LEMTRADA REMS (Risk Evaluation and Mitigation Strategy)

What is the LEMTRADA REMS?

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 LEMTRADA REMS is to inform prescribers, pharmacies, healthcare facilities, and patients about the risks of:

LEMTRADA causes serious, sometimes fatal, autoimmune conditions such as immune thrombocytopenia and anti-glomerular basement membrane disease. Monitor complete blood counts with differential, serum creatinine levels, and urinalysis with urine cell counts at periodic intervals for 48 months after the last dose of LEMTRADA.

LEMTRADA causes serious and life threatening infusion reactions. LEMTRADA must be administered in a setting with appropriate equipment and personnel to manage anaphylaxis or serious infusion reactions.

Serious and life-threatening stroke (including ischemic and hemorrhagic stroke) has been reported within 3 days of LEMTRADA administration. Instruct patients to seek immediate medical attention if symptoms of stroke occur.

LEMTRADA may cause an increased risk of malignancy including thyroid cancer, melanoma, and lymphoproliferative disorders. Perform baseline and yearly skin exams.