The .gov means it's official. Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.
The site is secure. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.
The goals of the Kymriah REMS Program are to mitigate the risks of cytokine release syndrome (CRS) and neurological toxicities by:
Ensuring that hospitals and their associated clinics that dispense Kymriah are specially certified and have on-site, immediate access to tocilizumab.
Ensuring those who prescribe, dispense, or administer Kymriah are aware of how to manage the risks of cytokine release syndrome 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 Kymriah must:
To become certified to
dispense
Have a minimum of 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 on
behalf of the hospital and their associated clinics.
Have the authorized representative take the Live Training Program provided
by the REMS Program.
| Live Program Training Slides |
Have the authorized representative successfully complete the Knowledge
Assessment and submit it to the REMS Program.
| 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 Kymriah on the REMS Program requirements using the Live Training
Program.
| Live Program Training Slides |
Have all relevant staff involved in prescribing, dispensing, or administering
successfully complete the Knowledge Assessment.
| Program Knowledge Assessment |
Establish processes and procedures to ensure new staff involved in the
prescribing, dispensing, or administration of Kymriah are trained and
complete the Knowledge Assessment.
| 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 on-site 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 dishcarge
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 authorized
representative
Have the new authorized representative enroll in the REMS Program
by completing the Hospital Enrollment Form.
| Hospital Enrollment Form |
To maintain certification to dispense, if Kymriah has not been dispensed at least
once annually from the date of certification in the REMS Program
Train all relevant staff involved in prescribing, dispensing, or
administering of Kymriah on the REMS Program requirements using the Live Training Program.
| Live Program Training Slides |
Have all relevant staff involved in prescribing, dispensing, or
administering successfully complete the Knowledge Assessment
| Program Knowledge Assessment |
At all times
Report any adverse events suggestive of cytokine release syndrome or
neurological toxicities to the REMS Program.
Maintain records of staff training.
Maintain records that all processes and procedures are in place and are
being followed.
Comply with audits carried out by Novartis or a third party acting on behalf
of Novartis to ensure that all processes and procedures are in place and are
being followed.
Patients who are dipsensed Kymriah:
Before discharge
Receive the Patient Wallet Card
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 Kymriah REMS, see the DailyMed link(s).
REMS assessment plan unavailable for posting at this time.
What updates have been made to the REMS?
Date
Summary of change
05/27/2022
Modified to make changes to the REMS Patient Wallet Card, Live Training Program, Knowledge Assessment, and REMS Program
Website to align with labeling changes related to the new indication for the treatment of adult
patients with relapsed or refractory (r/r) follicular lymphoma (FL) after two or more lines of systemic therapy.
06/11/2021
Modified to revise the REMS Training Slides and REMS Program website screenshots to align with the revisions to the USPI based on updated clinical trial
safety data for CRS and neurologic toxicity.
06/20/2019
Modified to update the REMS Training Slides, to include flat dosing guidelines for high dose vasopressors and relevant references, and minor edits to clarify the signs and symptoms of cytokine release
syndrome (CRS). To better align with the REMS Document, the Hospital Enrollment
form and REMS Supporting Document were updated to clarify the reporting of adverse
events related to CRS and neurotoxicity.
05/01/2018
Modified REMS training material to align with labeling changes related to the new indication and update the
REMS Document to the new format.
08/30/2017
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.
