Jinarc® (Tolvaptan) – New drug for treatment for Autosomal Dominant Polycystic Kidney Disease (ADPKD) and Risk of Liver Injury
A Dear Healthcare Professional Letter has been issued by Otsuka Pharmaceuticals (Singapore) Pte Ltd to inform healthcare professionals of the approval of Jinarc
® (tolvaptan) for the treatment of autosomal dominant polycystic kidney disease (ADPKD) as well as the risk of liver injury associated with its use. Jinarc
® has been associated with idiosyncratic elevations of blood alanine and aspartate aminotransferases with infrequent cases of concomitant elevations in bilirubin-total. In post-marketing experience with Jinarc
® in ADPKD, acute liver failure requiring liver transplantation has been reported. Jinarc
® is only available through a restricted distribution programme, which is part of a risk management programme that Otsuka has put in place to manage the risk of idiosyncratic hepatic toxicity associated with the use of Jinarc
®. Only prescribers, pharmacies, and patients enrolled in the programme can prescribe, dispense, and receive Jinarc
® respectively. Jinarc
® treatment must be initiated and monitored under the supervision of physicians with expertise in managing ADPKD and a full understanding of the risks of Jinarc
®, including hepatic toxicity and monitoring requirements. Healthcare professionals are advised to inform their patients about regular blood testing required to monitor and manage the risk of liver injury while taking Jinarc
® and to discuss with them the monitoring of symptoms that may indicate liver injury. Please refer to the letter for details.
Healthcare professional, Industry member, Therapeutic Products
Published:
Dear Healthcare Professional Letters