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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 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.

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  • Prescribing Information

How Lemtrada Is Given

WHAT IS THE DOSING FOR LEMTRADA?

LEMTRADA is given by intravenous (IV) infusion through a needle placed in your vein.

ROUND 1

One infusion a day on 5 consecutive days

ROUND 2 (1 YEAR LATER)

One infusion a day on 3 consecutive days

2 rounds of treatment over 2 years with LEMTRADA for relapsing MS with additional courses, as needed.

ADDITIONAL ROUNDS IF NEEDED

You and your healthcare provider may decide that you need one or more additional rounds of treatment. If so, this would occur at least 1 year after your last round. Any additional rounds would consist of one infusion a day on 3 consecutive days.

HOW LEMTRADA WAS STUDIED

Of the 387 patients who entered the Study 1 Extension of LEMTRADA:

(192 patients) did not receive additional rounds of LEMTRADA

or any other disease-modifying therapy (DMT).

  • 29% (114 patients) received 1 additional round of LEMTRADA
  • 13% (50 patients) received 2 additional rounds of LEMTRADA
  • 2% (9 patients) received 3 additional rounds of LEMTRADA
  • 1% (4 patients) received 4 additional rounds of LEMTRADA
  • 5% (18 patients) received another DMT and no additional LEMTRADA rounds

Information beyond 3 treatment courses is limited.

MONTHLY MONITORING

Monthly monitoring to detect potential side effects starts after your first infusion and continues until 4 years or longer after the last round of treatment.

WHAT HAPPENS DURING TREATMENT?

  • It will take at least 4 hours to receive 1 dose of LEMTRADA
  • You will be monitored closely during the infusion and for at least 2 hours following the completion of the infusion to watch for any infusion reactions
  • You will be given certain medications prior to treatment
  • LEMTRADA can cause serious side effects during infusion or up to 24 hours or longer after you receive LEMTRADA. Tell your healthcare provider immediately if you experience any discomfort during or after your infusion. You may also be given other medicines before, during, or after the infusion to try to reduce your chances of getting these reactions or to treat them if they happen

WHAT HAPPENS AFTER TREATMENT?

  • You will need monthly blood and urine tests, self-checks, and yearly skin checks. These help to monitor for possible side effects that can show up months or even years after your last infusion, including autoimmune side effects and some kinds of cancers, including skin cancer (melanoma). It is important to have your blood and urine tested, even if you are feeling well and do not have any symptoms from LEMTRADA or your MS. This may help your healthcare provider find side effects early

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Discussion Guide

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Next Section: LEMTRADA in the Body