Digihaler® Dashboard Support

​ ​ ​

Digihaler® Dashboard Support

Digihaler Dashboard
Reference Guide

View now

Getting Started on the Dashboard

Is there a guide for getting started using my Digihaler Dashboard?

Download the Dashboard User Guide here.

Was this helpful?

How do I access the Digihaler Dashboard?

Both new and existing users can access the Dashboard here.

Bookmark this link for easy access in the future:

https://us.dhp.ehealth.teva/careprogram/welcome

Was this helpful?

As a Health Care Provider, can I sign up for the Digihaler Dashboard on my own?

Yes, but you won’t be able to access any of the Dashboard’s healthcare programs. To sign up and gain access to your patients' data, first you will need to be invited by a Teva representative or by an Admin or Super Admin in your organization who already has access to the specific healthcare program. This person will need to add you to the correct healthcare program and then provide you with the invitation link needed to access the Dashboard.

From this link, you will complete the signup process. When you sign in for the first time you will be asked to enter a 6-digit one-time sign-in code that will be sent to your account’s email address. (This is the same email address that the Admin or Super Admin used to invite you to the Dashboard.)

Was this helpful?

I didn’t receive the one-time sign-in code email. Why?

There are a few possible reasons:

  • It may take a few minutes for the email to appear.
  • The email may have gone to your spam or junk folder.
  • The email address you used on the sign-up screen may have been spelled
    incorrectly.

Was this helpful?

Why is my one-time sign-in code not being accepted?

This can happen for the following reasons:

  • If you enter the code incorrectly once or it was sent over 10 minutes ago, a new one is automatically generated. Only the most recently sent code is valid. Please check your inbox for a new code.
  • Make sure you did not add any spaces to your code, a space will result in an error.

Was this helpful?

Why did I get an “Account Not Authorized” message?

This can happen for the following reasons:

  • The email address that was used when inviting you is not the same as the email address you used to sign up.
  • It’s been more than 30 days since the invite was created. Unused invites expire after 30 days for security reasons. If the invitation has expired, a Dashboard Admin will be able to manually renew the invitation for another 30 days.

Was this helpful?

Why am I being asked to re-enter a one-time sign-in code if I already did this on a previous login?

This can happen for the following reasons:

  • You are using a different device to log in than before.
  • Your browser’s cache was cleared.
  • Another user used the same device to log into the Dashboard.

Was this helpful?

Can I join more than one Healthcare Program through the Digihaler Dashboard?

Yes, Admins and Super Admins can invite you to join other healthcare programs. If you are invited to join another program, upon login you’ll be able to select Join next to the name of the program.

Was this helpful?

Managing My Patients in the Dashboard

How do I add patients to my healthcare program through the Digihaler Dashboard?

From the Patient list, click on Invite Patient and provide the patient with the 10-character code shown on the screen.

Was this helpful?

Why can’t I find my patient in the patient list on the Digihaler Dashboard?

There are a few possible reasons:

  • The patient has not joined the healthcare program in their app.
  • The patient entered the wrong code when they attempted to join the healthcare program.
  • The patient removed themselves from the healthcare program.
  • You or a colleague removed the patient from the healthcare program.

Was this helpful?

How do I create an invitation code for a patient?

  1. Click on Patient List from the left side menu of the Dashboard.
  2. Click Invite Patient.
  3. A code will be created automatically for you to share with your patient.

Note:

  • The code must be used within 7 days, or you will need to repeat the process
  • The code can only be used once

Was this helpful?

What if my patient and I both lose the patient’s invitation code?

You can generate a new invitation code and provide it to the patient. The previous code will expire automatically after 7 days.

Was this helpful?

How do I remove a patient from my Digihaler Dashboard program?

  1. Click on the Patient List from the left side menu of the Dashboard.
  2. Select a patient to view their “Patient Detail Screen.”
  3. Click Remove Patient on the top right side of the screen.

Note: The patient can also remove themselves from the app. Click here to see: How do I unenroll from a Healthcare Program?

Was this helpful?

Will the patient lose their data when they’re removed from my Digihaler Dashboard program?

No, the patient can always access their data through the app, even if they aren’t part of your Digihaler Dashboard program.

