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The goal of the TURALIO REMS is to mitigate the risk of serious and potentially fatal liver injury by:
Ensuring that prescribers are educated on the following:
approved indication for TURALIO
the risk of serious and potentially fatal liver injury associated with the use of TURALIO
the need for liver monitoring at baseline and periodically during treatment with dose modifications as described in the Prescribing Information
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
Ensuring that prescribers adhere to the requirement of baseline and periodic monitoring as described in the Prescribing Information
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.
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 |
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.
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.
