Approved Risk Evaluation and Mitigation Strategies (REMS)

Lemtrada (alemtuzumab)

BLA #103948

REMS last update: 03/12/2021

Goals
Summary
REMS Materials
Update history

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 must:

To become certified to prescribe	Review the drug's Prescribing Information. Review the following: Education Program. \| REMS Education Program \| Successfully complete the Prescriber Knowledge Assessment and submit it to the REMS Program. \| Prescriber Knowledge Assessment \| Enroll in the REMS by completing the Prescriber Enrollment Form and submitting it to the REMS Program. \| Prescriber Enrollment Form \|
Before treatment initiation (first dose)	Counsel the patient on the risks associated with LEMTRADA, including autoimmune conditions, infusion reactions, stroke and malignancies, and the need for baseline and periodic monitoring, using the LEMTRADA Treatment and Infusion Reactions Patient Guide and the Patient Safety Information Card. Provide a copy of the materials to the patient. \| Patient Safety Information Card \| \| LEMTRADA Treatment and Infusion Reactions Patient Guide \| Enroll the patient by completing and submitting the Patient Enrollment and Prescription Ordering Formto the REMS Program. Provide a completed copy to the patient and retain a copy in the patient’s record. \| Patient Enrollment and Prescription Ordering Form \| Order the prescription using the Patient Enrollment and Prescription Ordering Form and submit it to the REMS Program. \| Patient Enrollment and Prescription Ordering Form \|
Before treatment initiation and during treatment, within 30 days prior to the first infusion date of each treatment course	Assess the patient’s health status by completing the laboratory testing and monitoring as described in the Prescribing Information. Document and submit to the REMS Program using the Patient Authorization and Baseline Lab Form. \| Patient Authorization and Baseline Lab Form \|
During treatment, at periodic intervals	Assess the patient’s health status by completing the laboratory testing and monitoring as described in the Prescribing Information. Order the prescription using the Patient Enrollment and Prescription Ordering Form and submit it to the REMS Program. \| Patient Enrollment and Prescription Ordering Form \|
During treatment, every 6 months	Assess the patient for adverse events and completion of laboratory testing and monitoring. Document and submit to the REMS Program using the Patient Status Form. \| Patient Status Form \|
After the last infusion, every 6 monhts for 48 months.	Assess the patient for adverse events and completion of laboratory testing and monitoring. Document and submit to the REMS Program using the Patient Status Form. \| Patient Status Form \|
At all times	Report any adverse events suggestive of autoimmune conditions, infusion reactions, stroke, and malignancies to Genzyme. Report if an enrolled patient who has received LEMTRADA within the last 48 months is no longer under your care to Genzyme. Document and submit to the REMS Program using the Patient Transfer of Care Form, when transferring patients to a new Healthcare Provider. \| Patient Transfer of Care Form \|

Patients who are prescribed LEMTRADA:

Before treatment initiation	Receive counseling from the prescriber on the risks associated with LEMTRADA, including autoimmune conditions, infusion reactions, stroke and malignancies, and the need for laboratory testing and monitoring, using LEMTRADA Treatment and Infusion Reactions Patient Guide and the Patient Safety Information Card. \| Patient Safety Information Card \| \| LEMTRADA Treatment and Infusion Reactions Patient Guide \| Enroll in the REMS Program by completing the Patient Enrollment and Prescription Ordering Form with the prescriber. Enrollment information will be provided to the REMS Program. \| Patient Enrollment and Prescription Ordering Form \| Get a skin exam.
Before treatment initiation, within 30 days prior to the first infusion date of each treatment course	Be monitored for autimmune conditions and/or malignancies.
During treatment; after each infusion for at least 2 hours	Be monitored for infusion reactions
During treatment, at periodic intervals	Be monitored for autoimmune conditions and/or malignancies. Inform the prescriber if you have had a stroke.
During treatment, yearly	Get a skin exam.
After last infusion, at periodic intervals for 48 months	Be monitored for autoimmune conditions and/or malignancies. Inform your prescriber if you have had a stroke.
At all times	Inform the prescriber if any reactions or symptoms are experienced after receiving LEMTRADA. Have the Patient Safety Information Card with you. \| Patient Safety Information Card \|