Was this helpful?

How do I make sure I am inviting my patient to the right program in the Digihaler Dashboard?

  • Using the left side menu, select the program in which you want to view. The names will be listed.
  • Click the Patient List to find the program you want to invite a patient to.
  • Click on Invite Patient to generate a new invite code and provide it to the patient for entering in their app.

Was this helpful?

I invited a patient to the wrong program. How do I fix that?

If the patient has not yet joined the program:

  • Tell them to ignore the invitation code you sent them.
  • Invite them to the right program. A new invitation code will be created.
  • Share the new 10-character code with the patient.

If the patient has already joined the program:

  • Select your patient from the list and click Remove Patient.
  • Switch to the proper program and invite them again.
  • Share the new 10-character code with the patient.

Was this helpful?

Viewing Patient Data

Who has access to patient data?

All Dashboard users can see all patient Digihaler data inside a given healthcare program.

Was this helpful?

How current is the data in the Digihaler Dashboard?

The data should not be more than a few minutes old if the patient’s:

  • Inhaler is connected to their phone
  • Digihaler app is running
  • Phone is connected to the internet

You can view the last known time a patient’s inhaler was connected to the app by
viewing their “All Connected” data on the Patient List.

Was this helpful?

Why does my patient have inhaler events listed under tomorrow's date?

If your patient is in a time zone where the next day has already started for them, you may see inhalations that appear on tomorrow’s date.

Was this helpful?

Can I add information to the patient record in the Digihaler Dashboard?

No, you cannot add information to a patient’s record. The Dashboard only allows viewing of data created by the patient’s inhaler and app.

Was this helpful?

Can I change a patient’s personal information such as name and email address?

No, as a Dashboard user you cannot change a patient’s personal information.

Was this helpful?

The data showing for my patient is incorrect or there’s no data showing at all, what should I do?

This can happen for the following reasons:

  • The patient’s Digihaler and phone were out of range of each other (approximately 15 feet apart)
  • The patient has their phone on airplane mode
  • The patient has their phone’s Bluetooth® or internet connection turned off
  • The patient has logged out of the app
  • The patient force-quit the app or rebooted their phone, and did not relaunch the app

Speak to your patient to confirm none of the issues above are preventing connectivity. If the patient continues to have connectivity issues, have the patient contact Teva Customer Support at +1(888) 603-0788 Monday through Friday.

Was this helpful?

What are filters and what do they do?

Filters allow you to view a subset of your patient list based on criteria. For example, rather than viewing all patients in the program you can select a filter to show only patients that had an inhaler event over the last 3 days.

Note: Filters are configured by your Dashboard Admin for your specific program and selected by clicking on the Filter button on the Patient List page.

Was this helpful?

How do I export patient data from the Digihaler Dashboard?

You can export patient data to a CSV file that is viewable in a spreadsheet. The report shows patient inhaler event data as presented on your patient list.

To export data:

  1. On the Patient List, click the Export Data button at the top-right of the page.
  2. Select an All time or Custom date range
  3. Click Export CSV.
  4. When the export is finished click Download at the bottom of the screen. The download link will expire after 15 minutes.

Note: You can apply a filter to your patient list and then export data based on the filtered patient list.

Was this helpful?

Managing My Teammates

How do I invite a Teammate to the Digihaler Dashboard?

You can invite a new Teammate if you have Admin or Super Admin permissions.

  1. From the Team List, click Invite Teammate
  2. Enter the email address of the invitee and select their role (if you want the new Teammate to be able to invite additional colleagues, assign them with an Admin or Super Admin role)
  3. After you click the Invite Teammate button, you will be prompted to copy an invitation message and link to the Dashboard
  4. Manually send this information to the invited Teammate through the communication method of your choice

Note: Your Admins and Super Admins are individuals within your healthcare program, not someone from Teva.

Was this helpful?

How do I view pending Dashboard invitations for Teammates?

Admins or Super Admins can view pending invitations to the Digihaler Dashboard by clicking the Pending Invitations tab on the Team List page. On this tab, you can do the following:

  • View the status of invited Teammates
  • Change the role of an invited Teammate
  • Cancel an invitation
  • Renew any expired invitations

Was this helpful?

