Yupelri (revefenacin)
YUPELRI 175 MCG in 3 ML Inhalation Solution
NO BOXED WARNING
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Yupelri FAQs
8.1 Pregnancy Risk SummaryThere are no adequate and well-controlled studies with YUPELRI in pregnant women. If a woman becomes pregnant while taking YUPELRI, it is advisable to contact their physician. Animal reproduction studies showed no evidence of fetal harm at exposures up to 209 times the maximum recommended human dose.
8.2 Lactation Risk SummaryThere is no information available regarding the presence of revefenacin in human milk or its effects on breastfed infants. However, revefenacin was found in the milk of lactating rats. The decision to breastfeed should consider both the benefits of breastfeeding and the clinical need for YUPELRI, weighing potential effects on the infant from YUPELRI or the mother's underlying condition.
8.4 Pediatric UseThe safety and effectiveness of YUPELRI have not been established in pediatric patients, and it is not indicated for use in children.
8.5 Geriatric UseAvailable data indicate no need for dosage adjustment in geriatric patients. Clinical trials included subjects aged 65 years and older, with no overall differences in safety or effectiveness observed between these subjects and younger subjects.
8.6 Hepatic ImpairmentRevefenacin exposure remains unchanged in subjects with hepatic impairment, while the active metabolite's exposure increases. YUPELRI's safety has not been evaluated in COPD patients with hepatic impairment and is not recommended for patients with any degree of hepatic impairment.
8.7 Renal ImpairmentNo dosage adjustment is necessary for patients with renal impairment. However, COPD patients with severe renal impairment should be monitored for systemic antimuscarinic side effects.
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