Budesonide/glycopyrronium bromide/formoterol

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Budesonide/glycopyrronium bromide/formoterol
Combination of
Budesonide Inhaled corticosteroid
Glycopyrronium bromide Anticholinergic muscarinic antagonist
Formoterol Long-acting β2 agonist
Clinical data
Trade names Breztri Aerosphere, Trixeo Aerosphere, Riltrava Aerosphere
Other namesBudesonide/glycopyrrolate/formoterol fumarate
AHFS/Drugs.com Professional Drug Facts
License data
Routes of
administration 		By mouth (inhalation)
ATC code
Legal status
Legal status
Identifiers
CAS Number
KEGG

Budesonide/glycopyrronium bromide/formoterol, sold under the brand name Breztri Aerosphere among others, is an inhalable fixed-dose combination medication for the treatment of chronic obstructive pulmonary disease (COPD). [5] [6] [7] It contains budesonide, glycopyrronium bromide, and formoterol fumarate dihydrate. [5] [6] [7] It is inhaled. [5] [6] [7]

Contents

The most common side effects include oral candidiasis (a fungal infection of the mouth), upper respiratory tract infection, pneumonia, back pain, muscle spasms, influenza, urinary tract infection, cough, sinusitis, and diarrhea. [5] Headache is also a common side effect. [6] [7]

The combination was approved for medical use in the United States in July 2020, [8] [9] and in the European Union in December 2020. [6]

Medical uses

Budesonide/glycopyrronium bromide/formoterol is indicated for the maintenance treatment of chronic obstructive pulmonary disease (COPD) in adults. [5] [6] [7]

Society and culture

Trixeo Aerosphere was authorized for medical use in the European Union in December 2020. [6] Riltrava Aerosphere was authorized for medical use in the European Union in January 2022. [7]

Propellant

In 2025, a new budesonide/glycopyrronium bromide/formoterol inhaler using the propellant HFO-1234ze(E) was approved in the United Kingdom, for the treatment of COPD. [10]

In July 2025, the European Medicines Agency recommended a change in the composition of Trixeo Aerosphere and its duplicate product Riltrava Aerosphere to replace the existing gas propellant with a low global warming potential gas alternative. [11] The low global warming potential alternative propellant has a 1000-fold reduction in global warming potential and similar physical properties. [11]

See also

References

  1. ↑ "Health product highlights 2021: Annexes of products approved in 2021". Health Canada . 3 August 2022. Retrieved 25 March 2024.
  2. ↑ "Trixeo Aerosphere 5 micrograms/7.2 micrograms/160 micrograms pressurised inhalation, suspension - Summary of Product Characteristics (SmPC)". (emc). Retrieved 12 November 2021.
  3. ↑ "Trimbow NEXThaler (DPI) 88 micrograms/5 micrograms/9 micrograms per actuation inhalation powder - Summary of Product Characteristics (SmPC)". (emc). 6 September 2021. Retrieved 12 November 2021.
  4. ↑ "Trimbow pMDI 87 micrograms/5 micrograms/9 micrograms pressurised inhalation, solution - Summary of Product Characteristics (SmPC)". (emc). 4 June 2021. Retrieved 12 November 2021.
  5. 1 2 3 4 5 6 "Breztri- budesonide, glycopyrrolate, and formoterol fumarate aerosol, metered". DailyMed. Retrieved 15 September 2020.
  6. 1 2 3 4 5 6 7 8 "Trixeo Aerosphere EPAR". European Medicines Agency (EMA). 13 October 2020. Retrieved 5 January 2021. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
  7. 1 2 3 4 5 6 7 "Riltrava Aerosphere EPAR". European Medicines Agency. 10 November 2021. Retrieved 20 May 2022.
  8. ↑ "Breztri Aerosphere approved in the US for the maintenance treatment of COPD". AstraZeneca (Press release). 24 July 2020. Retrieved 15 September 2020.
  9. ↑ "Drug Approval Package: Breztri Aerosphere". U.S. Food and Drug Administration (FDA). 1 July 2021. Retrieved 20 May 2022.
  10. ↑ "MHRA approves world's first low-carbon version of COPD inhaler Trixeo Aerosphere". GOV.UK.
  11. 1 2 "First reformulation of an inhaled medicine with environmentally friendly gas propellant". European Medicines Agency (EMA) (Press release). 25 July 2025. Retrieved 28 July 2025.
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