Important Safety Information for ANORO ELLIPTA (cont’d)
WARNINGS AND PRECAUTIONS (cont’d)
• Use with caution in patients with convulsive disorders, thyrotoxicosis, diabetes mellitus, and ketoacidosis,
and in patients who are unusually responsive to sympathomimetic amines.
• Use with caution in patients with narrow-angle glaucoma. Instruct patients to contact a physician immediately
if signs or symptoms of acute narrow-angle glaucoma develop.
• Use with caution in patients with urinary retention, especially in patients with prostatic hyperplasia or bladder-neck
obstruction. Instruct patients to contact a physician immediately if signs or symptoms of urinary retention develop.
• Be alert to hypokalemia and hyperglycemia.
• The most common adverse reactions (≥1% and more common than placebo) reported in four 6-month clinical
trials with ANORO ELLIPTA (and placebo) were: pharyngitis, 2% (<1%); sinusitis, 1% (<1%); lower respiratory tract
infection, 1% (<1%); constipation, 1% (<1%); diarrhea, 2% (1%); pain in extremity, 2% (1%); muscle spasms, 1%
(<1%); neck pain, 1% (<1%); and chest pain, 1% (<1%).
• In addition to the 6-month efficacy trials with ANORO ELLIPTA, a 12-month trial evaluated the safety of
umeclidinium/vilanterol 125 mcg/25 mcg in subjects with COPD. Adverse reactions (incidence ≥1% and more
common than placebo) in subjects receiving umeclidinium/vilanterol 125 mcg/25 mcg were: headache, back pain,
sinusitis, cough, urinary tract infection, arthralgia, nausea, vertigo, abdominal pain, pleuritic pain, viral respiratory
tract infection, toothache, and diabetes mellitus.
• Caution should be exercised when considering the coadministration of ANORO ELLIPTA with ketoconazole and
other known strong CYP3A4 inhibitors (eg, ritonavir, clarithromycin, conivaptan, indinavir, itraconazole, lopinavir,
• ANORO ELLIPTA should be administered with extreme caution to patients being treated with monoamine
oxidase inhibitors, tricyclic antidepressants, or drugs known to prolong the QTc interval, or within 2 weeks of
discontinuation of such agents, because the effect of adrenergic agonists, such as vilanterol, on the cardiovascular
system may be potentiated by these agents.
• Use beta-blockers with caution as they not only block the pulmonary effect of beta-agonists, such as vilanterol,
but may produce severe bronchospasm in patients with COPD.
• Use with caution in patients taking non–potassium-sparing diuretics, as electrocardiographic changes and/or
hypokalemia associated with non–potassium-sparing diuretics may worsen with concomitant beta-agonists.
• Avoid coadministration of ANORO ELLIPTA with other anticholinergic-containing drugs as this may lead to an
increase in anticholinergic adverse effects.
Reference: 1. Donohue JF, Maleki-Yazdi MR, Kilbride S, et al. Efficacy and safety of once-daily
umeclidinium/vilanterol 62.5/25 mcg in COPD. Respir Med. 2013;107( 10):1538-1546.
by 167 mL vs placebo (P<0.001) at Day 1691
A 24-week, multicenter, randomized, double-blind, placebo-controlled, parallel-group study compared
the efficacy and safety of ANORO ELLIPTA (n=413) and placebo (n=280), each administered once daily
by the ELLIPTA inhaler. The primary endpoint was trough (predose) FEV1 at Day 169
(defined as the mean of the FEV1 values obtained 23 and 24 hours after dosing on Day 168). 1
Please see Brief Summary of Prescribing Information, including
Boxed Warning, for ANORO ELLIPTA on the following pages.