Trelegy Ellipta (fluticasone furoate/umeclidinium/vilanterol)

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Trelegy Ellipta is generally well tolerated1

  • Adverse Reactions - England, Scotland & Wales (GB)

    Common Adverse Reactions (≥1/100 to <1/10): pneumonia, upper respiratory tract infection, bronchitis, pharyngitis, rhinitis, sinusitis, influenza, nasopharyngitis, candidiasis of mouth and throat, urinary tract infection, headache, cough, oropharyngeal pain, constipation, arthralgia, back pain1

    Other Important Side Effects Uncommon (≥1/1,000 to <1/100): supraventricular tachyarrhythmia, tachycardia, atrial fibrillation, blurred vision, eye pain, glaucoma. Rare (≥1/10,000 to <1/1000) hypersensitivity reactions, including anaphylaxis, angioedema, urticaria, and rash.1

    This is not an exhaustive list. Please consult the Summary of Product Characteristic for a full list of adverse reactions before prescribing.

  • Adverse Reactions - Northern Ireland (NI)

    Common Adverse Reactions Common (≥1/100 to <1/10): pneumonia, upper respiratory tract infection, nasopharyngitis, bronchitis, pharyngitis, rhinitis, sinusitis, influenza, candidiasis of mouth and throat, urinary tract infection, headache, cough, oropharyngeal pain, constipation, arthralgia, back pain.4

    Other Important Side Effects Uncommon (≥1/1,000 to <1/100): supraventricular tachyarrhythmia, tachycardia, atrial fibrillation, glaucoma, eye pain, vision blurred. Rare (≥1/10,000 to <1/1000) hypersensitivity reactions, including anaphylaxis, angioedema, urticaria, and rash.4

    This is not an exhaustive list. Please consult the Summary of Product Characteristic for a full list of adverse reactions before prescribing.

  • Warnings and Precautions

    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.

  • Contraindications

    Contraindications: Hypersensitivity to the active substances or to any of the excipients (lactose monohydrate & magnesium stearate).1

How does the benefit of an ICS-containing treatment in COPD compare to the risk of pneumonia?

Watch the video below to understand how the benefits of being on an ICS-containing treatment such as Trelegy outweigh the risk of pneumonia, in patients who are symptomatic and at risk of an exacerbation

Prescribing Information

Anoro▼ Ellipta (umeclidinium bromide/vilanterol) Prescribing Information

Relvar Ellipta (fluticasone furoate/vilanterol) Prescribing Information

Trelegy Ellipta Prescribing Information

Trelegy Ellipta OD is indicated for maintenance treatment in adult patients with moderate-to-severe chronic obstructive pulmonary disease (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

Anoro Ellipta is indicated as a once-daily maintenance bronchodilator treatment to relieve symptoms in adult patients with COPD.2

Relvar Ellipta 92/22 mcg is indicated for the symptomatic treatment of adults with COPD with a FEV1 <70% predicted normal (post-bronchodilator) with an exacerbation history despite regular bronchodilator therapy3

References

  1. Trelegy SmPC
  2. Anoro SmPC
  3. Relvar SmPC
  4. Trelegy Northern Ireland SmPC

Adverse events should be reported. Reporting forms and information can be found at https://yellowcard.mhra.gov.uk/ or search for MHRA Yellowcard in the Google Play or Apple App store. Adverse events should also be reported to GlaxoSmithKline on 0800 221 441.

September 2022 | PM-GB-FVU-WCNT-200007 (V6.0)