Approved Risk Evaluation and Mitigation Strategies (REMS)

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Lemtrada (alemtuzumab)
BLA #103948
REMS last update: 04/05/2016

View the Lemtrada Prescribing Information and Medication Guide at DailyMed.
View Lemtrada's Regulatory Information at Drugs@FDA

What do participants need to know?

Below is a general overview of the REMS for all REMS participants (e.g., patients, pharmacies, and healthcare providers). See the application holder(s) REMS Website or the approved REMS materials for more information.

View application holder(s) REMS Website See Disclaimer page regarding links to external sites

Healthcare Providers who prescribe Lemtrada

To be able to prescribe Lemtrada
  • Review the prescribing information for Lemtrada.
  • Review the educational materials for prescribers, including: Program Overview and Education Program for Prescribers.
  • Complete the Knowledge Assessment and submit the successfully completed knowledge assessment to the sponsor.
  • Enroll in the REMS by completing and submitting the Prescriber Enrollment Form.
Before writing the first prescription for a patient
  • Counsel the patient on the risks, including the risks of autoimmune conditions, infusion reactions, and malignancies, and the need for baseline and periodic monitoring using the What You Need to Know About Lemtrada Treatment: A Patient Guide and the Patient Safety Information Card.
  • Provide the patient with a copy of the What You Need to Know About Lemtrada Treatment: A Patient Guide and the Patient Safety Information Card.
  • Assess the patient’s baseline status by ordering laboratory tests described in the prescribing information, within 30 days prior to the patient’s first infusion. Document and submit the results using Patient Authorization and Baseline Lab Form.
  • Enroll the patient by completing and submitting the Patient Enrollment Form Provide a completed copy of the form to the patient and retain a completed copy in the patient’s record.
  • Complete and submit the Prescription Ordering form.
Before writing each prescription after the first prescription
  • Complete and submit the Prescription Ordering form.
  • Within 30 days prior to the patient’s infusion, assess the patient’s baseline status by ordering laboratory tests described in the prescribing information. Document and submit the results using Patient Authorization and Baseline Lab Form.
While patient is being treated with Lemtrada
  • Assess patient’s laboratory tests and whether the patient has experienced an adverse event as described in the prescribing information for Lemtrada.
  • At 6 months following the patient’s first infusion and every 6 months thereafter, complete and submit the Patient Status Form.
After a patient’s final infusion
  • Assess patient’s laboratory tests and whether the patient has experienced an adverse event as described in the prescribing information for Lemtrada.
  • Every 6 months until 48 months after the patient’s last infusion, complete and submit the Patient Status Form.
Ongoing
  • Report events suggestive of autoimmune conditions, infusion reactions, and malignancies to the sponsor.
  • Report if an enrolled patient who has received Lemtrada within the last 48 months is no longer under your care to the sponsor.

Patients who receive Lemtrada

To be able to receive Lemtrada
  • Enroll in the REMS by completing the Patient Enrollment Form with the prescriber.
Before receiving the initial Lemtrada prescription
  • Receive counseling from the prescriber the risks of Lemtrada using the What You Need to Know About Lemtrada Treatment: A Patient Guide and the Patient Safety Information Card.
  • Receive a copy of the What You Need to Know About Lemtrada Treatment: A Patient Guide and the Patient Safety Information Card.

Pharmacies that dispense Lemtrada

To be able to dispense Lemtrada
  • Designate an authorized representative to carry out the certification process on behalf of the pharmacy.
  • Have the authorized representative review the educational materials for dispensers, including: Program Overview.
  • Train all relevant staff involved in the dispensing of Lemtrada using the Program Overview.
  • Establish processes and procedures to verify dispensing to certified infusion centers only.
  • Enroll in the REMS by completing and submitting the Pharmacy Enrollment Form.
Before dispensing Lemtrada
  • Obtain Prescription Ordering Forms from the Lemtrada REMS Program.
  • Obtain authorization to dispense by calling the Lemtrada REMS Program.
Ongoing
  • Re-enroll in the Lemtrada REMS program every 2 years.
  • Do not distribute, transfer, loan, or sell product except to certified dispensers.
  • Cooperate with audits carried out by the sponsor to ensure that all processes and procedures are in place and are being followed.

Infusion centers that dispense and/or infuse Lemtrada

To be able to dispense and/or infuse Lemtrada
  • Designate an authorized representative to carry out the certification process on behalf of the infusion center.
  • Have the authorized representative review the educational materials for dispensers, including: Program Overview and Education Program for Healthcare Facilities.
  • Ensure the healthcare setting has personnel and/or equipment on-site to manage severe infusion reactions (including anaphylaxis, cardiac and respiratory emergencies).
  • Train all relevant staff involved in the dispensing of Lemtrada using the Program Overview and Education Program for Healthcare Facilities.
  • Enroll in the REMS by completing and submitting the Healthcare Facility Enrollment Form.
Before dispensing Lemtrada
  • Counsel the patient on the risk of infusion reactions.
  • Provide the patient with a copy of the What You Need to Know about Lemtrada Treatment and Infusion Reactions: A Patient Guide.
  • Obtain Prescription Ordering Forms from the Lemtrada REMS Program.
  • Obtain authorization to dispense and/or infuse by calling the Lemtrada REMS Program.
After Lemtrada is administered
  • During infusion and for at least 2 hours after, assess patient for infusion reactions.
  • Within 5 business days, complete and submit the Infusion Checklist to the sponsor.
Ongoing
  • Re-enroll in the Lemtrada REMS program every 2 years.
  • Return unused product to the manufacturer within 50 days of submission of the Patient Authorization and Baseline Lab Form.
  • Do not distribute, transfer, loan, or sell product.
  • Cooperate with audits carried out by the sponsor to ensure that all processes and procedures are in place and are being followed.

What materials are included in the REMS?

The REMS includes a REMS Document. In addition, the REMS includes the following materials intended for patients and healthcare providers:


Disclaimer: This webpage provides general information about REMS programs to various REMS participants (e.g., patients, pharmacies, and healthcare providers). The summary information provided herein is not comprehensive and may not include all of the information relevant to REMS participants. This webpage does not constitute a replacement, modification, or revision of the approved REMS document, including any appended REMS materials. Refer to the approved REMS document for complete information on the REMS requirements for each approved application.

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