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Approved Risk Evaluation and Mitigation Strategies (REMS)

Tecvayli (teclistamab-cqyv)
BLA #761291
REMS last update: 11/08/2022



What is the purpose of the REMS?

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:
  1. 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.

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

Healthcare providers who prescribe TECVALYI 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) to carry the Patient Wallet Card at all times.
      | Patient Wallet Card |
    1. 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 review the Pharmacy and Healthcare Setting Training Program.
    | Pharmacy and Healthcare Setting Training Program |
  • 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
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).
Material Name Material Name Link
Adverse Reaction Management Guide (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Tecvayli_2022_11_08_Adverse_Reaction_Management_Guide.pdf
Healthcare Provider REMS Letter (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Tecvayli_2022_11_08_Healthcare_Provider_REMS_Letter.pdf
Knowledge Assessment (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Tecvayli_2022_11_08_Knowledge_Assessment.pdf
Patient Wallet Card (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Tecvayli_2022_11_08_Patient_Wallet_Card.pdf
Pharmacy and Healthcare Setting Enrollment Form (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Tecvayli_2022_11_08_Pharmacy_and_Healthcare_Setting_Enrollment_Form.pdf
Pharmacy and Healthcare Setting Training Program (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Tecvayli_2022_11_08_Pharmacy_and_Healthcare_Setting_Training_Program.pdf
Prescriber Enrollment Form (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Tecvayli_2022_11_08_Prescriber_Enrollment_Form.pdf
Prescriber Training Program (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Tecvayli_2022_11_08_Prescriber_Training_Program.pdf
Professional Society REMS Letter (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Tecvayli_2022_11_08_Professional_Society_REMS_Letter.pdf
REMS Document (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Tecvayli_2022_11_08_REMS_Document.pdf
REMS Fact Sheet (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Tecvayli_2022_11_08_REMS_Fact_Sheet.pdf
REMS Full (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Tecvayli_2022_11_08_REMS_Full.pdf
REMS Website Screenshots (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Tecvayli_2022_11_08_REMS_Website_Screenshots.pdf

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
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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