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APPROVED USES: AIRDUO® DIGIHALER®
(fluticasone
propionate and salmeterol) AND ARMONAIR® DIGIHALER®
(fluticasone propionate)

  • AIRDUO® DIGIHALER® (fluticasone propionate and salmeterol) inhalation powder is a prescription medicine used to control symptoms of asthma and to prevent symptoms such as wheezing in people 12 years of age and older.
  • ARMONAIR® DIGIHALER® (fluticasone propionate) inhalation powder is a prescription medicine for the long-term treatment of asthma in patients 12 years and older.
  • AIRDUO DIGIHALER and ARMONAIR DIGIHALER are not used to relieve sudden breathing problems from asthma and won't replace a rescue inhaler.

AIRDUO DIGIHALER and ARMONAIR DIGIHALER each contain a built-in electronic module that records and stores information about inhaler events. AIRDUO DIGIHALER and ARMONAIR DIGIHALER may be used with, and transmit information to, a mobile App. AIRDUO DIGIHALER and ARMONAIR DIGIHALER do not need to be connected to the app in order for you to take your medicine.

IMPORTANT SAFETY INFORMATION FOR AIRDUO DIGIHALER AND ARMONAIR DIGIHALER

  • AIRDUO DIGIHALER contains salmeterol. Long-acting beta2-agonist (LABA) medicines such as salmeterol when used alone increase the risk of hospitalizations and death from asthma problems. AIRDUO DIGIHALER contains an inhaled corticosteroid (ICS) and a LABA. When an ICS and a LABA are used together, there is not a significant increased risk in hospitalizations and death from asthma problems.
  • Do not use AIRDUO DIGIHALER or ARMONAIR DIGIHALER to treat sudden breathing problems from asthma. Always have a rescue inhaler with you to treat sudden symptoms.
  • Do not use AIRDUO DIGIHALER or ARMONAIR DIGIHALER if you have a severe allergy to milk proteins or if you are allergic to any of the ingredients in the product. Ask your healthcare provider if you are not sure.
  • Do not use AIRDUO DIGIHALER or ARMONAIR DIGIHALER more often than prescribed.
  • Do not take AIRDUO DIGIHALER with other medicines that contain a LABA for any reason.
  • Tell your healthcare provider about all the medicines you take and about all of your health conditions.
  • Do not stop using ARMONAIR DIGIHALER, even if you are feeling better, unless your healthcare provider tells you to. If you miss a dose of ARMONAIR DIGIHALER, just skip that dose. Take your next dose at your usual time. Do not take 2 doses at 1 time.
  • AIRDUO DIGIHALER and ARMONAIR DIGIHALER can cause serious side effects, including:
    • Fungal infection in your mouth or throat (thrush). Rinse your mouth with water without swallowing after using AIRDUO DIGIHALER or ARMONAIR DIGIHALER to help reduce your chance of getting thrush.
    • Weakened immune system and increased chance of getting infections (immunosuppression). You should avoid exposure to chickenpox and measles, and, if exposed, tell your healthcare provider right away. Worsening of existing tuberculosis, fungal, bacterial, viral, or parasitic infections, or herpes infection of the eye (ocular herpes simplex) may occur.
    • Reduced adrenal function. This can happen when you stop taking an oral corticosteroid (such as prednisone) and start taking a medicine containing an ICS (such as AIRDUO DIGIHALER or ARMONAIR DIGIHALER). During this transition period, when your body is under stress such as from fever, trauma (such as a car accident), infection, or surgery, adrenal insufficiency can get worse and may cause death. Symptoms of adrenal insufficiency include:
      • feeling tired
      • lack of energy
      • weakness
      • nausea and vomiting
      • low blood pressure
  • For AIRDUO DIGIHALER, there may be sudden breathing problems immediately after inhaling your medicine. If you have sudden breathing problems immediately after inhaling your medicine, stop using AIRDUO DIGIHALER and call your healthcare provider right away.
  • Serious allergic reactions. Stop using AIRDUO DIGIHALER or ARMONAIR DIGIHALER and call your healthcare provider or get emergency medical care if you get any of the following symptoms of a serious allergic reaction:
      • rash
      • hives
      • swelling of your face, mouth, and tongue
      • breathing problems
  • AIRDUO DIGIHALER can also cause additional serious side effects, including:
    • Effects on the heart
      • increased blood pressure
      • a fast or irregular heartbeat
      • chest pain
    • Effects on the nervous system
      • tremor
      • nervousness
  • AIRDUO DIGIHALER and ARMONAIR DIGIHALER can cause:
    • Bone thinning or weakness (osteoporosis)
    • Slowed growth in children. A child's growth should be checked often.
    • Eye problems including glaucoma and cataracts. You should have regular eye exams while using AIRDUO DIGIHALER or ARMONAIR DIGIHALER.
  • For AIRDUO DIGIHALER, changes may occur in laboratory blood values (sugar, potassium, certain types of white blood cells)
  • For ARMONAIR DIGIHALER increased wheezing (bronchospasm) may occur. Increased wheezing can happen right away after using ARMONAIR DIGIHALER. If this occurs, stop using ARMONAIR DIGIHALER and call your healthcare provider. Always have a rescue inhaler with you to treat sudden wheezing.
  • Common side effects of AIRDUO DIGIHALER and ARMONAIR DIGIHALER include:
    • thrush in your mouth or throat. Rinse your mouth with water without swallowing after use to help prevent this.
    • headache
    • cough
  • Additionally, AIRDUO DIGIHALER has common side effects of:
    • back pain
    • infection of nose and throat (nasopharyngitis)
  • ARMONAIR DIGIHALER has common side effects of:
    • upper respiratory tract infection
    • infection or inflammation of nose and throat (nasopharyngitis)
  • These are not all the possible side effects of AIRDUO DIGIHALER and ARMONAIR DIGIHALER. Call your healthcare provider for medical advice about side effects.
  • You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

