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REMS that have more than one drug product but are not Shared System REMS will not display the product name and ingredient properly on this website due to database limitations. Please refer to the REMS document for the correct product names.
The goal of the TECVAYLI and TALVEY REMS is to mitigate the risk of Cytokine Release Syndrome (CRS) and
neurologic toxicity including Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS) by:
Ensuring prescribers are aware of the importance of monitoring patients for signs and symptoms of
CRS and neurologic toxicity including ICANS in patients exposed to TECVAYLI or TALVEY.
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 and submitting the Prescriber
Enrollment Form 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. the need to carry the Patient Wallet Card at all times.
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 and neurologic
toxicity, including ICANS, to the REMS.
Patients who are prescribed TECVAYLI or TALVEY:
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 or TALVEY.
| Patient Wallet Card |
Pharmacies and healthcare settings that dispense TECVAYLI and/or TALVEY 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 and submitting the Pharmacy and Healthcare Setting
Enrollment Form to the REMS.
| Pharmacy and Healthcare Setting Enrollment Form |
Train all relevant staff involved in dispensing TECVAYLI and/or
TALVEY on the REMS requirements using the Pharmacy and
Healthcare Setting Training Program.
| Pharmacy and Healthcare Setting Enrollment Form |
Before dispensing
Obtain authorization to dispense each prescription by contacting the
REMS Program to verify the prescriber is certified.
To maintain
certification to
dispense
Have a new Authorized Representative enroll in the REMS by
completing and submitting the Pharmacy and Healthcare Setting
Enrollment Form to the REMS if the Authorized Representative
changes.
| 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 and/or TALVEY 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 and TALVEY 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.
Wholesalers-distributors that distribute TECVAYLI and/or TALVEY must:
To be able to distribute
Establish processes and procedures to ensure that TECVAYLI and/or
TALVEY are 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 and submit records of drug distribution to the REMS 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.
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
07/02/2024
Modified to add the 'delegate function' to the Pharmacy and Healthcare Setting Training Program, delete the 'Pharmacy and Healthcare Setting Reattestation Requirements' from the Pharmacy and Healthcare Setting Training, delete the 'Important Program Updates' pop-up from the Tecvayli and Talvey REMS Website, and add the Prescriber Enrollment Form to the Tecvayli and Talvey REMS Website.
02/20/2024
Modified to update the REMS materials to incorporate the revised dosing regimen for Tecvayli (teclistamab).
11/16/2023
Modified to add Spanish and Mandarin Patient Wallet Cards to the Tecvayli and Talvey REMS website.
10/20/2023
Revised to correct misspelled drug name in the English Patient Wallet Card
08/09/2023
Modified to update the REMS name from TECVAYLI REMS to TECVAYLI and TALVEY REMS in the
labeling and proposed modifications to the approved TECVAYLI REMS to form a
combined REMS with talquetamab.
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.