Pharmacies that dispense LEMTRADA must:

To become certified to dispense	Designate an authorized representative to carry out the certification process and oversee implementation and compliance with the REMS Program on behalf of the pharmacy. Have the authorized representative review the Education Program. \| REMS Education Program \| Have the authorized representative enroll in the REMS Program by completing the Pharmacy Enrollment Form and submitting it to the REMS Program. \| Pharmacy Enrollment Form \| Train all relevant staff involved in dispensing LEMTRADA using the Education Program. \| REMS Education Program \| Establish processes and procedures to verify that the Patient Enrollment and Prescription Ordering Form is received for each prescription. \| Patient Enrollment and Prescription Ordering Form \|
Before dispensing	Verify that the Patient Enrollment and Prescription Ordering Form is received for each prescription through the processes and procedures established as a requirement of the REMS Program. \| Patient Enrollment and Prescription Ordering Form \| Obtain authorization to dispense each prescription by contacting the REMS Program to verify that the prescriber is certified, the healthcare facility administering the infusion is certified, and the patient is enrolled and authorized to receive LEMTRADA.
To maintain certification to dispense, every 2 years	Have the authorized representative re-enroll in the REMS Program by completing the Pharmacy Enrollment Form. \| Pharmacy Enrollment Form \|
At all times	Maintain records of training. Maintain records of all processes and procedures including compliance with those processes and procedures. Comply with audits carried out by Genzyme to ensure that all processes and procedures are in place and are being followed.

Healthcare facilities that dispense and administer LEMTRADA must:

To become certified to dispense and administer	Have the necessary on-site equipment and personnel available to appropriately manage serious infusion reactions (including anaphylaxis, cardiac and respiratory emergencies). Designate an authorized representative to carry out the certification process and oversee implementation and compliance with the REMS Program on behalf of the healthcare facility. Have the authorized representative review the Education Program. \| REMS Education Program \| Have the authorized representative enroll in the REMS Program by completing the Healthcare Facility Enrollment Form and submitting it to the REMS Program. \| Healthcare Facility Enrollment Form \| Train all relevant staff involved in the dispensing and administration of LEMTRADA using the Education Program. \| REMS Education Program \| Establish processes and procedures to verify that (1) the Prescription Ordering Form is received for each prescription, (2) patients are counseled, (3) the patient is monitored for infusion reactions during and for at least 2 hours after each infusion, (4) the Infusion Checklist is completed and submitted for each patient, and (5) Lemtrada is not dispensed outside of the certified healthcare facility administering the infusion.
Before administering	Verify that the Patient Enrollment and Prescription Ordering Form is received for each prescription through the processes and procedures established as a requirement of the REMS Program. \| Patient Enrollment and Prescription Ordering Form \| Obtain authorization to dispense each prescription by contacting the REMS Program to verify that the prescriber is certified and the patient is enrolled and authorized to receive LEMTRADA. Counsel the patient about the risk for infusion reactions using the LEMTRADA Treatment and Infusion Reactions Patient Guide. Provide a copy of the material to the patient. \| LEMTRADA Treatment and Infusion Reactions Patient Guide \|
During and after administering for at least 2 hours	Assess the patient for infusion reactions.
After the last infusion, within 5 business days	Complete the Infusion Checklist for each patient and submit it to the REMS Program. \| REMS Infusion Checklist \|
To maintain certification to dispense and administer every 2 years	Have the authorized representative enroll in the REMS Program by completing the Healthcare Facility Enrollment Form and submitting it to the REMS Program. \| Healthcare Facility Enrollment Form \|
At all times, within 75-business days of submission of the Patient Authorization and Baseline Lab Form	Return unused product to the distributor. \| Patient Authorization and Baseline Lab Form \|
At all times	Not distribute, transfer, loan, or sell Lamtrada. Maintain records of training. Maintain records of all processes and procedures including compliance with those processes and procedures. Comply with audits carried out by Genzyme to ensure that all training, processes and procedures are in place and are being followed.

