Approved Risk Evaluation and Mitigation Strategies (REMS)

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Vigabatrin
Shared System REMS
REMS last update: 05/30/2019

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
Vigadrone (vigabatrin) (Info at Drugs@FDA) ANDA 210196 AUCTA 06/21/2018
vigabatrin (Info at Drugs@FDA) ANDA 211481 DR REDDYS LABS LTD 11/20/2018
vigabatrin (Info at Drugs@FDA) ANDA 209822 TEVA PHARMS USA 01/14/2019
vigabatrin ( PI and MG at DailyMed , Info at Drugs@FDA ) ANDA 208218 PAR PHARM INC 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

What is the purpose of the REMS?

The goal of the Vigabatrin REMS Program is to mitigate the risk of vision loss associated with vigabatrin by:

  1. 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.
  2. 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 See Disclaimer page regarding links to external sites

Health Care 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/parent or legal guardian on the risks associated with vigabatrin, including vision loss, and the need for periodic visual monitoring.
  • Provide the patient with the 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/parent or legal guardian. Retain a completed copy in the patient’s record
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.

Patients who are prescribed vigabatrin products

Before treatment initiation
  • Review the Patient Guide
  • 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.
At all times
  • 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.
  • Get vision testing, including ophthalmologic assessments, as decribed in the 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 epresentative enroll in the REMS Program by completing the Pharmacy Enrollment Form and submitting it to the REMS Program.
  • Train all relevant staff involved in dispensing on the REMS program requirements.
Before dispensing
  • Obtain authorization to dispense each prescription by contaction the REMS program or via the REMS Program Website. Document the confirmed prescriber and patient identification numbers, and authorization code.
To maintain certification to dipsense
  • Have the new authorized representative enroll in the REMS Program by completing the Pharmacy Enrollment Form if the authorized representative changes.
At all times
  • Comply with audits carried out by Vigabatrin Sponsors, FDA, or a third party acting on behalf of the Vigabatrin Sponsors 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 pharm
  • Have the authorized epresentative enroll in the REMS Program by completing the Pharmacy Enrollment Form and submitting it to the REMS Program.
  • Train all relevant staff involved in dispensing on the REMS program requirements.
  • Establish processes and procedures to verify that patients are enrolled in the REMS Program prior to admission in the inpatient setting and prior to dispensing. 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 codes.
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.
At all times
  • Comply with audits carried out by Vigabatrin Sponsors, or a third party acting on behalf of the Vigabatrin Sponsors to ensure that all processes and procedures are in place and are being followed.

Wholesalers 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 Sponsors, or a third party acting on behalf of Vigabatrin Sponsors or FDA 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 2019 05 30 Patient Guide.pdf
Patient/Parent/Legal Guardian -Physician Agreement Form (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Vigabatrin 2019 05 30 Patient Parent Legal Guardian Physician Agreement Form.pdf
Pharmacy Enrollment Form (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Vigabatrin 2019 05 30 Pharmacy Enrollment Form.pdf
Prescriber Enrollment and Agreement Form (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Vigabatrin 2019 05 30 Prescriber Enrollment and Agreement Form.pdf
REMS Document (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Vigabatrin 2019 05 30 REMS Document.pdf
REMS Full (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Vigabatrin 2019 05 39 REMS Full.pdf
REMS Website Screenshots (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Vigabatrin 2019 05 30 REMS Website Screenshots.pdf

What updates have been made to the REMS?

Date Summary of change
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.

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