LEMTRADA is a prescription medicine used to treat relapsing forms of multiple sclerosis (MS), to include relapsing-remitting disease and active secondary progressive disease, in adults. Since treatment with LEMTRADA can increase your risk of getting certain conditions and diseases, LEMTRADA is generally prescribed for people who have tried 2 or more MS medicines that have not worked well enough. LEMTRADA is not recommended for use in patients with clinically isolated syndrome (CIS). It is not known if LEMTRADA is safe and effective for use in children under 17 years of age.

LEMTRADA is a prescription medicine used to treat relapsing forms of multiple sclerosis (MS), to include relapsing-remitting disease and active secondary progressive disease, in adults. Since treatment with LEMTRADA can increase your risk of getting certain conditions and diseases, LEMTRADA is generally prescribed for people who have tried 2 or more MS medicines that have not worked well enough. LEMTRADA is not recommended for use in patients with clinically isolated syndrome (CIS). It is not known if LEMTRADA is safe and effective for use in children under 17 years of age.

the LEMTRADA Monitoring program

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:

Post-infusion monitoring includes monthly blood and urine tests

Monthly blood and
urine tests

Post-infusion monitoring includes ongoing symptom self-checks

Ongoing symptom
self-checks

Post-infusion monitoring includes yearly skin exams

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 monitoring options include any LabCorp or Quest Diagnostics patient service center

LAB

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

Lab monitoring options include your healthcare provider's office

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 Genzyme 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.

The LEMTRADA REMS enrolls and educates patients and has required monitoring

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

The LEMTRADA REMS trains and certifies healthcare providers

Trains and certifies healthcare providers to prescribe LEMTRADA.

The LEMTRADA REMS ensures healthcare facilities are trained and certified in the program and have the ability to manage infusion reactions

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

The LEMTRADA REMS ensures approved pharmacies are enrolled in the program and working with trained facilities

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

Stephanie
LEMTRADA
PATIENT

Monitoring
can help

find problems that come up.

Watch real LEMTRADA patients discuss their monitoring experiences.

Donnie
LEMTRADA
PATIENT

You have
to make a

Commitment To monitoring.

Donnie shares how he made monitoring a part of his treatment routine.

Important Safety Information See More

LEMTRADA can cause serious side effects including serious autoimmune problems. Some people receiving LEMTRADA develop a condition where the immune cells in your body attack other cells or organs in the body (autoimmunity), which can be serious and may cause death. Serious autoimmune problems may include: