Yupelri Generic Name & Formulations
Store Yupelri in the protective foil pouch; should only be opened immediately before use.
Store at room temperature from 68°F to 77°F (20°C to 25°C); excursions permitted from 59°F to 86°F (15°C to 30°C).
Protect from direct sunlight and excessive heat.
The vial and any residual content should be discarded after use.
Yupelri Dosage and Administration
Yupelri Boxed Warnings
There are no adequate and well-controlled studies with Yupelri in pregnant women.
Nursing Mother Considerations
There is no information regarding the presence of revefenacin in human milk, the effects on the breastfed infant, or the effects on milk production. Consider the benefits to the mother vs the potential for adverse effects on the breastfed infant.
Yupelri is not indicated for children; safety and effectiveness have not been established in this population.
Clinical trials included 441 patients aged 65 years and older (101 patients were aged 75 years and older). No overall differences in safety or effectiveness were observed between older and younger patients. No dosage adjustment in geriatric patients is necessary.
Renal Impairment Considerations
No dosage adjustment is required in patients with renal impairment.
Severe renal impairment: Monitor for systemic antimuscarinic side effects.
Hepatic Impairment Considerations
Yupelri is not recommended in patients with any degree of hepatic impairment.
Systemic exposure of the active metabolite of revefenacin is increased in patients with moderate hepatic impairment.
Following inhaled administration, Cmax of revefenacin and its active metabolite occurred at the first postdose sampling time which ranged from 14 to 41 minutes after start of nebulization.
Protein binding of revefenacin and its active metabolite in human plasma was on average 71% and 42%, respectively.
Terminal half-life of revefenacin and its active metabolite after once-daily is 22 to 70 hours.
Yupelri Adverse Reactions
Yupelri Clinical Trials
Yupelri was evaluated in 2 dose-ranging trials, 2 replicate 12-week, phase 3 confirmatory trials, and a 52-week safety trial. In the 2 replicate 12-week, phase 3 placebo-controlled trials (N=1229), patients aged ≥40 years with moderate to very severe COPD were randomly assigned to receive Yupelri 175mcg once daily or placebo. The primary endpoint was the change from baseline in trough FEV1 at day 85.
Treatment with Yupelri showed significant improvement in lung function vs placebo. In Trial 1 (ClinicalTrials.gov Identifier: NCT02459080), the least square mean change in trough FEV1 was 127mL and -19mL in the Yupelri and placebo groups, respectively (treatment difference 146, 95% CI, 103.7-188.8).
In Trial 2 (ClinicalTrials.gov Identifier: NCT02512510) , the least square mean change in trough FEV1 was 102mL and -45mL in the Yupelri and placebo groups, respectively (treatment difference 147, 95% CI, 97.0-197.1).
In addition, the mean peak FEV1 (within the first 2 hours after dosing) improvement on day 1 relative to placebo was 133mL and 129mL in Trials 1 and 2, respectively.
In Trial 1, the St. Georges Respiratory Questionnaire (SGRQ) responder rate (defined as an improvement in score of ≥4 as threshold) on day 85 was 49% for the Yupelri arm vs 34% for placebo (odds ratio [OR] 2.11, 95% CI 1.14-3.92). In Trial 2, the SGRQ responder rate was 45% vs 39%, respectively (OR 1.31, 95% CI, 0.72-2.38).
Yupelri Patient Counseling
Yuperli should only be administered via a standard jet nebulizer; do not mix with other medications.
Yupelri is not meant to relieve acute symptoms of COPD; extra doses should not be used for that purpose.
Yupelri can cause paradoxical bronchospasm; discontinue treatment if this occurs.
Be alert for signs and symptoms of acute narrow-angle glaucoma (eg, eye pain or discomfort, blurred vision, visual halos, or colored images in association with red eyes from conjunctival congestion and corneal edema).
Be alert for signs and symptoms of urinary retention (eg, difficulty passing urine, painful urination).