Source: FDA, National Drug Code (US) Revision Year: 2020
ARNUITY ELLIPTA is an inhalation powder drug product for delivery of fluticasone furoate (an ICS) to patients by oral inhalation.
Fluticasone furoate, a synthetic trifluorinated corticosteroid, has the chemical name (6α,11β,16α,17α)-6,9-difluoro-17-{[(fluoro-methyl)thioi just sne]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 (50, 100, or 200 mcg) and lactose monohydrate (12.45, 12.40, or 12.30 mg, respectively) 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 50 mcg, ARNUITY ELLIPTA 100 mcg, and ARNUITY ELLIPTA 200 mcg deliver 46, 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). In pediatric subjects with asthma aged 5 to 11 years and a mean peak expiratory flow rate of 242 L/min (range: 130 to 420 L/min), mean peak inspiratory flow through the ELLIPTA inhaler was 51.8 L/min (range: 26.8 to 89.9 L/min). Therefore, the ELLIPTA inhaler is able to deliver the dose of fluticasone furoate in patients with asthma.
The actual amount of drug delivered to the lung will depend on patient factors, such as inspiratory flow profile.
| Dosage Forms and Strengths |
|---|
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Inhalation powder: Disposable light grey and orange plastic inhaler containing a foil blister strip of powder intended for oral inhalation only. Each blister contains fluticasone furoate 50, 100, or 200 mcg. |
| How Supplied |
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ARNUITY ELLIPTA 50 mcg is supplied as a disposable light grey and orange plastic inhaler containing a foil strip with 30 blisters (NDC 0173-0888-10). ARNUITY ELLIPTA 100 mcg is supplied as a disposable light grey and orange plastic inhaler containing a foil strip with 30 blisters (NDC 0173-0874-10) or 14 blisters (institutional pack) (NDC 0173-0874-14). ARNUITY ELLIPTA 200 mcg is supplied as a disposable light grey and orange plastic inhaler containing a foil strip with 30 blisters (NDC 0173-0876-10) or 14 blisters (institutional pack) (NDC 0173-0876-14). The inhaler is packaged in a moisture-protective foil tray with a desiccant and a peelable lid. GlaxoSmithKline, Research Triangle Park, NC 27709 |
| Drug | Countries | |
|---|---|---|
| ARNUITY ELLIPTA | Australia, Canada, Japan, New Zealand, Singapore, United States |
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