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The goal of the TECVAYLI REMS is to mitigate the risk of Cytokine Release Syndrome (CRS) and
neurologic toxicity including Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS) by:
Educating prescribers on the importance of monitoring patients for signs and symptoms of
CRS and neurologic toxicity including ICANS
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.
Successfully complete the Knowledge Assessment and submit it
to the REMS.
| Knowledge Assessment |
Enroll in the REMS by completing the Prescriber Enrollment Form
and submitting it to the REMS.
| Prescriber Enrollment Form |
Before treatment
initiation (first dose)
Counsel the patient on:
a) how to recognize and respond to signs and symptoms of CRS
and neurologic toxicity including ICANS,b) the need to report all symptoms suggestive of CRS and
neurologic toxicity including ICANS to their healthcare provider
or emergency room provider immediately, and
c) to carry the Patient Wallet Card at all times.
| Patient Wallet Card |
Complete the Patient Wallet Card and provide the Patient Wallet
Card to the patient.
| Patient Wallet Card |
At all times
Report serious adverse events suggestive of CRS or neurologic
toxicity including ICANS to the REMS.
Patients who are prescribed TECVAYLI:
Before treatment
Receive counseling from the prescriber using the Patient Wallet
Card.
| Patient Wallet Card |
At all times
Have the Patient Wallet Card with you and inform other
healthcare providers about treatment with TECVAYLI.
| Patient Wallet Card |
Pharmacies and healthcare settings that dispense TECVALYI must:
To become certified to
dispense
Designate an Authorized Representative to carry out the
certification process and oversee implementation and compliance
with the REMS requirements on behalf of the pharmacy and/or
healthcare setting.
Have the Authorized Representative enroll in the REMS by
completing the Pharmacy and Healthcare Setting Enrollment
Form and submitting it to the REMS.
| Pharmacy and Healthcare Setting Enrollment Form |
Train all relevant staff involved in dispensing TECVAYLI on the
REMS requirements using the Pharmacy and Healthcare Setting
Training Program.
| Pharmacy and Healthcare Setting Training Program |
Before dispensing
Obtain authorization to dispense each prescription by contacting
the REMS Program to verify the prescriber is certified.
To maintain
certification to
dispense
If there is a change in the Authorized Representative, have the
new Authorized Representative enroll in the REMS by completing
the Pharmacy and Healthcare Setting Enrollment Form.
| Pharmacy and Healthcare Setting Enrollment Form |
At all times
Report serious adverse events suggestive of CRS and neurologic
toxicity including ICANS to the REMS.
Not distribute, transfer, loan or sell TECVAYLI except to certified
pharmacies and healthcare settings.
Maintain records of staff training.
Maintain records that processes and procedures are in place and
are being followed.
Maintain records of all TECVAYLI dispenses and provide data to
the REMS and Wholesaler-Distributor, as requested.
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.
Wholesaler-distributors that distribute TECVAYLI must:
To be able to
distribute
Establish processes and procedures to ensure that TECVAYLI is
distributed only to certified pharmacies & healthcare settings.
Train all relevant staff involved in distribution on the REMS
requirements.
At all times
Distribute only to certified pharmacies and healthcare settings.
Maintain records that all processes and procedures are in place
and are being followed.
Maintain records of drug distribution and provide these records
to the REMS Program at least on a monthly basis.
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. For a specific Medication Guide of a product in the Tecvayli 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
11/08/2022
Revised to correct a spelling error in a multiple choice answer in the REMS Knowledge Assessment.
10/25/2022
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.
