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

Healthcare Providers who prescribe TURALIO must:

To become certified to prescribe	Review the drug's Prescribing Information. Review the following: Program Overview and Prescriber Training. | Prescriber Training | | Program Overview | Successfully complete the Prescriber Knowledge Assessment and submit it to the REMS. | Prescriber Knowledge Assessment | Enroll in the REMS by completing the Prescriber Enrollment Form and submitting it to the REMS Program. | Patient Enrollment Form |
Before treatment initiation (first dose)	Provide the patient with the Patient Guide. | Patient Guide | Assess the patient’s baseline liver function. Document and submit the results to the REMS Program using the Patient Enrollment Form. | Patient Enrollment Form | Enroll the patient by completing and submitting the Patient Enrollment Form to the REMS Program. | Prescriber Enrollment Form |
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.
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 Program using the Patient Status Form. | Patient Status Form |
At all times	Report adverse events suggestive of serious and potentially fatal liver injury to the REMS Program using the Liver Adverse Event Reporting Form. | Liver Adverse Event Reporting Form |

Patients who are prescribed TURALIO:

Before treatment initiation	Review the Patient Guide. | Patient Guide | Get blood tests to check your liver. Enroll in the REMS Program by completing the Patient Enrollment Form with the prescriber. Enrollment information will be provided to the REMS Program. | Patient Enrollment Form |
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 your TURALIO treatment, if needed.
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 certification process and oversee implementation and compliance with the REMS Program on behalf of the pharmacy. Have the authorized representative review the Program Overview. | Program Overview | Have the authorized representative enroll in the REMS by completing the Pharmacy Enrollment Form and submitting it to the REMS Program. | Pharmacy Enrollment Form | Train all relevant staff involved in dispensing TURALIO using the Program Overview. | Program Overview |
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.
Before dispensing; for the first 3 months	Dispense no more than a 30 days supply.
At all times dispense	Report adverse events suggestive of serious and potentially fatal liver injury to the REMS Program using the Liver Adverse Event Reporting Form. | 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.
To maintain certification to dispense	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. | Pharmacy Enrollment Form |

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.

Material Name	Material Name Link
Letter for Healthcare Providers (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/rems/Turalio_2023_04_17_Letter_for_Healthcare_Providers.pdf
Letter for Professional Societies (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/rems/Turalio_2023_04_17_Letter_for_Professional_Societies.pdf
Liver Adverse Event Reporting Form (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/rems/Turalio_2023_04_17_Liver_Adverse_Event_Reporting_Form.pdf
Patient Enrollment Form (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/rems/Turalio_2023_04_17_Patient_Enrollment_Form.pdf
Patient Guide (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/rems/Turalio_2023_04_17_Patient_Guide.pdf
Patient Status Form (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/rems/Turalio_2023_04_17_Patient_Status_Form.pdf
Pharmacy Enrollment Form (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/rems/Turalio_2023_04_17_Pharmacy_Enrollment_Form.pdf
Prescriber Enrollment Form (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/rems/Turalio_2023_04_17_Prescriber_Enrollment_Form.pdf
Prescriber Knowledge Assessment (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/rems/Turalio_2023_04_17_Prescriber_Knowledge_Assessment.pdf
Prescriber Training (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/rems/Turalio_2023_04_17_Prescriber_Training.pdf
Program Overview (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/rems/Turalio_2023_04_17_Program_Overview.pdf
REMS Document (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/rems/Turalio_2023_04_17_REMS_Document.pdf
REMS Full (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/rems/Turalio_2023_04_17_REMS_Full.pdf
REMS Website Screenshots (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/rems/Turalio_2023_04_17_REMS_Website_Screenshots.pdf

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.