Indications for TRELEGY ELLIPTA:
Maintenance treatment of COPD.
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.
LABA as monotherapy (without ICS) for asthma can increase risk of asthma-related events. Do not initiate in rapidly deteriorating or potentially life-threatening episodes of COPD. Prescribe a short-acting, inhaled β2-agonist for acute symptoms; monitor for increased need. Do not exceed recommended dose. 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 or a severe COPD exacerbation. May unmask previously suppressed allergic conditions. Reevaluate periodically. Monitor for hypercorticism and HPA axis suppression (if occurs, discontinue gradually), 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); 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). Moderate or severe hepatic impairment; monitor. Labor & delivery. Pregnancy. Nursing mothers.
Corticosteroid + anticholinergic + long-acting beta-2 agonist (LABA).
Not for use with other drugs containing LABAs. 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 when concomitant other anticholinergic-containing drugs; avoid.
Upper RTI, pneumonia, bronchitis, oral candidiasis, headache, back pain, arthralgia, influenza, sinusitis, pharyngitis, rhinitis, dysgeusia, constipation, UTI, diarrhea, gastroenteritis, oropharyngeal pain, cough, dysphonia; hypersensitivity reactions.
Dry pwd inhaler—30 doses