BlackBoxRX
 
We highly recommend enabling Javascript while using the BlackBoxRX site.

Brexucabtagene Autoleucel

Cytokine Release Syndrome and Neurologic Toxicities

Cytokine Release Syndrome

  • Cytokine Release Syndrome (CRS), including life-threatening reactions, occurred in patients receiving TECARTUS. Do not administer TECARTUS to patients with active infection or inflammatory disorders. Treat severe or life-threatening CRS with tocilizumab or tocilizumab and corticosteroids [see DOSAGE AND ADMINISTRATION (2.22.3)WARNINGS AND PRECAUTIONS (5.1)].

Neurologic Toxicities

  • Neurologic toxicities, including life-threatening reactions, occurred in patients receiving TECARTUS, including concurrently with CRS or after CRS resolution. Monitor for neurologic toxicities after treatment with TECARTUS. Provide supportive care and/or corticosteroids as needed [see DOSAGE AND ADMINISTRATION (2.22.3)WARNINGS AND PRECAUTIONS (5.2)].

TECARTUS is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the YESCARTA and TECARTUS REMS Program [see WARNINGS AND PRECAUTIONS (5.3)].


Approved Risk Evaluation and Mitigation Strategies (REMS)

YESCARTA and TECARUS (brexucatagene autoleucel) Suspension

Patient Counseling Information

Package Inserts

Brexucabtagene Autoleucel

Additional Information

PubMed - TECARTUS

Updated March 2021