Home' Australian Pharmacist : Australian Pharmacist July 2015 Contents For more information on Anoro Ellipta,
please visit anoroellipta.com.au
Please review full Product Information before prescribing.
The Product Information can be accessed at www.gsk.com.au
STREAMLINED AUTHORITY CODE 4655
Symptoms of COPD are chronic and progressive. Other medicines that contain a LAMA or LABA should not be used together with Anoro
Ellipta. 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 with caution in patients with severe cardiovascular disease.1
LAMA: Long-acting muscarinic antagonist. LABA: Long-acting ß2-agonist. †COPD: Chronic obstructive pulmonary disease. ‡FEV1: Forced expiratory volume in 1 second. #TDI: Transition Dyspnoea Index.
ANORO ® ELLIPTA ® (umeclidinium bromide/vilanterol trifenatate) 62.5 mcg umeclidinium/25 mcg vilanterol inhalation powder. 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 (v2.0). 2. The COPD-X Plan: Australian and New Zealand Guidelines for the management of Chronic Obstructive Pulmonary Disease 2014. Version 2.39
(October 2014). 3. Donohue JF et al. Respir Med 2013; 107(10): 1538–46. 4. Maltais F et al. Ther Adv Respir Dis 2014; 8(6): 169 81. 5. Riley JH et al. Use of a new dry powder inhaler to deliver umeclidinium/
viltanerol in the treatment of COPD. (P4145). Poster presented at ERS, September 2013. 6. Maleki-Yazdi MR et al. Respir Med 2014; 108(12): 1752–60 . 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 trade marks of the GSK group of companies. Anoro Ellipta was developed in collaboration with
Theravance, Inc. GlaxoSmithKline Australia Pty Ltd. ABN 47 100 162 481. Melbourne, VIC. AUS/UCV/0001/15f. Date of Approval June 2015. AM5489/AP.
PBS Information: Authority required (STREAMLINED). Refer to PBS schedule for full authority information.
A 24 week Phase III, multicentre, randomised, blinded, double-dummy, parallel group study of moderate to very severe COPD patients (Intention to Treat, ITT n=905)
with a once daily, inhaled, fixed-dose combination of umeclidinium/vilanterol 62.5/25mcg vs tiotropium 18mcg. Primary endpoint: trough FEV1
‡ at day 169 (p<0.001).
Improves lung function vs tiotropium
In moderate to very severe COPD patients (p<0.001)6
TDI# score (p≤0.001)1,3
For full device use instructions,
please see the Product Information.
A once-daily dual bronchodilator (LAMA/LABA)*
COPD-X recommendations include dual bronchodilator
(LAMA/LABA) therapy for use in appropriate breathless COPD†
patients on a maintenance bronchodilator monotherapy2
15/06/15 11:19 AM
Links Archive Australian Pharmacist June 2015 Australian Pharmacist August 2015 Navigation Previous Page Next Page