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Approved Risk Evaluation and Mitigation Strategies (REMS)

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.

Tecvayli and Talvey (talquetamab-tgvs)
BLA #761342 BLA #761291
REMS last update: 12/02/2024



What is the purpose of the REMS?

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:
  1. 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.

View application holder(s) REMS Website See Disclaimer page regarding links to external sites

Healthcare providers who prescribe TECVALYI and/or TALVEY must:

To become certified to prescribe
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 | | 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 review the Pharmacy and Healthcare Setting Training Program.
    | Pharmacy and Healthcare Setting Training Program |
  • 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:

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.
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.

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.

Material Name Material Name Link
Adverse Reaction Management Guide (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Tecvayli_and_Talvey_2024_12_02_Adverse_Reaction_Management_Guide.pdf
Healthcare Provider REMS Letter (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Tecvayli_and_Talvey_2024_12_02_Healthcare_Provider_REMS_Letter.pdf
Knowledge Assessment (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Tecvayli_and_Talvey_2024_12_02_Knowledge_Assessment.pdf
Patient Wallet Card (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Tecvayli_and_Talvey_2024_12_02_Patient_Wallet_Card.pdf
Pharmacy and Healthcare Setting Enrollment Form (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Tecvayli_and_Talvey_2024_12_02_Pharmacy_and_Healthcare_Setting_Enrollment_Form.pdf
Pharmacy and Healthcare Setting Training Program (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Tecvayli_and_Talvey_2024_12_02_Pharmacy_and_Healthcare_Setting_Training_Program.pdf
Prescriber Enrollment Form (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Tecvayli_and_Talvey_2024_12_02_Prescriber_Enrollment_Form.pdf
Prescriber Training Program (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Tecvayli_and_Talvey_2024_12_02_Prescriber_Training_Program.pdf
Professional Society REMS Letter (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Tecvayli_and_Talvey_2024_12_02_Professional_Society_REMS_Letter.pdf
REMS Document (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Tecvayli_and_Talvey_2024_12_02_REMS_Document.pdf
REMS Fact Sheet (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Tecvayli_and_Talvey_2024_12_02_REMS_Fact_Sheet.pdf
REMS Full (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Tecvayli_and_Talvey_2024_12_02_REMS_Full.pdf
REMS Website (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Tecvayli_and_Talvey_2024_12_02_REMS_Website.pdf
Assessment Plan
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
12/02/2024 Modified to include:

1. Updates to the Talvey logo

2. Moving the trademark symbols for Talvey and Tecvayli to REMS materials headers

3. Changes in the manufacturer’s logo, phone and email updates, and date versioning

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.

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