Approved Risk Evaluation and Mitigation Strategies (REMS)

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Jynarque (tolvaptan)
NDA #204441
REMS last update: 12/01/2018



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 See Disclaimer page regarding links to external sites

Healthcare Providers who prescribe Jynarque must:

To become certified to prescribe
  • Review the drug's Prescribing Information.
  • Review the following: Program Overview and Prescriber Training.
  • Successfully complete the Knowledge Assessment and submit it to the REMS Program.
  • Enroll in the REMS by completing the Prescriber Enrollment Form and submitting it to the REMS Program.
Before treatment initiation (first dose)
  • Counsel the patient on the risk of serious and potentially fatal liver injury and the requirement for liver function monitoring at baseline and at specific intervals during treatment using the Patient Guide. Provide a copy of the material to the patient.
  • Assess the patient's liver function and appropriateness of initating treatment. Document and submit to the REMS Program using the Patient Enrollment Form. Provide a completed copy of the form to the patient.
  • Enroll the patient by completing and submitting the Patient Enrollment Form to the REMS Program.
During treatment; 2 weeks and 4 weeks after treatment initiation, then monthly for the first 18 months and every 3 months thereafter
  • Assess the patient's liver function and appropriateness of continuing treatment.
During treatment; every 3 months for the first 18 months and every 6 months thereafter
  • Assess the patient's liver function and appropriateness of continuing treatment. Document appropriateness of continuing treatment and submit to the REMS Program using the Patient Status Form.
At all times
  • Report adverse events suggestive of serious and potentially fatal liver injury by contacting the REMS Program by phone, using the Liver Adverse Events Reporting Form, or using the Patient Status Form.
  • Report treatment discontinuation or transfer of care to the REMS Program.

Patients who are prescribed Jynarque:

Before treatment initiation
  • Review the Patient Guide.
  • Enroll in the REMS Program by completing the Patient Enrollment Form with the prescriber. Enrollment information will be provided to the REMS Program.
  • Get a blood test to check your liver.
  • Receive counseling from the prescriber on the risk of serious and potentially fatal liver injury and requirements to get blood tests using the Patient Guide.
During treatment; 2 weeks and 4 weeks after treatment initiation, then monthly for the first 18 months and every 3 months thereafter
  • Get a blood test to check your liver.
At all times
  • Inform the prescriber of signs and symptoms of serious liver injury.

Outpatient Pharmacies that dispense Jynarque must:

To become certified to dispense
  • Designate an authorized representative to carry out the certification process and oversee implementation and compliance with the REMS Program on behalf of the pharmacy.
  • Have the authorized representative review the Program Overview.
  • Have the authorized representative enroll in the REMS Program by completing the Outpatient Pharmacy Enrollment Form and submitting it to the REMS Program.
  • Train all relevant staff involved in dispensing Jynarque using the Program Overview.
  • Establish processes and procedures to dispense no more than a 30 day supply.
Before dispensing
  • Obtain authorization to dispense each prescription by contacting the REMS Program to verify the prescriber is certified, and the patient is enrolled and authorized to receive the drug.
  • Dispense no more than 30 days supply.
To maintain certification to dispense
  • Have a new authorized representative enroll in the REMS Program by completing the Outpatient Pharmacy Enrollment Form and submitting it to the REMS Program if the authorized representative changes.
At all times
  • Report adverse events suggestive of serious and potentially fatal liver injury by contacting the REMS Program by phone or using the Liver Adverse Events Reporting Form.
  • Not distribute, transfer, loan, or sell Jynarque.
  • Maintain records documenting staff's completion of REMS training.
  • Maintain records that all processes and procedures are in place and are being followed.
  • Comply with audits carried out by Otsuka Pharmaceuticals or third party acting on behalf of the applicant to ensure that all processes and procedures are in place and are being followed.

