Afrezza inhalation

Follow all directions on your prescription label. Your doctor may occasionally change your dose. Do not use this medicine in larger or smaller amounts or for longer than recommended.

Read all patient information, medication guides, and instruction sheets provided to you. Ask your doctor or pharmacist if you have any questions.

Use insulin inhalation at the beginning of a meal.

Insulin inhalation is a powder contained inside a plastic cartridge that fits into the inhaler device supplied with this medicine. Only one cartridge can be placed in the inhaler device at one time. You may use each inhaler device for up to 15 days before replacing it with a new one.

Each blue cartridge of insulin inhalation powder is equal to 4 units of injectable insulin. Each green cartridge is equal to 8 units of injectable insulin. If your dose is more than 8 units, you will need to use more than one cartridge. Always use the least number of cartridges possible to get your correct dose. For example, if your dose is 12 units, use one 4-unit cartridge and one 8-unit cartridge to equal 12 units. For a dose of 16 units, use two 8-unit cartridges. Follow the dosing chart provided with this medicine to learn about combining cartridges to get the correct dose.

Insulin inhalation cartridges are packaged in a plastic blister card that is sealed inside a foil package. Store each unopened foil package in a refrigerator. An unopened foil package that is not refrigerated must be used within 10 days.

When you open the foil package, remove only the number of cartridges needed for your dose, put the rest of the blister card back into the foil package and return it to the refrigerator. Leave the cartridges needed for your dose at room temperature for 10 minutes before using them.

Once you have opened a foil package, you may store it at room temperature. After tearing open an individual blister-card strip, you must use the cartridges in that strip within 3 days.

While using insulin inhalation, your blood sugar will need to be checked often. You may also need to have lung function tests every 6 to 12 months.

Low blood sugar (hypoglycemia) can happen to everyone who has diabetes. Symptoms include headache, hunger, sweating, irritability, dizziness, nausea, fast heart rate, and feeling anxious or shaky. To quickly treat low blood sugar, always keep a fast-acting source of sugar with you such as fruit juice, hard candy, crackers, raisins, or non-diet soda.

Your doctor can prescribe a glucagon emergency injection kit to use in case you have severe hypoglycemia and cannot eat or drink. Be sure your family and close friends know how to give you this injection in an emergency.

Also watch for signs of high blood sugar (hyperglycemia) such as increased thirst or urination, blurred vision, headache, and tiredness.

Blood sugar levels can be affected by stress, illness, surgery, exercise, alcohol use, or skipping meals. Ask your doctor before changing your insulin dose or schedule.

Insulin is only part of a treatment program that may also include diet, exercise, weight control, regular blood sugar testing, and special medical care. Follow your doctor's instructions very closely.

Wear a diabetes medical alert tag in case of emergency. Any medical care provider who treats you should know that you have diabetes.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. Insulin overdose can cause life-threatening hypoglycemia. Symptoms include drowsiness, confusion, blurred vision, numbness or tingling in your mouth, trouble speaking, muscle weakness, clumsy or jerky movements, seizure (convulsions), or loss of consciousness.

Do not smoke while using insulin inhalation. If you start smoking, you will have to stop using insulin inhalation and switch to another form of insulin to control your blood sugar.

Insulin can cause low blood sugar. Avoid driving or operating machinery until you know how this medicine will affect you.

Avoid drinking alcohol or taking medicines that contain alcohol.

Get emergency medical help if you have signs of insulin allergy: redness or swelling where an insulin injection was given, itchy skin rash over the entire body, trouble breathing, fast heartbeats, sweating, feeling like you might pass out, or swelling in your tongue or throat.

Call your doctor at once if you have:

• bronchospasm (wheezing, chest tightness, trouble breathing);

• fluid retention--weight gain, swelling in your hands or feet, feeling short of breath; or

• low potassium--leg cramps, constipation, irregular heartbeats, fluttering in your chest, increased thirst or urination, numbness or tingling, muscle weakness or limp feeling.

Common side effects may include:

• low blood sugar;

• cough; or

• sore throat.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Many other medicines can affect your blood sugar, and some medicines can increase or decrease the effects of insulin. Some drugs can also cause you to have fewer symptoms of hypoglycemia, making it harder to tell when your blood sugar is low. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using. This includes prescription and over-the-counter medicines, vitamins, and herbal products.

