Approved Risk Evaluation and Mitigation Strategies (REMS)

REMS that have more than one drug product but are not Shared System REMS will not display the product name and ingredient properly on this website due to database limitations. Please refer to the REMS document for the correct product names.

Turalio (pexidartinib)

NDA #211810

REMS last update: 04/17/2023

• View the Turalio Prescribing Information at DailyMed
• View Turalio'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 TURALIO REMS is to mitigate the risk of serious and potentially fatal liver injury by:

1. Ensuring that prescribers are educated on the following:
   1. approved indication for TURALIO
   2. the risk of serious and potentially fatal liver injury associated with the use of TURALIO
   3. the need for liver monitoring at baseline and periodically during treatment with dose modifications as described in the Prescribing Information
   4. the need to counsel patients about the risk of serious and potentially fatal liver injury, liver monitoring at baseline and periodically during treatment with TURALIO as described in the Patient Guide and to report signs and/or symptoms of liver injury to the prescriber during therapy
2. Ensuring that prescribers adhere to the requirement of baseline and periodic monitoring as described in the Prescribing Information
3. Enrollment of all patients in a registry to further assess the safe use and acute, chronic and irreversible hepatotoxicity of 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.

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
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.