Breo Ellipta Generic Name & Formulations
Fluticasone furoate, vilanterol 100/25mcg, 200/25mcg; per inh; dry pwd for oral inh.
Corticosteroid + long-acting beta-2 agonist (LABA).
Dry pwd inhaler—30 inh
Breo Ellipta Indications
Long-term maintenance treatment of COPD, including chronic bronchitis and/or emphysema. To reduce exacerbations of COPD in patients with a history of exacerbations. Treatment of asthma in patients not adequately controlled on a long-term asthma control medication [eg, inhaled corticosteroid (ICS)] or whose disease warrants initiation of both an ICS and LABA.
Limitations of Use
Not for relief of acute bronchospasm.
Breo Ellipta Dosage and Administration
COPD: 1 inh of 100/25mcg once daily (max). Asthma: initially 1 inh of 100/25mcg or 200/25mcg once daily, based on disease severity and previous asthma therapy; max 1 inh of 200/25mcg once daily. Rinse mouth after use.
≤17yrs: not established.
Breo Ellipta Contraindications
Primary treatment of status asthmaticus or acute episodes of asthma or COPD requiring intensive measures. Severe hypersensitivity to milk proteins.
Breo Ellipta Boxed Warnings
Breo Ellipta Warnings/Precautions
Increased risk of asthma-related events (death, hospitalizations, intubations) with LABA monotherapy (without ICS). Do not initiate in rapidly or acutely deteriorating COPD or asthma. Not for use with other long-acting β2-agonists. Do not exceed recommended dose. Prescribe a short-acting, inhaled β2-agonist for acute symptoms; monitor for increased need. Monitor for signs/symptoms of pneumonia. Immunosuppressed. Tuberculosis. Systemic infections. Ocular herpes simplex. If exposed to chickenpox or measles, consider immune globulin prophylaxis or antiviral treatment. Monitor for adrenal insufficiency when transferring from systemic steroids. May need supplemental systemic corticosteroids during periods of stress, a severe COPD exacerbation, or a severe asthma attack. May unmask previously suppressed allergic conditions. 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. Cardiovascular disease (esp. coronary insufficiency, arrhythmias, hypertension). Convulsive disorders. Thyrotoxicosis. Hyperresponsiveness to sympathomimetics. Diabetes. Ketoacidosis. Hypokalemia. Hyperglycemia. Moderate or severe hepatic impairment; monitor. Assess bone mineral density if risk factors exist (eg, prolonged immobilization, osteoporosis, postmenopausal, advanced age, others). Labor & delivery. Pregnancy. Nursing mothers.
Breo Ellipta Pharmacokinetics
Breo Ellipta Interactions
Caution with concomitant strong CYP3A4 inhibitors (eg, ketoconazole, ritonavir, clarithromycin, conivaptan, indinavir, itraconazole, lopinavir, nefazodone, nelfinavir, saquinavir, telithromycin, troleandomycin, voriconazole), during or within 2 weeks of discontinuing MAOIs, tricyclic antidepressants, or drugs known to prolong QT interval (increased cardiac effects), β-blockers (consider cardioselective), K+-depleting diuretics.
Breo Ellipta Adverse Reactions
Nasopharyngitis, upper respiratory tract infection, headache, oral candidiasis, back pain, pneumonia, bronchitis, sinusitis, cough, oropharyngeal pain, arthralgia, hypertension, influenza, pharyngitis, pyrexia, dysphonia; hypersensitivity reactions.
Breo Ellipta Clinical Trials
Breo Ellipta Note
Breo Ellipta Patient Counseling