Approved Risk Evaluation and Mitigation Strategies (REMS)

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Sabril (vigabatrin)
NDA #22006 NDA #20427
REMS last update: 10/22/2015

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

To be able to prescribe Sabril
  • Have experience in the treatment of epilepsy.
  • Review the prescribing information for Sabril.
  • Review the educational materials for prescribers, including: the Medication Guide.
  • Enroll in the REMS by completing and submitting the Prescriber Enrollment and Agreement Form.
Before writing the first prescription for a patient
  • Counsel the patient on the risks and benefits of Sabril using the Medication Guide.
  • Within 4 weeks of starting Sabril, assess the patient’s baseline visual acuity and field of vision. Document and submit the results using the Ophthalmologic Assessment Form
  • Enroll the patient by completing and submitting the Treatment Initiation Form and the Patient/Parent/Legal Guardian-Physician Agreement Form.
While patient is being treated with Sabril
  • For patients younger than age 3: assess the effectiveness of Sabril within 2-4 weeks.
  • For patients age 3 or older: assess the effectiveness of Sabril within 12 weeks.
  • For patients without clinical benefit: discontinue treatment using information in the Dear Healthcare Professional Medication Taper Letter.
  • For patients with clinical benefit: document and submit a Treatment Maintenance Form.
  • Every 3 months, assess patient’s visual acuity and field of vision. Document and submit the results using the Ophthalmologic Assessment Form.
  • Counsel the patient if the patient is not complying with the required vision monitoring beyond the baseline test and remove the patient from therapy if patient still fails to comply with required vision monitoring.
Ongoing
  • Report any serious adverse events to the sponsor.

Patients or caregivers of patients who receive Sabril

To be able to receive Sabril
  • Enroll in the REMS by completing the Treatment Initiation Form and the Patient/Parent/Legal Guardian-Physician Agreement Form.
Before receiving the initial Sabril
  • Within 4 weeks of starting Sabril, undergo a baseline visual assessment.
  • Receive counseling from the prescriber using the Medication Guide.
  • Read the Medication Guide.
While taking Sabril
  • Every 3 months, undergo a visual assessment.
After discontinuing Sabril
  • Undergo a vision assessment.

Pharmacies that dispense Sabril

To be able to dispense Sabril
  • Designate an authorized representative to carry out the certification process on behalf of the pharmacy.
  • Train all relevant staff involved in the dispensing of Sabril on REMS program procedures and materials.
Before dispensing Sabril
  • Obtain treatment forms and prescriptions only from the REMS Coordinating Center.
  • Obtain authorization to dispense by contacting the REMS Coordinating Center
Ongoing
  • Cooperate with audits carried out by the sponsor 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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