Approved Risk Evaluation and Mitigation Strategies (REMS)

Vigabatrin

Shared System REMS

REMS last update: 09/12/2024

Products
Goals
Summary
REMS Materials
Assessment Plan
Update history

What medicines are included in the REMS?

Product Name	Application Number	Application Holder	Added to REMS	DailyMed Link	FDA Link
Sabril (vigabatrin) ( PI and MG at DailyMed , Info at Drugs@FDA )	NDA 020427	LUNDBECK PHARMS LLC	04/27/2017	a5d389d2-d0e1-4395-a2a2-b552808e7f98	http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=020427
Sabril (vigabatrin) ( PI and MG at DailyMed , Info at Drugs@FDA )	NDA 022006	LUNDBECK PHARMS LLC	04/27/2017	a88ac1b4-e2c9-45c0-b321-4785902172e3	http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=022006
vigabatrin (vigabatrin) (Info at Drugs@FDA)	ANDA 215363	MSN	09/07/2022
Vigadrone (vigabatrin) (Info at Drugs@FDA)	ANDA 214749	UPSHER SMITH LABS	06/29/2023
Vigadrone (vigabatrin) (Info at Drugs@FDA)	ANDA 210196	AUCTA	06/21/2018
Vigafyde (vigabatrin) ( PI and MG at DailyMed , Info at Drugs@FDA )	NDA 217684	PYROS PHARMS	06/17/2024	8d3d6316-33ab-41e8-9485-4495c218be56	http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=217684
Vigpoder (vigabatrin) (Info at Drugs@FDA)	ANDA 214961	PYROS PHARMS	06/24/2022
vigabatrin (Info at Drugs@FDA)	ANDA 213104	HIKMA	08/29/2022
vigabatrin (Info at Drugs@FDA)	ANDA 214671	ZYDUS LIFESCIENCES	03/02/2023
vigabatrin (Info at Drugs@FDA)	ANDA 215519	RYAN LABS	04/28/2023
vigabatrin ( PI and MG at DailyMed , Info at Drugs@FDA )	ANDA 208218	ENDO OPERATIONS	04/27/2017	e7cbc0a5-8c28-4451-9176-b608e228ba66
vigabatrin (Info at Drugs@FDA)	ANDA 210155	AMNEAL PHARMS	03/13/2018
vigabatrin (Info at Drugs@FDA)	ANDA 209824	TEVA PHARMS USA	04/24/2018
vigabatrin (Info at Drugs@FDA)	ANDA 211481	DR REDDYS	11/20/2018
vigabatrin (Info at Drugs@FDA)	ANDA 209822	TEVA PHARMS USA	01/14/2019
vigabatrin (Info at Drugs@FDA)	ANDA 211592	INVAGEN PHARMS	12/03/2019
vigabatrin (Info at Drugs@FDA)	ANDA 213469	GRANULES	04/24/2020
vigabatrin (Info at Drugs@FDA)	ANDA 214425	ACCORD HLTHCARE	11/13/2020
vigabatrin (Info at Drugs@FDA)	ANDA 213375	ALKEM LABS LTD	12/02/2020
vigabatrin (Info at Drugs@FDA)	ANDA 213519	ANNORA PHARMA	01/27/2021
vigabatrin (Info at Drugs@FDA)	ANDA 211539	DR REDDYS	01/29/2021
vigabatrin (Info at Drugs@FDA)	ANDA 214992	DEXCEL	05/13/2021
vigabatrin (Info at Drugs@FDA)	ANDA 213390	PROPEL PHARMA	07/29/2021
vigabatrin (Info at Drugs@FDA)	ANDA 215109	DEXCEL	09/23/2021
vigabatrin (Info at Drugs@FDA)	ANDA 213899	AUROBINDO PHARMA LTD	09/29/2021
vigabatrin (Info at Drugs@FDA)	ANDA 215707	ZYDUS LIFESCIENCES	01/19/2022
vigabatrin (Info at Drugs@FDA)	ANDA 215601	AUROBINDO PHARMA LTD	05/10/2022
vigabatrin (Info at Drugs@FDA)	ANDA 210042	AMNEAL PHARMS	06/22/2022

What is the purpose of the REMS?

