Budesonide/glycopyrronium bromide/formoterol

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
Other names	Budesonide/glycopyrrolate/formoterol fumarate
AHFS/Drugs.com	Professional Drug Facts
License data	US DailyMed: Breztri;
Routes of; administration	By mouth (inhalation)
ATC code	R03AL11 (WHO) ;
Legal status
Legal status	UK: POM (Prescription only) ; US: ℞-only ; EU: Rx-only ;
Identifiers
CAS Number	2588185-76-4;
KEGG	D11584;

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).^[4]^[5] It contains budesonide, glycopyrronium bromide, and formoterol fumarate dihydrate.^[4]^[5] It is inhaled.^[4]

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.^[4]

The combination was approved for medical use in the United States in July 2020,^[6]^[7] and in the European Union in December 2020.^[5]

Medical uses[]

Budesonide/glycopyrronium bromide/formoterol is indicated for the maintenance treatment of chronic obstructive pulmonary disease (COPD) in adults.^[4]^[5]

Society and culture[]

Legal status[]

On 15 October 2020, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion, recommending the granting of a marketing authorization for the medicinal product Trixeo Aerosphere (formoterol fumarate dihydrate/glycopyrronium bromide/budesonide), intended for maintenance treatment of chronic obstructive pulmonary disease (COPD) in adults whose disease is not adequately controlled.^[8] Trixeo Aerosphere was approved for medical use in the European Union in December 2020.^[5]

On 11 November 2021, the CHMP adopted a positive opinion, recommending the granting of a marketing authorization for the medicinal product Riltrava Aerosphere (formoterol fumarate dihydrate/glycopyrronium bromide/budesonide), intended for maintenance treatment of chronic obstructive pulmonary disease (COPD) in adults whose disease is not adequately controlled.^[9]

References[]

^ "Trixeo Aerosphere 5 micrograms/7.2 micrograms/160 micrograms pressurised inhalation, suspension - Summary of Product Characteristics (SmPC)". (emc). Retrieved 12 November 2021.
^ "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.
^ "Trimbow pMDI 87 micrograms/5 micrograms/9 micrograms pressurised inhalation, solution - Summary of Product Characteristics (SmPC)". (emc). 4 June 2021. Retrieved 12 November 2021.
^ ^a ^b ^c ^d ^e ^f "Breztri- budesonide, glycopyrrolate, and formoterol fumarate aerosol, metered". DailyMed. 23 July 2020. Retrieved 15 September 2020.
^ ^a ^b ^c ^d ^e ^f "Trixeo Aerosphere EPAR". European Medicines Agency (EMA). Retrieved 5 January 2021.
^ "Breztri Aerosphere approved in the US for the maintenance treatment of COPD". AstraZeneca (Press release). 24 July 2020. Retrieved 15 September 2020.
^ "Drugs@FDA: Breztri Aerosphere". U.S. Food and Drug Administration (FDA). Retrieved 15 September 2020.
^ "Trixeo Aerosphere: Pending EC decision". European Medicines Agency (EMA). 16 October 2020. Retrieved 16 October 2020. Text was copied from this source which is © European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
^ "Riltrava Aerosphere: Pending EC decision". European Medicines Agency. 12 November 2021. Retrieved 11 November 2021. Text was copied from this source which is © European Medicines Agency. Reproduction is authorized provided the source is acknowledged.

External links[]

"Budesonide". Drug Information Portal. U.S. National Library of Medicine.
"Glycopyrronium bromide". Drug Information Portal. U.S. National Library of Medicine.
"Formoterol fumarate". Drug Information Portal. U.S. National Library of Medicine.

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[1] "Trixeo Aerosphere 5 micrograms/7.2 micrograms/160 micrograms pressurised inhalation, suspension - Summary of Product Characteristics (SmPC)". (emc). Retrieved 12 November 2021.

[2] "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.

[3] "Trimbow pMDI 87 micrograms/5 micrograms/9 micrograms pressurised inhalation, solution - Summary of Product Characteristics (SmPC)". (emc). 4 June 2021. Retrieved 12 November 2021.

[Breztri_FDA_label-4] ^ ^a ^b ^c ^d ^e ^f "Breztri- budesonide, glycopyrrolate, and formoterol fumarate aerosol, metered". DailyMed. 23 July 2020. Retrieved 15 September 2020.

[Trixeo_Aerosphere_EPAR-5] ^ ^a ^b ^c ^d ^e ^f "Trixeo Aerosphere EPAR". European Medicines Agency (EMA). Retrieved 5 January 2021.

[6] "Breztri Aerosphere approved in the US for the maintenance treatment of COPD". AstraZeneca (Press release). 24 July 2020. Retrieved 15 September 2020.

[7] "Drugs@FDA: Breztri Aerosphere". U.S. Food and Drug Administration (FDA). Retrieved 15 September 2020.

[8] "Trixeo Aerosphere: Pending EC decision". European Medicines Agency (EMA). 16 October 2020. Retrieved 16 October 2020. Text was copied from this source which is © European Medicines Agency. Reproduction is authorized provided the source is acknowledged.

[Riltrava_Aerosphere:_Pending_EC_decision-9] "Riltrava Aerosphere: Pending EC decision". European Medicines Agency. 12 November 2021. Retrieved 11 November 2021. Text was copied from this source which is © European Medicines Agency. Reproduction is authorized provided the source is acknowledged.

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