Risk Evaluation and Mitigation Strategies (REMS) Summary

Goal of the Lemtrada (alemtuzumab) Injection REMS Program

The goal of the LEMTRADA REMS is to mitigate the risks of autoimmune conditions, infusion reactions, and malignancies associated with LEMTRADA by:

Helping to ensure informed decisions about the safe use of LEMTRADA by:

• Informing patients about the serious risks of autoimmune conditions, infusion reactions, and malignancies with LEMTRADA and the need for baseline and periodic monitoring; and
• Informing healthcare providers about the serious risks of autoimmune conditions, infusion reactions, and malignancies with LEMTRADA, the need to counsel patients, and the need for baseline and periodic monitoring.

Helping to ensure the safe use of LEMTRADA by:

• Ensuring that only certified prescribers prescribe LEMTRADA;
• Ensuring that LEMTRADA is dispensed only in certain healthcare settings, by certified pharmacies, and certified infusion sites, which have on-site access to equipment and personnel trained to manage infusion reactions; and
• Ensuring that only enrolled and authorized patients receive LEMTRADA;
• Ensuring that certified prescribers submit documentation of periodic monitoring of patients who receive LEMTRADA to identify autoimmune conditions and malignancies

REMS Elements

• Communication Plan

• Elements to Assure Safe Use

• Implementation System

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REMS Summary of Terms