Objective data can be used to help you make more informed treatment decisions.1,2

Inhaler use is recorded as an event when the cap is opened
or a patient inhales.

 

Please read Indications and Important Safety Information for ProAir Digihaler, AirDuo Digihaler and ArmonAir Digihaler.

The Digihaler system includes the first
and only

smart inhalers with built-in sensors that allow patients to track their inhaler events.
The objective data is collected in a connected smartphone app and can be shared with you for more informed treatment decisions.

Inspiratory flow rates

Rates are categorized in the app as:

  • Good (>45 L/min)
  • Fair (30-45 L/min)
  • Low or no inhalation (<30 L/min)
  • Exhalation, or possible air vent block

Viewing these rates may help you assess if inhaler technique might need improvement.1-3

Connection to the app is required for transmission of data but is not required for delivery of the medicine from the inhaler. There is no evidence the use of Digihaler technology alone leads to improved clinical outcomes, including safety and effectiveness.

 

ProAir Digihaler rates are used for this example, but can also be evaluated on AirDuo Digihaler or ArmonAir Digihaler

Inspiratory flow rates are referred to as inhalation airflow in the app

ProAir Digihaler rates are used for this example, but can also be evaluated on AirDuo Digihaler or ArmonAir Digihaler

For patients on maintenance therapy - Inhaler events

See how many maintenance inhaler events are recorded every day

Data on maintenance events may help you assess if patients are using their inhaler 
as prescribed.

Data can be viewed if the patient chooses to share it with you.

Inhaler use is recorded as an event when the cap is opened or a patient inhales.

Patients can receive alerts that remind them to take their AirDuo Digihaler or ArmonAir Digihaler maintenance medications.

For patients on
rescue therapy - SABA usage

The Digihaler technology may help you understand patients’ SABA use

Seeing when and how often patients have inhaler events can help you assess if their SABA inhaler use is increasing.

Inhaler use is recorded as an event when
the cap is opened or a patient inhales.

The Digihaler app notifies patients when they have more than 12 ProAir Digihaler events (when the cap is opened or a patient inhales) in the past 24 hours.

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

Data can be viewed if the patient chooses to share it with you.

Also, patients can share reports with you

Reports designed to support data-driven decisions1,4

Events

View daily and monthly Digihaler events for every connected inhaler

Data can be viewed if the patient chooses to share it with you.

Inhalation categories

Tracking inspiratory flow rates over time may help identify if patient
technique might need improvement1-3

Data can be viewed if the patient chooses to share it with you.

Patients can share their data in 3 ways:

1

The app can generate a PDF report that patients can share through text, email, or AirDrop®

2

Patients can print a PDF report and bring it to their next office visit

3

Patients can share their objective inhaler use data with you directly from the app by viewing screens during office visits

Inhaler use is recorded as an event when the cap is opened or a patient inhales.

And receive feedback on their inhalations right away

Notifications to help patients stay informed

Patients can receive notifications from their Digihaler app, such as the notification below, which will alert them when 6 out of 12 of their recent Digihaler events have been categorized as "low or no inhalation,” “exhalation,” or “possible air vent block.”

The Digihaler app provides patients with instructions on how to use their inhalers accurately.1,2

Find helpful resources for your patients

Explore
patient resources

IMPORTANT SAFETY INFORMATION: 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: especially: 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.

INDICATIONS FOR PROAIR DIGIHALER

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 INFO:
AIRDUO & 
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.

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 AND ARMONAIR DIGIHALER

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.

References: 1. Global Initiative for Asthma. Global Strategy for Asthma Management and Prevention. 2020. https://www.ginasthma.org. Accessed on July 7, 2020. 2. Global Initiative for Chronic Obstructive Lung Disease. Global Strategy for the Diagnosis, Management, and Prevention of Chronic Obstructive Pulmonary Disease. 2020. https://goldcopd.org. Accessed on June 7, 2020. 3. Sharma G, Mahler DA, Mayorga VM, et al. Prevalence of low peak inspiratory flow rate at discharge in patients hospitalized for COPD exacerbation. Chronic Obstr Pulm Dis. 2017;4(3):217-224. 4.Patel M, Perrin K, Pritchard A, et al. Accuracy of patient self-report as a measure of inhaled asthma medication use. Respirology. 2013;18(3):546-552. 5. ProAir Digihaler Prescribing Information. Frazer, PA: Teva Respiratory, LLC. 6. AirDuo Digihaler Prescribing Information. Frazer, PA: Teva Respiratory, LLC. 7. ArmonAir Digihaler Prescribing Information. Frazer, PA: Teva Respiratory, LLC.