ArmonAir Digihaler Dosage

2.1 Important Administration Instructions

Administer ArmonAir Digihaler as 1 inhalation twice daily (approximately 12 hours apart at the same time every day) by the orally inhaled route. Advise the patient to rinse his/her mouth with water without swallowing after each dose.

• ArmonAir Digihaler does not require priming.
• Do not use ArmonAir Digihaler with a spacer or volume holding chamber.
• Do not use ArmonAir Digihaler by other routes.
• Do not use more than 2 times every 24 hours. The safety and efficacy of ArmonAir Digihaler when administered in excess of recommended dosages have not been established.

If symptoms arise between doses, an inhaled short-acting beta2-agonist should be used for immediate relief.

2.2 Recommended Dosage

The recommended starting dosage for ArmonAir Digihaler is based on asthma severity and current asthma drug therapy and strength. For example:

• For patients with greater asthma severity, use the higher doses: either
  • 113 mcg (113 mcg of fluticasone propionate) administered twice daily; or
  • 232 mcg (232 mcg of fluticasone propionate) administered twice daily.
• For patients not taking inhaled corticosteroids (ICS), with less severe asthma, select 55 mcg (55 mcg of fluticasone propionate), administered twice daily.
• For patients switching to ArmonAir Digihaler from another ICS: select the low (55 mcg), medium (113 mcg), or high (232 mcg) dose strength of ArmonAir Digihaler based on the strength of the previous ICS product and disease severity.

The maximum benefit may not be achieved for up to 2 weeks or longer after starting treatment. Individual patients will experience a variable time to onset and degree of symptom relief. For patients who do not respond adequately to the starting dose of ArmonAir Digihaler after 2 weeks of therapy, increasing the dose may provide additional asthma control. The highest recommended dose is 232 mcg twice daily.

If a previously effective dosage regimen of ArmonAir Digihaler fails to provide adequate control of asthma, the therapeutic regimen should be re-evaluated and additional therapeutic options (e.g., replacing the current strength of ArmonAir Digihaler with a higher strength, or adding additional controller therapies) should be considered. After asthma stability has been achieved, it is desirable to titrate to the lowest effective dosage to reduce the possibility of side effects.

2.3 Storing and Cleaning the Inhaler

• Keep the inhaler in a cool dry place.
• Routine maintenance is not required. If the mouthpiece needs cleaning, gently wipe the mouthpiece with a dry cloth or tissue as needed.
• Never wash or put any part of the inhaler in water.

2.4 Dose Counter and Storage of Inhaler Events Data

The ArmonAir Digihaler inhaler has a dose counter.

• The number 60 is displayed (prior to use).
• The dose counter will count down each time the mouthpiece is opened and closed [see Patient Counseling Information (17)].

ArmonAir Digihaler contains a built-in electronic module which detects, records, and stores data on inhaler events, including peak inspiratory flow rate (L/min), for transmission to the mobile App where inhaler events are categorized. Use of the App is not required for administration of fluticasone propionate to the patient. There is no evidence the use of the App leads to improved clinical outcomes, including safety and effectiveness [see How Supplied/Storage and Handling (16.2)].