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TECVAYLI™ RISK EVALUATION AND MITIGATION STRATEGY (REMS)


TECVAYLI REMS

The purpose of the TECVAYLI REMS is to mitigate the risks of cytokine release
syndrome (CRS) and neurologic toxicity, including Immune Effector
Cell-Associated Neurotoxicity (ICANS) by educating prescribers on the importance
of monitoring patients for signs and symptoms of CRS and neurologic toxicity,
including ICANS.


PRESCRIBERS


Prescribers must be certified in the TECVAYLI REMS to treat patients with
TECVAYLI.

Learn More


PHARMACIES AND HEALTHCARE SETTINGS


Pharmacies and Healthcare Settings must be certified in the TECVAYLI REMS to
dispense TECVAYLI to patients.

Learn More


WHAT IS THE TECVAYLI REMS?

A Risk Evaluation and Mitigation Strategy (REMS) is a safety program to manage
known or potential serious risks associated with a drug product and is required
by the Food and Drug Administration (FDA).

The FDA has determined that a REMS is necessary to ensure that the benefits of
TECVAYLI outweigh the risks of cytokine release syndrome and neurologic
toxicity, including ICANS.


INDICATION

TECVAYLI is a bispecific B-cell maturation antigen (BCMA)-directed CD3 T-cell
engager indicated for the treatment of adult patients with relapsed or
refractory multiple myeloma who have received at least four prior lines of
therapy, including a proteasome inhibitor, an immunomodulatory agent and an
anti-CD38 monoclonal antibody.


REPORTING ADVERSE REACTIONS

To report any serious adverse events suggestive of CRS or neurologic toxicity
contact Janssen Biotech, Inc. at 1-800-Janssen (1-800-526-7736) or FDA at
1-800-FDA-1088 or www.fda.gov/medwatch

Healthcare providers are also encouraged to report any suspected serious adverse
events associated with TECVAYLI as detailed above.


RESOURCES FOR PRESCRIBERS

 * Prescriber Enrollment Form
 * Prescriber Training Program
 * Adverse Reaction Management Guide
 * Knowledge Assessment
 * Patient Wallet Card
 * Fact Sheet
 * Healthcare Provider Letter
 * Professional Society Letter

Download
All Prescriber Resources


RESOURCES FOR PHARMACIES AND HEALTHCARE SETTINGS

 * Pharmacy and Healthcare Setting Enrollment Form
 * Pharmacy and Healthcare Setting Training Program

Download
All Pharmacy and Healthcare Setting Resources


RESOURCES FOR PATIENTS

All patients treated with TECVAYLI receive a Patient Wallet Card. Patients
should carry the Wallet Card to remind them of the signs and symptoms of CRS and
neurologic toxicity, including ICANS, and when to seek immediate medical
attention. Patients can share this card with any healthcare provider who
provides care to them to inform them of receipt of TECVAYLI treatment and when
to contact the patient’s oncologist.

 * Patient Wallet Card


HAVE QUESTIONS?

Contact the TECVAYLI REMS by calling 1-855-810-8064







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This site is published by Janssen Biotech, Inc., which is solely responsible for
its contents. This site is intended for use by healthcare professionals in the
United States and Puerto Rico. Janssen Biotech, Inc. recognizes that the
internet is a global communications medium; however, laws, regulatory
requirements, and medical practices for pharmaceutical products vary from
country to country. The Prescribing Information included here may not be
appropriate for use outside the United States and Puerto Rico.

Third party trademarks used herein are trademarks of their respective owners.

©Janssen Biotech, Inc. 2022




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