The US Food and Drug Administration (FDA) has approved fluticasone furoate inhalation powder (Arnuity Ellipta, GlaxoSmithKline) as maintenance treatment for asthma in patients aged 12 years and older, the company said today.
The FDA approved 2 doses, 100 and 200 μg, to be administered once daily via the company's dry powder inhaler Ellipta.
The efficacy and safety of Arnuity Ellipta have been evaluated in more than 3600 patients with asthma, the company notes in a statement. The most common adverse reactions (reported in at least 5% of subjects) were upper respiratory tract infection, nasopharyngitis, headache, and bronchitis.
Arnuity Ellipta is not indicated for relief of acute bronchospasm.
Other important safety information included in the highlights section of the prescribing information includes the following: "Arnuity Ellipta is contraindicated for primary treatment of status asthmaticus or acute episodes of asthma requiring intensive measures and in patients with severe hypersensitivity to milk proteins or any ingredients of Arnuity Ellipta." The section also highlights the following points:
Candida albicans infection of the mouth and throat may occur in patients treated with Arnuity Ellipta.
Patients who use corticosteroids are at risk for potential worsening of existing tuberculosis; fungal, bacterial, viral, or parasitic infections; or ocular herpes simplex. A more serious or even fatal course of chickenpox or measles may occur in susceptible patients.
Risk for impaired adrenal function when transferring from systemic corticosteroids. Wean patients slowly from systemic corticosteroids if transferring to Arnuity Ellipta.
Hypercorticism and adrenal suppression may occur with very high dosages or at the regular dosage in susceptible individuals.
Discontinue Arnuity Ellipta and institute alternative therapy if paradoxical bronchospasm occurs.
Monitor patients with major risk factors for decreased bone mineral content.
Monitor growth of adolescent patients.
Close monitoring for glaucoma and cataracts is warranted.
Use Arnuity Ellipta with caution in patients taking strong cytochrome P450 3A4 inhibitors (e., ketoconazole) because this may cause systemic corticosteroid effects.
Fluticasone furoate exposure may increase in patients with moderate or severe hepatic impairment. Monitor for systemic corticosteroid effects.
The company says full prescribing information including a patient information leaflet will be available soon on their Web site.
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Cite this: FDA OKs New Maintenance Asthma Treatment Arnuity Ellipta - Medscape - Aug 20, 2014.