其 他 安 全 警 示
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| Singapore: Jinarc® (Tolvaptan): New drug for treatment for autosomal dominant polycystic kidney disease (ADPKD) and risk of liver injury (English only) |
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Health Sciences Authority (HSA) announces that 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 following website in HSA for details:
http://www.hsa.gov.sg/announcements/dear-healthcare-professional-letter/jinarc-(tolvaptan)-new-drug-for-treatment-for-autosomal-dominant-polycystic-kidney-disease-(adpkd)-and-risk-of-liver-injury
In Hong Kong, Jinarc Tablets 30mg (HK-65098), Jinarc Tablets 90mg+30mg (HK-65099), Jinarc Tablets 45mg+15mg (HK-65100), Jinarc Tablets 15mg (HK-65101) and Jinarc Tablets 60mg+30mg (HK-65102) are pharmaceutical products registered by Otsuka Pharmaceutical (HK) Ltd. All products are prescription-only medicines. So far, the Department of Health (DH) has not received any case of adverse drug reaction related to tolvaptan.
Safety information on the risk of liver injury (including idiosyncratic elevations of blood alanine and aspartate aminotransferases with infrequent cases of concomitant elevations in bilirubin-total and acute liver failure requiring liver transplantation) has already been included in the package insert of Hong Kong registered Jinarc products. The DH will remain vigilant on safety update of the drug issued by other overseas drug regulatory authorities.
Ends/Monday, Nov 7, 2022
Issued at HKT 15:30
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