Approved Risk Evaluation and Mitigation Strategies (REMS)

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



What is the purpose of the REMS?

The goal of the LEMTRADA REMS is to mitigate the risks of autoimmune conditions, infusion reactions, and malignancies associated with LEMTRADA by:

  1. Helping to ensure informed decisions about the safe use of LEMTRADA by:
    1. Informing patients about the serious risks of autoimmune conditions, infusion reactions, and malignancies with LEMTRADA and the need for baseline and periodic monitoring; and
    2. Informing healthcare providers about the serious risks of autoimmune conditions, infusion reactions, and malignancies with LEMTRADA, the need to counsel patients, and the need for baseline and periodic monitoring.
  2. Helping to ensure the safe use of LEMTRADA by:
    1. Ensuring that only certified prescribers prescribe LEMTRADA;
    2. Ensuring that LEMTRADA is dispensed only in certain healthcare settings, by certified pharmacies, and certified infusion sites, which have on-site access to equipment and personnel trained to manage infusion reactions; and
    3. Ensuring that only enrolled and authorized patients receive LEMTRADA;
    4. Ensuring that certified prescribers submit documentation of periodic monitoring of patients who receive LEMTRADA to identify autoimmune conditions and malignancies.

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.
    | Program Overview |
  • Complete the Knowledge Assessment and submit the successfully completed knowledge assessment to the sponsor.
    | Knowledge Assessment |
  • Enroll in the REMS by completing and submitting the Prescriber Enrollment Form.
    | Prescriber Enrollment Form |
Before writing the first prescription for a patient
Before writing each prescription after the first prescription
  • Complete and submit the Prescription Ordering form.
    | 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.
    | 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.
    | 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.
    | 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
Before receiving the initial Lemtrada prescription

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.
    | Program Overview |
  • Train all relevant staff involved in the dispensing of Lemtrada using the Program Overview.
    | 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.
    | Pharmacy Enrollment Form |
Before dispensing Lemtrada
  • Obtain Prescription Ordering Forms from the Lemtrada REMS Program.
    | Prescription Ordering Form |
  • 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.
    | Program Overview | | 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.
    | Program Overview | | Education Program for Healthcare Facilities |
  • Enroll in the REMS by completing and submitting the Healthcare Facility Enrollment Form.
    | Healthcare Facility Enrollment Form |
Before dispensing Lemtrada
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.
    | 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. For a specific Medication Guide of a product in the Lemtrada REMS, see the DailyMed link(s).
Material Name Material Name Link
Education Program for Healthcare Facilities (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Lemtrada_2016-04-05_Education_Program_Healthcare_Facilities.pdf
Education Program for Prescribers (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Lemtrada_2016-04-05_Education_Program_Prescribers.pdf
Healthcare Facility Enrollment Form (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Lemtrada_2016-04-05_Healthcare_Facility_Enrollment_Form.pdf
Infusion Checklist (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Lemtrada_2016-04-05_Infusion_Checklist.pdf
Knowledge Assessment (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Lemtrada_2016-04-05_Knowledge_Assessment.pdf
Patient Authorization and Baseline Lab Form (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Lemtrada_2016-04-05_Patient_Authorization_Baseline_Lab_Form.pdf
Patient Enrollment Form (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Lemtrada_2016-04-05_Patient_Enrollment_Form.pdf
Patient Safety Information Card (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Lemtrada_2016-04-05_Patient_Safety_Information_Card.pdf
Patient Status Form (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Lemtrada_2016-04-05_Patient_Status_Form.pdf
Patient Status Reminder Letter (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Lemtrada_2016-04-05_Patient_Status_Reminder_Letter.pdf
Pharmacy Enrollment Form (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Lemtrada_2016-04-05_Pharmacy_Enrollment_Form.pdf
Prescriber Enrollment Form (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Lemtrada_2016-04-05_Prescriber_Enrollment_Form.pdf
Prescription Ordering Form (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Lemtrada_2016-04-05_Prescription_Ordering_Form.pdf
Program Overview (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Lemtrada_2016-04-05_Program_Overview.pdf
REMS document (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Lemtrada_2016-04-05_REMS_document.pdf
REMS full (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Lemtrada_2016-04-05_Full.pdf
REMS Website Screenshots (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Lemtrada_2016-04-05_REMS_website_screenshots.pdf
The REMS Letter for Healthcare Providers (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Lemtrada_2016-04-05_DHCP_Letter.pdf
What You Need to Know about LEMTRADA Treatment and Infusion Reactions: A Patient Guide (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Lemtrada_2016-04-05_Infusion_Reactions_A_Patient_Guide.pdf
What You Need to Know About Lemtrada Treatment: A Patient Guide (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Lemtrada_2016-04-05_A_Patient_Guide.pdf

What updates have been made to the REMS?

Date Summary of change
04/05/2016 Modified to:

  1. Make administrative and typographic changes to two Lemtrada REMS materials (the REMS Letter for Healthcare Providers and the Lemtrada REMS Infusion Checklist).
  2. Make administrative and typographic changes, along with an update, to the Lemtrada REMS website.
09/18/2015 Modified to:
  1. Update the Lemtrada logo throughout the REMS document and materials.
  2. Add an option to complete and submit most of the required REMS forms online (with the exception of the Lemtrada REMS Patient Enrollment Form and the Lemtrada REMS Prescription Ordering Form).
  3. Revise the REMS website that provide the ability to search for certified prescribers and healthcare facilities within the US and its territories.
11/14/2014 Approval of the REMS.

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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