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Prescribing Information TRIXEO®
(formoterol fumarate dihydrate/ glycopyrronium/budesonide)
Prescribing Information SYMBICORT®
(budesonide/formoterol) COPD 200/6 and 400/12
Prescribing Information BEVESPI®
(glycopyrronium/formoterol fumarate dihydrate)
Adverse Event
Reporting

This website is intended for UK Healthcare Professionals only. Other UK residents please visit astrazeneca.co.uk

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  • For you and your patient
TRIXEO AEROSPHERE®

TRIXEO AEROSPHERE®

(formoterol fumarate dihydrate/glycopyrronium/budesonide)

 

Next generation propellant Resources

TRIXEO - a combination of ICS/LABA/LAMA in 1 inhaler device.1

TRIXEO AEROSPHERE is indicated as a maintenance treatment in adult patients with moderate to severe COPD who are not adequately treated by a combination of an inhaled corticosteroid and a long-acting beta2-agonist or combination of a long-acting beta2-agonist and a long-acting muscarinic antagonist.1

Limitation of use: Not for acute use.

This medicinal product is not indicated for the treatment of acute episodes of bronchospasm, i.e. as a rescue therapy1

 

TRIXEO AEROSPHERE: The world’s first next-generation propellant containing inhaler2

HFO-1234ze, the NGP approved within TRIXEO AEROSPHERE, has a 99.9% reduction in global warming potential (GWP) vs current propellants2-5

Next-generation engineering, next-generation care. Providing a pMDI without compromise on the environment

Find out more about NGP
AEROSPHERE technology offers AEROSPHERE technology offers

The TRIXEO inhaler is a triple therapy pMDI combining well established active ingredients1:

LAMA LABA ICS active ingredients LAMA LABA ICS active ingredients

For illustration purposes only. Not to scale.

The TRIXEO inhaler ingredients are glycopyrronium, formoterol and budesonide.

LAMA: GLYCOPYRRONIUM

Induces bronchodilation through inhibition of the M3 receptor at the smooth muscle1

LABA: FORMOTEROL

Rapidly and effectively relaxes the central and peripheral airways1

ICS: BUDESONIDE

Anti-inflammatory action throughout the large and small airways1

AEROSPHERE device

TRIXEO is administered through the TRIXEO AEROSPHERE inhaler, equipped with next-generation device delivery technology.1, 6-8

Discover AEROSPHERE technology
Click here to order a TRIXEO placebo
inhaler inhaler

Recommended and maximum TRIXEO dose is1:

Trixeo recommended and maximum dose Trixeo recommended and maximum dose

If a TRIXEO dose is missed, it should be taken as soon as possible, and the next TRIXEO dose should be taken at the usual time.

A double dose should not be taken to make up for a forgotten dose.

TRIXEO patients should not take more than the recommended and maximum dose of two puffs twice a day on the same day.

Click here for information on overdose

How to use TRIXEO

TRIXEO AEROSPHERE significantly reduces the risk of moderate or severe exacerbations compared with dual therapy, as seen in the ETHOS study

twenty-four twenty-four

REDUCTION vs

LABA/LAMA (GFF) pMDI9

Annual rates 1.08 vs 1.42; 
RR 0.76, 95% CI 0.69–0.83,
 p<0.001; ARR 0.34
 exacerbations per patient
 per year. NNT 310

thirteen thirteen

REDUCTION vs

ICS/LABA (BFF) pMDI9

Annual rates 1.08 vs 1.24;
 RR 0.87, 95% CI 0.79–0.95, 
p=0.003; ARR 0.16 
exacerbations per patient 
per year. NNT 610

See TRIXEO's efficacy data

ICS/LABA (BFF) AEROSPHERE pMDI is not licensed in the UK and is confirmed as non-inferior to the UK licensed ICS/LABA (BFF) DPI by KRONOS study

 

Resources for you
and your patients

Access a range of resources to help support you and your patients, including expert-led webinars and patient user guides.

Access support resources
patient patient

ARR, absolute rate reduction; BFF, budesonide/formoterol fumarate; CI, confidence interval; COPD, chronic obstructive pulmonary disease; DPI, dry powder inhaler; GFF, glycopyrronium/formoterol fumarate; ICS, inhaled corticosteroid; LABA, long-acting beta2-agonist; LAMA, long-acting muscarinic antagonist; NNT, number needed to treat; pMDI, pressurised metered-dose inhaler; RR, rate ratio.

  1. TRIXEO AEROSPHERE 5 micrograms/7.2 micrograms/160 micrograms pressurised inhalation, suspension. Summary of Product Characteristics. 
  2. MHRA. MHRA approves world’s first low-carbon version of COPD inhaler, Trixeo Aerosphere. May 2025. Available at: https://www.gov.uk/government/news/mhra-approves-worlds-first-low-carbon-version-of-copd-inhaler-trixeo-aerosphere [Accessed 13 May 2025]
  3. Smith C, et al. The Earth’s energy budget, climate feedbacks and climate sensitivity supplemental material. In: Masson-Delmotte V, et al. Climate change 2021: the physical science basis. 2021. Available from: ipcc.ch/report/ar6/wg1/downloads/report/IPCC_AR6_WGI_Chapter07_SM.pdf. Accessed May 2025 
  4. Hargreaves C, et al. Abstract presented at BTS 2022 (Abstract S60); 
  5. Hargreaves C, et al. Oral presentation at BTS 2022 (Abstract S60) 
  6. Van Den Berge M. 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. Respiratory Research. 2021;22:191 
  7. Israel S et al. Pulmonary deposition of budesonide/glycopyrronium/formoterol fumarate dihydrate metered dose inhaler formulated using co-suspension delivery technology in healthy male subjects. Eur J Pharm Sci. 2020;153:105472. doi: 10.1016/j.ejps.2020.105472. 
  8. Usmani OS et al. Consistent Pulmonary Drug Delivery with Whole Lung Deposition Using the Aerosphere Inhaler: A Review of the Evidence. Int J Chron Obstruct Pulmon Dis. 2021;16:113–124. 
  9. Rabe KF, et al. N Engl J Med 2020;383:35–48. 
  10. AstraZeneca. Data on File. REF-197183. July 2023

GB-70571 | Sept 2025

TRIXEO and AEROSPHERE are registered trademarks of the AstraZeneca group of companies.

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.

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