AIRDUO® DIGIHALER® (fluticasone propionate and salmeterol)
inhalation powder

Asthma
control
with
less medicine

Dosing Features Efficacy Adverse
Events

AirDuo ® Digihaler ® (fluticasone propionate and salmeterol) inhalation powder offers the lowest approved dose of fluticasone propionate and salmeterol at each strength2

AIRDUO® DIGIHALER®

 

FLUTICASONE PROPRIONATE

*

SALMETEROL

Low

55 mcg

*

14 mcg

Medium

113 mcg

*

14 mcg

High

232 mcg

*

14 mcg

ADVAIR DISKUS®2

 

FLUTICASONE PROPRIONATE

*

SALMETEROL

Low

100 mcg

*

50 mcg

Medium

250 mcg

*

50 mcg

High

500 mcg

*

50 mcg

Advair Diskus ® is a registered trademark of the GSK group of companies

AirDuo Digihaler should be given:

  • As 1 inhalation twice daily about 12 hours apart
  • By oral inhalation only

Table is intended to show differences in dosing only and should not be construed to imply safety or efficacy similarities or differences

 

AirDuo Digihaler (fluticasone propionate and salmeterol) inhalation powder is the first breath-actuated, digital ICS/LABA inhaler

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

See how AirDuo Digihaler compares to:

Features

Contains a built-in dose counter

Measures inspiratory flow rates

Tracks how often the inhaler is used

Connects to a companion mobile app for viewing inhaler use

Requires no hand-breath coordination during inhalation1

AirDuo®
Digihaler®

 

 

 

 

 

Other DPIs

 

 

 

 

 

BAIs

 

 

 

 

 

Metered-dose
Inhalers

 

 

 

 

 

Abbreviations: BAI=breath-actuated inhaler; DPI=dry-powder inhaler; ICS=inhaled corticosteroid; LABA=long-acting beta agonist; MDI= metered-dose inhaler

Product characteristics listed are not all-inclusive and cannot be used to infer product efficacy or safety

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.

The safety of AirDuo Digihaler has been established from adequate and well-controlled studies of fluticasone propionate and salmeterol MDPI.

Improvements in lung function in clinical trials

 

Fluticasone propionate and salmeterol MDPI demonstrated significantly greater FEV1 improvement vs placebo across all dosage strengths.

TRIAL 1: Mean change from baseline in trough FEV1 at each visit by
treatment group (FAS)

Trial 1 Design: This randomized, double-blind, placebo-controlled, 12-week, global efficacy and safety
trial compared fluticasone propionate and salmeterol MDPI 55/14 mcg and 113/14 mcg (1 inhalation
twice daily) and placebo in adolescent and adult patients with persistent symptomatic asthma despite
low-dose or mid-dose ICS or ICS/LABA therapy. Additional arms in this study received fluticasone
propionate MDPI 55 mcg and 113 mcg (1 inhalation twice daily).

Abbreviations: FAS=full analysis set; FEV1= forced expiratory volume in 1 second; MDPI=multidose dry powder inhaler

Trial 2: Mean change from baseline in trough FEV1 at each visit by
treatment group (FAS)

Trial 2 Design: This randomized, double-blind, placebo-controlled, 12-week, global efficacy and safety
trial compared fluticasone propionate and salmeterol MDPI 113/14 mcg and 232/14 mcg (1 inhalation
twice daily) and placebo in adolescent and adult patients with persistent symptomatic asthma despite
ICS or ICS/LABA therapy. Additional arms in this study received fluticasone propionate MDPI 113 mcg
and 232 mcg (1 inhalation twice daily).

Abbreviations: FAS=full analysis set; FEV1= forced expiratory volume in 1 second; MDPI=multidose dry powder inhaler

Early onset of action and sustained efficacy in a clinical trials program

 

Fluticasone propionate and salmeterol MDPI demonstrated improvement in lung function within 15 minutes of the first dose across all dosage strengths. Maximum improvement in FEV1 generally occurred within 3 hours for fluticasone propionate/salmeterol MDPI 55/14 mcg and within 6 hours for fluticasone propionate/salmeterol MDPI 113/14 mcg.

TRIAL 1: Serial spirometry—Mean change from baseline in FEV1 at Day 1 by
time point and treatment group (FAS; serial spirometry subset)

Trials 1 and 2: The primary endpoints for these trials were the changes from baseline in trough FEV1 at week 12 for all patients and standardized baseline-adjusted FEV1 AUEC0-12h at week 12 analyzed for a subset of 312 patients who performed post dose serial spirometry.

