CARVYKTI is a CAR-T cell therapy by Janssen Biotech designed for adult patients treating relapsed or refractory multiple myeloma. Explore REMS guides and manuals.
CARVYKTI® (ciltacabtagene autoleucel) is a specialized CAR-T cell therapy indicated for the treatment of adult patients with relapsed or refractory multiple myeloma. Developed by Janssen Biotech, Inc. and Legend Biotech, this advanced treatment involves genetically modifying a patient's own immune cells to target and fight multiple myeloma.
Due to the complex nature and safety profile of CARVYKTI, its administration is strictly regulated through the Risk Evaluation and Mitigation Strategy (REMS) program. Hospitals and associated clinics must be certified to dispense and administer this therapy. On this page, healthcare providers and certified representatives can find essential documentation, REMS enrollment instructions, and patient information leaflets to ensure compliance and safe administration.
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For any questions or additional information, please visit the REMS website at www.CARVYKTIREMS.com or call the CARVYKTI REMS Coordinating Center at 1-844-672-0067.
Hospitals and their Associated Clinics must be certified in the CARVYKTI REMS and complete the Hospital Enrollment Form. They must also have on-site immediate access to at least two doses of tocilizumab for each patient.
Suspected adverse events should be reported to Janssen at 1-800-526-7736 (1-800-Janssen) or the FDA at 1-800-FDA-1088.
You can contact the CARVYKTI REMS program via email at CARVYKTI@JanssenREMS.com or by fax at 1-877-778-3865.