Please see full Prescribing Information for AIRDUO DIGIHALER and ARMONAIR DIGIHALER.

APPROVED USES: PROAIR® DIGIHALER® (albuterol sulfate)

ProAir® Digihaler®
 (albuterol sulfate) Inhalation Powder is a prescription medicine used in people 4 years of age and older to:

  • treat or prevent bronchospasm in people who have reversible obstructive airway disease
  • prevent exercise-induced bronchospasm

ProAir Digihaler contains a built-in electronic module that detects, records and stores inhaler event information. ProAir Digihaler may be used with, and transmits information to, a mobile App. ProAir Digihaler does not need to be connected to the mobile app in order for you to take your medicine.

IMPORTANT SAFETY INFORMATION FOR PROAIR DIGIHALER

Do not use ProAir Digihaler (albuterol sulfate) Inhalation Powder if you are allergic to albuterol sulfate, lactose, milk proteins, or any of the ingredients in ProAir Digihaler. Ask your healthcare provider if you have any questions or are not sure

Before using ProAir Digihaler, tell your healthcare provider about all of your medical conditions, including if you:

  • have heart problems
  • have high blood pressure (hypertension)
  • have convulsions (seizures)
  • have thyroid problems
  • have diabetes
  • have low potassium levels in your blood
  • are pregnant or planning to become pregnant
  • are breastfeeding or planning to breastfeed

Tell your healthcare provider about all the medicines you take, especially:

  • other inhaled medicines or asthma medicines
  • beta blocker medicines
  • diuretics
  • digoxin
  • monoamine oxidase inhibitors
  • tricyclic antidepressants

Do not increase your dose or take extra doses of ProAir Digihaler without first talking to your healthcare provider

Get medical help right away if ProAir Digihaler no longer helps your symptoms, your symptoms get worse or you need to use your inhaler more often

While you are using ProAir Digihaler, do not use other inhaled rescue medicines and asthma medicines unless your healthcare provider tells you to do so

ProAir Digihaler may cause serious side effects, including:

