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US-AFR-1262

Important Safety Information for Afrezza® (insulin human) Inhalation Powder

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.

 

Important Safety Information

What is the most important information I should know about Afrezza®?

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.

  • 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®. See the end of this Medication Guide for a complete list of 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.

  • Read the detailed Instructions for Use that 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 not change 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.

  • 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.

Afrezza® may cause serious side effects that can lead to death, including:

See “What is the most important information I should know about Afrezza®?” at the top of this page.

  • Low blood sugar (hypoglycemia). Signs and symptoms that may indicate low blood sugar include:

    • Dizziness or light-headedness, sweating, confusion, headache, blurred vision, slurred speech, shakiness, fast heartbeat, anxiety, irritability or mood change, hunger.
  • Decreased lung function. Your healthcare provider should check how your lungs are working before you start using Afrezza®, 6 months after you start using it and yearly after that.
  • Lung cancer. In studies of Afrezza® in people with diabetes, lung cancer occurred in a few more people who were taking Afrezza® than in people who were taking other diabetes medications. There were too few cases to know if lung cancer was related to Afrezza®. If you have lung cancer, you and your healthcare provider should decide if you should use Afrezza®.
  • Diabetic ketoacidosis. Talk to your healthcare provider if you have an illness. Your Afrezza® dose or how often you check your blood sugar may need to be changed.
  • Severe allergic reaction (whole body reaction). Get medical help right away if you have any of these signs or symptoms of a severe allergic reaction:

    • A rash over your whole body, trouble breathing, a fast heartbeat, or sweating.
  • Low potassium in your blood (hypokalemia).
  • Heart failure. Taking certain diabetes pills called thiazolidinediones or “TZDs” with Afrezza® may cause heart failure in some people. This can happen even if you have never had heart failure or heart problems before. If you already have heart failure it may get worse while you take TZDs with Afrezza®. Your healthcare provider should monitor you closely while you are taking TZDs with Afrezza®. Tell your healthcare provider if you have any new or worse symptoms of heart failure including:

    • Shortness of breath, swelling of your ankles or feet, sudden weight gain.

Treatment with TZDs and Afrezza® may need to be changed or stopped by your healthcare provider if you have new or worse heart failure.

Get emergency medical help if you have:

• Trouble breathing, shortness of breath, fast heartbeat, swelling of your face, tongue, or throat, sweating, extreme drowsiness, dizziness, confusion.

The most common side effects of Afrezza® include:

  • Low blood sugar (hypoglycemia), cough, sore throat

These are not all the possible side effects of Afrezza®. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 (1-800-332-1088).

Active ingredient: human insulin

Inactive ingredients: fumaryl diketopiperazine, polysorbate 80

General information about the safe and effective use of Afrezza®.

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use Afrezza® for a condition for which it was not prescribed. Do not give Afrezza® to other people, even if they have the same symptoms that you have. It may harm them.

This Medication Guide summarizes the most important information about Afrezza®. If you would like more information, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information about Afrezza® that is written for health professionals.


AFREZZA®, MANNKIND, and the Afrezza® and MannKind logos are registered marks, all owned by MannKind Corporation. © MannKind Corporation 2020.
This site is intended for use by U.S. residents only

AFREZZA® (INSULIN HUMAN) INHALATION POWER
SAVINGS PROGRAM TERMS AND CONDITIONS

With the Afrezza® Savings Card, an eligible, commercially-insured patient age 18 years and older can receive one of the following two offers:

Bridge Offer: If the patient’s health plan requires a prior authorization and/or appeal(s) to obtain coverage for Afrezza, the patient can qualify for the Bridge Offer and receive Afrezza for $15 for each 30-day supply for up to 4 fills, while coverage is being pursued. By participating in this offer, patient acknowledges intent to pursue insurance coverage for Afrezza with their healthcare provider. For the 5th and subsequent fills, patients must have obtained coverage through their commercial insurance plan to receive the Copay Offer. Maximum limits apply. See full Terms and Conditions below.

Copay Offer: If coverage for Afrezza (insulin human) Inhalation Powder is approved by the patient’s health plan, a patient can qualify for the Copay Offer and pay as little as $15 per fill (saving as much as $1500 per month), up to a maximum of 12 fills annually. Maximum limits apply. See full Terms and Conditions below.

