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ProAir Digihaler

  • About ProAir Digihaler
    • What is ProAir Digihaler?
      • ProAir Digihaler 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 records and stores information about inhaler events. ProAir Digihaler may be used with, and transmits information to, an App through Bluetooth® wireless technology.
    • What are the ingredients in ProAir Digihaler?
      • Active ingredient: albuterol sulfate

        Inactive ingredients: lactose (may contain milk proteins)

    • What is albuterol sulfate?
      • Albuterol is a short-acting beta2-agonist, or SABA. SABAs relieve the sudden acute symptoms of asthma by causing relaxation of the smooth muscles of the airways. SABAs can also be used before exercise to prevent bronchospasms and are also recommended for COPD episodes.
    • Should I discuss other medications and medical conditions with my healthcare provider before using ProAir Digihaler?
      • Yes, you should tell your healthcare provider about all of the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. 

        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 of the medicines you take, especially:

        • other inhaled medicines or asthma medicines
        • beta blocker medicines
        • diuretics
        • digoxin
        • monoamine oxidase inhibitors
        • tricyclic antidepressants
    • What are possible side effects of ProAir Digihaler?
      • 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. Paradoxical bronchospasm is more likely to happen with your first use of a new asthma inhalation medicine
        • 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 the following symptoms of an allergic reaction:
            • itchy skin
            • swelling beneath your skin or in your throat
            • rash
            • worsening trouble breathing
        • worsening of other medical problems in people who also use ProAir Digihaler including increases in blood sugar
        • low potassium levels in your blood

        The most common side effects of ProAir Digihaler include:

        • back pain
        • body aches and 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

        These are not all of the possible side effects of ProAir Digihaler. Call your healthcare provider for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

    • What does it mean that ProAir Digihaler is "Breath Actuated"?
      • ProAir Digihaler is “breath-actuated”—meaning it releases the medicine when you breathe in. There’s no need to press a canister and breathe in at the same time as with traditional inhalers. 

    • What type of technology is inside ProAir Digihaler?
      • ProAir Digihaler has sensors that are built into the electronic module on top of the inhaler. The sensors in the module track your inhaler events (recorded in the app as an inhalation, exhalation, or air vent block) and measure inspiratory flow (recorded as liters per minute), which tells you about your inhalation technique or how you are inhaling when you use your ProAir Digihaler.  There is also Bluetooth® technology built in to the module so that the information from your ProAir Digihaler can be sent to the mobile app. The electronic module stores your inhaler events as they happen, even if you are not within range of your smartphone. The information will be sent to the app once the inhaler is within range of your smartphone and Bluetooth® is turned on. ProAir Digihaler does not need to be connected to the app in order for you to take your medicine. The electronic module does not control or interfere with delivery of the medicine through the inhaler.

    • How can I get ProAir Digihaler?
      • ProAir Digihaler is a prescription medication, and must be prescribed by your healthcare provider. ProAir Digihaler will initially be available in 2019 through a small number of healthcare programs, which will be conducted in a few healthcare systems in limited geographies.  Speak with your healthcare provider to see if your healthcare system is involved. A national launch is planned for 2020.

  • Caring for your ProAir Digihaler
    • How do I take care of my inhaler?
        • Be sure to keep your ProAir Digihaler clean and dry.
        • Never wash or put any part of your inhaler in water.  If your inhaler gets wet it will need to be replaced.
        • Store at room temperature (between 15° and 25°C; 59° and 77°F). Avoid exposure to extreme heat, cold, or humidity.
        • Remember to close the red cap after using your inhaler.
        • If the mouthpiece needs cleaning, gently wipe the mouthpiece with a dry cloth or tissue as needed.

        Please see Instructions for Use for additional information.

    • Do I need to charge or change the battery in my ProAir Digihaler inhaler?
      • No, the battery does not require charging or changing.

    • Is the battery inside ProAir Digihaler allowed for air travel?
      • Yes. It is a low power CR2032 coin cell battery, which is allowed for air travel.

    • When should I replace my ProAir Digihaler inhaler?
      • The counter on the back of your inhaler shows how many doses you have left.  When there are 20 doses left, the dose counter color will change to red and you should refill your prescription or ask your healthcare provider for another prescription.  When the counter displays ‘0’ your ProAir Digihaler inhaler is empty and you should stop using the inhaler and throw it away.

        Throw away your ProAir Digihaler inhaler 13 months after removing it from the foil pouch for the first time, when the dose counter displays ‘0’, or after the expiration date on the package, whichever comes first.

  • Using ProAir Digihaler

Using the App

  • Bluetooth and Connectivity
    • How does ProAir Digihaler track my inhaler use?
      • ProAir Digihaler contains an electronic module with Bluetooth® technology and inhalation sensors built into the top of the inhaler, which detect and record how often you use your inhaler and also measure inspiratory flow rates. When used with ProAir Digihaler companion mobile app, you can track your inhaler use information. ProAir Digihaler will still deliver medicine even if it is not connected to the app.

    • Do I need to be connected to the internet to use the app?
      • It is possible to use the app while not connected to the internet, although certain features will be unavailable, such as viewing Environmental information. Ensure that you are connected to the internet to use all application features.

