TRELEGY ELLIPTA Rx
Generic Name and Formulations:
Fluticasone furoate, umeclidinium, vilanterol 100mcg/62.5mcg/25mcg; per inh; dry pwd for oral inhalation.
Indications for TRELEGY ELLIPTA:
Long-term maintenance treatment of COPD, including chronic bronchitis and/or emphysema in patients who are on a fixed-dose combination of fluticasone furoate and vilanterol for airflow obstruction and reducing exacerbations in whom additional treatment of airflow obstruction is desired or for those who are already receiving umeclidinium and a fixed-dose combination of fluticasone furoate and vilanterol.
Limitations Of use:
Not indicated for relief of acute bronchospasm or for treatment of asthma.
1 inh once daily (max). Rinse mouth after use.
Severe hypersensitivity to milk proteins.
LABAs increase risk of asthma-related death. Do not initiate in rapidly or acutely deteriorating COPD. 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 or a severe COPD exacerbation. May unmask previously suppressed allergic conditions. Reevaluate periodically. Monitor for hypercorticism and HPA axis suppression (if occurs, discontinue gradually), intraocular pressure, glaucoma, or cataracts. Discontinue if paradoxical bronchospasm occurs; use alternative therapy. Cardiovascular disease (esp. coronary insufficiency, arrhythmias, hypertension); discontinue if significant effects occur. Convulsive disorders. Thyrotoxicosis. Hyperresponsiveness to sympathomimetics. Diabetes. Ketoacidosis. Hypokalemia. Hyperglycemia. Urinary retention. Prostatic hyperplasia. Bladder-neck obstruction. Assess bone mineral density if risk factors exist (eg, prolonged immobilization, osteoporosis, postmenopausal, advanced age, others). Fluticasone furoate: moderate or severe hepatic impairment (monitor). 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), MAOIs, tricyclic antidepressants, drugs known to prolong the QT interval or within 2 weeks of discontinuing such agents (increased cardiac effects), K+-depleting diuretics. Antagonized by β-blockers; if needed, consider cardioselective agents. Additive effects with concomitant other anticholinergic-containing drugs; avoid.
Corticosteroid + anticholinergic + long-acting beta-2 agonist (LABA).
Headache, back pain, dysgeusia, diarrhea, cough, oropharyngeal pain, gastroenteritis, oral candidiasis; hypersensitivity reactions.
Dry pwd inhaler—30 doses