The goal of the Vigabatrin REMS 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.

View application holder(s) REMS Website

Healthcare providers who prescribe vigabatrin must:

To become certified to prescribe	Review the drug’s Prescribing Information. Enroll by completing and submitting the Prescriber Enrollment and Agreement Form to the REMS. \| 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. 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.

Patients who are prescribed vigabatrin:

Before treatment initiation	Review the Patient Guide. \| Patient Guide \| Enroll in the REMS by completing the Patient/Parent/Legal- Guardian-Physician Agreement Form with the prescriber. Enrollment information will be provided to the REMS. \| Patient/Parent/Legal-Guardian-Physician Agreement Form \| Receive counseling from the prescriber on the risk of vision loss and 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 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 enroll by completing and submitting the Pharmacy Enrollment Form to the REMS. \| Pharmacy Enrollment Form \| Train all relevant staff involved in dispensing on the REMS requirements.
Before dispensing	Obtain authorization to dispense each prescription by contacting the REMS or via the REMS Website. Document the confirmed prescriber and patient identification numbers, and authorization code.
To maintain certification to dispense	Have a new authorized representative enroll by completing and submitting the Pharmacy Enrollment Form to the REMS, if the authorized representative changes.
At all times	Comply with audits carried out by the 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 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 enroll by completing and submitting the Pharmacy Enrollment Form to the REMS. \| Pharmacy Enrollment Form \| Train all relevant staff involved in dispensing on the REMS requirements. Establish processes and procedures to verify the patient is enrolled in the REMS 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. Document the patient identification number.
During treatment, within 15 days of inpatient admission	Obtain authorization to continue dispensing by contacting the REMS or via the REMS Website to verify a certified prescriber authorizes continuing vigabatrin for an enrolled patient. Document the confirmed prescriber and patient identification numbers and authorization code.
Upon discharge	Dispense no more than a 15 days’ supply.
To maintain certification to dispense	Have a new authorized representative enroll by completing and submitting the Pharmacy Enrollment Form to the REMS, if the authorized representative changes. \| Pharmacy Enrollment Form \|
At all times	Comply with audits carried out by the 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 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 requirements.
At all times	Distribute only to certified pharmacies. Maintain and submit records of all distributions to the REMS. Comply with audits carried out by the 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.

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.

Material Name	Material Name Link
Patient Guide (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/rems/Vigabatrin_2024_09_12_Patient_Guide.pdf
Patient/Parent/Legal-Guardian-Physician Agreement Form (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/rems/Vigabatrin_2024_09_12_Patient_Parent_Legal_Guardian_Physician_Agreement_Form.pdf
Pharmacy Enrollment Form (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/rems/Vigabatrin_2024_09_12_Pharmacy_Enrollment_Form .pdf
Prescriber Enrollment and Agreement Form (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/rems/Vigabatrin_2024_09_12_Prescriber_Enrollment_and_Agreement_Form.pdf
REMS Document (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/rems/Vigabatrin_2024_09_12_REMS_Document .pdf
REMS Full (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/rems/Vigabatrin_2024_09_12_REMS_Full.pdf
REMS Website Screenshots (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/rems/Vigabatrin_2024_09_12_REMS_Website_Screenshots.pdf

Assessment Plan
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.

Assessment Plan

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
09/12/2024	Modified the REMS Document to: Make changes to align with the REMS Document Technical Conformance Guide Make changes to the audit requirements for pharmacies and wholesalersdistributors REMS Materials modifications include: Global changes to materials updated to align with changes to the REMS Document Patient Guide-changed name of material from “What You Need to Know About Vigabatrin Treatment: A Patient Guide” to “Patient Guide” and removed instructions to healthcare providers
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.

Vigabatrin Shared System REMS REMS last update: 09/12/2024