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The goal of the AQVESME REMS is to mitigate the risk of hepatocellular injury associated with AQVESME.
Prescribers monitor liver tests to determine the appropriateness of continuing treatment.
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.
Successfully complete the Prescriber Knowledge Assessment and
submit it to the REMS.
Enroll by completing and submitting the Prescriber Enrollment
Form to the REMS.
Before treatment initiation (first
dose)
Provide the patient with the Patient Guide.
Counsel the patient on the risk of hepatocellular injury; the
monitoring requirements; the signs and symptoms of
hepatocellular injury; and to seek medical attention right away if
the patient develops any new or worsening signs or symptoms
of hepatocellular injury using the Patient Guide.
Assess the patient's liver tests and appropriateness of initiating
treatment per the Prescribing Information. Document and
submit confirmation of liver test monitoring, confirmation of
patient counseling, and appropriateness of initiating treatment
to the REMS using the Patient Enrollment Form.
Enroll the patient by completing and submitting the Patient
Enrollment Form to the REMS. Provide a completed copy of the
form to the patient and retain a copy in the patient’s record.
During treatment; every 4 weeks
before each prescription for an
initial 24 weeks on-treatment with
monitoring
Assess the patient for hepatocellular injury by ordering and
reviewing liver tests per the Prescribing Information and
determine the appropriateness of continuing treatment.
Counsel the patient on the risk of hepatocellular injury; the
monitoring requirements; the signs and symptoms of
hepatocellular injury; and to seek medical attention right away if
the patient develops any new or worsening signs or symptoms
of hepatocellular injury using the Patient Guide.
Document and submit confirmation of liver test monitoring,
confirmation of patient counseling, and appropriateness of
continuing treatment using the Patient Status Form to the
REMS.
Prescribe no more than a 28-day supply.
During treatment; at any time for
24 weeks on-treatment with
monitoring
Report adverse events suggestive of hepatocellular injury to the
REMS using the Liver Adverse Event Reporting Form.
Report any non-liver related treatment interruption or
discontinuation to the REMS using the Patient Status Form.
Before treatment reinitiation
For patients with a completed Liver Adverse Event Reporting
Form: Reinitiate treatment by completing and submitting the
Patient Reinitiation Form.
For patients with a treatment interruption of more than 8 weeks
who have not completed 24 weeks on-treatment with
monitoring: Reinitiate treatment by completing and submitting
the Patient Reinitiation Form.
After treatment reinitiation, every
4 weeks before each prescription
for an additional 24 weeks ontreatment
with monitoring
For patients described in requirement 15 for whom AQVESME-related
liver injury is not ruled out and/or any patient in
requirement 16 above: Assess the patient for hepatocellular
injury by ordering and reviewing liver tests per the Prescribing
Information and determine the appropriateness of continuing
treatment.
For patients described in requirement 15 for whom AQVESME-related
liver injury is not ruled out and/or any patient in
requirement 16 above: Counsel the patient on the risk of
hepatocellular injury; the monitoring requirements; the signs
and symptoms of hepatocellular injury; and to seek medical
attention right away if the patient develops any new or
worsening signs or symptoms of hepatocellular injury using the
Patient Guide.
For patients described in requirement 15 for whom AQVESME-related
liver injury is not ruled out and/or any patient in
requirement 16 above: Document and submit confirmation of
liver test monitoring, confirmation of patient counseling and
appropriateness of continuing treatment using the Patient Status
Form to the REMS.
For patients described in requirement 15 for whom AQVESMErelated
liver injury is not ruled out and/or any patient in
requirement 16 above: Prescribe no more than a 28-day supply.
At all times
Report adverse events suggestive of hepatocellular injury to the
REMS using the Liver Adverse Event Reporting Form.
Report transfer of care to the REMS using the Patient Status
Form.
Patients who are prescribed AQVESME:
Before treatment initiation
Review the Patient Guide.
