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The goal of the Vigabatrin REMS Program is to mitigate the risk of vision loss associated with vigabatrin by:
Ensuring that healthcare providers are educated about the risk of vision loss, the need to counsel patients about the risk, and the need for periodic visual monitoring.
Ensuring that vigabatrin is only dispensed to patients with documentation that patients are informed about the risk of vision loss associated with vigabatrin and the need for
periodic visual monitoring.
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.
Healthcare Providers who prescribe vigabatrin products must:
To become certified to prescribe
Review the drug’s Prescribing Information.
Enroll in the REMS by completing the Prescriber Enrollment and
Agreement Form and submitting it to the REMS Program.
| Prescriber Enrollment and Agreement Form |
Before treatment initiation (first
dose)
Counsel the patient on the risks associated with vigabatrin,
including vision loss, and the need for periodic visual monitoring.
Provide the patient with the Patient Guide.
| Patient Guide |
Enroll the patient by completing and submitting the
Patient/Parent/Legal Guardian-Physician Agreement Form to the
REMS Program. Provide a completed copy of the form to the
patient. Retain a completed copy in the patient’s record.
| Patient/Parent/Legal-Guardian-Physician Agreement Form |
At all times
Assess the patient’s vision, including ophthalmologic
assessments, as described in the Prescribing Information.
Report any adverse event suggestive of vision loss to the REMS
Program.
Enroll in the REMS Program by completing the
Patient/Parent/Legal-Guardian-Physician Agreement Form with
the prescriber. Enrollment information will be provided to the
REMS Program.
| Patient/Parent/Legal-Guardian-Physician Agreement Form |
Receive counseling from the prescriber on the risk of vision loss,
the need for periodic visual monitoring, including ophthalmologic
assessments.
At all times
Get vision testing, including ophthalmologic assessments, as
described in the Patient Guide.
| Patient Guide |
Inform the prescriber if you experience any problems when using
vigabatrin or if you stop taking vigabatrin.
Outpatient pharmacies that dispense vigabatrin products 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 enroll in the REMS Program
by completing the Pharmacy Enrollment Form and submitting it
to the REMS Program.
| Pharmacy Enrollment Form |
Train all relevant staff involved in dispensing on the REMS
Program requirements.
Before dispensing
Obtain authorization to dispense each prescription by contacting
the REMS program or via the REMS Program Website. Document
the confirmed prescriber and patient identification numbers, and
authorization code.
| REMS Program Website |
To maintain certification to
dispense
Have the new authorized representative enroll in the REMS
Program by completing the Pharmacy Enrollment Form if the
authorized representative changes.
| Pharmacy Enrollment Form |
At all times
Comply with audits carried out by Vigabatrin Applicants, or a
third party acting on behalf of the Vigabatrin Applicants to ensure
that all processes and procedures are in place and are being
followed.
Inpatient pharmacies that dispense vigabatrin products 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 enroll in the REMS Program
by completing the Pharmacy Enrollment Form and submitting it
to the REMS Program.
| Pharmacy Enrollment Form |
Train all relevant staff involved in dispensing on the REMS
Program requirements.
Establish processes and procedures to verify the patient is
enrolled in the REMS Program before dispensing.
Establish processes and procedures to verify that within 15 days
of inpatient admission a certified prescriber authorizes continuing
treatment for an enrolled patient.
Before dispensing
Verify the patient is enrolled through the processes and
procedures established as a requirement of the REMS Program.
Document the patient identification number.
During treatment, within 15
days of inpatient admission
Obtain authorization to continue dispensing by contacting the
REMS program or via the REMS Program Website to verify a
certified prescriber authorizes continuing vigabatrin for an
enrolled patient. Document the confirmed prescriber and patient
identification numbers and authorization code.
| REMS Program Website |
Upon discharge
Dispense no more than a 15 days’ supply.
To maintain certification to
dispense
Have the new authorized representative enroll in the REMS
Program by completing the Pharmacy Enrollment Form if the
authorized representative changes.
| Pharmacy Enrollment Form |
At all times
Comply with audits carried out by Vigabatrin Applicants, or a third
party acting on behalf of the Vigabatrin Applicants to ensure that
all processes and procedures are in place and are being followed.
Wholesalers-distributors that distribute vigabatrin products 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 distributing on the REMS
program requirements.
At all times
Distribute only to certified pharmacies.
Maintain and submit records of all distributions to the REMS
Program.
Comply with audits carried out by Vigabatrin Applicants, or a
third party acting on behalf of Vigabatrin Applicants 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 Vigabatrin REMS, see the DailyMed link on the Products tab.
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
06/17/2024
Modified to:
Add Vigafyde (vigabatrin) product information
Clarify indication statements, dosing, and administration information for the approved vigabatrin products
10/12/2022
Modified to:
Change the timetable for submitting REMS assessments to every two years, rather than annually, beginning with the next REMS assessment due on April 27, 2022, and the following assessment on April 27, 2024.
Update the REMS materials to align with the labeling approved on October 20, 2021.
10/02/2020
Modified to make REMS Document revisions to accurately reflect stakeholder requirements and REMS operations and updates to the
REMS Program website screenshots, including removal of a pop-up on the landing page and addition of a verification history function.
01/24/2020
Modified to make changes to the REMS materials to reflect the revised age range for the rCPS indication. The Prescriber Enrollment and Agreement Form, Patient Guide, and REMS Website have been revised to align with the revised age range for the rCPS indication.
09/12/2019
Modified to make changes to the nonpublic REMS website screenshots for the
inpatient pharmacy REMS verification process.
05/30/2019
Modified to allow for the continuation of therapy for patients currently enrolled in the Vigabatrin REMS by an
uncertified prescriber in the inpatient setting, and incorporating the requirement that a
certified prescriber must authorize additional vigabatrin dispenses for these patients
within 15 days of inpatient admission. The REMS document and Pharmacy Enrollment
Form were revised to align with these changes. The REMS document was also revised
to align with the Format and Content of a REMS Document Guidance for Industry.
10/23/2017
Modified to make changes to the website screenshots that include the addition of language that will prevent the need for a REMS modification each time an ANDA is added and/or removed from the REMS, and/or a pharmacy is added to, or removed from the list of certified pharmacies.
05/24/2017
Revised to make an editorial change.
04/27/2017
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.