By participating in the Afrezza Savings Card program, you acknowledge that you are an eligible patient, age 18 years or older, and that you understand and agree to comply with the terms and conditions of this offer, as described in further detail below.

Terms and Conditions for Bridge Offer: Afrezza® for $15 per month for up to 4 fills. Patient must be prescribed Afrezza (insulin human) Inhalation Powder. If commercial coverage for Afrezza is available under patients insurance, but subject to prior authorization, patient can receive Afrezza for $15 for a 30-day supply for up to 4 fills, while pursuing approval from their health plan. Available if patient is commercially insured and 18 years or older. This offer is not valid if patient is receiving prescription reimbursement under any federal-, state-, or government-funded healthcare program, such as Medicare, Medicare Advantage, Medicare Part D, Medicaid, Medigap, Veterans Affairs (VA), the Department of Defense (DoD), or TRICARE or where prohibited by law. If at any time patient begins receiving coverage under any such federal-, state-, or government-funded healthcare program, patient will no longer be able to use this offer and patient must call 1-844-3AFREZZA / 1-844-323-7399  to discontinue participation. Once insurance approval is obtained, patient is no longer eligible for the Bridge Offer and will automatically be enrolled into the Copay Offer. Patient may not seek reimbursement for value received from this offer from any third-party payers, including flexible spending accounts or healthcare savings accounts. Other restrictions may apply. By participating in this offer, patient acknowledges intent to pursue insurance coverage for Afrezza with their healthcare provider. Once insurance approval is obtained, patient is no longer eligible for the Bridge Offer. No purchase necessary. This offer is subject to change or discontinuation without notice. This is not health insurance and participation is not a guarantee of insurance coverage. This offer is not renewable. Valid in the United States, Puerto Rico, and the US territories.

Maximum Quantities Allowed Under Bridge Offer:
NDC 47918-0874-90, 47918-0878-90; NDC 47918-0891-90: Max 270 cartridge
NDCs 47918-0880-18; NDC 47918-0902-18; NDC 47918-0898-18: Max 540 cartridges

Terms and Conditions for Copay Offer: Pay as little as $15 for Afrezza® per month, up to a maximum savings of $1500. Patient must be prescribed Afrezza (insulin human) Inhalation Powder. Patient will pay as little as $15 per month (saving as much as $1500 per month), up to a maximum of 12 fills annually. The Copay Offer applies to patient out-of-pocket costs, including deductible, co-insurance, and copayments for Afrezza. Patient is responsible for the first $15 and any costs above the maximum benefit limit. Available if patient is commercially insured and 18 years or older. This offer is not valid if patient is receiving prescription reimbursement under any federal-, state-, or government-funded healthcare program, such as Medicare, Medicare Advantage, Medicare Part D, Medicaid, Medigap, Veterans Affairs (VA), the Department of Defense (DoD), or TRICARE or where prohibited by law. If at any time patient begins receiving coverage under any such federal-, state-, or government-funded healthcare program, patient will no longer be able to use this offer and patient must call 1-844-3AFREZZA / 1-844-323-7399 to discontinue participation. Patient may not seek reimbursement for value received from this offer from any third-party payers, including flexible spending accounts or healthcare savings accounts. Other restrictions may apply. This offer is subject to change or discontinuation without notice. This is not health insurance. If you become aware that your health plan or pharmacy benefit manager does not allow the use of manufacturer copay support as part of your health plan design, you agree to comply with your obligations, if any, to disclose your use of the card to your insurer. Offer benefits will reset annually; on-going participation may require periodic re-enrollment. Valid in the United States, Puerto Rico, and the US territories.

Maximum Quantities Allowed Under Copay Offer:
NDC 47918-0874-90, 47918-0878-90; NDC 47918-0891-90:
Max 810 cartridges/ 90 Day Supply
NDCs 47918-0880-18; NDC 47918-0902-18; NDC 47918-0898-18:
Max 1,620 cartridges/ 90 Day Supply

For additional questions regarding program benefits, terms, conditions or participation requirements, please contact 1-844-3AFREZZA / 1-844-323-7399.