Sanofi Genzyme
Medication
Guide Prescribing Information,
including serious side effects For Healthcare
Professionals

For U.S. Residents Only

LEMTRADA is a prescription medicine used to treat adults with relapsing forms of multiple sclerosis (MS). Because of its risks, LEMTRADA is generally used in people who have tried 2 or more MS medicines that have not worked well enough. It is not known if LEMTRADA is safe and effective for use in children under 17 years of age.

Do not receive LEMTRADA if you are infected with human immunodeficiency virus (HIV).

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  • Prescribing Information

Lemtrada Safety

A look at some of the potential side effects

When considering LEMTRADA as your relapsing MS medicine, it's important to discuss potential common and serious side effects with your healthcare provider.

In two 2-year clinical trials, LEMTRADA was studied in over 800 patients.

LEMTRADA can cause serious infusion reactions that may cause death. Serious infusion reactions may happen while you receive, or up to 24 hours or longer after you receive LEMTRADA. You will receive your infusion at a healthcare facility with equipment and staff trained to manage infusion reactions, including serious allergic reactions, and urgent heart or breathing problems. You will be watched while you receive, and for 2 hours or longer after you receive, LEMTRADA. If a serious infusion reaction happens while you are receiving LEMTRADA, your infusion may be stopped. 92% of patients experienced infusion reactions on LEMTRADA, 3% of these reactions were serious.

Tell your healthcare provider right away if you have any of the following symptoms of a serious infusion reaction during the infusion, and after you have left the healthcare facility:

  • swelling in your mouth or throat
  • trouble breathing
  • weakness
  • fast, slow, or irregular heartbeat
  • chest pain
  • rash

These are not the only possible side effects of LEMTRADA. Tell your healthcare provider if you have any side effects that bother you or don't go away.

PREMEDICATIONS

To lower your chances of getting a serious infusion reaction, your healthcare provider will give you a medicine called corticosteroids before your first 3 infusions of a treatment course. You may also be given other medicines before or after the infusion to try to reduce your chances of having these reactions or herpes viral infection.

CORTICOSTEROIDS

These will be given to you right before your LEMTRADA infusion for the first 3 days of each round of treatment

ANTIHISTAMINES AND/OR FEVER REDUCERS

Your healthcare provider may consider administering antihistamines and/or a fever reducer prior to your LEMTRADA infusion

ANTIVIRALS

You’ll be given an antiviral before treatment and will continue it until your immune cells reach certain levels

Infusion reactions can occur despite pretreatment.

Next Section: Learn about Monitoring