Update on Sabril Prescribing and Monitoring Program

The U.S. Food and Drug Administration (FDA) approved a modified Risk Evaluation and Mitigation Strategy (REMS) for Sabril or vigabatrin. There is no change in the risk for visual problems with Sabril, but the process for monitoring and reporting has been changed to make it easier.

The new Sabril REMS program will be effective as of July 21, 2016. Information for health care providers and forms from Lundbeck are available here.

Highlights of the program:

1. Sabril will continue to be available through certain specialty pharmacies and inpatient pharmacies. A free starter prescription will still be available through Lundbeck while benefits and payment assistance is being done.
2. Less paperwork will be needed from prescribing health care providers before the medication can be prescribed. Download the REMS forms here.
3. Health care providers can use a Sabril prescription form through Lundbeck’s SHAREPlus Program or send prescriptions directly to a pharmacy able to dispense the drug. 
4. Health care providers need to complete an enrollment form to be certified with the new Sabril REMS program and prescribe Sabril for patients. 
   • People who were previously enrolled with the SHARE program have 90 days from June 21st to update their enrollment.
5. With the new REMS program, providers do not need to complete treatment initiation, maintenance, or ophthalmologic assessment forms. 
   • Benefit risks assessments and vision testing should still be done as outlined in prescribing information for Sabril. 
6. Find more information about the Sabril REMS program. The optional Sabril prescription form will be available soon.