Budesonide and Formoterol Fumarate
Brand Names: Breyna
Methodology & AI Transparency ⓘ
Budesonide and Formoterol Fumarate Key Takeaways
Translated by Sarah Jenkins (AI RN Plain-English Translator) at a 7th-grade reading level
- 1 What it does: 1 Indications and usage breyna: is a combination product containing a corticosteroid and a long-acting beta 2 -adrenergic agonist indicated for: ; Treatment of asthma in patients 6 years of age and older.
- 2 Real-world patient consensus: 80% patient "Worth It" rating across 17 anonymous logs for Budesonide and Formoterol Fumarate (RxNorm 1246288).
- 3 Typical cash cost range: Uninsured 30-day outlay compares $185.00 cash mean against $453.25 retail pharmacy pricing.
- 4 Top reported side effects / signs: Most commonly reported Budesonide and Formoterol Fumarate tolerability events: nausea (9.3%), headache (7.5%), dizziness (5.3%).
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Budesonide and Formoterol Fumarate Mechanism, CYP450 Pathways & DailyMed Monograph
1 Indications and usage breyna: is a combination product containing a corticosteroid and a long-acting beta 2 -adrenergic agonist indicated for: ; Treatment of asthma in patients 6 years of age and older. ( 1.1 ) ; Maintenance treatment of airflow obstruction and reducing exacerbations in patients with chronic obstructive pulmonary disease (COPD) including chronic bronchitis and/or emphysema. ( 1.2 ) Important limitations: ; Not indicated for the relief of acute bronchospasm. ( 1.1 , 1.2 ) 1.1 Treatment of Asthma BREYNA is indicated for the treatment of asthma in patients 6 years of age and older.
12.1 Mechanism of Action BREYNA BREYNA contains both budesonide and formoterol fumarate dihydrate; therefore, the mechanisms of action described below for the individual components apply to BREYNA. These drugs represent two classes of medications (a synthetic corticosteroid and a long-acting selective beta 2 -adrenoceptor agonist) that have different effects on clinical, physiological, and inflammatory indices of COPD and asthma. Budesonide Budesonide is an anti-inflammatory corticosteroid that exhibits potent glucocorticoid activity and weak mineralocorticoid activity.
Pharmacokinetic profiling of Budesonide and Formoterol Fumarate demonstrates an elimination half-life of Approximately 3–10 hours terminal plasma half-life for Budesonide and Formoterol Fumarate with Estimated 51%–63% oral systemic absorption for Budesonide and Formoterol Fumarate systemic bioavailability; clearance proceeds via phase i/ii hepatic conjugation of budesonide and formoterol fumarate coupled with glomerular and tubular renal excretion, reaching clinical onset within peak plasma tmax within 1 to 2 hours (budesonide and formoterol fumarate).
Titration schedules for Budesonide and Formoterol Fumarate (160 ug/1 / 4.5 ug/1 Aerosol, Metered → 80 ug/1 / 4.5 ug/1 Aerosol, Metered) require excluding the use of breyna is contraindicated in the following conditions:; primary treatment of status asthmaticus or other acute episodes of asthma or copd where intensive measures are required.; hypersensitivity to any of the ingredients in breyna.; real-world patient logs highlight nausea (9.3% of reports), headache (7.5% of reports), fatigue (5.5% of reports) alongside a 80.00% Worth-It consensus.
Strong CYP3A4 blockade slows first-pass metabolism of Budesonide and Formoterol Fumarate, elevating systemic AUC exposure.
Avoid overlapping corticosteroid prescriptions alongside Budesonide and Formoterol Fumarate to prevent cumulative receptor toxicity.
Standard Adult Titration & Dosages
Absolute & Relative Contraindications
- The use of BREYNA is contraindicated in the following conditions:
- Primary treatment of status asthmaticus or other acute episodes of asthma or COPD where intensive measures are required.
- Hypersensitivity to any of the ingredients in BREYNA.
