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For U.S. Residents Only Afrezza (insulin human) Inhalation Powder
IMPORTANT SAFETY INFORMATION FOR AFREZZA®
WARNING: RISK OF ACUTE BRONCHOSPASM IN PATIENTS WITH CHRONIC LUNG DISEASE
  • Acute bronchospasm has been observed in patients with asthma and COPD using Afrezza®.
  • Afrezza® is contraindicated in patients with chronic lung disease such as asthma or COPD.
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Prescribing Information
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Afrezza® Inhalable Insulin

Afrezza® is a rapid acting insulin inhaled at mealtimes to improve blood sugar control in adult patients with diabetes. Do not use Afrezza® as a substitute for long-acting insulin; Afrezza® must be used in combination with long-acting insulin in patients with type 1 diabetes. Do not use Afrezza® to treat diabetic ketoacidosis. Afrezza® is not recommended in patients who smoke or who have recently stopped smoking. So ask your doctor if Afrezza® could be right for you.

Afrezza (insulin human) Inhalation Powder Inhaler

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Afrezza Prescribing Information

Afrezza® Prescribing Information

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Prescribing Information.

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Afrezza Medication Guide

Afrezza® Medication Guide

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INDICATIONS AND USAGE FOR AFREZZA®

Prescription Afrezza® is a rapid-acting inhaled insulin used to treat adults with type 1 and type 2 diabetes for the control of high blood sugar.

Limitations of Use:
  • Do not use Afrezza® as a substitute for long-acting insulin; Afrezza® must be used in combination with long-acting insulin in patients with type 1 diabetes.
  • Do not use Afrezza® to treat diabetic ketoacidosis.
  • Afrezza® is not recommended in patients who smoke or who have recently stopped smoking.

IMPORTANT SAFETY INFORMATION FOR AFREZZA®

WARNING: RISK OF ACUTE BRONCHOSPASM IN PATIENTS WITH CHRONIC LUNG DISEASE
  • Acute bronchospasm has been observed in patients with asthma and COPD using Afrezza®.
  • Afrezza® is contraindicated in patients with chronic lung disease such as asthma or COPD.
  • Before initiating Afrezza®, perform a detailed medical history, physical examination, and spirometry to identify potential lung disease in all patients.

Do not use Afrezza® if you have problems with your lungs, such as asthma or COPD. Do not use Afrezza® during a low blood sugar reaction (hypoglycemia). If you are allergic to any of the ingredients in Afrezza®, do not use Afrezza® as this may cause a significant and severe allergic reaction.

Before using Afrezza®, your doctor will take a medical history, and do a physical exam and a breathing test (called spirometry) to determine if you have lung problems. Patients with lung problems should not use Afrezza®. If your doctor finds you have lung problems, use of Afrezza® may cause a severe asthma-like breathing problem. Afrezza® can reduce lung function, so your doctor will also want to test your breathing 6 months after starting Afrezza®, and then each year after that, with more frequent testing done if you have symptoms such as wheezing or coughing. Tell your doctor if you currently have lung cancer or have had it in the past, or if you have an increased risk of developing lung cancer.

You must test your blood sugar levels while using insulin, such as Afrezza®. Do not make any changes to your dose or type of insulin without talking to your doctor. Any change of insulin should be made carefully and only under your doctor’s care.

The most common side effect of insulin, including Afrezza®, is low blood sugar (hypoglycemia), which can be serious and life-threatening. Some people may experience symptoms such as shaking, sweating, fast heartbeat, and blurred vision. It may cause harm to your heart or brain. It is important for you to understand how to manage the use of Afrezza®, and to understand how to lessen the risk of hypoglycemia events.

Tell your doctor about other medicines you take, especially ones commonly called TZDs (thiazolidinediones) and supplements, because they can change the way insulin works. If you have heart failure or other heart problems, it may get worse while you take TZDs with Afrezza®. Before starting Afrezza®, it is important to tell your doctor about all your medical conditions including if you have a history of lung problems, if you are pregnant or plan to become pregnant, or if you are breast feeding or planning to breast-feed.

In addition to low blood sugar (hypoglycemia), other possible side effects associated with Afrezza® include cough, throat pain or irritation, headache, diarrhea, tiredness, and nausea.

You are encouraged to report negative side effects of all prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

The health information contained herein is provided for general educational purposes only. Your healthcare professional is the single best source of information regarding your health. Please consult your healthcare professional if you have any questions about your health treatment.

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*Offer is not valid for patients if their prescriptions are paid in part or in full by any state or federally funded programs, including, but not limited to, Medicare or Medicaid, Medigap, VA, DOD or TriCare. Offer is not valid where prohibited by law. Sanofi US reserves the right to rescind, revoke, or amend this offer without notice. Maximum benefit is $150 per prescription depending on your out-of-pocket costs for the duration of the program. Eligibility criteria: Only patients who reside in the United States, Puerto Rico, Guam or the U.S. Virgin Islands can participate in this program. If you have any questions about this program, please call 866-991-2840, or if you have questions about Afrezza®, talk to your healthcare professional.