Evaluating the impact of a Risk Evaluation and Mitigation Strategy with tolvaptan to monitor liver safety in patients with autosomal dominant polycystic kidney disease

BACKGROUND: On approval of JYNARQUE (tolvaptan) for use in patients with autosomal dominant polycystic kidney disease (ADPKD) at risk for rapid progression, the US Food and Drug Administration required a Risk Evaluation and Mitigation Strategy (REMS) from the sponsor, which includes collection of po...

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Detalles Bibliográficos
Autores principales: Estilo, Alvin, Tracy, LaRee, Matthews, Carol, Riggen, Michele, Stemhagen, Annette, Wilt, Timothy, Krakovich, Anatoliy, Jones-Burton, Charlotte, George, Vinu, McQuade, Robert, Rahman, Mirza
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Oxford University Press 2022
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Original Article
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9942433/
https://www.ncbi.nlm.nih.gov/pubmed/36824061
http://dx.doi.org/10.1093/ckj/sfac076

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