|Generic name||Brexucabtagene autoleucel|
|Brand name(s), other common name(s)||Tecartus®|
|Drug type||CD19-directed genetically modified autologous T-cell immunotherapy|
|How the drug is given||Suspension for intravenous infusion|
Indications and Usage
Brexucabtagene autoleucel is FDA approved for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL).
This indication is approved under accelerated approval based on overall response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.
Side effects needing medical attention
The most common adverse reactions are: fever, cytokine release syndrome (CRS), low blood pressure (hypotension), disease that affects the brain (encephalopathy), fatigue, fast heart beat (tachycardia), problem with the rhythm of the heartbeat (arrhythmia), infection – pathogen unspecified, chills, body does not get enough oxygen (hypoxia), cough, tremor, musculoskeletal pain, headache, nausea, edema, motor dysfunction, constipation, diarrhea, decreased appetite, difficult breathing (dyspnea), rash, insomnia, pleural effusion, and loss of ability to understand speech, caused by brain damage (aphasia).
WARNING: CYTOKINE RELEASE SYNDROME AND NEUROLOGIC TOXICITIES:
See full prescribing information for complete boxed warning.
- 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.
- 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.