Drug updated on 3/28/2024
| Dosage Form | Nebulizer (oral inhalation; 175 mcg/3mL) |
| Drug Class | Anticholinergics |
| Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- To maintain treatment of chronic obstructive pulmonary disease.
Summary
- Revefenacin (Yupelri) is used for the maintenance treatment of chronic obstructive pulmonary disease (COPD).
- Two systematic reviews/meta-analyses were reviewed, providing insights into the safety and efficacy of revefenacin in treating COPD.
- The first review found that there were no significant differences between patients receiving 175µg revefenacin and those receiving a placebo concerning risk of discontinuation due to adverse events, any all-grade adverse event or serious adverse event; it also noted that a lower dose of 88µg shared a comparable safety profile with the approved dose.
- This study concluded that revefenacin at its approved dosage is generally well-tolerated and safe with minimal side effects, supporting its use as once-daily nebulized long-acting muscarinic antagonist for moderate to severe stable COPD; however, additional studies are needed to complete the safety profile.
- The second review incorporated nine randomized controlled trials involving over 3000 participants; it indicated that daily intake of 175µg/day could significantly improve trough Forced Expiratory Volume in one second without increasing risks associated with adverse events or serious ones compared to placebo.
- Despite these promising results on efficacy and tolerability, this meta-analysis suggested further research comparing effectiveness, long-term safety and cost-effectiveness between REV(Yupelri) and other LAMAs across different populations since most evidence was graded as low quality; moreover, it showed inferiority against tiotropium regarding long-term efficacy while not having superior safety profiles than tiotropium or ipratropium at same dosage level (175 µg).
Product Monograph / Prescribing Information
| Document Title | Year | Source |
|---|---|---|
| Yupelri (revefenacin) Prescribing Information. | 2022 | Mylan Specialty L.P., Morgantown, WV |
Systematic Reviews / Meta-Analyses
| Document Title | Year | Source |
|---|---|---|
| Safety evaluation of revefenacin at the approved dose in patients with chronic obstructive pulmonary disease: a meta-analysis. | 2022 | Heart & Lung: The Journal of Acute and Critical Care |
| The efficacy and safety of revefenacin for the treatment of chronic obstructive pulmonary disease: a systematic review. | 2021 | Frontiers in Pharmacology |
| Efficacy of revefenacin in treatment of moderate-to-very-severe chronic obstructive pulmonary disease: a systematic review and meta-analysis. | 2021 | Journal of Health Policy and Economics |