Approved Risk Evaluation and Mitigation Strategies (REMS)

Jynarque (tolvaptan)

NDA #204441

REMS last update: 09/29/2023

• View the Jynarque Prescribing Information at DailyMed
• View Jynarque's Regulatory Information at Drugs@FDA

• Goals
• Summary
• REMS Materials
• Assessment Plan
• Update history

What is the purpose of the REMS?

The goal of the JYNARQUE REMS is to mitigate the risk of serious and potentially fatal liver injury by:

1. Ensuring that healthcare providers are educated on the following:
   • the risk of serious and potentially fatal liver injury associated with the use of JYNARQUE
   • the requirement for monitoring at baseline and periodic monitoring as described in the Prescribing Information
   • the need to counsel patients about the risk of serious and potentially fatal liver injury and the need for monitoring at baseline and periodic monitoring as described in the Prescribing Information

2. Ensuring that healthcare providers adhere to:
   • the requirement for monitoring at baseline and periodic monitoring as described in the Prescribing Information

3. Ensuring that patients are informed about:
   • the risk of serious and potentially fatal liver injury associated with the use of JYNARQUE
   • the requirement for monitoring at baseline and periodic monitoring as described in the Prescribing Information

4. Enrollment of all patients in a registry to further support long term safety and safe use of JYNARQUE

What do participants need to know?

Below is a general overview of the REMS for all REMS participants (e.g., patients, pharmacies, and healthcare providers). See the application holder(s) REMS Website or the approved REMS materials for more information.

View application holder(s) REMS Website

What assessment is available to the REMS?

Assessment Plan
REMS assessment plan unavailable for posting at this time.

What updates have been made to the REMS?

Date	Summary of change
09/29/2023	Revision of the REMS Document audit language to reflect the audit requirement for wholesaler-distributors and that pharmacy audits include all pharmacies, and to include annual audits of a representative sample based on the audit plan after the initial audit.
11/25/2020	Modified to: Allow certified outpatient pharmacies to transfer product between their certified sites, should one location close or have a surplus of JYNARQUE. Provide healthcare providers and delegates the ability to print or view previous completed Patient Status and Liver Adverse Event Reporting Forms. Allow addition of the Patient REMS ID to the patient grid in the patient list of the prescriber portal. Allow addition of a pop-up message on the Specialty Pharmacy portal that will display when the pharmacy generates an authorization code for a patient whose last shipment was filled by the Otsuka Patient Assistance Foundation. Update the resources page on the REMS public website to include a link to Spanish translated prescriber forms and materials.
12/03/2019	Modified to update the Liver Adverse Events Reporting Form, Patient Status Form, Prescriber Training, Prescriber Enrollment Form, Patient Online Enrollment, and the Patient Enrollment Form, more specifically: Liver Adverse Events Reporting Form and Patient Status Form: Updated instructions, definitions, and criteria for serious liver event reporting Added patient and prescriber REMS ID Added space for general liver laboratory information Added a checkbox to indicate whether treatment was discontinued due to a liver event Added text indicating Otsuka will reach out for additional information on reported liver events Prescriber Training: Added definition for serious and potentially fatal liver injury Prescriber Enrollment Form: Added attestation that the prescriber will be contacted for further information regarding reports of serious and potentially fatal liver injury Patient Online Enrollment: Updated patient online enrollment process Patient Enrollment Form: Added REMS Coordinating Center fax number
03/04/2019	Revised to reflect editorial changes.
12/01/2018	Modified to reflect updates to the Patient Enrollment Form, Prescriber Enrollment Form, REMS document, and website screenshots, more specifically: The addition of "Race" and "Ethnicity" fields in the Patient Information Section on the Patient Enrollment Form The addition of a Medical History Section on the Patient Enrollment Form An update to the Patient Agreement Section to provide insight into how the collected information will be used on the Patient Enrollment Form The addition of office liaison contact fields to the Prescriber Enrollment Form A change to the trigger date for the due date of the Patient Status Form in the REMS document Changes to the website screenshots: Corresponding updates to incorporate the changes listed above Addition of links to the Chinese and Spanish translations of the Patient Guide and Patient Enrollment Form Addition of progress wizard to the online prescriber enrollment process Enlarged "Complete Online Enrollment" button
07/30/2018	Modified to: update website screenshots of the Liver Adverse Events Reporting Form update the Patient Enrollment Form to delete a checkbox and the following sentence: "By checking this box, I agree to be contacted by the manufacturer's patient support program which provides patient support for the purposes of reimbursement, financial assistance, prescription tracking, patient advocacy, and coordinating care as necessary."
05/29/2018	Revised to reflect editorial changes.
04/23/2018	Approval of the REMS

Disclaimer: This webpage provides general information about REMS programs to various REMS participants (e.g., patients, pharmacies, and healthcare providers). The summary information provided herein is not comprehensive and may not include all of the information relevant to REMS participants. This webpage does not constitute a replacement, modification, or revision of the approved REMS document, including any appended REMS materials. Refer to the approved REMS document for complete information on the REMS requirements for each approved application.