What should I know about the Tecvayli REMS program?
The Tecvayli REMS Program is a restricted program developed by the manufacturer of Tecvayli (teclistamab) and the US Food and Drug Administration (FDA). It is designed to educate healthcare professionals and patients on the risks associated with Tecvayli, including:
- Cytokine release syndrome (CRS)
- Neurologic toxicity
This program ensures that the benefits of Tecvayli outweigh its potential risks.
What is Tecvayli?
Tecvayli was approved by the FDA in 2022. It is a subcutaneous (under the skin) injection used to treat adults with relapsed or refractory multiple myeloma who have received at least four prior treatments.
What is a REMS?
A REMS (Risk Evaluation and Mitigation Strategy) program is an FDA-required safety strategy for certain medications with serious side effects. It includes educational requirements and safety measures for prescribers, dispensers, and patients to help monitor and manage potential risks.
Who Must Enroll in the Tecvayli REMS Program?
- Prescribers who want to prescribe Tecvayli
- Pharmacies and healthcare settings that dispense Tecvayli
Prescribers must educate patients about the risks and provide them with a wallet card outlining safety information. Wholesalers and distributors can only supply Tecvayli to certified healthcare settings.
What Are the Requirements of the Tecvayli REMS Program?
For prescribers:
- Complete prescriber training and review the adverse reaction management guide
- Pass a knowledge assessment and submit an enrollment form
- Educate patients on CRS and neurologic toxicity risks before the first dose using the wallet card
For pharmacies and healthcare settings:
- Complete pharmacy and healthcare setting training
- Submit an enrollment form to the REMS program
- Ensure all staff involved in dispensing Tecvayli are trained on REMS requirements
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What is Cytokine Release Syndrome (CRS)?
Cytokine release syndrome (CRS) occurs when Tecvayli triggers an overactive immune response, leading to the excessive release of cytokines—chemical messengers that regulate immune function. CRS can be life-threatening.
Symptoms of CRS may include:
- Fever
- Chills
- Low oxygen
- Low blood pressure
- Fast heartbeat
- Headache
- Elevated liver enzymes
- Confusion
If you experience any of the symptoms listed above, seek medical attention immediately.
What Neurologic Toxicity Can Happen from Tecvayli?
During clinical trials, 57% of patients experienced neurologic toxicity, including Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS). This condition is believed to be triggered by inflammatory cytokines and typically occurs within the first week of treatment.
Symptoms of neurologic toxicity from Tecvayli may include:
- Headache
- Confusion
- Difficulty with writing
- Numbness or tingling
- Tremor
If you develop any of the symptoms above, seek medical attention right away.
How Can I Learn More?
For more information about the Tecvayli and Talvey REMS program, visit www.TEC-TALREMS.com or call 1-855-810-8064.
This is not all the information you need to know about Tecvayli (teclistamab) for safe and effective use and does not take the place of your doctor’s directions. Review the full product information and discuss this information and any questions you have with your doctor or other health care provider.
References
International Myeloma Foundation. Updated June 2024. What Is Cytokine Release Syndrome (CRS)? Accessed 10/21/2024 at https://www.myeloma.org/managing-complications-side-effects/cytokine-release-syndrome-crs
Rees, J. H. 2022. Management of Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS) 2022 Feb 7. In: Kröger N, Gribben J, Chabannon C, et al., editors. The EBMT/EHA CAR-T Cell Handbook [Internet]. Cham (CH): Springer; 2022. Chapter 27. Accessed 10/21/20224 at https://www.ncbi.nlm.nih.gov/books/NBK584157/
Tecvayli [package insert]. Updated July 2024. Janssen Biotech, Inc. Accessed 10/21/2024 at https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=54e0f974-ccee-44ea-9254-40e9883cee1e
https://www.tec-talrems.com/. Accessed 10/21/2024.
Read next
Where can I find the Tecvayli FDA package insert?
You can access the Tecvayli package insert from several places. You can find the Tecvayli FDA package insert on the Janssen website, on the Drugs@FDA website, or under the FDA Professional Drug Information section on Drugs.com.
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What is the success rate of Tecvayli?
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Drug information
- Tecvayli Information for Consumers
- Tecvayli prescribing info & package insert (for Health Professionals)
- Side Effects of Tecvayli (detailed)
- Tecvayli user reviews (5)
Related support groups
- Tecvayli (6 questions, 3 members)
- Multiple Myeloma (26 questions, 54 members)