Drug updated on 9/4/2024
Dosage Form | Nebulizer (oral inhalation; 175 mcg/3mL) |
Drug Class | Anticholinergics |
Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- Indicated for the maintenance treatment of chronic obstructive pulmonary disease (COPD).
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Summary
- Yupelri (revefenacin) is indicated for the maintenance treatment of chronic obstructive pulmonary disease (COPD).
- This summary is based on the review of two systematic review(s)/meta-analysis(es). [1-2]
- Revefenacin (REV) at a dose of 175 µg/day significantly improved trough FEV1 in patients with moderate to very severe COPD, with a mean difference (MD) of 143.67 mL (95% CI: 129.67 to 157.68), based on data from 809 participants across 4 studies.
- REV at 175 µg/day was found to be inferior to tiotropium regarding long-term efficacy, based on very low-quality to low-quality evidence.
- No specific differences in effectiveness among different population types or subgroups were noted in the evidence provided.
- There were no significant differences in the risk of discontinuation due to adverse events, all-grade adverse events (AEs), or serious adverse events (SAEs) between COPD patients receiving 175 µg revefenacin and those receiving a placebo. The most frequently reported adverse event in both groups was COPD worsening/exacerbation. The risk of antimuscarinic-related AEs, cardiovascular AEs, or 12 commonly reported AEs did not significantly increase with 175 µg revefenacin. Meta-analyses showed no increased risk of AEs (OR=0.98, 95% CI: 0.81 to 1.18) or SAEs (OR=0.89, 95% CI: 0.55 to 1.46).
- The safety profile of 175 µg/day revefenacin was comparable to that of tiotropium and ipratropium, with no superior safety advantage observed.
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 |