Cardiovascular: cardiovascular effects, such as cardiac arrhythmias (e.g. atrial fibrillation and tachycardia), may be seen after the administration of muscarinic receptor antagonists and sympathomimetics, including umeclidinium and vilanterol, respectively. Therefore, Trelegy Ellipta should be used with caution in patients with unstable or life-threatening cardiovascular disease.1
Pneumonia: in common with other corticosteroid-containing medicines, there is an increased risk of pneumonia in patients with COPD treated with Trelegy Ellipta, including pneumonia requiring hospitalisation. There is no conclusive clinical evidence for intra-class differences in the magnitude of the pneumonia risk among inhaled corticosteroid products. 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. Risk factors for pneumonia in patients with COPD include current smoking, older age, low body mass index and severe COPD.1
Paradoxical Bronchospasm: Administration of fluticasone furoate/umeclidinium/vilanterol may produce paradoxical bronchospasm with an immediate wheezing and shortness of breath after dosing and may be life-threatening. Treatment with Trelegy Ellipta should be discontinued immediately if paradoxical bronchospasm occurs.1
Systemic corticosteroid effects: Systemic effects may occur with any inhaled corticosteroid, particularly at high doses prescribed for long periods. These effects are much less likely to occur than with oral corticosteroids.1
Asthma: Trelegy Ellipta should not be used in patients with asthma since it has not been studied in this patient population.1
Anticholinergic activity: Trelegy Ellipta should be used with caution in patients with narrow-angle glaucoma or urinary retention. Patients should be informed about the signs and symptoms of acute narrow-angle glaucoma and should be informed to stop using Trelegy Ellipta and to contact their doctor immediately.1
This is not an exhaustive list. Please consult the Summary of Product Characteristic for a full list of precautions before prescribing.