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: 02/20/2024

• View the Tecvayli and Talvey Prescribing Information at DailyMed
• View Tecvayli and Talvey's Regulatory Information at Drugs@FDA
• View Tecvayli and Talvey's Regulatory Information at Drugs@FDA

• Goals
• Summary
• REMS Materials
• Assessment Plan
• Update history

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

What assessment is available to the REMS?

Assessment Plan
REMS assessment plan unavailable for posting at this time.

What updates have been made to the REMS?

Date	Summary of change
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.