Approved Risk Evaluation and Mitigation Strategies (REMS)

Turalio (pexidartinib)
NDA #211810
REMS last update: 08/20/2019



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 See Disclaimer page regarding links to external sites

Healthcare Providers who prescribe Turalio must:

To become certified to prescribe
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.
    | Patient 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.
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 |
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 |
  • 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 are 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.

Material Name Material Name Link
Letter for Healthcare Providers (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Turalio_2019_08_20_Letter_for_Healthcare_Providers.pdf
Letter for Professional Societies (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Turalio_2019_08_20_Letter_for_Professional_Societies.pdf
Liver Adverse Event Reporting Form (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Turalio_2019_08_20_Liver_Adverse_Event_Reporting_Form.pdf
Patient Enrollment Form (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Turalio_2019_08_20_Patient_Enrollment_Form.pdf
Patient Guide (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Turalio_2019_08_20_Patient_Guide.pdf
Patient Status Form (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Turalio_2019_08_20_Patient_Status_Form.pdf
Pharmacy Enrollment Form (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Turalio_2019_08_20_Pharmacy_Enrollment_Form.pdf
Prescriber Enrollment Form (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Turalio_2019_08_20_Prescriber_Enrollment_Form.pdf
Prescriber Knowledge Assessment (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Turalio_2019_08_20_Prescriber_Knowledge_Assessment.pdf
Prescriber Training (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Turalio_2019_08_20_Prescriber_Training.pdf
Program Overview (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Turalio_2019_08_20_Program_Overview.pdf
REMS Document (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Turalio_2019_08_20_REMS_Document.pdf
REMS Full (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Turalio_2019_08_20_REMS_Full.pdf
REMS Program Website Screenshots (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Turalio_2019_08_20_REMS_Program_Website_Screenshots.pdf

What updates have been made to the REMS?

Date Summary of change
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.

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