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The goal of the Tolvaptan for ADPKD Shared System REMS is to mitigate the risk of serious and potentially fatal liver injury associated with tolvaptan
Objective 1: Prescribers monitor patient’s liver enzymes at baseline and periodically during treatment as described in the Prescribing Information
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.
Healthcare Providers who prescribe tolvaptan for ADPKD must:
To become certified to prescribe
Review the drug’s Prescribing Information.
Review the following: Program Overview and Prescriber Training.
Successfully complete the Prescriber Knowledge Assessment and
submit it to the REMS.
Enroll in the REMS by completing the Prescriber Enrollment Form
and submitting it to the REMS.
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
initiating treatment. Document and submit to the REMS 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.
During treatment, 2 weeks and 4 weeks after treatment initiation, then monthly for ther 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 using the Patient Status Form.
At all times
Report adverse events suggestive of serious and potentially fatal
liver injury by contacting the REMS or using the Patient Status
Form.
Report treatment discontinuation or transfer of care to the REMS.
Patients who are prescribed tolvaptan for ADPKD:
Before treatment initiation
Review the Patient Guide.
Enroll in the REMS by completing the Patient Enrollment Form with
the prescriber. Enrollment information will be provided to the
REMS.
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 monhs 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 tolvaptan for ADPKD must:
To become certified to dispense
Designate an authorized representative to carry out the
certification process and oversee implementation and compliance
with the REMS on behalf of the pharmacy.
Have the authorized representative review the Program Overview.
Have the authorized representative enroll in the REMS by
completing the Outpatient Pharmacy Enrollment Form and
submitting it to the REMS.
Train all relevant staff involved in dispensing tolvaptan for ADPKD
using the Program Overview.
Establish processes and procedures to dispense no more than a
30 days’ supply.
Before dispensing
Obtain authorization to dispense each prescription by contacting
the REMS 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 by
completing the Outpatient Pharmacy Enrollment Form and
submitting it to the REMS if the authorized representative
changes.
At all times
Report adverse events suggestive of serious and potentially fatal
liver injury by contacting the REMS.
Not distribute, transfer, loan, or sell tolvaptan for ADPKD except
to certified pharmacies.
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 the Tolvaptan for ADPKD
Applicants or third party acting on behalf of the applicants to
ensure that all processes and procedures are in place and are
being followed.
Inpatient Pharmacies that dispense tolvaptan for ADPKD must:
To become certified to dispense
Designate an authorized representative to carry out the
certification process and oversee implementation and compliance
with the REMS on behalf of the pharmacy.
Have the authorized representative review the Program Overview.
Have the authorized representative enroll in the REMS by
completing the Inpatient Pharmacy Enrollment Form and
submitting it to the REMS.
Train all relevant staff involved in dispensing tolvaptan for ADPKD
using the Program Overview.
Establish processes and procedures to verify the prescriber is
certified, and the patient is enrolled in the REMS.
Establish processes and procedures to dispense no more than a
15 days’ supply of tolvaptan for ADPKD upon discharge of the
patient.
Before dispensing
Verify the prescriber is certified and the patient is enrolled in the
REMS.
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 by
completing the Inpatient Pharmacy Enrollment Form and
submitting it to the REMS if the authorized representative
changes.
At all times
Report adverse events suggestive of serious and potentially fatal
liver injury by contacting the REMS.
Not distribute, transfer, loan, or sell tolvaptan for ADPKD.
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 the Tolvaptan for ADPKD
Applicants or third party acting on behalf of the applicants to
ensure that all processes and procedures are in place and are
being followed.
Wholesalers-distributors that distribute tolvaptan for ADPKD 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.
Comply with audits carried out by the Tolvaptan for ADPKD
Applicants or third party acting on behalf of the applicants 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. For a specific Medication Guide of a product in the Tolvaptan for ADPKD Shared System REMS REMS, see the DailyMed link on the Products tab.
This webpage provides REMS assessment plan measures, metrics, and indicators for drug and biological products with a REMS. The REMS assessment plan measures, metrics, and indicators are part of the overall REMS assessment plan used by FDA to evaluate the performance of a REMS and are included in FDA approval letters. The current REMS assessment plan measures, metrics, and indicators are extracted from regulatory letters that contain REMS information, including FDA approval letters,
and posted here as they become available.
What updates have been made to the REMS?
Date
Summary of change
05/29/2025
Revised to make editorial changes
04/23/2025
Approval of the Shared System 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.
