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Submitted URL: http://tecvaylirems.com/
Effective URL: https://tec-talrems.com/
Submission: On August 10 via manual from US — Scanned from DE
Effective URL: https://tec-talrems.com/
Submission: On August 10 via manual from US — Scanned from DE
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* Prescribing Information * TECVAYLI Prescribing Information * TALVEY Prescribing Information * Medication Guide * TECVAYLI Medication Guide * TALVEY Medication Guide * Prescriber Registration * Login Toggle navigation * Home * Prescribers * Pharmacies and Healthcare Settings TECVAYLI® AND TALVEY™ RISK EVALUATION AND MITIGATION STRATEGY (REMS) TECVAYLI AND TALVEY REMS The purpose 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 for the signs and symptoms of CRS and neurologic toxicity, including ICANS, in patients exposed to TECVAYLI or TALVEY. PRESCRIBERS Prescribers must be certified in the TECVAYLI and TALVEY REMS to treat patients with TECVAYLI or TALVEY. Learn More PHARMACIES AND HEALTHCARE SETTINGS Pharmacies and Healthcare Settings must be enrolled in the TECVAYLI and TALVEY REMS to dispense TECVAYLI or TALVEY to patients. Learn More WHAT IS THE TECVAYLI AND TALVEY REMS? A Risk Evaluation and Mitigation Strategy (REMS) is a 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 and TALVEY outweigh the risks of CRS, neurologic toxicity, and ICANS. INDICATIONS 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. TALVEY is a bispecific GPRC5D-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 Reporting of suspected adverse events after administration of therapy is vital for the continued monitoring of the risk/benefit balance of therapy. Healthcare providers must report any serious adverse events suggestive of CRS and neurologic toxicity, including ICANS, to 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 should report all suspected adverse events or product quality complaints to Janssen at 1-800-Janssen (1-800-526-7736) or FDA at 1-800-FDA-1088 or online at www.fda.gov/medwatch. HAVE QUESTIONS? Contact the TECVAYLI and TALVEY REMS by calling 1-855-810-8064 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 or TALVEY 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 or TALVEY treatment and when to contact the patient’s oncologist. * Patient Wallet Card * Home * Legal Terms of Use * Privacy Policy 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. 2023 × IMPORTANT PROGRAM UPDATES THE TECVAYLI REMS IS NOW CALLED THE TECVAYLI AND TALVEY REMS. PRESCRIBERS * New prescribers must be certified in the TECVAYLI and TALVEY REMS to treat patients with TECVAYLI or TALVEY. Learn more here. * For prescribers that are certified in the TECVAYLI REMS, certification will automatically be transferred to the TECVAYLI and TALVEY REMS. * Prescribers must review each product's drug's USPI, the Adverse Reaction Management Guide and the Prescriber Training Program. PHARMACIES AND HEALTHCARE SETTINGS * New Pharmacies and Healthcare Settings must be enrolled in the TECVAYLI and TALVEY REMS to dispense TECVAYLI or TALVEY to patients. Learn more here. * Pharmacies and Healthcare Settings previously certified in the TECVAYLI REMS will have their enrollment transferred to the combined TECVAYLI and TALVEY REMS. * Authorized Representatives will be required to complete a re-attestation in the REMS before purchasing and dispensing TALVEY. Pharmacies and Healthcare Settings will be able to continue purchasing and dispensing TECVAYLI prior to completing their re-attestation. * To re-attest online, please login or contact the REMS for further assistance by calling 1-855-810-8064. Close