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Approved Risk Evaluation and Mitigation Strategies (REMS)

Lemtrada (alemtuzumab)
BLA #103948
REMS last update: 03/04/2024



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:

  1. 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
  2. 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:

  1. Ensuring that only certified prescribers prescribe LEMTRADA;
  2. 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
  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

What assessment is available to the REMS?

Assessment Plan
REMS assessment plan unavailable for posting at this time.

What updates have been made to the REMS?

Date Summary of change
03/04/2024 Modified to make updates to the REMS website to replace static screenshots with links to the most recently approved US Prescribing Information (USPI) and REMS Education Program; updates to the Patient Reminder Letter to reflect that email and phone patient reminder options are removed and patient reminders are only sent by post-mail; and changes to the audit requirement to audit a representative sample of healthcare facilities.
12/15/2023 Revised to add a privacy cookie opt-out banner to the REMS website.
09/02/2022 Revised to make an editorial change.
03/12/2021 Modified to include the following:
  1. Changes to the REMS materials to align with the labeling changes in supplements 5177 and 5179, which were approved on September 25, 2020
  2. Changes to enable online enrollment of patients (and to enable an online digital signature for LEMTRADA REMS patient enrollment forms)
  3. Changes to allow pharmacies to obtain authorization to ship product online via www.lemtradarems.com
  4. Incorporation of formatting, layout, and wording changes to the Infusion Checklist to provide clarity and consistency with LEMTRADA REMS materials
  5. Consolidation of selected REMS materials in order to eliminate redundancy
  6. Change in the timeframe to return unused Lemtrada vials from 50 business days to 75 business days
  7. Addition of a Patient Transfer of Care Form as a new REMS material
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:

  1. update the REMS document to the new format
  2. change the REMS document and REMS materials to conform to labeling changes being approved with supplement 5160
  3. reflect editorial changes to the REMS document and materials
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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