How do I remove a Teammate from the Digihaler Dashboard?

To remove a Teammate from the Digihaler Dashboard, navigate to the Team List and follow the steps below. Please note, only Admins and Super Admins have access to remove Teammates from the Digihaler Dashboard.

  1. Click Remove next to the Teammate’s name you wish to remove.
  2. Check the box to confirm you have selected the correct Teammate and click Remove Teammate.

Was this helpful?

Can I change an existing Teammate’s role?

If a user’s role needs to be changed, Super Admins and Admins can change an existing user’s role as long as they are not elevating a user beyond their own role or demoting a user who is at their role.

In other words, the following actions are permitted:

A Super Admin can…

  • Promote Dashboard User to Admin or Super Admin
  • Promote Admin to Super Admin
  • Demote Admin to Dashboard User

Was this helpful?

Have a question for us?

1-833-390-2147

Indications

AIRDUO® DIGIHALER® (fluticasone propionate and salmeterol) AND ARMONAIR® DIGIHALER® (fluticasone propionate)

ArmonAir® Digihaler® (fluticasone propionate) inhalation powder is indicated for the maintenance treatment of asthma as prophylactic therapy in patients 12 years of age and older.

Limitation of Use: ArmonAir Digihaler is not indicated for the relief of acute bronchospasm.

AirDuo® Digihaler® (fluticasone propionate and salmeterol) inhalation powder is indicated for the treatment of asthma in patients aged 12 years and older. AirDuo Digihaler is only for patients uncontrolled on an inhaled corticosteroid (ICS) or whose disease severity clearly warrants an ICS/Long-acting beta2- agonist (LABA).

Limitation of Use: AirDuo Digihaler is not indicated for the relief of acute bronchospasm.

ArmonAir Digihaler and AirDuo Digihaler contain a built-in electronic module which detects, records, and stores data on inhaler events for transmission to mobile App. Use of the App is not required for administration of medication to the patient.

PROAIR® DIGIHALER® (albuterol sulfate)

ProAir® Digihaler® (albuterol sulfate) Inhalation Powder is indicated in patients ≥4 years of age for the treatment or prevention of bronchospasm with reversible obstructive airway disease and in patients ≥4 years of age for the prevention of 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. Use of the mobile app is not required for administration of medication to the patient.

Important Safety Information:

AIRDUO DIGIHALER AND ARMONAIR DIGIHALER

Contraindications: ArmonAir Digihaler and AirDuo Digihaler are contraindicated in:

  • Primary treatment of status asthmaticus or other acute episodes of asthma requiring intensive measures
  • Patients with known severe hypersensitivity to milk proteins or any ingredients of ArmonAir Digihaler or AirDuo Digihaler

Serious Asthma-Related Events – Hospitalizations, Intubations, Death: Use of a LABA as monotherapy (without an ICS) for asthma is associated with an increased risk of asthma-related death. Available data from controlled clinical trials also suggest that use of LABA as monotherapy increases the risk of asthma-related hospitalization in pediatric and adolescent patients. These findings are considered a class effect of LABA monotherapy. When LABA are used in fixed-dose combination with ICS (such as AirDuo Digihaler), data from large clinical trials do not show a significant increase in the risk of serious asthma-related events (hospitalizations, intubations, death) compared with ICS alone

Deterioration of Disease and Acute Episodes: AirDuo Digihaler should not be initiated in patients during rapidly deteriorating or potentially life-threatening episodes of asthma. ArmonAir Digihaler and AirDuo Digihaler are not indicated for the relief of acute bronchospasm. An inhaled, short-acting beta2-agonist, not ArmonAir Digihaler or AirDuo Digihaler, should be used to relieve acute symptoms such as shortness of breath

Avoid Excessive Use and Avoid Use with Other Long acting Beta2-Agonists: AirDuo Digihaler should not be used more often than recommended, at higher doses than recommended, or in conjunction with other medicines containing LABA, as an overdose may result. Clinically significant cardiovascular effects and fatalities have been reported in association with excessive use of inhaled sympathomimetic drugs. Patients using AirDuo Digihaler should not use another medicine containing a LABA (e.g., salmeterol, formoterol fumarate, arformoterol tartrate, indacaterol) for any reason