    • How do I sync my ProAir Digihaler and app?
      • To sync your ProAir Digihaler to its companion mobile app, your ProAir Digihaler must be within 15 feet of your smartphone, and your Bluetooth® must be enabled.

    • How long does it take to sync my ProAir Digihaler to the app?
      • Sync speed may vary based on certain conditions. The app will sync most quickly if you open the app within 3 minutes of using your inhaler.  Remember to regularly open the app with the Digihaler within range to ensure that it syncs.

    • Can I pair inhalers from other people in my app?
      • When the app is installed, it is associated with only one profile (the account holder or their dependent). The paired inhaler belongs uniquely to that individual. The account holder cannot see the dependent's information unless they take their dependent's phone and look, or install the app using the profile of their dependent. There can only be one instance of the app per device and only one user per app. The app is intended to be used only with your personal Digihalers.

    • How many inhalers can I track?
      • A maximum of five devices can be tracked in the ProAir Digihaler App at a time. If you already have five paired devices and need to add a new one, please remove an existing inhaler. To remove an inhaler from the app, tap the "ProAir Digihalers" button in the lower right section of the home screen to bring up the list of inhalers. Click on the inhaler you want to remove. On the next screen, tap "Remove this Digihaler" and follow the onscreen instructions.

    • I haven't "synced" my ProAir Digihaler and my app in several days; do I lose that information in my inhaler?
      • No, all of your inhaler use information is stored in the eModule in the top of your ProAir Digihaler and does not get deleted when new inhaler use information is recorded. This information is sent to the app once the inhaler comes within range of your smartphone and Bluetooth® is enabled.

  • Data and Settings
  • Getting Started and Set Up
    • How do I get the app?
      • In order to use the app, you will need to download and install it on your smartphone. An Internet connection is required to download the app:

        • Search for “ProAir Digihaler” in the Apple App Store® or Google Play™
        • Download the free app
        • After the first download, you may be periodically prompted to update the ProAir Digihaler App as updates or newer versions are available
    • How do I set up an account?
      • After downloading and opening the app, you will be prompted to create an account and password. An Internet connection is required to create an account:

        • Enter your date of birth
        • Create your account and password
            • If you ever forget your password, you can reset it
            • If you have a dependent who will be using ProAir Digihaler, you will need to add an account for him or her
    • How do I pair or sync my ProAir Digihaler inhaler with the app for the first time?
      • After setting up an account, you will be prompted to register your ProAir Digihaler. The ProAir Digihaler device has a QR code that can be scanned to begin the registration process. Hold the ProAir Digihaler behind your smartphone, so you can see the ProAir Digihaler QR code on the smartphone screen. Align the ProAir Digihaler’s QR code with the yellow square on the screen. You will receive a “Got it” notification once the ProAir Digihaler is paired with your smartphone. Please note - camera access may need to be granted to ProAir Digihaler to scan QR code.

    • What does it mean to register an inhaler?
      • Your inhaler is registered when you scan and name it.

    • How do I register an inhaler if my camera is broken?
      • Your phone's camera must be functional to scan the inhaler QR code and register the inhaler.

    • Which smartphones can I use with the ProAir Digihaler App?
      • The ProAir Digihaler App is compatible with these smartphones; iPhones running iOS 11 or above and smartphones running Android 6.0 or above.

    • Can I download the app on a tablet?
      • No. The ProAir Digihaler App is only designed to work on a smartphone at this time.

  • Messages and Notifications
  • Reading and Sharing Reports
    • What types of reports are available and what do they show?
      • You will find the following reports in your app:

        • Weekly Digihaler Events: Weekly chart of Digihaler events over 12 weeks
        • Daily Digihaler Events: Daily chart of Digihaler events over the previous 30 days
        • Daily Self-Assessment: Log of all recorded Daily Self-Assessment ratings over the previous 30 days
    • How do I share my information with my caregiver or healthcare provider?
      • You can choose to share and discuss your ProAir Digihaler reports in a few different ways:

        • You can bring your phone to your next appointment and show your healthcare provider your reports within the app
        • You can print a PDF in advance of your next appointment using the share function within the app reports function
        • You can email the PDF directly to your healthcare provider using the share function within the app reports function, if your practice allows email communications from patients
  • Using your ProAir Digihaler App
    • Where do I find information about how to use my inhaler and app?
      • When using the app for the first time, instructions will guide you through how to set up and use the app and inhaler.  Within the app menu, "How to Use This App" instructions, the ProAir Digihaler Instructions for Use and a video library containing links to instructional videos are always accessible.

    • How do I remove an inhaler from my app?
      • To remove an inhaler from the app, tap the "ProAir Digihalers" button in the lower right section of the home screen to bring up the list of inhalers. Click on the inhaler you want to remove. On the next screen, tap "Remove this Digihaler" and follow the onscreen instructions.

