Skip to main content
A Singapore Government Agency Website How to identify
Official website links end with .gov.sg
Secure websites use HTTPS
Look for a lock () or https:// as an added precaution. Share sensitive information only on official, secure websites.
Government officials will never ask you to transfer money or disclose bank log-in details over a phone call.

Call the 24/7 ScamShield Helpline at 1799 if you are unsure if something is a scam.

Health Sciences Authority
Dear Healthcare Professional Letters

Jinarc® (Tolvaptan) – New drug for treatment for Autosomal Dominant Polycystic Kidney Disease (ADPKD) and Risk of Liver Injury

Audiences

Healthcare professional

Industry member

Product type

Therapeutic Products

4 November 2022

This article has been migrated from an earlier version of the site and may display formatting inconsistencies.

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.

Only abstracts of the Dear Healthcare Professional Letters (DHCPL) are provided on this website. Details of these letters can be found in the MOH Alert System, which is accessible via the Health Professionals Portal (HPP), a one-stop portal for all healthcare professionals in Singapore. Dentists, medical doctors and pharmacists may access HPP at https://hpp.moh.gov.sg (opens in new tab) and follow the procedures below to access the MOH Alert system.

Step 1: Select your profession under ‘For Healthcare Professionals’.

Step 2: Click on ‘Useful links’.

Step 3: Click on ‘MOH Alert’ and log in via Singpass.

Step 4: Click on ‘Drug Alerts’ or ‘Med Device Alerts’ to view the DHCPLs.