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Approved Risk Evaluation and Mitigation Strategies (REMS)

Carvykti (ciltacabtagene autoleucel)
BLA #125746
REMS last update: 05/18/2023



What is the purpose of the REMS?

The goals of the CARVYKTI REMS are to mitigate the risks of cytokine release syndrome (CRS) and neurological toxicities by:
  1. Ensuring that hospitals and their associated clinics that dispense CARVYKTI are specially certified and have on-site, immediate access to tocilizumab.
  2. Ensuring that those who prescribe, dispense, or administer CARVYKTI are aware of how to manage the risks of CRS and neurological toxicities.

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

Hospitals and their associated clinics that dispense CARVYKTI must:

To become certified to dispense
  • Have a minimum two doses of tocilizumab available on-site for each patient for immediate administration (within 2 hours).
  • Designate an Authorized Representative to carry out the certification process and oversee implementation and compliance with the REMS Program requirements on behalf of the hospital and associated clinic(s).
  • Have the authorized representative complete the Training Program and Adverse Reaction Management Guide provided by the REMS Program.
    | Adverse Reaction Management Guide | | Training Program |
  • Have the Authorized Representative successfully complete the Knowledge Assessment and submit it to the REMS Program.
    | Knowledge Assessment |
  • Have the Authorized Representative enroll in the REMS Program by completing the Hospital Enrollment Form and submitting it to the REMS Program.
    | Hospital Enrollment Form |
  • Train all relevant staff involved in prescribing, dispensing, or administering of CARVYKTI on the REMS Program requirements using the Training Program and the Adverse Reaction Management Guide.
    | Adverse Reaction Management Guide | | Training Program |
  • Have all relevant staff involved in prescribing, dispensing, or administering of CARVYKTI successfully complete the Knowledge Assessment and submit it to the REMS Program.
    | Knowledge Assessment |
  • Establish processes and procedures to ensure relevant new staff CARVYKTI are trained and complete the Knowledge Assessment and submit it to the REMS Program.
    | Knowledge Assessment |
  • Establish processes and procedures to verify that a minimum of two doses of tocilizumab are available on-site for each patient and are ready for immediate administration (within 2 hours).
  • Establish processes and procedures to provide patients with the Patient Wallet Card.
    | Patient Wallet Card |
Before infusion
  • Verify that a minimum of two doses of tocilizumab are available onsite for each patient and are ready for immediate administration (within 2 hours) through the processes and procedures established as a requirement of the REMS Program.
Before discharge
  • Provide the patient with the Patient Wallet Card through the processes and procedures established as a requirement of the REMS Program.
    | Patient Wallet Card |
To maintain certification to dispense if there is a change in the authorized representative
  • Have a new Authorized Representative enroll in the REMS Program by completing the Hospital Enrollment Form.
    | Hospital Enrollment Form |
To maintain certification to dispense, if CARVYKTI has not been infused at least once annually from the date of certification in the REMS Program
  • Train all relevant staff involved in prescribing, dispensing, or administering of CARVYKTI on the REMS Program requirements using the Training Program and the Adverse Reaction Management Guide.
    | Adverse Reaction Management Guide | | Training Program |
  • Have all relevant staff involved in prescribing, dispensing, or administering CARVYKTI successfully complete the Knowledge Assessment.
    | Knowledge Assessment |
At all times
  • Report any seriousi adverse events suggestive of CRS or neurological toxicities to the REMS Program.
  • Maintain records of staff training.
  • Maintain records that processes and procedures are in place and are being followed.
  • Comply with audits carried out by Janssen Biotech, Inc. or a third party acting on behalf of Janssen Biotech, Inc. to ensure that all training, processes,and procedures are in place and are being followed.

Patients who are prescribed CARVYKTI:

Before discharge

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.

Material Name Material Name Link
Adverse Reaction Management Guide (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Carvykti_2023_05_18_Adverse_Reaction_Management_Guide.pdf
Hospital Enrollment Form (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Carvykti_2023_05_18_Hospital_Enrollment_Form.pdf
Knowledge Assessment (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Carvykti_2023_05_18_Knowledge_Assessment.pdf
Patient Wallet Card (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Carvykti_2023_05_18_Patient_Wallet_Card .pdf
REMS Document (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Carvykti_2023_05_18_REMS_Document.pdf
REMS Full (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Carvykti_2023_05_18_REMS_Full.pdf
REMS Website Screenshots (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Carvykti_2023_05_18_REMS_Website.pdf
Training Program (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Carvykti_2023_05_18_Training_Program.pdf

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
05/18/2023 Modified to align the REMS materials with the current U.S. package insert (USPI) approved on February 22, 2023.
02/28/2022 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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