SABRIL Risk Evaluation and Mitigation Strategy (REMS) Program

What is the SABRIL REMS Program?

A REMS is a strategy to manage known or potential serious risks associated with a drug product and is required by the FDA to ensure the benefits of a drug outweigh its risks.

The purpose of the SABRIL REMS Program is to mitigate vision loss associated with SABRIL by:

  • Ensuring that healthcare providers are educated about the risk of vision loss, the need to counsel patients about the risk, and the need for periodic visual monitoring
  • Ensuring that SABRIL is dispensed only to patients with documentation that they are informed about the risk of vision loss associated with SABRIL and the need for periodic visual monitoring

Indications and Usage:

Refractory Complex Partial Seizures (CPS)
SABRIL is indicated as adjunctive therapy for patients 10 years of age and older with refractory complex partial seizures (CPS) who have inadequately responded to several alternative treatments and for whom the potential benefits outweigh the risk of vision loss. SABRIL is not indicated as a first line agent for CPS.

Infantile Spasms (IS)
SABRIL is indicated as monotherapy for pediatric patients 1 month to 2 years of age with infantile spasms (IS) for whom the potential benefits outweigh the potential risk of vision loss.