Cardiovascular effects such as cardiac arrhythmias may be seen after the administration of sympathomimetic agents and muscarinic receptor antagonists. Therefore, Anoro Ellipta should be used in caution in patients with severe cardiovascular disease. 1
A once-daily, dual bronchodilator( LAMA / LABA) for COPD patients symptomatic on maintenance monotherapy 1, 2
Anoro
®
( umeclidinium / vilanterol)
Ellipta
®
Anoro Ellipta significantly improved lung function * vs. tiotropium in moderate-to-very severe COPD patients 3
*
Trough FEV 1 at day 169( p < 0.001)
Once daily, 1 easy-to-use device 4
For full device use instructions, please see the Product Information.
Cardiovascular effects such as cardiac arrhythmias may be seen after the administration of sympathomimetic agents and muscarinic receptor antagonists. Therefore, Anoro Ellipta should be used in caution in patients with severe cardiovascular disease. 1
Adapted from Maleki-Yazdi MR et al. 2014. 3 A 24 – week, Phase III, multicentre, randomised, blinded, double-dummy, parallel-group study in patients aged ≥ 40 years with moderate-to-very severe COPD and an established clinical history of COPD randomised to Anoro Ellipta 62.5 / 25 mcg( n = 454) or tiotropium 18 mcg via HandiHaler ®( n = 451). Primary endpoint was trough FEV 1 at day 169. 3
FEV 1: Forced expiratory volume in 1 second, LABA: long-acting beta 2-agonist, LAMA: long-acting muscarinic antagonist.
Anoro Ellipta PBS Information: Authority required( STREAMLINED). Refer to PBS Schedule for full authority information.
STREAMLINED AUTHORITY CODE 5763 Please review Product Information before prescribing. For Full Product Information visit www. gsk. com. au
Anoro ® Ellipta ®( umeclidinium bromide / vilanterol trifenatate) 62.5 mcg umeclidinium / 25 mcg vilanterol inhalation powder. Minimum Product Information. INDICATIONS: As a long-term once daily maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease( COPD). CONTRAINDICATIONS: Hypersensitivity to the active ingredient or any excipients, patients with severe milk-protein allergy. PRECAUTIONS: Should not be used in asthma. Can cause paradoxical bronchospasm- if this occurs, treatment should be discontinued and alternative therapy instituted if necessary. Should not be used for the relief of acute symptoms of bronchospasm. Use with caution in patients with severe cardiovascular disorders, particularly cardiac arrhythmias. See full PI. Use with caution in patients with narrow-angle glaucoma or urinary retention. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine. Pregnancy – Cat B3. Lactation – unknown whether umeclidinium or vilanterol are excreted in human milk. Paediatric – should not be used in children. INTERACTIONS: Beta-blockers, strong CYP3A4 inhibitors, P-glycoprotein inhibitors. ADVERSE EFFECTS: Cough, pharyngitis, constipation, dry mouth, UTI, URTI. Others see full PI. DOSAGE: One oral inhalation, via Anoro Ellipta inhaler, once a day. Do not use Anoro Ellipta more than once every 24 hours. Should be taken at the same time every day. No dosage adjustment is required in elderly, impaired renal function, mild or moderate hepatic impairment. Not recommended in children. Min PI v2.0. References: 1. Anoro Ellipta Approved Product Information. 2. Abramson M et al. COPD-X Concise Guide for Primary Care. Brisbane. Lung Foundation Australia. 2016. 3. Maleki-Yazdi MR et al. Respir Med 2014; 108: 1752 – 60. 4. Riley et al. Int J COPD 2016:11 1873-1880. For information on GSK products or to report an adverse event involving a GSK product, please contact GSK Medical Information on 1800 033 109. Anoro and Ellipta are registered trademarks of the GSK group of companies. GlaxoSmithKline Australia Pty Ltd, Level 4, 436 Johnston Street, Abbotsford Victoria 3067, ABN 47 100 162 481. AUS / UCV / 0018 / 16G Date of approval: January 2017. GSK0049 / AD / FPC.
For more information on Anoro Ellipta, please visit anoroellipta. com. au