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The goal of the TURALIO REMS is to mitigate the risk of serious and potentially fatal liver injury, including
vanishing bile duct syndrome.
Objective 1: Prescribers are educated on the risk of serious and potentially fatal liver injury
including vanishing bile duct syndrome and the need to counsel patients about the risk of serious
and potentially fatal liver injury including vanishing bile duct syndrome, the need for liver
monitoring, and the signs and symptoms of liver injury
Objective 2: Prescribers monitor patients’ liver tests at baseline and periodically during treatment
as described in the Prescribing Information
Objective 3: Daiichi Sankyo, Inc. maintains a registry of all enrolled patients to further assess the
safe use and acute, chronic, and irreversible liver injury associated with TURALIO
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.
Review the following: Program Overview and Prescriber Training.
Successfully complete the Prescriber Knowledge Assessment and
Enroll in the REMS by completing the Prescriber Enrollment Form
Before treatment initiation
(first dose)
Provide the patient with the Patient Guide.
Assess the patient’s baseline liver function. Document and
submit the results to the REMS using the Patient Enrollment
Form.
Enroll the patient by completing and submitting the Patient
During treatment, at least
weekly for the first 8 weeks,
then every 2 weeks for 1
month, then every 3 months
Assess the patient’s liver function and modify the dose of
TURALIO as needed as described in the Prescribing Information.
For patients with liver tests that do not return to normal: Provide
During treatment, monthly for
the first 3 months
Prescribe no more than a 30 days’ supply.
During treatment, monthly for
the first 3 months, then month
6, 9, and 12, and every 6
months thereafter
Assess the patient by performing liver tests. Document and
submit to the REMS using the Patient Status Form.
At all times
Report adverse events or laboratory abnormalities suggestive of
serious and potentially fatal liver injury to the REMS using the
Liver Adverse Event Reporting Form.
Patients who are prescribed TURALIO:
Before treatment initiation
Review the Patient Guide.
Get blood tests to check your liver.
Enroll in the REMS by completing the Patient Enrollment Form
with the prescriber. Enrollment information will be provided to
the REMS.
During treatment, weekly for the
first 8 weeks, then every 2
weeks for 1 month, then every 3
months or more often as
directed by your prescriber
Get blood tests to check your liver so your prescriber can modify
At all times
Inform the prescriber of signs and/or symptoms of liver injury.
Pharmacies that dispense TURALIO must:
To become certified to dispense
Designate an authorized representative to carry out the
Have the authorized representative review the Program
Overview.
Have the authorized representative enroll in the REMS by
completing the Pharmacy Enrollment Form and submitting it to
the REMS.
Train all relevant staff involved in dispensing TURALIO using the
Program Overview.
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.
Before dispensing; for the first 3
months
Dispense no more than a 30 days supply.
To maintain certification to
Have the new authorized representative enroll in the REMS by
completing the Pharmacy Enrollment Form and submitting it to
the REMS if the authorized representative changes.
At all times
Report adverse events or laboratory abnormalities suggestive of
serious and potentially fatal liver injury to the REMS using the
Liver Adverse Event Reporting Form.
Do not distribute, transfer, loan, or sell TURALIO, except to
certified dispensers.
Maintain records documenting the staff’s completion of REMS
training.
Maintain records that all processes and procedures are in place
and being followed.
Comply with audits carried out by Daiichi Sankyo, Inc. or a third
party acting on behalf of the applicant, to ensure that all
processes and procedures are in place and are being followed.
Wholesalers-Distributors that distribute TURALIO must:
To be able to distribute
Establish processes and procedures to ensure that the drug is
distributed only to certified pharmacies.
Train relevant staff involved in TURALIO distribution on the REMS
requirements.
At all times
Distribute only to certified pharmacies.
Maintain records of all drug distributions.
Comply with audits carried out by Daiichi Sankyo, Inc. or a 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.
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
08/27/2025
Modified to revise the REMS goal and pertinent REMS materials to include vanishing bile duct syndrome as part of the risks the REMS is intended to mitigate to align with the safety information added to the labeling that occurred with the approval of prior approval supplement 013 on January 3, 2025.
04/17/2023
Modified to:
Make the REMS modifications outlined in the REMS Assessment Acknowledgement/REMS Modification Notification letter dated June 21, 2022.
Revise the Patient Status Form Question 17 from “Other procedure/referral:” to “Other liver-related
procedure/referral:”.
10/14/2022
Modified to update the REMS materials to align with labeling changes related to the new capsule strength of pexidartinib.
12/16/2020
Modified to:
make changes to the Patient Status Form, Liver Adverse Event Reporting Form, Prescribing Training Slides, REMS Assessment Plan, and REMS website, to list gamma-glutamyl transferase (GGT), alkaline phosphatase (ALP) elevations and direct bilirubin (DBIL) elevations as a trigger
for liver adverse event reporting suggestive of serious and potentially fatal liver injury, and to align these materials with the product label.
make changes to the Patient Status Form and Liver Adverse Event Reporting Form to allow a more complete assessmentof a patient’s condition and treatment plan.
make revisions to the Patient Enrollment Form to provide more space for listing of a patient’s medications.
08/04/2020
Modified to reflect changes to the REMS Prescriber Enrollment form, the Patient Enrollment form, and the REMS public web portal to allow the prescriber to delegate administrative REMS tasks, for the applicant to obtain additional information related to safety reports, to allow up to two additional certified prescribers to contribute to patient care and complete REMS documents, and to save REMS forms as pending while waiting for additional information.
11/19/2019
Modified to reflect changes to the Patient Enrollment Form to clarify instructions and add additional fields.
08/20/2019
Revised to reflect editorial changes.
08/02/2019
Approval of 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.
