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Approved Risk Evaluation and Mitigation Strategies (REMS)

Carvykti (ciltacabtagene autoleucel)
BLA #125746
REMS last update: 04/05/2024



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.

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 of infusion).
  • Designate an Authorized Representative to carry out the certification process and oversee implementation and compliance with the REMS requirements on behalf of the hospital and associated clinic(s).
  • Have the Authorized Representative enroll by completing and submitting the Hospital Enrollment Form to the REMS.
  • 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 of infusion).
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 of infusion) through the processes and procedures established as a requirement of the REMS.
To maintain certification to dispense if there is a change in the authorized representative
  • Have a new Authorized Representative enroll by completing and submitting the Hospital Enrollment Form to the REMS, if the authorized representative changes.
At all times
  • 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 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.

Material Name Material Name Link
Hospital Enrollment Form (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Carvykti_2024_04_05_Hospital_Enrollment_Form.pdf
REMS Document (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Carvykti_2024_04_05_REMS_Document.pdf
REMS Full (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Carvykti_2024_04_05_REMS_Full.pdf
REMS Website Screenshots (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Carvykti_2024_04_05_REMS_Website_Screenshots.pdf
Assessment Plan
This webpage provides REMS assessment plan measures, metrics, and indicators for drug and biological products with a REMS. The REMS assessment plan measures, metrics, and indicators are part of the overall REMS assessment plan used by FDA to evaluate the performance of a REMS and are included in FDA approval letters. The current REMS assessment plan measures, metrics, and indicators are extracted from regulatory letters that contain REMS information, including FDA approval letters, and posted here as they become available.

What updates have been made to the REMS?

Date Summary of change
04/05/2024 Modified to align the REMS website with the U.S. package insert (USPI).
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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