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Safety

Please consult the full summary of product characteristics (SPC) for Trelegy Ellipta before prescribing.

Safety of Trelegy Ellipta

Safety has been assessed in 15,666 patients across the clinical development programmes for Trelegy and its components (FF/UMEC/VI). This included 911 patients for FF/UMEC/VI 92/55/22 mcg, 6,237 patients for FF/VI 92/22 mcg, 6,855 patients for UMEC/VI 55/22 mcg and 1,663 patients for UMEC 55 mcg. The safety profiles of FF/VI, UMEC/VI and UMEC are similar to that of FF/UMEC/VI.

Adverse events of special interest

In common with other ICS containing medicines, there is an increased risk of pneumonia in COPD patients treated with Trelegy Ellipta. 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 (BMI) and severe COPD.

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Trelegy and Ellipta are registered trademarks of the GlaxoSmithKline group of companies