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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)
Reaction Management Guide.
Counsel the patient on:
how to recognize and respond to signs and symptoms of
CRS and neurologic toxicity including ICANS
the need to report all symptoms suggestive of CRS and
neurologic toxicity including ICANS to their healthcare
provider or emergency room provider immediately, and
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 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
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.
REMS assessment plan unavailable for posting at this time.
What updates have been made to the REMS?
Date
Summary of change
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.
