YUPELRI

Revefenacin pharmacokinetic parameters are presented as the mean [standard deviation (SD)] unless otherwise specified. Following repeat dosing of inhaled YUPELRI, steady-state was achieved within 7 days with <1.6‑fold accumulation. Revefenacin exposure (C max and AUC) in COPD patients is approximately 60% lower as compared to healthy subjects. Exposure (C max and AUC) of the active metabolite in COPD patients is approximately 2-fold higher as compared to healthy subjects. Revefenacin C max was 0...

The safety and efficacy of YUPELRI 175 mcg once daily were evaluated in two dose‑ranging trials, two replicate 12-week, Phase 3 confirmatory clinical trials, and a 52-week safety trial. The efficacy of YUPELRI is primarily based on the two replicate 12-week, Phase 3 placebo-controlled trials in 1,229 subjects with COPD. 14.1 Dose-Ranging Trials Dose selection for YUPELRI was supported by a 28-day, randomized, double-blind, placebo-controlled, parallel-group trial of 355 subjects diagnosed with moderate to severe COPD, which was conducted to evaluate four doses of YUPELRI. YUPELRI 44, 88, 175, ...

The following clinically significant adverse reactions are described elsewhere in labeling:

• Paradoxical bronchospasm [see Warnings and Precautions (5.2) ]
• Worsening of narrow-angle glaucoma [see Warnings and Precautions (5.3) ]
• Worsening of urinary retention [see Warnings and Precautions (5.4) ]
• Immediate hypersensitivity reactions [see Warnings and Precautions (5.5) ] Most common adverse reactions (incidence greater than or equal to 2% and more common than placebo) include cough, nasop...

YUPELRI is contraindicated in patients with hypersensitivity to revefenacin or any component of this product. YUPELRI is contraindicated in patients with hypersensitivity to revefenacin or any component of this product. ( 4 )

• Do not initiate YUPELRI in acutely deteriorating COPD or to treat acute symptoms. ( 5.1 )
• If paradoxical bronchospasm occurs, discontinue YUPELRI and institute alternative therapy. ( 5.2 )
• Worsening of narrow-angle glaucoma may occur. Use with caution in patients with narrow-angle glaucoma and instruct patients to contact a healthcare provider immediately if symptoms occur. ( 5.3 )
• Worsening of urinary retention may occur. Use with caution in patients with prostatic hyperplasia or bladde...

7 DRUG INTERACTIONS

• Anticholinergics: May interact additively with concomitantly used anticholinergic medications. Avoid administration of YUPELRI with other anticholinergic-containing drugs. ( 7.1 )
• Transporter-related drug interactions: Coadministration of YUPELRI with OATP1B1 and OATP1B3 inhibitors (e.g. rifampicin, cyclosporine, etc.) may lead to an increase in exposure of the active metab...