    • What are "Digihaler events"?
      • Every opening of the cap (with or without inhalation) counts as a Digihaler Event. Only the first event (e.g. inhalation, exhalation) after cap opening is recorded. If the first event occurs after 1 minute of cap opening, regardless of flow rate, the event will be recorded as “Low (less than 30 L/min) or No Inhalation recorded within 1 min of cap open”. Types of Digihaler events:

        • Good inhalation (More than 45 L/min)
        • Fair inhalation (30 to 45 L/min)
        • Low or No inhalation recorded (Less than 30 L/min)
        • Exhalation
        • Possible Air Vent Block
    • How can I see my ProAir Digihaler usage in my app?
      • When tapping the "Digihaler Events" button on the bottom of the app home screen, you can see the details of your Digihaler events by day for each connected inhaler. You may also view your inhaler use data by selecting the “reports" icon on the top of the home page.

    • I read that ProAir Digihaler measures inspiratory flow, how can this be helpful?
      • Inspiratory flow rates, recorded as liters per minute, may tell you about your inhalation or how you are inhaling when you use ProAir Digihaler.  This may help tell you if your inhalation technique may need improvement.

    • How do I add my inhaler in the app when I refill my ProAir Digihaler prescription and get a new inhaler?
      • If you have refilled your ProAir Digihaler, follow these steps to register your new inhaler with your app:

        1. Open the ProAir Digihaler App
        2. Tap the "ProAir Digihalers" button at the bottom of the phone screen
        3. Select the "Add personal Digihaler" button and follow the instructions on the screen
        4. You will receive a "Got it!" notification once they are paired
    • What is the Send App Diagnostic Data Menu item?
      • If you encounter an issue with the App and contact Teva Customer Support, Teva Customer support may request that you send them your App diagnostic file. To accomplish this:

        • You will tap on the “Send App Diagnostic Data” menu item.
        • The App will ask you to confirm the sending of the file to Teva Customer Support.
        • Teva Customer Support will request the 6-digit reference code generated by the App that will be used to identify your App diagnostic data.

ACCOUNTS & DATA PRIVACY

TROUBLESHOOTING

  • Account Information
    • I tried to reset my password, but never received an email. What should I do?
      • Make sure that the email address you used to reset your password is the same email address that you used to register your Digihaler and log in. Also, check to see if the password reset email was redirected to your spam folder. Your password reset email will come from "noreply@gl.teva-pharm.com" If it was the same address and the email isn't in your spam folder, please call Teva Customer Support at (888) 603-0788 between 9AM and 5PM ET Monday through Friday for assistance.

  • Registering your Digihaler
    • Why won't my ProAir Digihaler register with the app?
      • The app is only intended for use with ProAir Digihaler with a QR code on top. If your inhaler is a ProAir Digihaler, make sure the camera on your smartphone is working and clean.  Also make sure the full QR code is in the camera window on the "Scan Inhaler" screen.

         

        If you're still having issues, please contact Teva Support at (888) 603-0788 between 9AM and 5PM ET Monday through Friday.

    • Why is the app telling me that the QR code is invalid?
      • Your QR code may be damaged or you might be scanning a device that is not a ProAir Digihaler. If the QR code is scratched or damaged, please contact Teva Support at (888) 603-0788 between 9AM and 5PM ET Monday through Friday.

    • Why is the app telling me that "This ProAir Digihaler is already registered"?
      • This message means that the Digihaler was already scanned and registered. To find out which Digihaler it is, check the ID codes of Digihalers registered in the app by selecting the "ProAir Digihaler" button on the bottom right of the screen (circle with inhaler icon). All registered inhalers will appear here with their corresponding ID numbers.

  • Bluetooth and Connectivity
    • My Digihaler stopped syncing with my smartphone. How do I fix that?
        1. Make sure that the smartphone's Bluetooth® connectivity is turned on and that the inhaler is connected and within Bluetooth® range (15 feet from your smartphone).
        2. If you are still having problems, try restarting your smartphone and reopen the app.
        3. If the Digihaler and app still do not sync, please call Teva Customer Support at (888) 603-0788 between 9AM and 5PM ET Monday through Friday.
  • Getting Started
  • Messages and Notifications
    • Why didn't I get a notification for one of my inhalations?
      • Notifications should appear when these conditions are met:

        1. Bluetooth® connectivity is turned on
        2. The inhalation took place within the last 15 minutes
        3. For Apple iPhones, the app is in use or operating in the background

        Note: Regardless of whether you receive a notification your data will not be lost. The Digihaler stores information to send to the app whenever it reconnects.

        If you continue to have issues, contact Teva Customer Support at (888) 603-0788 between 9AM and 5PM ET Monday through Friday.

Support Videos

CUSTOMER SUPPORT

If you have questions we haven’t answered, our customer support team is here to help. Call (888) 603-0788. We’re open Monday-Friday from 9:00AM - 5:00PM ET.

CALL US AT

+1 (888) 603-0788


Approved Uses

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

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. This is more likely to happen with your first use of a new asthma inhalation medicine
      • 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
      • changes in laboratory blood values (sugar, potassium)

The most common side effects of ProAir Digihaler include:

    • back pain
    • body aches and 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

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 full Prescribing Information for ProAir® Digihaler.

This device complies with part 15 of the FCC Rules. Operation is subject to the following two conditions: (1) This device may not cause harmful interference, and (2) this device 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.