n 15minutes of beginning treatment; although, maximum benefit may not be achieved for 1 week orlonger after starting treatment. Individual patients will experience a variable time to onset anddegree of symptom relief. For patients who do not respond adequately to the starting dosage after2 weeks of therapy, consider increasing the strength (replace with a higher strength) to possiblyprovide additional improvement in asthma control. The maximum recommended dosage ofAirDuo Digihaler is 232/14 mcg twice daily.
If a previously effective dosage regimen fails to provide adequate improvement in asthmacontrol, the therapeutic regimen should be reeva luated and additional therapeutic options (e.g.,replacing the current strength of AirDuo Digihaler with a higher strength, adding additionalcontroller therapies) should be considered. After asthma stability has been achieved, it isdesirable to titrate to the lowest effective dosage to reduce the risk of adverse reactions.
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 themouthpiece 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 AirDuo 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 [seePatient Counseling Information (17).
AirDuo Digihaler contains a built-in electronic module which detects, records, and stores data oninhaler events, including peak inspiratory flow rate (L/minute), for transmission to the mobileApp where inhaler events are categorized. Use of the App is not required for administration offluticasone propionate and salmeterol to the patient. There is no evidence the use of the Appleads to improved clinical outcomes, including safety and effectiveness [see HowSupplied/Storage and Handling (16)].
3 DOSAGE FORMS AND STRENGTHS
Inhalation Powder: AirDuo Digihaler is an inhalation-driven, multidose dry powder inhaler(MDPI) with an electronic module, for oral inhalation that meters 55 mcg, 113 mcg, or 232 mcg of fluticasone propionate with 14 mcg of salmeterol from the device reservoir and delivers 49mcg, 100 mcg, or 202 mcg of fluticasone propionate with 12.75 mcg of salmeterol, respectively,from the mouthpiece per actuation. The AirDuo Digihaler is a white inhaler with a yellow cap,and is provided in a sealed foil pouch with desiccant. AirDuo Digihaler contains a built-inelectronic module [see How Supplied/Storage and Handling (16.2)].
4 CONTRAINDICATIONS
4.1 Status Asthmaticus
AirDuo Digihaler is contraindicated in the primary treatment of status asthmaticus or other acuteepisodes of asthma where intensive measures are required [see Warnings and Precautions (5.2)].
4.2 Hypersensitivity
AirDuo Digihaler is contraindicated in patients with known severe hypersensitivity to milkproteins or who have demonstrated hypersensitivity to fluticasone propionate or any of theexcipients [see Warnings and Precautions (5.10) and Description (11)].
5 WARNINGS AND PRECAUTIONS
5.1 Serious Asthma-Related Events – Hospitalizations, Intubations,Death Use of LABA as monotherapy [without inhaled corticosteroids (ICS)] for asthma is associated
with an increased risk of asthma-related death [see Salmeterol Multicenter Asthma R |
