BREO ELLIPTA Rx
Generic Name and Formulations:
Fluticasone furoate, vilanterol 100/25mcg, 200/25mcg; per inh; dry pwd for oral inh.
Indications for BREO ELLIPTA:
Long term maintenance treatment of COPD, including chronic bronchitis and/or emphysema. To reduce exacerbations of COPD in patients with a history of exacerbations. Maintenance treatment of asthma in patients not adequately controlled on a long-term asthma control medication (eg, inhaled corticosteroid) or whose disease severity warrants initiation of 2 maintenance therapies.
Limitations Of use:
Not for relief of acute bronchospasm.
COPD: 1 inh of 100/25mcg once daily (max). Asthma: initially 1 inh of 100/25mcg or 200/25mcg once daily; max 1 inh of 200/25mcg once daily. Previously on low- to mid-dose corticosteroid: consider 100/25mcg; mid- to high-dose corticosteroid: consider 200/25mcg. Rinse mouth after use.
≤17yrs: not established.
Primary treatment of status asthmaticus or acute episodes of asthma or COPD requiring intensive measures. Severe hypersensitivity to milk proteins.
LABAs increase risk of asthma-related death. 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 or antiviral prophylactic therapies. 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, intraocular pressure, glaucoma, or cataracts. Discontinue 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.
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.
Corticosteroid + long-acting beta-2 agonist (LABA).
Nasopharyngitis, upper respiratory tract infection, headache, oral candidiasis, back pain, pneumonia, bronchitis, sinusitis, cough, oropharyngeal pain, arthralgia, hypertension, influenza, pharyngitis, pyrexia, dysphonia; hypersensitivity reactions.
Dry pwd inhaler—30 doses