Oropharyngeal Candidiasis has occurred in patients treated with ArmonAir Digihaler or AirDuo Digihaler. Advise patients to rinse the mouth with water without swallowing following inhalation

Immunosuppression and Risks of Infections: Patients who use corticosteroids, such as found in AirDuo Digihaler and ArmonAir Digihaler are at risk for potential worsening of existing tuberculosis; fungal, bacterial, viral, or parasitic infections; or ocular herpes simplex. A more serious or even fatal course of chickenpox or measles may occur in susceptible patients. Use with caution in patients with the above because of the potential for worsening of these infections

Transferring Patients from Systemic Corticosteroid Therapy: Particular care is needed for patients who have been transferred from systemically active corticosteroids to ICS because deaths due to adrenal insufficiency have occurred in patients with asthma during and after transfer from systemic corticosteroids to less systemically available ICS. Taper patients slowly from systemic corticosteroids if transferring to ArmonAir Digihaler or AirDuo Digihaler

Hypercorticism and Adrenal Suppression may occur with high doses of ICS, including fluticasone propionate, or at the recommended dose in susceptible individuals. If such changes occur, discontinue ArmonAir Digihaler or AirDuo Digihaler slowly

Drug Interactions with Strong Cytochrome P450 3A4 Inhibitors: The use of strong cytochrome P450 3A4 (CYP3A4) inhibitors (e.g., ritonavir, ketoconazole) with ArmonAir Digihaler or AirDuo Digihaler is not recommended because increased systemic corticosteroid adverse effects may occur; increased cardiovascular adverse effects may also occur with AirDuo Digihaler

Paradoxical Bronchospasm and Upper Airway Symptoms: Paradoxical bronchospasm may occur. if bronchospasm occurs treat immediately with an inhaled, short-acting bronchodilator discontinue AirDuo Digihaler or ArmonAir Digihaler and institute alternative therapy

Hypersensitivity Reactions, Including Anaphylaxis: Immediate hypersensitivity reactions (e.g., urticaria, angioedema, rash, bronchospasm, hypotension), including anaphylaxis, may occur after administration of ArmonAir Digihaler or AirDuo Digihaler. Discontinue ArmonAir Digihaler or AirDuo Digihaler if such reactions occur

Cardiovascular and Central Nervous System Effects: The salmeterol component of AirDuo Digihaler, can be associated with excessive beta-adrenergic stimulation which could present as the following symptoms: seizures, angina, hypertension or hypotension, tachycardia with rates up to 200 beats/min, arrhythmias, nervousness, headache, tremor, palpitation, nausea, dizziness, fatigue, malaise, and insomnia. Use with caution in patients with cardiac arrhythmias, hypertension, coronary insufficiency. Drug may need to be discontinued in certain patients.

Reduction in Bone Mineral Density (BMD): Decreases in BMD have been observed with long-term administration of products containing ICS. Patients with major risk factors for decreased bone mineral content, such as prolonged immobilization, family history of osteoporosis, or chronic use of drugs that can reduce bone mass (e.g., anticonvulsants, oral corticosteroids) should be monitored and treated with established standards of care when using ArmonAir Digihaler or AirDuo Digihaler

Effect on Growth: ICS may cause a reduction in growth velocity, Patients should be maintained on the lowest dose of inhaled corticosteroid that effectively controls their asthma. Monitor growth of pediatric patients receiving ArmonAir Digihaler and AirDuo Digihaler.

Glaucoma and Cataracts: Long-term use of ICS, including fluticasone propionate, a component of ArmonAir Digihaler and AirDuo Digihaler, may increase the risk for cataracts or glaucoma. Regular eye exams should be considered

Eosinophilic Conditions and Churg-Strauss Syndrome: Systemic eosinophilic conditions, such as Churg- Strauss syndrome, may occur when using ArmonAir Digihaler or AirDuo Digihaler. Be alert to eosinophilia, vasculitic rash, worsening pulmonary symptoms, cardiac complications, and/or neuropathy

Coexisting Conditions: Use AirDuo Digihaler with caution in patients with convulsive disorders, thyrotoxicosis, diabetes mellitus, ketoacidosis, and in patients who are unusually responsive to sympathomimetic amines

