Vigabatrin REMS Program

The U.S. Food and Drug Administration (FDA) has approved a single shared system Risk Evaluation and Mitigation Strategy (REMS) for all vigabatrin products called the Vigabatrin REMS Program. It is required by the FDA to ensure informed risk-benefit decisions before initiating treatment and to ensure appropriate use of vigabatrin while patients are treated.

Healthcare providers must be certified in the Vigabatrin REMS Program to prescribe VIGADRONE®, and patients must be enrolled in the Vigabatrin REMS Program to receive VIGADRONE®. All certified prescribers and enrolled patients in the SABRIL® REMS Program have been transitioned to the Vigabatrin REMS Program and do not need to recertify or re-enroll.

Vigabatrin REMS Forms

If you or your patient are not certified or enrolled in the Vigabatrin REMS Program, visit the website for instructions and FDA-mandated forms.

Phone: 1-866-244-8175, Fax: 1-866-205-3072