TRELEGY Ellipta safety profile
TRELEGY Ellipta is generally well tolerated and has a comparable safety profile to that of its components.1
The safety profile is based on three studies with 5589 patients treated with Trelegy Ellipta over 24-52 weeks. These studies were the FULFIL, IMPACT and 200812 studies.1
|Common adverse reactions (≥1/100 to <1/10):|
|Headache||Nasopharyngitis||Influenza||Upper respiratory tract infecction|
|Back pain||Rhinitis||Cough||Candidiasis of throat and mouth|
|Bronchitis||Constipation||Sinusitis||Urinary tract infection|
- 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 hospitalisation1
- There is no conclusive clinical evidence for intra-class differences in the magnitude of the pneumonia risk among inhaled corticosteroid products1
- 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 exacerbations1
- Risk factors for pneumonia in patients with COPD include current smoking, older age, low body mass index and severe COPD1
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
ICS, inhaled corticosteroid; LABA, long-acting β2-agonist; LAMA, long-acting muscarinic antagonist; OD, once daily
- TRELEGY Ellipta SmPC, 2018 Available at www.medicines.ie [Accessed December 2018].
- Lipson DA et al. Am J Respir Crit Care Med 2017; 196:438-446.
- Lipson DA et al. N Engl J Med 2018; 378:1671-1680
TRELEGY Ellipta was developed in collaboration with INNOVIVA Inc.