These highlights do not include all the information needed to use ARNUITY ELLIPTA safely and effectively. See full prescribing information for ARNUITY ELLIPTA.
ARNUITY ELLIPTA (fluticasone furoate inhalation powder) 100 mcg
ARNUITY ELLIPTA (fluticasone furoate inhalation powder) 200 mcg
FOR ORAL INHALATION
Initial U.S. Approval: 2014
INDICATIONS AND USAGE
ARNUITY ELLIPTA is a corticosteroid indicated for:
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once-daily maintenance treatment of asthma as prophylactic therapy in patients aged 12 years and older. (1.1)
Important limitation:
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Not indicated for relief of acute bronchospasm. ( 1.1, 5.2)
DOSAGE AND ADMINISTRATION
For oral inhalation only. (2.1)
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Starting dosage is based on prior asthma therapy and disease severity. ( 2.2)
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Treatment of asthma in patients aged 12 years and older: 1 inhalation of ARNUITY ELLIPTA 100 mcg or ARNUITY ELLIPTA 200 mcg once daily. ( 2.2)
DOSAGE FORMS AND STRENGTHS
Inhalation powder containing 100 or 200 mcg of fluticasone furoate per actuation. (3)
CONTRAINDICATIONS
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Primary treatment of status asthmaticus or acute episodes of asthma requiring intensive measures. ( 4.1)
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Severe hypersensitivity to milk proteins or any ingredients of ARNUITY ELLIPTA. ( 4.2)
WARNINGS AND PRECAUTIONS
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Localized infections: Candida albicans infection of the mouth and throat may occur. Monitor patients periodically. Advise the patient to rinse his/her mouth with water without swallowing after inhalation. (5.1)
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Deterioration of asthma and acute episodes: Do not use for relief of acute symptoms. Patients require immediate re-eva luation during rapidly deteriorating asthma. (5.2)
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Immunosuppression: Potential worsening of existing tuberculosis, fungal, bacterial, viral, parasitic infections or ocular herpes simplex. Use with caution in patients with these infections. More serious or even fatal course of chickenpox or measles can occur in susceptible patients. (5.3)
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Transferring patients from systemic corticosteroids: Risk of impaired adrenal function when transferring from systemic corticosteroids. Wean patients slowly from systemic corticosteroids if transferring to ARNUITY ELLIPTA. (5.4)
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Hypercorticism and adrenal suppression: May occur with very high dosages or at the regular dosage in susceptible individuals. If such changes occur, discontinue ARNUITY ELLIPTA slowly. (5.5)
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Paradoxical bronchospasm: Discontinue ARNUITY ELLIPTA and institute alternative therapy if paradoxical bronchospasm occurs. (5.7)
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Decreases in bone mineral density: Monitor patients with major risk factors for decreased bone mineral content. (5.9)
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Monitor growth of adolescent patients. (5.10)
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Close monitoring for glaucoma and cataracts is warranted. (5.11)
ADVERSE REACTIONS
Most common adverse reactions (reported in greater than or equal to 5% of subjects) are:
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upper respiratory tract infection, nasopharyngitis, headache, and bronchitis. ( 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.
DRUG INTERACTIONS
Strong cytochrome P450 3A4 inhibitors (e.g., ketoconazole): Use with caution. May cause systemic corticosteroid effects. (7.1)
USE IN SPECIFIC POPULATIONS
Hepatic impairment: Fluticasone furoate exposure may increase in patients with moderate or severe impairment. Monitor for systemic corticosteroid effects. (8.6, 12.3)
See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.
Revised: 11/2014