      • worsening trouble breathing, coughing and wheezing (paradoxical bronchospasm). If this happens, stop using ProAir Digihaler and call your healthcare provider or get emergency help right away.
      • heart problems, including faster heart rate and higher blood pressure
      • possible death in people with asthma who use too much ProAir Digihaler
      • allergic reactions. Call your healthcare provider right away if you have any of the following symptoms of an allergic reaction:
        • itchy skin
        • swelling beneath your skin or in your throat
        • rash
        • worsening trouble breathing
      • increases in blood sugar
      • low potassium levels in your blood

The most common side effects of ProAir Digihaler include:

    • back pain
    • pain
    • upset stomach
    • sinus headache
    • urinary tract infection
    • your heart feels like it is pounding or racing (palpitations)
    • chest pain
    • fast heart rate
    • shakiness
    • nervousness
    • headache
    • dizziness
    • sore throat
    • runny nose
    • vomiting

These are not all of the possible side effects of ProAir Digihaler. For more information, ask your healthcare provider or pharmacist

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

Please see the full Prescribing Information for ProAir Digihaler.

Devices comply with part 15 of the FCC Rules. Operation is subject to the following two conditions: (1) These devices may not cause harmful interference, and (2) these devices must accept any interference received, including interference that may cause undesired operation. Changes or modifications not expressly approved by Teva could void the user’s authority to operate the equipment.

Getting Started

This menu will become active after presentation of the Approved Uses and Important Safety Information

Getting Started with the Digihaler app

Learn how to register the Digihaler app with a smartphone, view features to help track inhaler use, and find out how to share reports with your healthcare provider or caregiver. Inhaler use is recorded as an event when the cap is opened or you inhale.

See Approved Uses and Important Safety Information, including Instructions for Use, available on this site and at digihaler.com

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On 06/01/2024 Teva will discontinue distribution of the Digihaler® products in the US [ProAir® Digihaler® (albuterol sulfate) Inhalation Powder, ArmonAir® Digihaler® (fluticasone propionate) Inhalation Powder, AirDuo® Digihaler® (fluticasone propionate and salmeterol) Inhalation Powder]. As of June 1, 2024, the Digihaler app and dashboard will not be available for patients and HCPs. Patients should no longer access the app for their data..

However, people who already have and are using Digihaler inhalers can continue using them as prescribed until their expiration date. As a reminder, the prescribing information for all the Digihaler inhalers states, use of the app is not required for administration of medication from the device to the patient. Patients can still use the inhalers without accompanying app. There is no evidence the use of the App leads to improved clinical outcomes, including safety and effectiveness. As of 06/01/2024, the Digihaler app and dashboard will not be available for patients and HCPs. Patients should no longer access the app for their data.

How to save Digihaler app data?

Tap Data at the bottom of your screen. You can see the details of your Digihaler events for each registered inhaler.

At the top right-hand side of the Data screen, you have the option to download and share your data by tapping the share report button.

Since Digihaler inhalers will not be available after 06/01/2024, patients and healthcare providers should consider appropriate therapeutic alternatives instead of prescribing and purchasing new Digihalers.

ProAir RespiClick (albuterol sulfate) Inhalation Powder and AirDuo RespiClick (fluticasone propionate and salmeterol) Inhalation Powder will continue to be available. These medications from Teva have the same formulation and device as their corresponding Digihaler versions, but do not have digital sensors or connectivity to an app or dashboard. There are also other alternatives available in the ProAir family of inhalers such as Albuterol Sulfate HFA Inhalation Aerosol. Teva currently has no marketed alternative inhaler products to substitute for ArmonAir Digihaler. However, fluticasone propionate inhalers, as branded or generic medications, are available through other manufacturers.

Please see full Prescribing Information for ProAir Digihaler and for AirDuo Digihaler and for ArmonAir Digihaler on Digihaler.com.

For medical or clinical questions please contact Teva US Medical Information at 1-888-483-8279 (M-F 9AM to 5PM EST) or by emailing USMedInfo@tevapharm.com

© 2024 Teva Respiratory, LLC. AHD-41125 March 2024