Hypokalemia and Hyperglycemia: Beta-adrenergic agonist medicines may produce significant hypokalemia in some patients, possibly through intracellular shunting, which has the potential to produce adverse cardiovascular effects. Decrease in serum potassium are usually transient, not requiring supplementation. Be alert to hypokalemia and hyperglycemia in patients using AirDuo Digihaler

Adverse Reactions with ArmonAir Digihaler: Most common adverse reactions (greater than or equal to 3% ) are: upper respiratory tract infection, nasopharyngitis, oral candidiasis, headache, and cough

Adverse Reactions with AirDuo Digihaler: Most common adverse reactions (greater than or equal to 3%) include nasopharyngitis, oral candidiasis, headache, cough and back pain



Please see full Prescribing Information for AIRDUO DIGIHALER and ARMONAIR DIGIHALER

PROAIR® DIGIHALER®

Contraindications: ProAir Digihaler (albuterol sulfate) Inhalation Powder is contraindicated in patients with hypersensitivity to albuterol or patients with a severe hypersensitivity to milk proteins. Rare cases of hypersensitivity reactions, including urticaria, angioedema, and rash have been reported after the use of albuterol sulfate. There have been reports of anaphylactic reactions in patients using inhalation therapies containing lactose

Paradoxical Bronchospasm: ProAir Digihaler can produce paradoxical bronchospasm that may be life-threatening. Discontinue ProAir Digihaler and institute alternative therapy if paradoxical bronchospasm occurs

Deterioration of Asthma: Need for more doses of ProAir Digihaler than usual may be a marker of acute or chronic deterioration of asthma and requires reevaluation of treatment, such as possible need for anti-inflammatory treatment, e.g., corticosteroids

Use of Anti-Inflammatory Agents: ProAir Digihaler alone may not be adequate to control asthma in many patients. Early consideration should be given to adding anti-inflammatory agents, e.g., corticosteroids

Cardiovascular Effects: ProAir Digihaler, like other beta-adrenergic agonists, can produce clinically significant cardiovascular effects in some patients, as measured by heart rate, blood pressure, and/or symptoms. If such effects occur, the drug may need to be discontinued. ProAir Digihaler, like all sympathomimetic amines, should be used with caution in patients with cardiovascular disorders, especially coronary insufficiency, cardiac arrhythmias, and hypertension

Do Not Exceed Recommended Dose: Fatalities have been reported in association with excessive use of inhaled sympathomimetic drugs in patients with asthma

Hypersensitivity Reactions including Anaphylaxis: Immediate hypersensitivity reactions may occur after administration of albuterol sulfate, as demonstrated by rare cases of urticaria, angioedema, rash, bronchospasm, anaphylaxis, and oropharyngeal edema. Hypersensitivity reactions including anaphylaxis, angioedema, pruritus, and rash have been reported with the use of therapies containing lactose, an inactive ingredient in ProAir Digihaler.

Coexisting Conditions: ProAir Digihaler, like all sympathomimetic amines, should be used with caution in patients with convulsive disorders, hyperthyroidism, or diabetes mellitus; and in patients who are unusually responsive to sympathomimetic amines.

Hypokalemia: As with other beta-agonists, ProAir Digihaler may produce significant hypokalemia in some patients. The decrease is usually transient, not requiring supplementation

Most common adverse reactions (≥1% and >placebo) are back pain, pain, gastroenteritis viral, sinus headache, urinary tract infection, nasopharyngitis, oropharyngeal pain and vomiting

Drug Interactions: Other short-acting sympathomimetic bronchodilators should not be used concomitantly with ProAir Digihaler

  • Beta-Blockers: Beta-adrenergic-receptor blocking agents not only block the pulmonary effect of beta-agonists, such as ProAir Digihaler, but may produce severe bronchospasm in asthmatic patients. Therefore, patients with asthma should not normally be treated with beta-blockers
  • Diuretics: Caution is advised in the coadministration of beta-agonists with non-potassium sparing diuretics (such as loop or thiazide diuretics). Consider monitoring potassium levels
  • Digoxin: Carefully evaluate the serum digoxin levels in patients who are currently receiving digoxin and ProAir Digihaler
  • Monoamine Oxidase Inhibitors or Tricyclic Antidepressants: ProAir Digihaler should be administered with extreme caution to patients being treated with these agents, or within 2 weeks of discontinuation of these agents, because the action of albuterol on the cardiovascular system may be potentiated. Consider alternative therapy

Please see 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.

