Treatment for COPD

Safety Information: Anoro Ellipta should not be used to relieve sudden breathing problems and does not replace a rescue inhaler. Like all medicines, Anoro Ellipta cam cause side effects, although not everybody gets them. Common side effects, which may affect up to one in ten people, include sore throat with or without runny nose, cough, constipation, dry mouth, painful and frequent urination (which may be signs of urinary tract infection), feeling of pressure or pain in the cheeks and forehead (which may be signs of inflammation of the sinuses called sinusitis), pain and irritation in the back of the mouth and throat, and infection of the upper airways.

References: 1. Kirby SY COPD 2016;13;167-175 2. Grant AC International Society for Aerosols in Medicine 2015;28;474-85 3. Anoro Ellipta Data Sheet, GSK New Zealand, available at www.medsafe.govt.nz 4. Anoro Ellipta Consumer Medical Information, GSK New Zealand, available at www.medsafe.govt.nz 5. PHARMAC Pharmaceutical Schedule April 2023. Available at schedule.pharmac.govt.nz

Anoro Ellipta ((umeclidinium [as bromide] 62.5 mcg, vilanterol [as trifenatate] 25 mcg inhaler) is a Prescription Medicine. Anoro Ellipta is indicated as a long-term maintenance bronchodilator treatment to relieve symptoms in adult patients with Chronic Obstructive Pulmonary Disease (COPD). Anoro Ellipta is a fully funded medicine; Special Authority criteria apply. Maximum Daily Dose: One inhalation once daily. Contraindications: Patients with severe milk-protein allergy or those who have hypersensitivity to umeclidinium, vilanterol trifenatate or any of the excipients. Common side effects: urinary tract infection, upper respiratory tract infection, nasopharyngitis, pharyngitis, sinusitis, cough, oropharyngeal pain, constipation, dry mouth. Warnings and Precautions: Not recommended for use in patients with asthma or for relief of acute symptoms or an acute exacerbation. Use with care when co-administering with strong CYP3A4 inhibitors (e.g. ketoconazole) and in patients with severe cardiovascular disease, narrow-angle glaucoma or urinary retention. Paradoxical bronchospasm may occur. Pregnancy: There are insufficient data from the use of umeclidinium/vilanterol in pregnant women. Anoro Ellipta should be used during pregnancy only if the expected benefit to the mother justifies the potential risk to the foetus. Before prescribing Anoro Ellipta, please review the data sheet for information on dosage, contraindications, precautions, interactions and adverse effects. The data sheet is available at www.medsafe.govt.nz. Trademarks are property of their respective owners. ©2023 GSK group of companies or its licensor. Anoro Ellipta was developed in collaboration with Innoviva Inc. Marketed by GlaxoSmithKline NZ Limited, Auckland. Adverse events involving GlaxoSmithKline products should be reported to GSK Medical Information on 0800 808 500. NP18614-PM-NZUCV-WCNT-200005 Date of Approval: 05 2023 Date of expiry: 05 2025