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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 infection Pneumonia
Back pain Rhinitis Cough Pharyngitis Arthralgia
Bronchitis Candiasis of throat and mouth   Sinusitis Urinary Tract Infection

Find the full list of adverse reactions in the TRELEGY Ellipta Summary of Product Characteristics.

  • 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 1
    • There is no conclusive clinical evidence for intra-class differences in the magnitude of the pneumonia risk among inhaled corticosteroid products 1
    • 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 1
    • Risk factors for pneumonia in patients with COPD include current smoking, older age, low body mass index and severe COPD 1

  • 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

Abbreviations
ICS, inhaled corticosteroid; LABA, long-acting β2-agonist; LAMA, long-acting muscarinic antagonist; OD, once daily

References:

  1. TRELEGY Ellipta SmPC, 2018 Available at www.medicines.ie [Accessed December 2018].
  2. Lipson DA et al. Am J Respir Crit Care Med 2017; 196:438-446.
  3. Lipson DA et al. N Engl J Med 2018; 378:1671-1680

TRELEGY Ellipta was developed in collaboration with INNOVIVA Inc.

Adverse events should be reported to the Health Products Regulatory Authority (HPRA) using an Adverse Reaction Report Form obtained either from the HPRA or electronically via the website at www.hpra.ie. Adverse reactions can also be reported to the HPRA by calling: (01) 6764971. Adverse events should also be reported to GlaxoSmithKline on 1800 244 255.

TRELEGY Ellipta OD is indicated for maintenance treatment in adult patients with moderate-to-severe COPD who are not adequately treated by a combination of an ICS and a LABA, or a combination of a LAMA and a LABA 1

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