Inpatient Pharmacies that dispense Jynarque must:

To become certified to dispense
  • Designate an authorized representative to carry out the certification process and oversee implementation and compliance with the REMS Program on behalf of the pharmacy.
  • Have the authorized representative review the Program Overview.
  • Have the authorized representative enroll in the REMS Program by completing the Inpatient Pharmacy Enrollment Form and submitting it to the REMS Program.
  • Train all relevant staff involved in dispensing Jynarque using the Program Overview.
  • Establish processes and procedures to verify the prescriber is certified, and the patient is enrolled in the REMS Program.
  • Establish processes and procedures to dispense no more than a 15 days supply of Jynarque upon discharge of the patient.
Before dispensing
  • Verify the prescriber is certified and the patient is enrolled in the REMS Program.
At/upon discharge
  • Dispense no more than a 15 days supply.
To maintain certification to dispense
  • Have a new authorized representative enroll in the REMS Program by completing the Inpatient Pharmacy Enrollment Form and submitting it to the REMS Program if the authorized representative changes.
At all times
  • Report adverse events suggestive of serious and potentially fatal liver injury by contacting the REMS Program by phone or using the Liver Adverse Events Reporting Form.
  • Not distribute, transfer, loan, or sell Jynarque.
  • Maintain records documenting staff's completion of REMS training.
  • Maintain records that all processes and procedures are in place and are being followed.
  • Comply with audits carried out by Otsuka Pharmaceutical Company, Ltd or third party acting on behalf of the applicant to ensure that all processes and procedures are in place and are being followed.

Wholesalers that distribute Jynarque must:

To be able to distribute
  • Establish processes and procedures to ensure that the drug is distributed only to certified pharmacies.
  • Train all relevant staff involved in distributing on the REMS requirements.
At all times
  • Distribute only to certified pharmacies.
  • Maintain and submit records of drug distribution to the REMS Program.
  • Comply with audits carried out by Otsuka Pharmaceutical Company, Ltd or third party acting on behalf of the applicant to ensure that all processes and procedures are in place and are being followed.

What materials are included in the REMS?

The REMS includes a REMS Document. In addition, the REMS includes the following materials intended for patients and healthcare providers.

Material Name Material Name Link
Inpatient Pharmacy Enrollment Form (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Jynarque_2018_12_01_Inpatient_Pharmacy_Enrollment_Form.pdf
Letter for Healthcare Providers (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Jynarque_2018_12_01_Letter_for_Healthcare_Providers.pdf
Liver Adverse Events Reporting Form (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Jynarque_2018_12_01_Liver_Adverse_Events_Reporting_Form.pdf
Outpatient Pharmacy Enrollment Form (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Jynarque_2018_12_01_Outpatient_Pharmacy_Enrollment_Form.pdf
Patient Enrollment Form (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Jynarque_2018_12_01_Patient_Enrollment_Form.pdf
Patient Guide (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Jynarque_2018_12_01_Patient_Guide.pdf
Patient Status Form (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Jynarque_2018_12_01_Patient_Status_Form.pdf
Prescriber Enrollment Form (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Jynarque_2018_12_01_Prescriber_Enrollment_Form.pdf
Prescriber Knowledge Assessment (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Jynarque_2018_12_01_Prescriber_Knowledge_Assessment.pdf
Prescriber Training (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Jynarque_2018_12_01_Prescriber_Training.pdf
Program Overview (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Jynarque_2018_12_01_Program_Overview.pdf
REMS Document (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Jynarque_2018_12_01_REMS_Document.pdf
REMS Full (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Jynarque_2018_12_01_REMS_Full.pdf
REMS Website Screenshots (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Jynarque_2018_12_01_REMS_Website_Screenshots.pdf

What updates have been made to the REMS?

Date Summary of change
12/01/2018 Modified to reflect updates to the Patient Enrollment Form, Prescriber Enrollment Form, REMS document, and website screenshots, more specifically:

  1. The addition of "Race" and "Ethnicity" fields in the Patient Information Section on the Patient Enrollment Form
  2. The addition of a Medical History Section on the Patient Enrollment Form
  3. An update to the Patient Agreement Section to provide insight into how the collected information will be used on the Patient Enrollment Form
  4. The addition of office liaison contact fields to the Prescriber Enrollment Form
  5. A change to the trigger date for the due date of the Patient Status Form in the REMS document
  6. 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:

  1. update website screenshots of the Liver Adverse Events Reporting Form
  2. 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.

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