Indications for: TRELEGY ELLIPTA

Maintenance treatment of COPD or asthma.

Limitations of Use:

Not indicated for relief of acute bronchospasm.

Adult Dosage:

COPD: 1 inh of 100/62.5/25mcg once daily (max). Asthma: initially 1 inh of 100/62.5/25mcg or 200/62.5/25mcg once daily, based on disease severity and previous asthma therapy. Max 1 inh of 200/62.5/25mcg once daily. Rinse mouth after use. Consider other therapeutic regimens and additional therapeutic options if patient does not respond adequately to 200/62.5/25mcg.

Children Dosage:

≤17yrs: not established.

TRELEGY ELLIPTA Contraindications:

Primary treatment of status asthmaticus or other acute episodes of COPD or asthma requiring intensive measures. Severe hypersensitivity to milk proteins.

TRELEGY ELLIPTA Warnings/Precautions:

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 or asthma. 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), growth in children and adolescents, 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.

TRELEGY ELLIPTA Classification:

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 (eg, loop or thiazides). Antagonized by β-blockers; if needed, consider cardioselective agents. Additive effects when concomitant other anticholinergic-containing drugs; avoid.

Adverse Reactions:

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. Asthma: also nasopharyngitis, viral upper RTI, RTI/viral RTI, acute sinusitis.

Generic Drug Availability:


How Supplied:

Dry pwd inhaler—30 inhalations (60 blisters)