; trouble concentrating; unusual hunger; unusual sweating; weakness.
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.
If OVERDOSE is suspected:
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org) or emergency room immediately. Symptoms may include chills; coma; dizziness; drowsiness; fainting; headache; increased heartbeat; loss of consciousness; nervousness; seizures; shakiness; sweating; tremor; vision changes; weakness.Proper storage of Exubera Powder:
Store Exubera Powder at 77 degrees F (25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Do NOT refrigerate or freeze. Throw away any frozen blisters. Store away from heat, moisture, and light. Do not store in the bathroom. Store inside the wrap to protect the blisters from moisture. Blisters must be used within 3 months after opening the foil wrap. The inhaler may be used for up to 1 year from the date of first use. Keep Exubera Powder out of the reach of children and away from pets.
- If you have any questions about Exubera Powder, please talk with your doctor, pharmacist, or other health care provider.
- Exubera Powder is to be used only by the patient for whom it is prescribed. Do not share it with other people.
- If your symptoms do not improve or if they become worse, check with your doctor.
This information is a summary only. It does not contain all information about Exubera Powder. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.
- Exubera Prescribing Information (FDA)
- Exubera Detailed Consumer Information (PDR)
- Exubera Consumer Overview