INDICATIONS FOR AIRDUO® DIGIHALER® (fluticasone propionate and salmeterol) AND ARMONAIR® DIGIHALER® (fluticasone propionate)

ArmonAir® Digihaler® (fluticasone propionate) inhalation powder is indicated for the maintenance treatment of asthma as prophylactic therapy in patients 12 years of age and older.

Limitation of Use: ArmonAir Digihaler is not indicated for the relief of acute bronchospasm.

AirDuo® Digihaler® (fluticasone propionate and salmeterol) inhalation powder is indicated for the treatment of asthma in patients aged 12 years and older. AirDuo Digihaler is only for patients uncontrolled on an inhaled corticosteroid (ICS) or whose disease severity clearly warrants an ICS/Long-acting beta2- agonist (LABA).

Limitation of Use: AirDuo Digihaler is not indicated for the relief of acute bronchospasm.

ArmonAir Digihaler and AirDuo Digihaler contain a built-in electronic module which detects, records, and stores data on inhaler events for transmission to mobile App. Use of the App is not required for administration of medication to the patient.

IMPORTANT SAFETY INFORMATION FOR AIRDUO DIGIHALER AND ARMONAIR DIGIHALER

Contraindications: ArmonAir Digihaler and AirDuo Digihaler are contraindicated in:

  • Primary treatment of status asthmaticus or other acute episodes of asthma requiring intensive measures
  • Patients with known severe hypersensitivity to milk proteins or any ingredients of ArmonAir Digihaler or AirDuo Digihaler

Serious Asthma-Related Events – Hospitalizations, Intubations, Death: Use of a LABA as monotherapy (without an ICS) for asthma is associated with an increased risk of asthma-related death. Available data from controlled clinical trials also suggest that use of LABA as monotherapy increases the risk of asthma-related hospitalization in pediatric and adolescent patients. These findings are considered a class effect of LABA monotherapy. When LABA are used in fixed-dose combination with ICS (such as AirDuo Digihaler), data from large clinical trials do not show a significant increase in the risk of serious asthma-related events (hospitalizations, intubations, death) compared with ICS alone

Deterioration of Disease and Acute Episodes: AirDuo Digihaler should not be initiated in patients during rapidly deteriorating or potentially life-threatening episodes of asthma. ArmonAir Digihaler and AirDuo Digihaler are not indicated for the relief of acute bronchospasm. An inhaled, short-acting beta2-agonist, not ArmonAir Digihaler or AirDuo Digihaler, should be used to relieve acute symptoms such as shortness of breath

Avoid Excessive Use and Avoid Use with Other Long acting Beta2-Agonists: AirDuo Digihaler should not be used more often than recommended, at higher doses than recommended, or in conjunction with other medicines containing LABA, as an overdose may result. Clinically significant cardiovascular effects and fatalities have been reported in association with excessive use of inhaled sympathomimetic drugs. Patients using AirDuo Digihaler should not use another medicine containing a LABA (e.g., salmeterol, formoterol fumarate, arformoterol tartrate, indacaterol) for any reason

Oropharyngeal Candidiasis has occurred in patients treated with ArmonAir Digihaler or AirDuo Digihaler. Advise patients to rinse the mouth with water without swallowing following inhalation

Immunosuppression and Risks of Infections: Patients who use corticosteroids, such as found in AirDuo Digihaler and ArmonAir Digihaler are at risk for potential worsening of existing tuberculosis; fungal, bacterial, viral, or parasitic infections; or ocular herpes simplex. A more serious or even fatal course of chickenpox or measles may occur in susceptible patients. Use with caution in patients with the above because of the potential for worsening of these infections

Transferring Patients from Systemic Corticosteroid Therapy: Particular care is needed for patients who have been transferred from systemically active corticosteroids to ICS because deaths due to adrenal insufficiency have occurred in patients with asthma during and after transfer from systemic corticosteroids to less systemically available ICS. Taper patients slowly from systemic corticosteroids if transferring to ArmonAir Digihaler or AirDuo Digihaler

