Trelegy Ellipta (fluticasone furoate/umeclidinium/vilanterol) 

TRELEGY ELLIPTA Rx

Generic Name and Formulations:

Fluticasone furoate, umeclidinium, vilanterol 100mcg/62.5mcg/25mcg; per inh; dry pwd for oral inhalation.

Company:

GlaxoSmithKline

Indications for TRELEGY ELLIPTA:

Long-term maintenance treatment of airflow obstruction in patients with COPD, including chronic bronchitis and/or emphysema. To reduce exacerbations of COPD in patients with a history of exacerbations. 

Limitations Of use:

Not indicated for relief of acute bronchospasm or for treatment of asthma.

Adult:

1 inh once daily (max). Rinse mouth after use. 

Children:

Not established.

Contraindications:

Severe hypersensitivity to milk proteins.

Warnings/Precautions:

Increased risk of asthma-related events (death, hospitalizations, intubations) with LABA as monotherapy (without ICS). 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 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. Reeva luate 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.

Pharmacological Class:

Corticosteroid + anticholinergic + long-acting beta-2 agonist (LABA).

Interactions:

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.

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.

Generic Availability:

NO

How Supplied:

Dry pwd inhaler—30 doses