Drugplain

Arnuity Ellipta 50 ug/1

fluticasone furoate · POWDER · GlaxoSmithKline LLC

2 Recalls on RecordCurrently in Shortage
Plain English

Arnuity Ellipta is a powder containing fluticasone furoate at 50 ug/1, taken respiratory (inhalation). Manufactured by GlaxoSmithKline LLC.

Key Facts

Brand Name
Arnuity Ellipta
Generic Name
fluticasone furoate
NDC Code (Product)
0173-0888
Manufacturer
GlaxoSmithKline LLC
Strength
50 ug/1
Dosage Form
POWDER
Route
RESPIRATORY (INHALATION)
Marketing Status
Application #
NDA205625
Marketing Start
05/17/2018

Recall History

2 Recalls on Record
Class II03/15/2021

Cardinal Health Inc.

CGMP Deviations: Intermittent exposure to temperature excursion during storage.

TerminatedVoluntary: Firm initiated
Class II03/15/2021

Cardinal Health Inc.

CGMP Deviations: Intermittent exposure to temperature excursion during storage.

TerminatedVoluntary: Firm initiated

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

drug ineffective1,501 reports
dyspnoea1,487 reports
asthma1,269 reports
wheezing876 reports
cough865 reports
off label use861 reports
therapeutic product effect incomplete752 reports
nausea633 reports
pain630 reports
macular degeneration624 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

1 INDICATIONS AND USAGE ARNUITY ELLIPTA is indicated for the maintenance treatment of asthma in adult and pediatric patients aged 5 years and older. Limitations of Use ARNUITY ELLIPTA is NOT indicated for the relief of acute bronchospasm. ARNUITY ELLIPTA is an inhaled corticosteroid indicated for the maintenance treatment of asthma in adult and pediatric patients aged 5 years and older. ( 1 ) Limitations of Use: Not indicated for relief of acute bronchospasm. ( 1 , 5.2 )

Dosage & Administration

2 DOSAGE AND ADMINISTRATION • For oral inhalation only. ( 2.1 ) • Maintenance treatment of asthma in adult and pediatric patients aged 12 years and older: The starting dosage, 1 actuation of ARNUITY ELLIPTA 100 mcg or ARNUITY ELLIPTA 200 mcg once daily, is based on prior asthma therapy and disease severity. ( 2.2 ) • Maintenance treatment of asthma in pediatric patients aged 5 to 11 years: 1 actuation of ARNUITY ELLIPTA 50 mcg once daily. ( 2.2 ) 2.1 Administration • Administer 1 actuation of ARNUITY ELLIPTA once daily by oral inhalation. • After inhalation, the patient should rinse his/her mouth with water without swallowing to help reduce the risk of oropharyngeal candidiasis. • ARNUITY ELLIPTA should be used at the same time every day. Do not use ARNUITY ELLIPTA more than 1 time every 24 hours. • 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. No dosage adjustment is required for geriatric patients, patients with renal impairment, or patients with mild hepatic impairment [see Clinical Pharmacology ( 12.3 )] . 2.2 Recommended Dosage Adult and Ped…

Contraindications

4 CONTRAINDICATIONS ARNUITY ELLIPTA is contraindicated in the following conditions: • Primary treatment of status asthmaticus or other acute episodes of asthma where intensive measures are required [see Warnings and Precautions ( 5.2 )] . • Severe hypersensitivity to milk proteins or demonstrated hypersensitivity to fluticasone furoate or any of the excipients [see Warnings and Precautions ( 5.8 ), Description ( 11 )] . • Primary treatment of status asthmaticus or acute episodes of asthma requiring intensive measures. ( 4 ) • Severe hypersensitivity to milk proteins ( 4 ) • Demonstrated hypersensitivity to any ingredients. ( 4 )

Drug Interactions

7 DRUG INTERACTIONS Strong cytochrome P450 3A4 inhibitors (e.g., ketoconazole): Use with caution. May cause systemic corticosteroid effects. ( 7.1 ) 7.1 Inhibitors of Cytochrome P450 3A4 Fluticasone furoate is a 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 ketoconazole and other known strong CYP3A4 inhibitors [see Warnings and Precautions ( 5.6 ), Clinical Pharmacology ( 12.3 )] .

Adverse Reactions

6 ADVERSE REACTIONS Systemic and local corticosteroid use may result in the following: • Oropharyngeal Candidiasis [see Warnings and Precautions ( 5.1 )] • Immunosuppression and Risk of Infections [see Warnings and Precautions ( 5.3 )] • Hypercorticism and Adrenal Suppression [see Warnings and Precautions ( 5.5 )] • Reduction in BMD [see Warnings and Precautions ( 5.9 )] • Growth Effects in Pediatrics [see Warnings and Precautions ( 5.10 )] • Glaucoma and Cataracts [see Warnings and Precautions ( 5.11 )] Most common adverse reactions reported in ≥5% of adult and pediatric subjects aged 12 years and older are nasopharyngitis, bronchitis, upper respiratory tract infection, and headache. ( 6.1 ) Most common adverse reactions reported in ≥3% of pediatric subjects aged 5 to 11 years are pharyngitis, bronchitis, and viral infection. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact GlaxoSmithKline at 1-888-825-5249 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical…

Frequently Asked Questions

What is Arnuity Ellipta used for?

Arnuity Ellipta contains fluticasone furoate. It is a powder taken respiratory (inhalation). Consult your doctor for specific uses.

Is Arnuity Ellipta a controlled substance?

Arnuity Ellipta is not classified as a controlled substance by the DEA.

What is the generic name for Arnuity Ellipta?

The generic name for Arnuity Ellipta is fluticasone furoate. There are 10 other brand versions of fluticasone furoate.

What is the NDC code for Arnuity Ellipta 50 ug/1?

The NDC (National Drug Code) for Arnuity Ellipta 50 ug/1 is 0173-0888, listed by GlaxoSmithKline LLC.

Product NDC

0173-0888

Package NDC

0173-0888-10

Other Fluticasone Brands

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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

Data from openFDA · Public domain (CC0 1.0)