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budesonide/formoterol/glycopyrrolate (Breztri Aerosphere)

Indications: - maintenance treatment of COPD - predominantly benefits patients with elevated blood eosinophil count (> 300 x 10E6/L) [3] Contraindications: - not indicated for relief of acute bronchospasm or for treatment of asthma Dosage: - 2 inhalations of twice daily Inhalation: budesonide (160 ug), glycopyrrolate (9 ug), & formoterol fumarate (4.8 ug) per inhalation Adverse effects: - > 2% - upper respiratory tract infection - pneumonia - back pain - oral candidiasis - influenza - muscle spasm - urinary tract infection (2.6% vs 2.3% with placebo) - cough (4.0% vs 2.7% with placebo) - sinusitis - diarrhea - due to budesonide - glaucoma & cataracts - adrenal suppression - decreased bone mineral density (osteoporosis) - hyperglycemia - due glycopyrrolate - urinary retention Drug interactions: - strong cytochrome P450 3A4 inhibitors (ritonavir) may result in systemic glucocorticoid (dexamethasone) effects - other adrenergic drugs may potentiate effect - diuretics, xanthine derivatives or steroids may potentiate hypokalemia or ECG changes - monoamine oxidase inhibitors & tricyclic antidepressants - beta-blockers may block bronchodilatory effects of beta-agonists & result in bronchospasm - anticholinergics may interact additively with glycopyrrolate Laboratory: - complete blood count - eosinophil count: > 300 x 10E6/L [3] Mechanism of action: - glucocorticoid/long-acting beta-2 agonist/long-acting muscarinic antagonist combination (triple therapy) - both 160 & 320 ug of budesonide reduce rates of moderate to severe COPD exacerbations relative to dual therapy [1] - only 320 ug dose of budesonide reduces mortality [1] Notes: - marketed by Atra-Zeneca

General

LABA/LAMA glucocorticoid combination (triple therapy)

References

  1. Boyles S Triple Treatment Reduces COPD Exacerbations. Also a suggestion of reduced mortality with one dose level, large multicenter ETHOS trial finds. MedPage Today June 25, 2021 https://www.medpagetoday.com/meetingcoverage/ats/87261
  2. Rabe KF, Martinez FJ, Ferguson GT et al Triple Inhaled Therapy at Two Glucocorticoid Doses in Moderate-to-Very-Severe COPD. N Engl J Med 2020; 383:35-48 PMID: 32579807 https://www.nejm.org/doi/full/10.1056/NEJMoa1916046
  3. Labaki WW, Rosenberg SR. Chronic obstructive pulmonary disease. Ann Intern Med 2020 Aug 4; 173:ITC17 PMID: 32745458 - Agusti A, Celli BR, Criner GJ et al. Global Initiative for Chronic Obstructive Lung Disease 2023 Report: GOLD executive summary. Am J Respir Crit Care Med. 2023 Apr 1;207(7):819-837. PMID: 36856433 PMCID: PMC10111975 Free PMC article https://www.atsjournals.org/doi/10.1164/rccm.202301-0106PP
  4. HIGHLIGHTS OF PRESCRIBING INFORMATION BREZTRI AEROSPHERE (budesonide, glycopyrrolate, &formoterol fumarate) inhalation aerosol, for oral inhalation use https://den8dhaj6zs0e.cloudfront.net/50fd68b9-106b-4550-b5d0-12b045f8b184/9d44f9af-438a-448b-bb5c-dae506e17e49/9d44f9af-438a-448b-bb5c-dae506e17e49_viewable_rendition__v.pdf

Components

budesonide (Rhinocort, Pulmicort, Turbuhaler, Flexhaler, Entocort EC, Uceris, Cortiment, Eohilia) formoterol (Foradil, Perforomist) glycopyrrolate (Robinul, Cuvposa, Qbrexza)