Clinical Information
Gen. Code and Des.
72723 fluticasone furoate INHALATION BLST W/DEV 200 MCG
GCN and Des.
37008 fluticasone furoate INHALATION BLST W/DEV 200 MCG
Strength
200MCG
Dose Form
BLISTER, WITH INHALATION DEVICE
Product Category
RX Pharmaceuticals
Fine Line Class
850085008510 All Rx Products
DEA Class
NC
OMP Family
AHFS Class
48100808 ORALLY INHALED PREPARATIONS (STEROIDS)
68040000 ADRENALS
Active Ingredients
12173 fluticasone furoate 397864447
Inactive Ingredients
2432 lactose 64044515
ARNUITY ELLIPTA- fluticasone furoate powder
GlaxoSmithKline LLC
reatment of Asthma
DESCRIPTION
The active component of ARNUITY ELLIPTA is fluticasone furoate, synthetic trifluorinated corticosteroid having the chemical name (6?,11?,16?,17?)-6,9-difluoro-17-{[(fluoro-methyl)thio]carbonyl}-11-hydroxy-16-methyl-3-oxoandrosta-1,4-dien-17-yl 2-furancarboxylate
Fluticasone furoate is white powder with molecular weight of 538.6, and the empirical formula is C27H29 F3 O6 S. It is practically insoluble in water.
ARNUITY ELLIPTA is light grey and orange plastic inhaler containing foil blister strip. Each blister on the strip contains white powder mix of micronized fluticasone furoate (100 or 200 mcg) and lactose monohydrate (12.4 or 12.3 mg) for 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 flow rate of 60 L/min for seconds.
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.
2 DOSAGE AND ADMINISTRATION
2.1 General
ARNUITY ELLIPTA should be administered only by the orally inhaled route [see Instructions for Use in the Patient info. leaflet]. Advise the patient to rinse his/her mouth with water without swallowing after each dose.
2.2 Dosing
ARNUITY ELLIPTA should be administered as 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 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 weeks of therapy, replacement with ARNUITY ELLIPTA 200 mcg may provide additional asthma control.
If 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 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 weeks or longer after starting treatment. Individual patients may experience 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.
3 DOSAGE FORMS AND STRENGTHS
Inhalation Powder. Disposable light grey and orange plastic inhaler containing foil blister strip of powder intended for oral inhalation only. Each blister contains fluticasone furoate 100 or 200 mcg.
4 CONTRAINDICATIONS
4.1 Status Asthmaticus
ARNUITY ELLIPTA is contraindicated in the primary treatment of status asthmaticus or other acute episodes of asthma where intensive measures are required [see Warnings and Precautions ].
4.2 Hypersensitivity
ARNUITY ELLIPTA is contraindicated in patients with known severe hypersensitivity to milk proteins or who have demonstrated hypersensitivity to fluticasone furoate or any of the excipients [see Warnings and Precautions
DRUG INTERACTIONS
7.1 Inhibitors of Cytochrome P450 3A4
Fluticasone furoate is substrate of CYP3A4. Concomitant administration of the strong CYP3A4 inhibitor ketoconazole increases the systemic exposure to fluticasone furoate. Caution should be exercised when considering the coadministration of ARNUITY ELLIPTA with long-term ketoconazole and other known strong CYP3A4 inhibitors (e.g., ritonavir, clarithromycin, conivaptan, indinavir, itraconazole, lopinavir, nefazodone, nelfinavir, saquinavir, telithromycin, troleandomycin, voriconazole)
Teratogenic Effects: Pregnancy Category C.
ARNUITY is trademark and ELLIPTA is registered trademark of the GSK group of companies.
GlaxoSmithKline
Research Triangle Park, NC 27709
?2014, the GSK group of companies. All rights reserved.
August 2014
ARN:1PIL
PRINCIPAL DISPLAY PANEL
NDC 0173-0874-10
ARNUITY? ELLIPTA
