Approved Risk Evaluation and Mitigation Strategies (REMS)
Lemtrada (alemtuzumab)
BLA #103948
REMS last update: 10/29/2019
What is the purpose of the REMS?
The goal of the LEMTRADA REMS is to mitigate the risks of autoimmune conditions, infusion reactions, stroke, and malignancies associated with LEMTRADA by:- Helping to ensure informed decisions about the safe use of LEMTRADA by:
- Informing patients about the serious risks of autoimmune conditions, infusion reactions, stoke, and malignancies with LEMTRADA and the need for baseline and periodic monitoring; and
- Informing healthcare providers about the serious risks of autoimmune conditions, infusion reactions, stroke, and malignancies with LEMTRADA, the need to counsel patients, and the need for baseline and periodic monitoring.
- Helping to ensure the safe use of LEMTRADA by:
- Ensuring that only certified prescribers prescribe LEMTRADA;
- Ensuring that LEMTRADA is dispensed only in certain healthcare settings, by certified pharmacies, and certified healthcare facilities administering the infusion, which have on-site access to equipment and personnel trained to manage infusion reactions; and
- Ensuring that only enrolled and authorized patients receive LEMTRADA;
- 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
Healthcare Providers who prescribe Lemtrada
To become certified to prescribe |
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Before treatment initiation (first dose) |
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Before treatment initiation and during treatment, within 30 days prior to the first infusion date of each treatment course |
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During treatment, at periodic intervals |
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During treatment, every 6 months |
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After the last infusion, every 6 months for 48 months |
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At all times |
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Patients who are prescribed Lemtrada
Before treatment initiation |
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Before treatment initiation, within 30 days prior to the first infusion date of each treatment course |
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During treatment; after each infusion for at least 2 hours |
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During treatment, at periodic intervals |
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During treatment, yearly |
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After last infusion, at periodic intervals for 48 months |
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At all times |
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Pharmacies that dispense Lemtrada must
To become certified to dispense |
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Before dispensing |
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To maintain certification to dispense, every 2 years |
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At all times |
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Healthcare facilities that dispense and administer Lemtrada must
To become certified to dispense and administer |
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Before administering |
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During and after administering for at least 2 hours |
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After the last infusion, within 5 business days |
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To maintain certification to dispense and administer every 2 years |
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At all times, within 50 business days of submission of the Patient Authorization and Baseline Lab Form |
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At all times |
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Wholesalers that distribute Lemtrada must
To be able to distribute |
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At all times |
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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 |
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Education Program for Healthcare Facilities (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/rems/Lemtrada_2019_10_29_Education_Program_for_Healthcare_Facilities.pdf |
Education Program for Prescribers (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/rems/Lemtrada_2019_10_29_Education_Program_for_Prescribers.pdf |
Healthcare Facility Enrollment Form (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/rems/Lemtrada_2019_10_29_Healthcare_Facility_Enrollment_Form.pdf |
Infusion Checklist (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/rems/Lemtrada_2019_10_29_Infusion_Checklist.pdf |
Knowledge Assessment (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/rems/Lemtrada_2019_10_29_Knowledge_Assessment.pdf |
Patient Authorization and Baseline Lab Form (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/rems/Lemtrada_2019_10_29_Patient_Authorization_and_Baseline_Lab_Form.pdf |
Patient Enrollment Form (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/rems/Lemtrada_2019_10_29_Patient_Enrollment_Form.pdf |
Patient Reminder Letter (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/rems/Lemtrada_2019_10_29_Patient_Reminder_Letter.pdf |
Patient Safety Information Card (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/rems/Lemtrada_2019_10_29_Patient_Safety_Information_Card.pdf |
Patient Status Form (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/rems/Lemtrada_2019_10_29_Patient_Status_Form.pdf |
Patient Status Reminder Letter (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/rems/Lemtrada_2019_10_29_Patient_Status_Reminder_Letter.pdf |
Pharmacy Enrollment Form (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/rems/Lemtrada_2019_10_29_Pharmacy_Enrollment_Form.pdf |
Prescriber Enrollment Form (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/rems/Lemtrada_2019_10_29_Prescriber_Enrollment_Form.pdf |
Prescription Ordering Form (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/rems/Lemtrada_2019_10_29_Prescription_Ordering_Form.pdf |
REMS Document (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/rems/Lemtrada_2019_10_29_REMS_Document.pdf |
REMS Full (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/rems/Lemtrada_2019_10_29_REMS_Full.pdf |
REMS Letter 1 for Healthcare Providers (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/rems/Lemtrada_2019_10_29_REMS_Letter_1_for_Healthcare_Provider.pdf |
REMS Letter 2 for Healthcare Providers (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/rems/Lemtrada_2019_10_29_REMS_Letter_2_for_Healthcare_Provider.pdf |
REMS Program Overview (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/rems/Lemtrada_2019_10_29_REMS_Program_Overview.pdf |
REMS Website Screenshots (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/rems/Lemtrada_2019_10_29_REMS_Website_Screenshots.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_2019_10_29_What_You_Need-to_Know_About_Lemtrada_Treatment_and_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_2019_10_29_What_You_Need-to_Know_About_Lemtrada_Treatment_A_Patient_Guide.pdf |
What updates have been made to the REMS?
Date | Summary of change |
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10/29/2019 | Modified to make revisions to the REMS materials to reflect the revised Indications and Usage statement and to incorporate myocardial ischemia as a potential manifestation of infusion reactions associated with Lemtrada. In addition, the REMS materials were revised to reflect the labeling revision advising prescribers to educate patients that serious infusion reactions can occur at the time of infusion or within 48 hours after the last infusion. |
04/23/2019 | Modified to change the goals of the REMS from “to mitigate the risks of autoimmune conditions, infusion reactions, and malignancies associated with LEMTRADA” to “to mitigate the risks of autoimmune conditions, infusion reactions, stroke, and malignancies associated with LEMTRADA.” Revisions to the appended materials to incorporate information about the risk of autoimmune hepatitis, reflecting labeling changes approved on January 16, 2019. |
11/28/2018 | Modified to:
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04/05/2016 | Modified to:
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09/18/2015 | Modified to:
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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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