Receive counseling on the risk of liver injury; the monitoring
requirements; the signs and symptoms of liver injury; and the
need to contact a healthcare provider right away if you have any
new or worsening signs or symptoms of liver injury using the
Patient Guide.
Get liver tests
Enroll in the REMS by completing the Patient Enrollment Form
with your prescriber. Enrollment information will be provided to
the REMS.
During treatment; every 4 weeks
before each prescription for at
least 24 weeks on-treatment with
monitoring and as needed
Get liver tests
Receive counseling on the risk of liver injury; the monitoring
requirements; the signs and symptoms of liver injury; and the
need to contact a healthcare provider right away if you have any
new or worsening signs or symptoms of liver injury using the
Patient Guide.
During treatment; at any time for
at least 24 weeks on-treatment
with monitoring and as needed
Inform your prescriber if you stop treatment for any reason.
At all times
Inform a healthcare provider right away if you have any new or
worsening signs or symptoms of liver injury as described in the
Patient Guide.
Pharmacies that dispense AQVESME must:
To become certified to dispense
Designate an authorized representative to carry out the
certification process and oversee implementation and
compliance with the REMS on behalf of the pharmacy.
Have the authorized representative review the Pharmacy Guide.
Have the authorized representative successfully complete the
Pharmacy Knowledge Assessment and submit it to the REMS.
Have the authorized representative enroll by completing and
submitting the Pharmacy Enrollment Form to the REMS.
Train all relevant staff involved in dispensing on the REMS
requirements using the Pharmacy Guide.
Establish processes and procedures to document the
authorization number and the dispense date for each
prescription.
Establish processes and procedures to report when AQVESME is
returned to inventory and reverse the authorization for that
dispense.
Before dispensing, for 24 weeks
on-treatment with monitoring
Obtain authorization to dispense each prescription by contacting
the REMS to verify the prescriber is certified, the patient is
counseled, and the patient is enrolled and authorized for
treatment.
Document the authorization number and the dispense date
through the processes and procedures established as a
requirement of the REMS.
Dispense no more than a 28-day supply.
Before dispensing, after treatment
reinitiation for patients who
require an additional 24 weeks ontreatment
with monitoring
Obtain authorization to dispense each prescription by contacting
the REMS to verify the prescriber is certified, the patient is
counseled, and the patient is enrolled and authorized for
treatment.
Document the authorization number and the dispense date
through the processes and procedures established as a
requirement of the REMS.
Dispense no more than a 28-day supply.
Before dispensing, after patients
complete 24 weeks on-treatment
with monitoring
Obtain authorization to dispense each prescription by contacting
the REMS to verify the prescriber is certified, the patient is
enrolled, and the patient is authorized for treatment.
Document the authorization number and the dispense date
through the processes and procedures established as a
requirement of the REMS.
To maintain certification to
dispense
Have a new authorized representative enroll by completing and
submitting the Pharmacy Knowledge Assessment and Pharmacy
Enrollment Form, if the authorized REMS representative
changes.
At all times
Report adverse events suggestive of hepatocellular injury to the
prescriber and REMS.
Report when AQVESME is returned to inventory and reverse the
authorization for that dispense through the processes and
procedures established as a requirement of the REMS.
Return unused product to Agios Pharmaceuticals, Inc.
Not distribute, transfer, loan, or sell AQVESME.
Maintain and submit records of dispensing information.
Maintain records of all processes and procedures including
compliance with those processes and procedures.
Maintain records of staff’s completion of training.
Comply with audits carried out by Agios Pharmaceuticals, 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, and other entities that distribute AQVESME must:
To be able to distribute
Establish processes and procedures to ensure that the drug is
distributed only to certified pharmacies.
Train all relevant staff involved in distribution on the REMS
requirements.
At all times
Distribute only to certified pharmacies.
Maintain and submit records of AQVESME distribution to Agios
Pharmaceuticals, Inc.
Comply with audits carried out by Agios Pharmaceuticals, 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. For a specific Medication Guide of a product in the Aqvesme REMS, see the DailyMed link(s).
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
12/23/2025
Approval of the 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.
