Arnuity Ellipta
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Questions & Answers
Side Effects & Adverse Reactions
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Manufacturer Warnings
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FDA Labeling Changes
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Uses
ARNUITY™ ELLIPTA® is indicated for the once-daily maintenance treatment of asthma as prophylactic therapy in patients aged 12 years and older.
Important Limitation of Use: ARNUITY ELLIPTA is NOT indicated for the relief of acute bronchospasm.
History
There is currently no drug history available for this drug.
Other Information
The active component of ARNUITY ELLIPTA is fluticasone furoate, a synthetic trifluorinated corticosteroid having the chemical name (6α,11β,16α,17α)-6,9-difluoro-17-{[(fluoro-methyl)thio]carbonyl}-11-hydroxy-16-methyl-3-oxoandrosta-1,4-dien-17-yl 2-furancarboxylate and the following chemical structure:
Fluticasone furoate is a white powder with a molecular weight of 538.6, and the empirical formula is C27H29F3O6S. It is practically insoluble in water.
ARNUITY ELLIPTA is a light grey and orange plastic inhaler containing a foil blister strip. Each blister on the strip contains a white powder mix of micronized fluticasone furoate (100 or 200 mcg) and lactose monohydrate (12.4 or 12.3 mg) for a total powder mix of 12.5 mg per blister. The lactose monohydrate contains milk proteins. After the inhaler is activated, the powder within the blister is exposed and ready for dispersion into the airstream created by the patient inhaling through the mouthpiece.
Under standardized in vitro test conditions, ARNUITY ELLIPTA 100 mcg and ARNUITY ELLIPTA 200 mcg deliver 90 and 182 mcg, respectively, of fluticasone furoate per blister when tested at a flow rate of 60 L/min for 4 seconds.
In adult subjects with asthma and a mean FEV1 of 2.55 L/sec (range: 1.63 to 3.97 L/sec), mean peak inspiratory flow through the ELLIPTA inhaler was 103.2 L/min (range: 71.2 to 133.1 L/min).
The actual amount of drug delivered to the lung will depend on patient factors, such as inspiratory flow profile.
Sources
Arnuity Ellipta Manufacturers
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Glaxosmithkline Llc
![Arnuity Ellipta (Fluticasone Furoate) Powder [Glaxosmithkline Llc]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Arnuity Ellipta | Glaxosmithkline Llc
2.1 GeneralARNUITY ELLIPTA should be administered only by the orally inhaled route [see Instructions for Use in the Patient Information leaflet]. Advise the patient to rinse his/her mouth with water without swallowing after each dose.
2.2 DosingARNUITY 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 is based upon patients’ asthma severity. The usual recommended starting dose for patients not on an inhaled corticosteroid is 100 mcg. For other patients, the starting dose should be based on previous asthma drug therapy and disease severity. For patients 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 inhaled corticosteroid and long-acting beta2-agonist (LABA) combination product, or initiating oral corticosteroids, should be considered.
The highest recommended daily dose is 200 mcg. 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.
After asthma stability has been achieved, it is desirable to titrate to the lowest effective dosage to help reduce the possibility of side effects.
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