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Arnuity Ellipta Generic Name & Formulations
Legal Class
Rx
General Description
Fluticasone furoate 50mcg, 100mcg, 200mcg; per inhalation; dry pwd for oral inhalation.
Pharmacological Class
Corticosteroid.
How Supplied
Dry pwd inhaler—30 doses
Manufacturer
Generic Availability
NO
Mechanism of Action
Fluticasone furoate is a synthetic trifluorinated corticosteroid with anti‑inflammatory activity. The precise mechanism through which fluticasone furoate affects asthma symptoms is not known. Corticosteroids have been shown to have a wide range of actions on multiple cell types (eg, mast cells, eosinophils, neutrophils, macrophages, lymphocytes) and mediators (eg, histamine, eicosanoids, leukotrienes, cytokines) involved in inflammation. Specific effects of fluticasone furoate demonstrated in in vitro and in vivo models included activation of the glucocorticoid response element, inhibition of pro-inflammatory transcription factors such as NFkB, and inhibition of antigen-induced lung eosinophilia in sensitized rats. These anti-inflammatory actions of corticosteroids may contribute to their efficacy.
Arnuity Ellipta Indications
Indications
Maintenance treatment of asthma in patients ≥5yrs.
Limitations of Use
Not for relief of acute bronchospasm.
Arnuity Ellipta Dosage and Administration
Adult
Base initial dose on previous asthma therapy and disease severity. Not on inhaled corticosteroid: usually initiate at 100mcg once daily; may increase to 200mcg once daily if inadequate response after 2 weeks. Max 200mcg/day. Rinse mouth after use.
Children
<5yrs: not established. 5–11yrs: 50mcg once daily. Rinse mouth after use.
Arnuity Ellipta Contraindications
Contraindications
Primary treatment of status asthmaticus or acute asthma episodes. Severe hypersensitivity to milk proteins.
Arnuity Ellipta Boxed Warnings
Not Applicable
Arnuity Ellipta Warnings/Precautions
Warnings/Precautions
Do not exceed recommended dose. Prescribe a short-acting, inhaled β2-agonist for acute symptoms; monitor for increased need. Immunosuppressed. Tuberculosis. Systemic infections (eg, fungal, bacterial, viral, parasitic). Ocular herpes simplex. If exposed to chickenpox or measles, consider immune globulin or antiviral prophylactic therapies. Monitor for adrenal insufficiency when transferring from systemic steroids. Reevaluate periodically. Monitor for hypercorticism and HPA axis suppression (if occurs, discontinue gradually), growth in children, IOP, glaucoma, or cataracts. Consider eye exams if ocular symptoms develop or in long-term use. Discontinue and treat if paradoxical bronchospasm occurs; use alternative therapy. Assess bone mineral density if risk factors exist (eg, prolonged immobilization, osteoporosis, postmenopausal, tobacco use, advanced age, poor nutrition, others). Moderate or severe hepatic impairment; monitor. Elderly. Labor & delivery. Pregnancy; monitor. Nursing mothers.
Arnuity Ellipta Pharmacokinetics
Absorption
Peak plasma concentrations: within 0.51 hour.
Absolute bioavailability by inhalation: 13.9%.
Distribution
Mean volume of distribution at steady state: 661 L.
Plasma protein bound: 99.6%.
Elimination
Fecal.
Half-life: ~24 hours.
Arnuity Ellipta Interactions
Interactions
Caution with concomitant strong CYP3A4 inhibitors (eg, ketoconazole, ritonavir, clarithromycin, conivaptan, indinavir, itraconazole, lopinavir, nefazodone, nelfinavir, saquinavir, telithromycin, troleandomycin, voriconazole).
Arnuity Ellipta Adverse Reactions
Adverse Reactions
Nasopharyngitis, upper respiratory tract infection, headache, bronchitis, oral candidiasis; hypersensitivity reactions (discontinue if occurs); children: also pharyngitis, viral infection.
Arnuity Ellipta Clinical Trials
See Literature
Arnuity Ellipta Note
Not Applicable
Arnuity Ellipta Patient Counseling
See Literature
