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