Logged Side-Effect Incidence (17 Reports)
Budesonide and Formoterol Fumarate Real-World Side Effects: openFDA FAERS vs. Patient Micro-Logs
Peer-Reviewed Human Clinical Trials & Meta-Analyses (Budesonide and Formoterol Fumarate)
| Study & Plain-English Finding | Sample (N) | Rigor | Primary Source |
|---|---|---|---|
| New Insights on Benefits of budesonide/glycopyrrolate/formoterol fumarate (BGF) on symptoms and: What a 8,509-Participant Study Found BGF triple therapy improved symptoms and HRQoL vs dual therapies over 24 and 52 weeks in patients with moderate-to-very severe COPD. Respiratory medicine • 2021-01-15 • Phase III Randomized Trial | N = 8,509 | 96/100 | PMID 34171789 ↗ |
| Can This Approach Help? Inside the Latest Research on Budesonide as induction therapy for incomplete microscopic colitis: A randomised, Budesonide decreased the frequency of soft or watery stools and improved the patients' quality of life significantly in MCi, but the primary endpoint was not met due to the low sample size (type 2 error). United European gastroenterology journal • 2021-09-15 • Phase III Randomized Trial | N = 44 | 88/100 | PMID 34414678 ↗ |
| New Insights on Budesonide Oral Suspension Improves Outcomes in Patients With Eosinophilic: What a 213-Participant Study Found In patients with EoE, BOS 2.0 mg twice daily was superior to placebo in improving histologic, symptomatic, and endoscopic outcomes over 12 weeks. Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association • 2022-03-15 • Phase III Randomized Trial | N = 213 | 88/100 | PMID 33887475 ↗ |
| Can This Approach Help? Inside the Latest Research on A Pilot compared against a dummy pill (placebo) Randomized Trial of Repeated High-dose magnesium appeared safe with only a modest possible benefit of medical readiness for discharge at 12 h. Journal of paediatrics and child health • 2026-10-15 • Phase III Randomized Trial | Multi-cohort | 88/100 | PMID 42605209 ↗ |
| Can This Approach Help? Inside the Latest Research on Albuterol-Budesonide Pressurized Metered Dose Inhaler in Patients With Both monocomponents contributed to albuterol-budesonide lung function efficacy. Chest • 2023-09-15 • Phase III Randomized Trial | Multi-cohort | 88/100 | PMID 37003355 ↗ |
Budesonide and Formoterol Fumarate Public Price Transparency Ledger
| Dispensing Channel / Benchmark | Verification Source | Reference Cost | Details |
|---|---|---|---|
| Pharmacy Acquisition Cost (CMS NADAC) | CMS Medicaid NADAC Weekly National Survey | $17.7066/unit (~$531.20/30u) | Wholesale baseline |
| Average U.S. Walk-In Retail Cash Price | Chain Pharmacy Uninsured Cash Index | $453.25 / mo | Before coupon/insurance |
| Patient-Logged Out-of-Pocket Average | 17 Anonymous DotMD Community Micro-Logs | $185.00 / mo | View logs ↓ |
Budesonide and Formoterol Fumarate Federal Verification & Benchmark Summary
| Metric | Verified Benchmark | Source |
|---|---|---|
| Budesonide and Formoterol Fumarate RxNorm Concept ID | 1246288 | U.S. National Library of Medicine (RxNorm) |
| CMS NADAC Pharmacy Acquisition Unit Cost | $17.7066 / unit | CMS Medicaid NADAC Weekly Feed |
| Walk-In Chain Pharmacy Cash Average | $453.25 / mo | U.S. Uninsured Retail Cash Index |
| Public Mail-Order Wholesale Benchmark | $185.00 / mo (Patient Mean) | Public Cash Reference |
| Real-World Patient Consensus | 80.00% Worth It (17 anonymous logs) | DotMD Zero-PHI Patient Ledger |
Budesonide and Formoterol Fumarate Patient Community, Cohort Filters & Dosage Logs
Cross-verified Budesonide and Formoterol Fumarate (corticosteroid) monograph synthesizing RxNorm 1246288, openFDA FAERS signals, and $185.00–$453.25 cash benchmarks.
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