FDA Approves New AFREZZA® Prescribing Info

What’s New with the AFREZZA Prescribing Information?

 

The information below is for general reference only. If you have questions on the use of Afrezza and if it is appropriate for you, please speak to your healthcare provider.

 

On September 29, 2017  we announced that the U.S. Food & Drug Administration (FDA) approved an update to the Afrezza prescribing information. This includes new clinical data that was presented at the American Diabetes Association’s 76th Scientific Sessions in June 2016. Afrezza (insulin human) inhalation powder is approved by the FDA to improve glycemic control in adult patients with diabetes mellitus. It is the only inhaled rapid-acting mealtime insulin available in the United States. Afrezza is dosed at the beginning of a meal and begins to appear in the blood in approximately one minute¹.

 

Key highlights of the label update:

 

  1. Inclusion of study data that describe the time-action profile by dosage strength, showing first measurable effect starts in approximately 12 minutes, peak effects occur approximately 35 to 45 minutes after dosing and return to baseline after approximately 1.5 to 3 hours for the 4 and 12 unit cartridges respectively.
  2. Clarity on “Starting” and “Adjusting” mealtime dose.
  3. Updated pregnancy and lactation section to conform to current FDA label guidance.

 

Details of the label update:

 

1) Clinical Pharmacology (Section 12): The basis of this label change comes from a randomized, controlled, six-treatment, crossover dose-response study comparing Afrezza to the rapid-acting insulin analog, lispro, in 30 patients with type 1 diabetes. The data highlighted below demonstrates the importance of understanding the time to peak effect and time for effect to return to baseline.

 

 

Parameter for Insulin Effect AFREZZA 4 units AFREZZA 12 units
Time to first measurable effect ~12 minutes ~12 minutes
Time to peak effect ~35 minutes ~45 minutes
Time for effect to return to baseline ~90 minutes ~180 minutes

 

For the 48 unit dose, the time to first measurable effect is ~12 minutes, time to peak effect ~55 minutes, and time for effect to return to baseline is ~4.5 hours.

 

 

2) Dosage and Administration (Section 2): The Dosing Information section has been updated with “Step 1” to inform how patients on injected mealtime insulin should initially be dosed on Afrezza (Figure 1). Additionally, “Step 2” was added to highlight that mealtime dose adjustments may be required based on the individual metabolic needs and glycemic control goals.

 

Figure 1. Mealtime AFREZZA Starting Dose Conversion Table

Starting Afrezza Dosing Table

 

 

3) Use in Specific Populations (Section 8): The Pregnancy and Lactation sections of the label have been updated to conform to the current FDA label guidance. These areas have been configured to provide healthcare providers with clearer risk benefit information for informed decision making in these populations.

 

REFERENCES
(1) Data on file, MannKind Corporation

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 perform a detailed medical history, physical examination, and will give you a breathing test (called spirometry) to check how your lungs are working.

AFREZZA is a man-made rapid-acting inhaled insulin breathed in through your lungs and is used to control high blood sugar in adults with diabetes. AFREZZA is available by prescription only.

  • 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.
  • 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.
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 perform a detailed medical history, physical examination, and will give you a breathing test (called spirometry) to check how your lungs are working.

Who should not use AFREZZA?

Do not use AFREZZA:

  • During episodes of low blood sugar (hypoglycemia).
  • If you have chronic lung problems such as asthma or COPD.
  • If you are allergic to regular human insulin or any of the ingredients of AFREZZA as this may cause a significant and severe allergic reaction.

What should I tell my healthcare provider before using 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 detailed Instructions for Use that comes with your AFREZZA.
  • Take AFREZZA exactly as your healthcare provider tells you to, including 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 level should be and when you should check your blood sugar levels.
  • Keep AFREZZA and all medicines out of 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.

What should I avoid while using AFREZZA?

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.

What are the possible side effects of AFREZZA?

AFREZZA may cause serious side effects that can lead to death including:

  • Low blood sugar (hypoglycemia). Signs and symptoms of 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 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 (TZDs) with AFREZZA may cause heart failure in some people. This can happen even if you 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 are low blood sugar (hypoglycemia), cough, sore throat, headache, diarrhea, tiredness and nausea.

These are not all the possible side effects of AFREZZA. Call your doctor for medical advice about side effects.

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.

Please click here for full Prescribing Information, including Boxed WARNING, Medication Guide, and Instructions for Use for AFREZZA.

*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. MannKind Corporation 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 855-262-5296, or if you have questions about AFREZZA, talk to your healthcare professional.