Wholesalers-distributors that distribute LEMTRADA must:

To be able to distribute

Establish processes and procedures to ensure that the drug is distributed only to certified pharmacies and certified healthcare facilities.
Train all relevant staff involved in distributing LEMTRADA on the REMS Program requirements.

At all times

Distribute only to certified pharmacies and certified healthcare facilities.
Maintain and submit patient level distribution records of all shipments of LEMTRADA to the REMS Program.
Maintain records of all processes and procedures including compliance with those processes and procedures.
Comply with audits carried out by Genzyme 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
Healthcare Facility Enrollment Form (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/rems/Lemtrada_2021_03_12_Healthcare_Facility_Enrollment_Form.pdf
Healthcare Provider Letter (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/rems/Lemtrada_2021_03_12_Healthcare_Provider_Letter.pdf
LEMTRADA Treatment and Infusion Reactions Patient Guide (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/rems/Lemtrada_2021_03_12_LEMTRADA_Treatment_and_Infusion_Reactions_Patient_Guide.pdf
Patient Authorization and Baseline Lab Form (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/rems/Lemtrada_2021_03_12_Patient_Authorization_and_Baseline_Lab_Form.pdf
Patient Enrollment and Prescription Ordering Form (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/rems/Lemtrada_2021_03_12_Patient Enrollment_and_Prescription_Ordering_Form.pdf
Patient Letter (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/rems/Lemtrada_2021_03_12_Patient_Letter.pdf
Patient Safety Information Card (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/rems/Lemtrada_2021_03_12_Patient_Safety_Information_Card.pdf
Patient Status Form (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/rems/Lemtrada_2021_03_12_Patient_Status_Form.pdf
Patient Transfer of Care Form (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/rems/Lemtrada_2021_03_12_Patient_Transfer_of_Care_form.pdf
Pharmacy Enrollment Form (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/rems/Lemtrada_2021_03_12_Pharmacy_Enrollment_Form.pdf
Prescriber Enrollment Form (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/rems/Lemtrada_2021_03_12_Prescriber_Enrollment_Form.pdf
Prescriber Knowledge Assessment (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/rems/Lemtrada_2021_03_12_Prescriber_Knowledge_Assessment.pdf
REMS Document (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/rems/Lemtrada_2021_03_12_REMS_Document.pdf
REMS Education Program (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/rems/Lemtrada_2021_03_12_REMS_Education_Program.pdf
REMS Full (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/rems/Lemtrada_2021_03_12_REMS_Full.pdf
REMS Infusion Checklist (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/rems/Lemtrada_2021_03_12_REMS_Infusion_Checklist.pdf
REMS Program Website www.LemtradaREMS.com (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/rems/Lemtrada_2021_03_12_REMS_Program_Website_www.LemtradaREMS.com.pdf

What updates have been made to the REMS?

Date	Summary of change
03/12/2021	Modified to include the following: Changes to the REMS materials to align with the labeling changes in supplements 5177 and 5179, which were approved on September 25, 2020 Changes to enable online enrollment of patients (and to enable an online digital signature for LEMTRADA REMS patient enrollment forms) Changes to allow pharmacies to obtain authorization to ship product online via www.lemtradarems.com Incorporation of formatting, layout, and wording changes to the Infusion Checklist to provide clarity and consistency with LEMTRADA REMS materials Consolidation of selected REMS materials in order to eliminate redundancy Change in the timeframe to return unused Lemtrada vials from 50 business days to 75 business days 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: update the REMS document to the new format change the REMS document and REMS materials to conform to labeling changes being approved with supplement 5160 reflect editorial changes to the REMS document and materials
04/05/2016	Modified to: Make administrative and typographic changes to two Lemtrada REMS materials (the REMS Letter for Healthcare Providers and the Lemtrada REMS Infusion Checklist). Make administrative and typographic changes, along with an update, to the Lemtrada REMS website.
09/18/2015	Modified to: Update the Lemtrada logo throughout the REMS document and materials. 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). 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.

Lemtrada (alemtuzumab) BLA #103948 REMS last update: 03/12/2021