Approved Risk Evaluation and Mitigation Strategies (REMS)

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Sabril (vigabatrin)
NDA #22006 NDA #20427
REMS last update: 06/21/2016

View the Sabril Prescribing Information and Medication Guide at DailyMed.
View Sabril's Regulatory Information at Drugs@FDA View the Sabril Prescribing Information and Medication Guide at DailyMed.
View Sabril's Regulatory Information at Drugs@FDA

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).

Healthcare Providers who prescribe Sabril must

To be able to prescribe
  • Review the drug’s prescribing information.
  • Enroll in the REMS by completing and submitting the Prescriber Enrollment and Agreement Form.
Before the first prescription
  • Counsel the patient and/or their caregiver on the risks associated with Sabril, including visual loss, and the need for periodic visual monitoring.
  • Provide the patient and/or their caregiver with the What You need to Know About Sabril Treatment: A Patient Guide.
  • Enroll the patient by completing and submitting the Patient/Parent/Legal Guardian-Physician Agreement Form. Provide a completed copy of the form to the patient and/or their caregiver.
At specified interval during treatment, as described in the prescribing information
  • Assess the patient’s condition by periodic visual monitoring.
At all times
  • Report any adverse event suggestive of vision loss to the application holder.

Patients and/or their caregiver who are prescribed Sabril

Before the first prescription
  • Review the What You Need to Know About Sabril Treatment: A Patient Guide.
  • Enroll in the REMS by completing the Patient/Parent/Legal Guardian-Physician Agreement Form with the prescriber.
  • Receive counseling from the prescriber on the risk of vision loss and the need for periodic visual monitoring, including ophthalmologic assessments, based on the recommendation in the Prescribing Information.

Outpatient pharmacies that dispense Sabril must

To be able to dispense
  • Designate an authorized representative to carry out the certification process on behalf of the pharmacy.
  • Train all relevant staff involved in dispensing on the program requirements.
  • Establish processes and procedures to verify that prescribers are certified and patients are enrolled in the REMS prior to dispensing.
  • Have the authorized representative enroll in the REMS by completing and submitting the Pharmacy Enrollment Form.
At all times
  • Cooperate with audits carried out by the application holder to ensure that all processes and procedures are in place and are being followed.

Inpatient pharmacies that dispense Sabril must

To be able to dispense
  • Designate an authorized representative to carry out the certification process on behalf of the pharmacy.
  • Train all relevant staff involved in dispensing on the program requirements.
  • Establish processes and procedures to verify that prescribers are certified and patients are enrolled in the REMS prior to dispensing.
  • Have the authorized representative enroll in the REMS by completing and submitting the Pharmacy Enrollment Form.
Upon discharge
  • Dispense no more than a 15 days’ supply.
At all times
  • Cooperate with audits carried out by the application holder 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:


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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