Source: FDA, National Drug Code (US) Revision Year: 2020
ARNUITY ELLIPTA is indicated for the once-daily maintenance treatment of asthma as prophylactic therapy in patients aged 5 years and older.
Important Limitation of Use:
ARNUITY ELLIPTA is NOT indicated for the relief of acute bronchospasm.
ARNUITY ELLIPTA should be administered only by the orally inhaled route [see Instructions for Use leaflet]. After inhalation, the patient should rinse his/her mouth with water without swallowing to help reduce the risk of oropharyngeal candidiasis.
If symptoms arise between doses, an inhaled, short-acting beta2-agonist should be used for immediate relief.
The maximum benefit may not be achieved for up to 2 weeks or longer after starting treatment. Individual patients may experience a variable time to onset and degree of symptom relief.
ARNUITY ELLIPTA should be administered as 1 inhalation once daily by the orally inhaled route. ARNUITY ELLIPTA should be used at the same time every day. Do not use ARNUITY ELLIPTA more than 1 time every 24 hours.
The starting dosage for ARNUITY ELLIPTA should be based upon patients' asthma severity. The usual recommended starting dose for adults and adolescents aged 12 years and older not on an inhaled corticosteroid (ICS) is 100 mcg. For other adults and adolescents aged 12 years and older, the starting dose should be based on previous asthma drug therapy and disease severity. For adults and adolescents aged 12 years and older who do not respond to ARNUITY ELLIPTA 100 mcg after 2 weeks of therapy, replacement with ARNUITY ELLIPTA 200 mcg may provide additional asthma control.
If a dosage regimen of ARNUITY ELLIPTA 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 ARNUITY ELLIPTA with a higher strength, initiating an ICS and long-acting beta2-agonist (LABA) combination product, or initiating oral corticosteroids, should be considered.
The highest recommended daily dose in adults and adolescents aged 12 years and older is 200 mcg.
After asthma stability has been achieved, it is desirable to titrate to the lowest effective dosage to help reduce the possibility of side effects.
The recommended dosage for children aged 5 to 11 years is 50 mcg administered once daily [see Warnings and Precautions (5.10)].
No human overdosage data have been reported for ARNUITY ELLIPTA. The potential for acute toxic corticosteroid effects following overdosage with ARNUITY ELLIPTA is low. Because of low systemic bioavailability (13.9%) and an absence of acute drug-related systemic findings in clinical trials, overdosage of fluticasone furoate is unlikely to require any treatment other than observation. If used at excessive doses for prolonged periods, systemic effects such as hypercorticism may occur [see Warnings and Precautions (5.5)].
Single- and repeat-dose trials of fluticasone furoate at doses of 50 to 4,000 mcg have been studied in human subjects. Decreases in mean serum cortisol were observed at dosages of 500 mcg or higher given once daily for 14 days.
Store at room temperature between 68°F and 77°F (20°C and 25°C); excursions permitted from 59°F to 86°F (15°C to 30°C) [See USP Controlled Room Temperature]. Store in a dry place away from direct heat or sunlight. Keep out of reach of children.
ARNUITY ELLIPTA should be stored inside the unopened moisture-protective foil tray and only removed from the tray immediately before initial use. Discard ARNUITY ELLIPTA 6 weeks after opening the foil tray or when the counter reads “0” (after all blisters have been used), whichever comes first. The inhaler is not reusable. Do not attempt to take the inhaler apart.
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