
Monitoring is just as important as getting treatment
Monitoring after LEMTRADA infusion treatment
Because of risks of autoimmunity, infusion reactions, and some kinds of cancers, LEMTRADA is only available through a restricted program called the LEMTRADA Risk Evaluation and Mitigation Strategy (REMS).
Certain side effects of LEMTRADA can happen months and even years after treatment. That’s why it is important to begin monitoring after your first infusion and continue regular monitoring until 4 years or longer after your last round of treatment. Monitoring can help your healthcare provider find potential side effects early.
AUTOIMMUNE DISEASES
Some of the potential serious side effects of LEMTRADA can include autoimmune diseases, which may cause death. These may include:
- blood disorders (e.g., immune thrombocytopenic purpura)
- thyroid problems
- inflammation of the liver
- overactivity of the immune system (e.g., hemophagocytic lymphohistiocytosis)
- bleeding disorder (e.g., acquired hemophilia A)
- kidney disorders (e.g., anti-glomerular basement membrane disease)
Kidney disease can lead to kidney failure needing dialysis or transplant and can be life-threatening if untreated.
CERTAIN CANCERS
LEMTRADA may also be associated with some kinds of cancers, including:
- skin cancer (melanoma)
- thyroid cancer
- blood cancers (e.g., lymphoproliferative disorders and lymphoma)
In addition to the REMS program, there are other steps taken to keep track of certain LEMTRADA side effects, like monitoring. Monitoring may help your healthcare provider find side effects early.
Monitoring Includes:

Monthly blood and
urine tests

Ongoing symptom
self-checks

Yearly skin exams
It’s very important to have your blood and urine tested even if you’re feeling well and do not have any symptoms from LEMTRADA and relapsing MS.
Your lab monitoring options

LAB
Testing at any LabCorp® or Quest Diagnostics™ patient service centers.

Healthcare provider’s office
Samples can be taken at your healthcare provider’s office. With this option, you may incur a co-pay for your doctor’s visit. However, the cost of analyzing the samples will be covered by the LEMTRADA Central Lab Program.
Sanofi reserves the right at any time and without notice to modify or change eligibility criteria or discontinue this program.
Trademarks not owned by Genzyme Corporation or Sanofi are the property of their respective owners.
THE LEMTRADA REMS
A REMS program is required by the FDA for certain medications to help ensure that the potential benefits of a drug outweigh its potential risks.
During an appointment, your healthcare provider will tell you more about the program and how to enroll.

Confirms patients are enrolled and educated about treatment and ongoing monitoring requirements.

Trains and certifies healthcare providers to prescribe LEMTRADA.

Verifies healthcare facilities are enrolled in the program and have on-site access to equipment and personnel trained to manage infusion reactions.

Makes sure approved pharmacies are certified with the program and working with trained facilities.