Hypercorticism and Adrenal Suppression may occur with high doses of ICS, including fluticasone propionate, or at the recommended dose in susceptible individuals. If such changes occur, discontinue ArmonAir Digihaler or AirDuo Digihaler slowly

Drug Interactions with Strong Cytochrome P450 3A4 Inhibitors: The use of strong cytochrome P450 3A4 (CYP3A4) inhibitors (e.g., ritonavir, ketoconazole) with ArmonAir Digihaler or AirDuo Digihaler is not recommended because increased systemic corticosteroid adverse effects may occur; increased cardiovascular adverse effects may also occur with AirDuo Digihaler

Paradoxical Bronchospasm and Upper Airway Symptoms: Paradoxical bronchospasm may occur. if bronchospasm occurs treat immediately with an inhaled, short-acting bronchodilator discontinue AirDuo Digihaler or ArmonAir Digihaler and institute alternative therapy

Hypersensitivity Reactions, Including Anaphylaxis: Immediate hypersensitivity reactions (e.g., urticaria, angioedema, rash, bronchospasm, hypotension), including anaphylaxis, may occur after administration of ArmonAir Digihaler or AirDuo Digihaler. Discontinue ArmonAir Digihaler or AirDuo Digihaler if such reactions occur

Cardiovascular and Central Nervous System Effects: The salmeterol component of AirDuo Digihaler, can be associated with excessive beta-adrenergic stimulation which could present as the following symptoms: seizures, angina, hypertension or hypotension, tachycardia with rates up to 200 beats/min, arrhythmias, nervousness, headache, tremor, palpitation, nausea, dizziness, fatigue, malaise, and insomnia. Use with caution in patients with cardiac arrhythmias, hypertension, coronary insufficiency. Drug may need to be discontinued in certain patients.

Reduction in Bone Mineral Density (BMD): Decreases in BMD have been observed with long-term administration of products containing ICS. Patients with major risk factors for decreased bone mineral content, such as prolonged immobilization, family history of osteoporosis, or chronic use of drugs that can reduce bone mass (e.g., anticonvulsants, oral corticosteroids) should be monitored and treated with established standards of care when using ArmonAir Digihaler or AirDuo Digihaler

Effect on Growth: ICS may cause a reduction in growth velocity, Patients should be maintained on the lowest dose of inhaled corticosteroid that effectively controls their asthma. Monitor growth of pediatric patients receiving ArmonAir Digihaler and AirDuo Digihaler.

Glaucoma and Cataracts: Long-term use of ICS, including fluticasone propionate, a component of ArmonAir Digihaler and AirDuo Digihaler, may increase the risk for cataracts or glaucoma. Regular eye exams should be considered

Eosinophilic Conditions and Churg-Strauss Syndrome: Systemic eosinophilic conditions, such as Churg- Strauss syndrome, may occur when using ArmonAir Digihaler or AirDuo Digihaler. Be alert to eosinophilia, vasculitic rash, worsening pulmonary symptoms, cardiac complications, and/or neuropathy

Coexisting Conditions: Use AirDuo Digihaler with caution in patients with convulsive disorders, thyrotoxicosis, diabetes mellitus, ketoacidosis, and in patients who are unusually responsive to sympathomimetic amines

Hypokalemia and Hyperglycemia: Beta-adrenergic agonist medicines may produce significant hypokalemia in some patients, possibly through intracellular shunting, which has the potential to produce adverse cardiovascular effects. Decrease in serum potassium are usually transient, not requiring supplementation. Be alert to hypokalemia and hyperglycemia in patients using AirDuo Digihaler

Adverse Reactions with ArmonAir Digihaler: Most common adverse reactions (greater than or equal to 3% ) are: upper respiratory tract infection, nasopharyngitis, oral candidiasis, headache, and cough

Adverse Reactions with AirDuo Digihaler: Most common adverse reactions (greater than or equal to 3%) include nasopharyngitis, oral candidiasis, headache, cough and back pain



Please see full Prescribing Information for AIRDUO DIGIHALER and ARMONAIR DIGIHALER

INDICATIONS FOR PROAIR® DIGIHALER® (albuterol sulfate)

ProAir® Digihaler® (albuterol sulfate) Inhalation Powder is indicated in patients ≥4 years of age for the treatment or prevention of bronchospasm with reversible obstructive airway disease and in patients ≥4 years of age for the prevention of 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. Use of the mobile app is not required for administration of medication to the patient.

