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AFREZZA- insulin human powder, meteredAFREZZA- insulin human kit


  1. Patient Information
  2. Afrezza Can Cause Serious Side Effects, Including:
  3. What Is Afrezza?
  4. Do Not Use Afrezza If You:
  5. Before Using Afrezza, Tell Your Healthcare Provider About All Your Medical Conditions, Including If You:
  6. How Should I Use Afrezza?
  7. Your Dose Of Afrezza May Need To Change Because Of:
  8. While Using Afrezza Do Not:
  9. Active Ingredient:
  10. Inactive Ingredients:

Patient Information 

Advise the patient to read the FDA-approved patient labeling (Medication Guide and Instructions for Use).

Instructions

Instruct patients to read the Medication Guide before starting AFREZZA therapy and to reread it each time the prescription is renewed, because information may change. Instruct patients to inform their healthcare provider or pharmacist if they develop any unusual symptom, or if any known symptom persists or worsens.

Inform patients of the potential risks and benefits of AFREZZA and of alternative modes of therapy. Inform patients about the importance of adherence to dietary instructions, regular physical activity, periodic blood glucose monitoring and HbA1c testing, recognition and management of hypoglycemia and hyperglycemia, and assessment for diabetes complications. Advise patients to seek medical advice promptly during periods of stress such as fever, trauma, infection, or surgery, as medication requirements may change.

Instruct patients to use AFREZZA only with the AFREZZA inhaler.

Inform patients that the most common adverse reactions associated with the use of AFREZZA are hypoglycemia, cough, and throat pain or irritation.

Advise women with diabetes to inform their physician if they are pregnant or are planning to become pregnant while using AFREZZA.

Acute Bronchospasm in Patients with Chronic Lung Disease

Advise patients to inform their physicians if they have a history of lung disease, because AFREZZA should not be used in patients with chronic lung disease (e.g., asthma, COPD, or other chronic lung disease(s))[seeContraindications (4)andWarnings and Precautions (5.1)].

Advise patients that if they experience any respiratory difficulty after inhalation of AFREZZA, they should report it to their physician immediately for assessment.

Hypoglycemia

Instruct patients on self-management procedures including glucose monitoring, proper inhalation technique, and management of hypoglycemia and hyperglycemia especially at initiation of AFREZZA therapy. Instruct patients on handling of special situations such as intercurrent conditions (illness, stress, or emotional disturbances), an inadequate or skipped insulin dose, inadvertent administration of an increased insulin dose, inadequate food intake, and skipped meals.

Instruct patients on the management of hypoglycemia. Inform patients that their ability to concentrate and react may be impaired as a result of hypoglycemia. Advise patients who have frequent hypoglycemia or reduced or absent warning signs of hypoglycemia to use caution when driving or operating machinery[seeWarnings and Precautions (5.3)].

Decline in Pulmonary Function and Monitoring

Inform patients that AFREZZA can cause a decline in lung function and their lung function will be evaluated by spirometry before initiation of AFREZZA treatment[seeWarnings and Precautions (5.4)].

Lung Cancer

Inform patients to promptly report any signs or symptoms potentially related to lung cancer[seeWarnings and Precautions (5.5)].

Diabetic Ketoacidosis

Instruct patients to carefully monitor their blood glucose during illness, infection, and other risk situations for diabetic ketoacidosis and to contact their healthcare provider if their blood glucose control worsens[seeWarnings and Precautions (5.6)].

Hypersensitivity Reactions

Advise patients that hypersensitivity reactions can occur with insulin therapy including AFREZZA. Inform patients on the symptoms of hypersensitivity reactions[seeWarnings and Precautions (5.7)].

AFREZZA is a registered trademark owned by MannKind Corporation
Patented: http://www.mannkindcorp.com/research-development/patent-notices

MannKind Corporation
Danbury, CT 06810

Afrezza Can Cause Serious Side Effects, Including: 

  • Sudden lung problems (bronchospasms). Do not use AFREZZA if you have long-term (chronic) lung problems such as asthma or chronic obstructive pulmonary disease (COPD).Before starting AFREZZA, your healthcare provider will give you a breathing test to check how your lungs are working.

What Is Afrezza? 

  • AFREZZA is a man-made insulin that is breathed-in through your lungs (inhaled) and is used to control high blood sugar in adults with diabetes mellitus.
  • AFREZZA is not for use in place of long-acting insulin. AFREZZA must be used with long-acting insulin in people who have type 1 diabetes mellitus.
  • AFREZZA is not for use to treat diabetic ketoacidosis.
  • It is not known if AFREZZA is safe and effective for use in people who smoke. AFREZZA is not for use in people who smoke or have recently stopped smoking (less than 6 months).
  • It is not known if AFREZZA is safe and effective in children under 18 years of age.

Do Not Use Afrezza If You: 

  • Have chronic lung problems such as asthma or COPD.
  • Are allergic to regular human insulin or any of the ingredients in AFREZZA.

Before Using Afrezza, Tell Your Healthcare Provider About All Your Medical Conditions, Including If You: 

  • Have lung problems such as asthma or COPD
  • Have or have had lung cancer
  • Are using any inhaled medications
  • Smoke or have recently stopped smoking
  • Have kidney or liver problems
  • Are pregnant, planning to become pregnant, or are breastfeeding. AFREZZA may harm your unborn or breastfeeding baby.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins or herbal supplements.

Before you start using AFREZZA, talk to your healthcare provider about low blood sugar and how to manage it.

How Should I Use Afrezza? 

  • Read the detailedInstructions for Usethat comes with your AFREZZA.
  • Take AFREZZA exactly as your healthcare provider tells you to. Your healthcare provider should tell you how much AFREZZA to use and when to use it.
  • Know the strength of AFREZZA you use.Do notchange the amount of AFREZZA you use unless your healthcare provider tells you to.
  • Take AFREZZA at the beginning of your meal.
  • Check your blood sugar levels.Ask your healthcare provider what your blood sugar should be and when you should check your blood sugar levels.
  • Keep AFREZZA and all medicines out of the reach of children.

Your Dose Of Afrezza May Need To Change Because Of: 

  • Change in level of physical activity or exercise, weight gain or loss, increased stress, illness, change in diet, or because of other medicines you take.

While Using Afrezza Do Not: 

  • Drive or operate heavy machinery, until you know how AFREZZA affects you
  • Drink alcohol or use over-the-counter medicines that contain alcohol
  • Smoke

Active Ingredient: 

human insulin

Inactive Ingredients: 

fumaryl diketopiperazine, polysorbate 80

AFREZZAis a registered trademark owned by MannKind Corporation

Patented: http://www.mannkindcorp.com/research-development/patent-notices

MannKind Corporation, Danbury, CT 06810

For more information, go to www.AFREZZA.com or call MannKind Corp. 1-877-323-8505.

This Medication Guide has been approved by the U.S. Food and Drug Administration.

Revised 10/2018



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