20220721 Trixeo PSC - digital

Information intended for healthcare professionals only.

This prescribing summary card was developed from content provided by AstraZeneca Limited in a format developed by Guidelines. AstraZeneca Limited commissioned the development of the prescribing card and carried out full medical approval to ensure compliance with regulations.

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Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard. Adverse events should also be reported to AstraZeneca by visiting www.aereporting.astrazeneca.com  or by calling 0800 783 0033.

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View Trixeo (formoterol fumarate dihydrate/ glycopyrronium/ budesonide) prescribing information and adverse event reporting information

View Bevespi (glycopyrronium/formoterol fumarate dihydrate) prescribing information and adverse event reporting information

Indication1

  • Trixeo Aerosphere® is indicated as a maintenance treatment in adult patients with moderate to severe chronic obstructive pulmonary disease (COPD) who are not adequately treated by a combination of an inhaled corticosteroid (ICS) and a long-acting beta2‑agonist (LABA) or combination of a LABA and a long-acting muscarinic antagonist (LAMA).

Dose1

  • The recommended and maximum dose is two inhalations twice daily (two inhalations in the morning, and two in the evening)
  • If a dose is missed, it should be taken as soon as possible and the next dose should be taken at the usual time; a double dose should not be taken to make up for a forgotten dose.

Device1

Trixeo Inhaler

  • Trixeo Aerosphere is a pressurised metered dose inhaler (pMDI) that combines three agents in one device:
    • budesonide (ICS)
    • glycopyrronium (LAMA)
    • formoterol fumarate (LABA)
  • Trixeo’s innovative Aerosphere technology enables 38% to 41% deposition2
  • The patient should be shown how to use the inhaler correctly by a healthcare professional and inhalation technique should be checked regularly
  • Patients who find it difficult to coordinate actuation with inhalation may use Trixeo Aerosphere with a spacer to ensure proper administration of the medicinal product.

Guideline recommendations

Stepping up from dual to triple therapy3

  • NICE recommends offering a LAMA+LABA+ICS for people with COPD who are taking LABA+ICS if:
    • their day-to-day symptoms continue to adversely impact their quality of life
    • or they have a severe exacerbation (requiring hospitalisation)
    • or they have two moderate exacerbations within a year
  • NICE recommends considering a LAMA+LABA+ICS for people with COPD who are taking LAMA+LABA if:
    • they have a severe exacerbation (requiring hospitalisation)
    • or they have two moderate exacerbations within a year
  • NICE recommends offering a 3-month trial of triple therapy for people with COPD who are taking LAMA+LABA and whose day-to-day symptoms adversely impact their quality of life. After 3 months, if symptoms have not improved, switch back to LAMA+LABA. If symptoms have improved, continue with LAMA+LABA+ICS.

Prescribing inhalers3

  • NICE recommends minimising the number of inhalers and the number of different types of inhaler used by the patient, as far as possible3
  • NICE recommends specifying the brand and inhaler in the prescription to ensure patients receive inhalers they have been trained to use.

Clinical evidence

  • Patients with frequent exacerbations have a risk of death 4.3 times greater than patients with no exacerbations4*
  • Trixeo Aerosphere protects against moderate and severe exacerbations5
  • Trixeo Aerosphere reduces symptoms of COPD and improves quality of life vs formoterol/glycopyrronium MDI (p<0.0001) and formoterol/budesonide MDI** (p<0.0001).6,7

*In the 52-week ETHOS study (n=8588), Trixeo Aerosphere met the primary endpoint and significantly reduced the annual rate of on-treatment moderate/severe exacerbations by 24% (95% CI: 17, 31; p<0.0001) compared with FOR/GLY MDI (rate; 1.08 vs 1.42 events per patient year) and by 13% (95% CI: 5, 21; p=0.0027) compared with FOR/BUD MDI (rate; 1.08 vs 1.24 events per patient year).

**This regimen is not licensed in the UK.

Safety profile

  • Trixeo Aerosphere’s safety profile is consistent with the well-established profiles of its components1,5,8
  • The most commonly reported adverse reactions in patients were pneumonia (4.6%), headache (2.7%), and urinary tract infection (2.7%).1

References

  1. Trixeo Aerosphere 5 micrograms/7.2 micrograms/160 micrograms pressurised inhalation, suspension – summary of product characteristics. www.medicines.org.uk/emc/product/12028/smpc (Accessed June 2022)
  2. van den Berge et al. Functional respiratory imaging assessment of budesonide/glycopyrrolate/formoterol fumarate and glycopyrrolate/formoterol fumarate metered dose inhalers in patients with COPD: the value of inhaled corticosteroids. Respir Res 2021; 22: 191.
  3. NICE. Chronic obstructive pulmonary disease in over 16s: diagnosis and management. Guideline 115. NICE, 2018. Last updated July 2019. www.nice.org.uk/ng115 (Accessed June 2022)
  4. Soler-Cataluna JJ et al. Severe acute exacerbations and mortality in patients with chronic obstructive pulmonary disease. Thorax 2005; 60: 925–931.
  5. Rabe KF et al. Triple inhaled therapy at two glucocorticoid doses in moderate-to-very severe COPD. N Engl J Med 2020; 383: 35–48.
  6. Martinez FJ et al. Benefits of budesonide/glycopyrrolate/formoterol fumarate metered dose inhaler (BGF MDI) on symptoms and quality of life in patients with chronic obstructive pulmonary disease (COPD) in the ETHOS Trial. Am J Respir Crit Care Med 2020; 201: A5073.
  7. Rabe KF et al. Triple inhaled therapy at two glucocorticoid doses in moderate-to-very severe COPD. N Engl J Med 2020; 383: 35–48. (Supplementary Appendix).
  8. Ferguson GT et al. Triple therapy with budesonide/glycopyrrolate/formoterol fumarate with co-suspension delivery technology versus dual therapies in chronic obstructive pulmonary disease (KRONOS): a double-blind, parallel-group, multicentre, phase 3 randomised controlled trial. Lancet Respir Med 2018; 6 (10):747–758.

Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard, or search for MHRA Yellow Card in the Google Play or Apple App Store. Adverse events should also be reported to AstraZeneca by visiting
https://contactazmedical.astrazeneca.com or by calling 0800 783 0033.

GB-37784
Date of preparation: July 2022