Abbreviation: AUEC0-12h=area under effect-time curve 0-12 hours

TRIAL 2: Serial spirometry—Mean change from baseline FEV1 at Day 1 by time point and treatment group (FAS; serial spirometry subset)

Trials 1 and 2: The primary endpoints for these trials were the changes from baseline in trough FEV1 at week 12 for all patients and standardized baseline-adjusted FEV1 AUEC0-12h at week 12 analyzed for a subset of 312 patients who performed post dose serial spirometry.

Abbreviation: AUEC0-12h=area under effect-time curve 0-12 hours

Safety profile

The safety of fluticasone propionate and salmeterol MDPI was evaluated in patients with asthma who were previously treated with an ICS.

Adverse reactions with ≥3% incidence with fluticasone propionate and salmeterol MDPI, and more common than placebo in subjects with asthma in trials 1 and 2

ADVERSE REACTION

Flucticasone propionate and salmeterol MDPI 55/14 mcg (n=128) %

Flucticasone propionate and salmeterol MDPI 113/14 mcg (n=269) %

Flucticasone propionate and salmeterol MDPI 232/14 mcg (n=145) %

Placebo (n=273) %

Nasopharyngitis

8.6

4.8

6.9

4.4

Oral candidiasis*

1.6

2.2

3.4

0.7

Backpain

3.1

0.7

0.0

1.8

Headache

5.5

4.8

2.8

4.4

Cough

2.3

3.7

0.7

2.6

*Oral candidiasis includes oropharyngeal candidiasis, oral fungal infection, and oropharyngitis fungal.

In a long-term, open-labeled safety study, the types of adverse reactions were similar to those reported above in the placebo-controlled studies. The 26-week safety study included 674 patients previously treated with ICS who were treated twice daily with fluticasone propionate MDPI 113 mcg or 232 mcg; fluticasone propionate/salmeterol MDPI 113/14 mcg or 232/14 mcg; fluticasone propionate inhalation aerosol 110 mcg or 220 mcg; fluticasone propionate and salmeterol inhalation powder (250/50 mcg), or fluticasone propionate and salmeterol inhalation powder (500/50 mcg), the types of adverse reactions were similar to those reported above in placebo-controlled study.

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Indications and Important Safety Information for ProAir Digihaler

INDICATIONS FOR PROAIR DIGIHALER

INDICATIONS

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.

IMPORTANT SAFETY INFORMATION

IMPORTANT SAFETY INFORMATION

  • 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
  • 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
  • Adverse Reactions: In controlled studies in patients 12 years of age and older, adverse events that occurred in ≥1% and >placebo included back pain (2% vs 1%), pain (2% vs <1%), gastroenteritis viral (1% vs <1%), sinus headache (1% vs <1%), and urinary tract infection (1% vs <1%). In controlled studies in patients 4 to 11 years of age, adverse events that occurred in ≥2% and >placebo included nasopharyngitis (2% vs 1%), oropharyngeal pain (2% vs 1%), and vomiting (3% vs 1%)
  • 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 read the full Prescribing Information for ProAir Digihaler.

Indications And Important Safety Information for Armonair Digihaler and AirDuo Digihaler

INDICATIONS FOR AIRDUO DIGIHALER AND
ARMONAIR DIGIHALER

INDICATIONS

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.

Important 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).

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

IMPORTANT SAFETY INFORMATION

Important safety information

  • 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 AirDuo Digihaler, LABA as monotherapy (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
  • Excessive Use and 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
  • Local Effects of ICS: 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: 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. Decreases 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 (reported in greater than or equal to 3% of subjects) are: upper respiratory tract infection, nasopharyngitis, oral candidiasis, headache, and cough
  • Adverse Reactions with AirDuo Digihaler: Most common adverse reactions (reported in greater than or equal to 3% of patients) 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.

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References: 1. Khassawneh BY, Al-Ali MK, Alzoubi KH, et al. Handling of inhaler devices in actual pulmonary practice: metered-dose inhaler versus dry powder inhalers. Respir Care. 2008;53(3):324-328. 2. Advair Diskus Prescribing Information. Research Triangle Park, NC: GSK group of companies. 3. ProAir Digihaler Prescribing Information. Frazer, PA: Teva Respiratory, LLC. 4. AirDuo Digihaler Prescribing Information. Frazer, PA: Teva Respiratory, LLC. 5. ArmonAir Digihaler Prescribing Information. Frazer, PA: Teva Respiratory, LLC.