insulin regular human 4 unit (90)/8 unit (90) cartridge with inhaler

Generic name:
Insulin powder inhaler - oral inhalation

Pronunciation
(IN-su-lin)

Brand name(s)
Afrezza

This medication can cause trouble breathing in people with long-term (chronic) lung disease (such as asthma, chronic obstructive pulmonary disease-COPD). This medication should not be used by people with chronic lung problems. Tell your doctor right away if you have cough that doesn't go away, trouble breathing, shortness of breath, or wheezing.

Your doctor will check your lung function before you start using this medication. (See also Notes section.)

Inhaled insulin powder is used with a proper diet and exercise program to control high blood sugar in people with diabetes. Controlling high blood sugar helps prevent kidney damage, blindness, nerve problems, loss of limbs, and sexual function problems. Proper control of diabetes may also lessen your risk of a heart attack or stroke.

This man-made insulin product is the same as human insulin. It replaces the insulin that your body would normally make. It is a short-acting insulin. It works by helping blood sugar (glucose) get into cells so your body can use it for energy. This product is absorbed into the blood through your lungs. It starts working faster and lasts for a shorter time than regular insulin injected under the skin. It is usually used in combination with a medium- or long-acting insulin product. This medication may also be used alone or with other oral diabetes drugs (such as metformin).

Read the Medication Guide and Instructions for Use Leaflet provided by your pharmacist before you start using inhaled insulin and each time you get a refill. Follow the illustrated directions for the proper use of this medication. If you have any questions, ask your doctor, diabetes educator, or pharmacist.

This medication comes in cartridges in a blister package. Do not try to open the cartridges. The inhaler opens the blister/cartridge containing the insulin powder, allowing the insulin to be inhaled. Bring the medication and inhaler to room temperature before using. Follow your doctor's directions carefully.

Inhale this medication by mouth at the beginning of a meal as directed by your doctor. Because inhaled insulin is fast-acting, not eating immediately after inhaling a dose of this insulin may lead to low blood sugar.

The dosage is based on your medical condition and response to treatment.

Do not change brands or types of insulin without directions on how to do so from your doctor.

Use this medication regularly to get the most benefit from it. To help you remember, use it at the same times each day.

Check your blood sugar regularly as directed by your doctor. Keep track of your results and share them with your doctor. This is very important in order to determine the correct insulin dose.

Tell your doctor if your condition does not get better or if it gets worse (your blood sugar is too high or too low).

See also Warning section.

Weight gain, cough or throat pain/irritation may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including:

• signs of low potassium level in the blood (such as muscle cramps, weakness, irregular heartbeat)

This medication can cause low blood sugar (hypoglycemia). This may occur if you do not consume enough calories from food or if you do unusually heavy exercise. Symptoms of low blood sugar include sudden sweating, shaking, fast heartbeat, hunger, blurred vision, dizziness, or tingling hands/feet. It is a good habit to carry glucose tablets or gel to treat low blood sugar. If you don't have these reliable forms of glucose, rapidly raise your blood sugar by eating a quick source of sugar such as table sugar, honey, or candy, or drink fruit juice or non-diet soda. Tell your doctor right away about the reaction and the use of this product. To help prevent low blood sugar, eat meals on a regular schedule, and do not skip meals. Check with your doctor or pharmacist to find out what you should do if you miss a meal.

Symptoms of high blood sugar (hyperglycemia) include increased thirst/urination. If these symptoms occur, tell your doctor right away. Your doctor may need to adjust your diabetes medication, exercise program, or diet.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including:

• rash
• itching/swelling (especially of the face/tongue/throat)
• severe dizziness
• trouble breathing

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

See also Warning section.

Before using inhaled insulin, tell your doctor or pharmacist if you are allergic to it; or to other insulins; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Do not use this medication when you have low blood sugar.

Before using this medication, tell your doctor or pharmacist your medical history, especially of:

• smoking (either currently or recently)
• kidney disease
• liver disease
• thyroid problems
• lung cancer

You may experience blurred vision, dizziness, or drowsiness due to extremely low or high blood sugar. Do not drive, use machinery, or do anything that needs alertness or clear vision until you are sure you can perform such activities safely.

Limit alcohol while taking this medication because it can increase your risk of developing low blood sugar.

It may be harder to control your blood sugar when your body is stressed (such as due to fever, infection, injury, or surgery). Consult your doctor because this may require a change in your treatment plan, medications, or blood sugar testing.

Check your blood sugar before and after exercise. You may need a snack before exercising.

If traveling across time zones, ask your doctor about how to adjust your insulin schedule. Take extra insulin with you.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Older adults may be more sensitive to the side effects of this drug, especially low blood sugar.

Tell your doctor if you are pregnant before using this medication. Pregnancy may cause or worsen diabetes. Discuss a plan with your doctor for managing your blood sugar while pregnant. Your doctor may change your diabetes treatment during your pregnancy (such as diet and medications including insulin).

This medication passes into breast milk, but is unlikely to harm a nursing infant. Consult your doctor before breastfeeding. Your insulin needs may change while breastfeeding.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Beta-blocker medications (such as metoprolol, propranolol, glaucoma eye drops such as timolol) may prevent the fast/pounding heartbeat you would usually feel when your blood sugar falls too low (hypoglycemia). Other symptoms of low blood sugar, such as dizziness, hunger, or sweating, are unaffected by these drugs.

Many drugs can affect your blood sugar levels, making it more difficult to control your blood sugar. Before you start, stop, or change any medication, talk with your doctor or pharmacist about how the medication may affect your blood sugar. Check your blood sugar regularly as directed by your doctor. Tell your doctor about the results and of any symptoms of high or low blood sugar. (See also Side Effects section.) Your doctor may need to adjust your diabetes medication, exercise program, or diet.

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call 1-800-222-1222. Canada residents can call 1-844-764-7669. Symptoms of overdose may include: shakiness, fast heartbeat, sweating, loss of consciousness.

Do not share this medication with others.

Attend a diabetes education program to learn more about how to manage your diabetes with medications, diet, exercise, and regular medical exams.

Learn the symptoms of high and low blood sugar and how to treat low blood sugar. Check your blood sugar regularly as directed.

Lab and/or medical tests (such as pulmonary function/spirometry, liver and kidney function tests, fasting blood glucose, hemoglobin A1c, complete blood counts) should be done before you start taking this medication and while you are taking it. Keep all medical and lab appointments. Consult your doctor for more details.

It is very important to follow your insulin regimen exactly. Ask your doctor ahead of time what you should do if you miss a dose of insulin.

Store the unopened medication in the refrigerator. Once opened, check the product package for instructions on how to store your medication and inhaler, or ask your pharmacist. Discard the inhaler after 15 days. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

Your condition can cause complications in a medical emergency. For information about enrolling in MedicAlert, call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).

HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.