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For US Healthcare Professionals Sanofi Genzyme

Helping Ensure Safe Use

Because of the risk of autoimmunity, infusion reactions, and malignancies, LEMTRADA is available only through restricted distribution under Risk Evaluation and Mitigation Strategy (REMS).1

  • Pharmacies, prescribers, healthcare facilities, and patients must be enrolled and comply with all program requirements
  • Healthcare facilities must have on-site access to equipment and personnel trained to manage infusion reactions
  • Prescribers must initiate monitoring at baseline and after the first treatment course, and continue until 48 months after the last course of LEMTRADA, or longer, if clinically indicated

What does LEMTRADA REMS do?

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.

Steps to Enroll

Please select an option to see the REMS requirements that apply.

To prescribe LEMTRADA, prescribers must be enrolled in the LEMTRADA REMS program. Complete the following steps to enroll:

  • Register with the LEMTRADA REMS Online Training Center.
  • Review the LEMTRADA REMS Education Program and the LEMTRADA Prescribing Information in the online module on this site.
  • Successfully complete the 8-question knowledge assessment at the end of the module.
  • After completing the assessment, complete and sign the LEMTRADA REMS Prescriber Enrollment Form.
Begin Enrollment

To dispense or administer LEMTRADA, healthcare facilities must be enrolled in the LEMTRADA REMS program.

  • Designate an authorized representative.
  • Register the authorized representative with the LEMTRADA REMS Training Center.
  • Authorized representative must review the LEMTRADA REMS Education Program through the online module on this site.
  • After completing the online module, complete and sign the LEMTRADA REMS Healthcare Facility Enrollment Form. This enrollment must be renewed every 2 years.
  • Implement and document the necessary staff training and processes to comply with the LEMTRADA REMS requirements.
Begin Enrollment

To dispense LEMTRADA, an authorized representative of the pharmacy must be enrolled in the LEMTRADA REMS program.

  • Designate an authorized representative.
  • Register the authorized representative with the LEMTRADA REMS Training Center.
  • Authorized representative must review the LEMTRADA REMS Program Overview.
  • After reviewing the material, complete and sign the LEMTRADA REMS Pharmacy Enrollment Form. This enrollment must be renewed every 2 years.
  • Implement and document the necessary staff training and processes to comply with the LEMTRADA REMS requirements.
Begin Enrollment

Patients must be enrolled and comply with monitoring requirements. A certified prescriber will educate patients on LEMTRADA REMS.

Download Patient Guide

INDICATION

LEMTRADA is indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include relapsing-remitting disease and active secondary progressive disease, in adults. Because of its safety profile, the use of LEMTRADA should generally be reserved for patients who have had an inadequate response to two or more drugs indicated for the treatment of MS.

Limitations of Use: LEMTRADA is not recommended for use in patients with clinically isolated syndrome (CIS) because of its safety profile.

IMPORTANT SAFETY INFORMATION

WARNING: AUTOIMMUNITY, INFUSION REACTIONS, STROKE AND MALIGNANCIES

CONTRAINDICATIONS

LEMTRADA is contraindicated in patients:

WARNINGS AND PRECAUTIONS

Most Common Adverse Reactions

In controlled clinical trials, the most common adverse reactions (incidence ≥10% and >interferon beta-1a) with LEMTRADA vs interferon beta-1a were: rash (53% vs 6%), headache (52% vs 23%), pyrexia (29% vs 9%), nasopharyngitis (25% vs 19%), nausea (21% vs 9%), urinary tract infection (19% vs 8%), fatigue (18% vs 13%), insomnia (16% vs 15%), upper respiratory tract infection (16% vs 13%), herpes viral infection (16% vs 3%), urticaria (16% vs 2%), pruritus (14% vs 2%), thyroid gland disorders (13% vs 3%), fungal infection (13% vs 4%), arthralgia (12% vs 9%), pain in extremity (12% vs 9%), back pain (12% vs 8%), diarrhea (12% vs 6%), sinusitis (11% vs 8%), oropharyngeal pain (11% vs 5%), paresthesia (10% vs 8%), dizziness (10% vs 5%), abdominal pain (10% vs 5%), flushing (10% vs 4%), and vomiting (10% vs 3%).

Use in Specific Populations

Physicians are encouraged to register patients in the pregnancy exposure registry by calling 1-866-758-2990. Antibodies, including anti-CD52 and autoantibodies, may be transferred from the mother to the fetus during pregnancy. Placental transfer of anti-thyroid antibodies resulting in neonatal Graves’ disease has been reported.

Safety and effectiveness in pediatric patients less than 17 years of age have not been established. Use of LEMTRADA is not recommended in pediatric patients due to the risks of autoimmunity and infusion reactions, stroke, and because it may increase the risk of malignancies.

Please see full Prescribing Information, including Boxed WARNING.

Reference:

  1. LEMTRADA [prescribing information]. Cambridge, MA: Genzyme Corporation.

Indication

LEMTRADA is indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include relapsing-remitting disease and active secondary progressive disease, in adults. Because of its safety profile, the use of LEMTRADA should generally be reserved for patients who have had an inadequate response to two or more drugs indicated for the treatment of MS.

Limitations of Use: LEMTRADA is not recommended for use in patients with clinically isolated syndrome (CIS) because of its safety profile.

IMPORTANT SAFETY INFORMATION

WARNING: AUTOIMMUNITY, INFUSION REACTIONS, STROKE AND MALIGNANCIES

  • LEMTRADA causes serious, sometimes fatal, autoimmune conditions such as immune thrombocytopenia and anti-glomerular basement membrane (anti-GBM) disease. Monitor complete blood counts with differential, serum
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