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The goals of the CARVYKTI REMS are to mitigate the risks of cytokine release syndrome (CRS) and neurological toxicities by:
Ensuring that hospitals and their associated clinics that dispense CARVYKTI are specially certified and have on-site, immediate access to tocilizumab.
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.
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 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
involved in the prescribing, dispensing, or administration of
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 serious 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.
REMS assessment plan unavailable for posting at this time.
What updates have been made to the REMS?
Date
Summary of change
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.