You should not use Afrezza inhalation if you are allergic to insulin, or if you are having an episode of hypoglycemia (low blood sugar).

Afrezza can cause sudden or serious lung problems. Do not use this medicine if you have:

• chronic lung disease, such as asthma or chronic obstructive pulmonary disease (COPD); or

• diabetic ketoacidosis (call your doctor for treatment).

Do not use Afrezza if you smoke or have recently quit smoking (within the past 6 months).

In studies with Afrezza, lung cancer occurred in a small number of people. It is not clear whether this medicine was the actual cause of lung cancer. Your doctor will perform lung function tests before and during your treatment with Afrezza.

Afrezza is not approved for use by anyone younger than 18 years old.

To make sure Afrezza is safe for you, tell your doctor if you have ever had:

• asthma, COPD, or other breathing problems;

• lung cancer;

• liver or kidney disease; or

• if you use other inhaled medicines.

Tell your doctor if you also take pioglitazone or rosiglitazone (sometimes contained in combinations with glimepiride or metformin). Taking certain oral diabetes medicines while you are using insulin may increase your risk of serious heart problems.

It is not known whether Afrezza will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

It is not known whether insulin inhalation passes into breast milk or if it could harm a nursing baby. You should not breast-feed while using Afrezza.

Many other medicines can affect your blood sugar, and some medicines can increase or decrease the effects of insulin. Some drugs can also cause you to have fewer symptoms of hypoglycemia, making it harder to tell when your blood sugar is low. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using. This includes prescription and over-the-counter medicines, vitamins, and herbal products.

Applies to insulin inhalation, rapid acting: inhalation powder

Respiratory

In clinical trials of up to 2 years duration, a 15% or greater reduction in forced expiratory volume (FEV1) occurred in 6% of patients treated with inhaled insulin compared with a 3% decline in patients receiving comparator anti-diabetes treatment. Patients with chronic lung disease were not included in these studies. The FEV1 decline occurred during the first 3 months and persisted; it did not appear to worsen with increased duration of use. The changes in FEV1 were similar in patients with type 1 and type 2 diabetes mellitus.[Ref]

Very common (10% or more): Cough (25.6% to 29.4%)
Common (1% to 10%): Bronchitis, productive cough, decreased pulmonary function test[Ref]

Metabolic

Very common (10% or more): Hypoglycemia, non-severe (67%)
Common (1% to 10%): Hypoglycemia, severe
Uncommon (0.1% to 1%): Diabetic ketoacidosis
Frequency not reported: Weight gain[Ref]

Diabetic ketoacidosis:
In patients with type 1 diabetes, diabetic ketoacidosis occurred in 0.43% (n= 13) of patients who received inhaled insulin compared with 0.14% (n=3) of patients receiving subcutaneous insulin.

Hypoglycemia:
The incidence of non-severe hypoglycemia in patients with type 2 diabetes was 67%. The incidence of severe hypoglycemia was reported at 5.1%. A severe episode was defined as a hypoglycemic event requiring assistance of another person and associated with either a blood glucose value consistent with hypoglycemia or prompt recovery following treatment. A non-severe episode was defined as symptoms of hypoglycemia with or without a low blood glucose value. The incidence of hypoglycemia was not reported for patients with type 1 diabetes.

Weight gain:
In patients with type 2 diabetes mellitus who received inhaled insulin therapy, a mean weight gain of 0.49 kg occurred compared with a mean weight loss of 1.13 kg in placebo-treated patients.[Ref]

Gastrointestinal

Common (1% to 10%): Diarrhea, nausea[Ref]

General

The most common adverse reactions reported included hypoglycemia, cough, throat pain or irritation.

The most common reason for drug discontinuation was cough.[Ref]

Local

Common (1% to 10%): Throat pain or irritation[Ref]

Genitourinary

Common (1% to 10%): Urinary tract infection[Ref]

Oncologic

During clinical trials, 2 cases of lung cancer were reported; in both cases, heavy tobacco use was reported. Following completion of clinical trials, 2 cases of squamous cell lung cancer were reported in non-smokers.[Ref]

Frequency not reported: Lung cancer[Ref]

Other

Common (1% to 10%): Fatigue[Ref]

Psychiatric

Common (1% to 10%): Headache[Ref]

Some side effects of Afrezza may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.