Revefenacin

(Yupelri®)

Yupelri®

Drug updated on 9/4/2024

Dosage FormNebulizer (oral inhalation; 175 mcg/3mL)
Drug ClassAnticholinergics
Ongoing and
Completed Studies
ClinicalTrials.gov

Indication

  • Indicated for the maintenance treatment of chronic obstructive pulmonary disease (COPD).

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Summary
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  • 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 TitleYearSource
Yupelri (revefenacin) Prescribing Information.2022Mylan Specialty L.P., Morgantown, WV

Systematic Reviews / Meta-Analyses