Approved Risk Evaluation and Mitigation Strategies (REMS)

REMS@FDA

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Lemtrada (alemtuzumab)

BLA #103948

REMS last update: 11/28/2018

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, 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, 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, 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: Program Overview and Education Program for Prescribers. Successfully complete the Knowledge Assessment and submit it to the REMS Program. Enroll in the REMS by completing the Prescriber Enrollment Form and submitting it to the REMS Program.
Before treatment initiation (first dose)	Counsel the patient on the risks associated with Lemtrada, including autoimmune conditions, infusion reactions, and malignancies, and the need for baseline and periodic monitoring, using What You Need to Know About Lemtrada Treatment: A Patient Guide and the Patient Safety Information Card. Provide a copy of the materials to the patient. Enroll the patient by completing and submitting the Patient Enrollment Form to the REMS Program. Order the prescription using the Prescription Ordering Form and submit it to the REMS Program.
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.
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 Prescription Ordering Form and submit it to the REMS Program.
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.
After the last infusion, every 6 months 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.
At All Times	Report any adverse events suggestive of autoimmune conditions, infusion reactions, 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.

Patients who are prescribed Lemtrada

Before treatment initiation	Receive counseling from the prescriber on the risks associated with Lemtrada, including autoimmune conditions, infusion reactions and malignancies, and the need for laboratory testing and monitoring, using What You Need to Know About Lemtrada Treatment: A Patient Guide and the Patient Safety Information Card. Enroll in the REMS Program by completing the Patient Enrollment Form with the prescriber. Enrollment information will be provided to the REMS Program. Get a skin exam.
Before treatment initiation, within 30 days prior to the first infusion date of each treatment course	Be monitored for autoimmune 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.
During treatment, yearly	Get a skin exam.
After last infusion, at periodic intervals for 48 months	Be monitored for autoimmune conditions and/or malignancies.
At all times	Inform the prescriber if any reactions or symptoms are experienced after receiving Lemtrada. Have the Patient Safety Information Card with you.

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 Program Overview. Have the authorized representative enroll in the REMS Program by completing the Pharmacy Enrollment Form and submitting it to the REMS Program. Train all relevant staff involved in dispensing Lemtrada using the Program Overview. Establish processes and procedures to verify that the Prescription Ordering Form is received for each prescription.
Before dispensing	Verify that the Prescription Ordering Form is received for each prescription through the processes and procedures established as a requirement of the REMS Program. 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.
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 REMS Program Overview and Education Program for Healthcare Facilities. Have the authorized representative enroll in the REMS Program by completing the Healthcare Facility Enrollment Form and submitting it to the REMS Program. Train all relevant staff involved in the dispensing and administration of Lemtrada using the Program Overview and Education Program for Healthcare Facilities. 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 Prescription Ordering Form is received for each prescription through the processes and procedures established as a requirement of the REMS Program. 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 What You Need to Know about Lemtrada Treatment and Infusion Reactions: A Patient Guide. Provide a copy of the material to the patient.
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.
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.
At all times, within 50 business days of submission of the Patient Authorization and Baseline Lab Form	Return unused product to the distributor.
At all times	Not distribute, transfer, loan, or sell Lemtrada. 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 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
Education Program for Healthcare Facilities (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/rems/Lemtrada_2018_11_28_Education_Program_for_Healthcare_Facilities.pdf
Education Program for Prescribers (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/rems/Lemtrada_2018_11_28_Education_Program_for_Prescribers.pdf
Healthcare Facility Enrollment Form (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/rems/Lemtrada_2018_11_28_Healthcare_Facility_Enrollment_Form.pdf
Infusion Checklist (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/rems/Lemtrada_2018_11_28_Infusion_Checklist.pdf
Knowledge Assessment (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/rems/Lemtrada_2018_11_28_Knowledge_Assessment.pdf
Patient Authorization and Baseline Lab Form (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/rems/Lemtrada_2018_11_28_Patient_Authorization_and_Baseline_Lab_Form.pdf
Patient Enrollment Form (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/rems/Lemtrada_2018_11_28_Patient_Enrollment_Form.pdf
Patient Reminder Letter (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/rems/Lemtrada_2018_11_28_Patient_Reminder_Letter.pdf
Patient Safety Information Card (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/rems/Lemtrada_2018_11_28_Patient_Safety_Information_Card.pdf
Patient Status Form (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/rems/Lemtrada_2018_11_28_Patient_Status_Form.pdf
Patient Status Reminder Letter (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/rems/Lemtrada_2018_11_28_Patient_Status_Reminder_Letter.pdf
Pharmacy Enrollment Form (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/rems/Lemtrada_2018_11_28_Pharmacy_Enrollment_Form.pdf
Prescriber Enrollment Form (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/rems/Lemtrada_2018_11_28_Prescriber_Enrollment_Form.pdf
Prescription Ordering Form (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/rems/Lemtrada_2018_11_28_Prescription_Ordering_Form.pdf
REMS Document (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/rems/Lemtrada_2018_11_28_REMS_Document.pdf
REMS Full (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/rems/Lemtrada_2018_11_28_REMS_Full.pdf
REMS Letter for Healthcare Providers (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/rems/Lemtrada_2018_11_28_REMS_Letter_for_Healthcare_Providers.pdf
REMS Program Overview (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/rems/Lemtrada_2018_11_28_REMS_Program_Overview.pdf
REMS Program Website Screenshots (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/rems/Lemtrada_2018_11_28_REMS_Program_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_2018_11_28_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_2018_11_28_What_You_Need_to_Know_About_Lemtrada_Treatment_A_Patient_Guide.pdf

What updates have been made to the REMS?

Date	Summary of change
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.