Indications for: YUPELRI
Maintenance treatment of COPD.
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).
Administer by the orally inhaled route via standard jet nebulizer connected to an air compressor. Inhale 1 vial (175mcg) once daily (using a mouthpiece).
Do not initiate during acutely deteriorating or potentially life-threatening COPD episodes. Not for treating acute symptoms. Prescribe a short-acting β2-agonist for acute symptoms; monitor for increased need. Do not exceed recommended dose. Discontinue immediately and treat if paradoxical bronchospasm or immediate hypersensitivity reactions occur; use alternative therapy. Narrow-angle glaucoma. Urinary retention. Prostatic hyperplasia. Bladder-neck obstruction. Hepatic impairment: not recommended. Severe renal impairment: monitor. Pregnancy. Nursing mothers.
Additive effects with concomitant other anticholinergic-containing drugs; avoid. Concomitant OATP1B1 and OATP1B3 inhibitors (eg, rifampicin, cyclosporine): not recommended.
Cough, nasopharyngitis, upper respiratory tract infection, headache, back pain; paradoxical bronchospasm.
Terminal half-life of revefenacin and its active metabolite after once-daily is 22 to 70 hours.
Generic Drug Availability:
Vials (3mL)—7, 30