LEMTRADA REMS (Risk Evaluation and Mitigation Strategy) Program

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

AUTOIMMUNE CONDITIONS

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.

INFUSION REACTIONS

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.

MALIGNANCIES

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

Enroll in the LEMTRADA
REMS Program

Prescribers, healthcare facilities, pharmacies, and patients must be enrolled in the LEMTRADA REMS Program to be able to dispense, administer, or receive LEMTRADA, respectively. Enroll in the program and gain access to the online tools and resources available to help you manage your LEMTRADA patients.

Find a REMS Certified Prescriber
or Healthcare Facility

Search for prescribers or healthcare facilities that are certified by the LEMTRADA REMS Program to prescibe, dispense, or administer LEMTRADA.

LEMTRADA REMS
Program Requirements

Prescribers

Prescribers must be enrolled in the LEMTRADA REMS Program to prescribe LEMTRADA for patients with multiple sclerosis.
Learn about Prescriber Enrollment

Healthcare Facilities

Healthcare facilities must be enrolled in the LEMTRADA REMS Program to dispense/administer LEMTRADA for patients with multiple sclerosis.One representative needs to enroll per healthcare setting.
Learn about Healthcare Facility Enrollment

Pharmacies

Pharmacies must be enrolled in the LEMTRADA REMS Program to be able to dispense LEMTRADA for patients with multiple sclerosis.
Learn about Pharmacy Enrollment

LEMTRADA REMS
Program Requirements

Prescribers

Healthcare Facilities

Pharmacies

If you have questions about the LEMTRADA REMS Program
or need help enrolling, call 1-855-676-6326, Mon – Fri, 8:30 am – 8:00 pm ET.
If you have questions about the LEMTRADA REMS Program
or need help enrolling, call 1-855-676-6326, Mon – Fri, 8:30 am – 8:00 pm ET.