IMPORTANT SAFETY INFORMATION FOR PROAIR DIGIHALER

Contraindications: ProAir Digihaler (albuterol sulfate) Inhalation Powder is contraindicated in patients with hypersensitivity to albuterol or patients with a severe hypersensitivity to milk proteins. Rare cases of hypersensitivity reactions, including urticaria, angioedema, and rash have been reported after the use of albuterol sulfate. There have been reports of anaphylactic reactions in patients using inhalation therapies containing lactose

Paradoxical Bronchospasm: ProAir Digihaler can produce paradoxical bronchospasm that may be life-threatening. Discontinue ProAir Digihaler and institute alternative therapy if paradoxical bronchospasm occurs

Deterioration of Asthma: Need for more doses of ProAir Digihaler than usual may be a marker of acute or chronic deterioration of asthma and requires reevaluation of treatment, such as possible need for anti-inflammatory treatment, e.g., corticosteroids

Use of Anti-Inflammatory Agents: ProAir Digihaler alone may not be adequate to control asthma in many patients. Early consideration should be given to adding anti-inflammatory agents, e.g., corticosteroids

Cardiovascular Effects: ProAir Digihaler, like other beta-adrenergic agonists, can produce clinically significant cardiovascular effects in some patients, as measured by heart rate, blood pressure, and/or symptoms. If such effects occur, the drug may need to be discontinued. ProAir Digihaler, like all sympathomimetic amines, should be used with caution in patients with cardiovascular disorders, especially coronary insufficiency, cardiac arrhythmias, and hypertension

Do Not Exceed Recommended Dose: Fatalities have been reported in association with excessive use of inhaled sympathomimetic drugs in patients with asthma

Hypersensitivity Reactions including Anaphylaxis: Immediate hypersensitivity reactions may occur after administration of albuterol sulfate, as demonstrated by rare cases of urticaria, angioedema, rash, bronchospasm, anaphylaxis, and oropharyngeal edema. Hypersensitivity reactions including anaphylaxis, angioedema, pruritus, and rash have been reported with the use of therapies containing lactose, an inactive ingredient in ProAir Digihaler.

Coexisting Conditions: ProAir Digihaler, like all sympathomimetic amines, should be used with caution in patients with convulsive disorders, hyperthyroidism, or diabetes mellitus; and in patients who are unusually responsive to sympathomimetic amines.

Hypokalemia: As with other beta-agonists, ProAir Digihaler may produce significant hypokalemia in some patients. The decrease is usually transient, not requiring supplementation

Most common adverse reactions (≥1% and >placebo) are back pain, pain, gastroenteritis viral, sinus headache, urinary tract infection, nasopharyngitis, oropharyngeal pain and vomiting

Drug Interactions: Other short-acting sympathomimetic bronchodilators should not be used concomitantly with ProAir Digihaler

  • Beta-Blockers: Beta-adrenergic-receptor blocking agents not only block the pulmonary effect of beta-agonists, such as ProAir Digihaler, but may produce severe bronchospasm in asthmatic patients. Therefore, patients with asthma should not normally be treated with beta-blockers
  • Diuretics: Caution is advised in the coadministration of beta-agonists with non-potassium sparing diuretics (such as loop or thiazide diuretics). Consider monitoring potassium levels
  • Digoxin: Carefully evaluate the serum digoxin levels in patients who are currently receiving digoxin and ProAir Digihaler
  • Monoamine Oxidase Inhibitors or Tricyclic Antidepressants: ProAir Digihaler should be administered with extreme caution to patients being treated with these agents, or within 2 weeks of discontinuation of these agents, because the action of albuterol on the cardiovascular system may be potentiated. Consider alternative therapy

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.

You are about to leave this site.

You are about to leave DigihalerHCP.com/support and enter a website operated by a third party.

Would you like to continue?

Yes