* ICS= Inhaled corticosteroid; LAMA=Long-acting muscarinic antagonist (also known as an anticholinergic); LABA=Long-acting beta2-agonist.
† Clinically significant improvement in serial FEV1 from 15 minutes compared with placebo, p<0.001.
‡ The prescriber must provide written endorsement that the patient has been diagnosed as having COPD using spirometry.
Anoro® Ellipta® (umeclidinium bromide/vilanterol trifenatate inhaler 62.5/25mcg per inhalation) is a fully funded medicine; Special Authority criteria apply. Maximum Daily Dose: One inhalation once daily. Prescription Medicine for long-term regular treatment to relieve symptoms in adult patients with Chronic Obstructive Pulmonary Disease (COPD). This medicine has risks and benefits.
Warnings and Precautions: Not recommended for use in patients with asthma or for relief of acute symptoms or an acute exacerbation. Use care when co-administering with strong CYP3A4 inhibitors (e.g. ketoconazole), beta-blockers and in patients with severe cardiovascular disease, narrow-angle glaucoma or urinary retention. Common Side Effects: Nasopharyngitis, oropharyngeal pain, sinusitis, pharyngitis, cough, urinary tract infection, constipation, dry mouth, hypertension. Paradoxical bronchospasm may occur. Before prescribing Anoro Ellipta, please review the Data Sheet at www.medsafe.govt.nz.
Incruse® Ellipta®: In addition to the Anoro Ellipta information above which also applies to Incruse Ellipta (umeclidinium bromide), Incruse is available in a 62.5mcg per inhalation in the Ellipta device. Incruse Ellipta is a fully funded medicine. The prescriber must provide written endorsement that the patient has been diagnosed as having COPD using spirometry to access subsidy. Before prescribing Incruse Ellipta, please review the Data Sheet at www.medsafe.govt.nz.
Breo® Ellipta® (fluticasone furoate/vilanterol trifenatate inhaler 100/25mcg per inhalation) is a fully funded medicine. Breo Ellipta 200/25mcg is a private purchase medicine (dose indicated in asthma only); a prescription charge will apply. Maximum Daily Dose: One inhalation once daily. Maintenance Dose: Titrate to lowest effective dose. Prescription Medicine for the regular treatment of asthma (12 years of age and older) (100/25 and 200/25mcg) and/or COPD (100/25mcg) with a FEV1<70% predicted normal (post-bronchodilator) in patients with an exacerbation history. This medicine has risks and benefits. Warnings and Precautions: Not for relief of acute symptoms or an acute exacerbation. Do not discontinue abruptly. Use care when co-administering with strong CYP3A4 inhibitors (e.g. ketoconazole, ritonavir) or in patients with hepatic impairment, severe cardiovascular disease, pulmonary tuberculosis or chronic or untreated infections. Common Side Effects: Candidiasis of mouth and throat, headache, nasopharyngitis, oropharyngeal pain, sinusitis, pharyngitis, rhinitis, cough, dysphonia, upper respiratory tract infection, bronchitis, influenza, abdominal pain, arthralgia, back pain, pyrexia. Paradoxical bronchospasm may occur. Physicians should remain vigilant for the possible development of pneumonia in patients with COPD as the clinical features of such infections overlap with the symptoms of COPD exacerbations. The incidence of pneumonia in patients with asthma was uncommon. Avoid beta-blockers if possible. Before prescribing Breo Ellipta, please review the Data Sheet at www.medsafe.govt.nz.
Anoro, Incruse, Breo and Ellipta are registered trade marks of the GlaxoSmithKline group of companies. Anoro and Breo Ellipta were developed in collaboration with Theravance Inc. Marketed by GlaxoSmithKline NZ Limited, Auckland. Adverse events involving GlaxoSmithKline products should be reported to GSK Medical Information on 0800 808 500.
Last updated April 2016: DA1638MR/16AP/COM/0005/15