18% of patients experienced Grade 3 or higher CRS and 37% experienced Grade 3 or higher neurologic events1

Table showing summary of CRS and neurologic events. Table showing summary of CRS and neurologic events.
  • Most CRS or neurologic events occurred early1
    • 85% of all treated patients experienced the first CRS or neurological event within the first 7 days after TECARTUS™ infusion1
  • In ZUMA-2, 99% of CRS events (n=74/75) and 79% of neurologic events (n=52/66) resolved1,3
    • 66% (n=54/82) of patients experienced CRS before neurologic events started
    • 6% (n=5/82) of patients who developed neurologic events did not have CRS
    • 10% (n=8/82) developed neurologic events after the resolution of CRS

Recommended monitoring based on the ZUMA-2 trial

Day 0 to Day 7

On-site monitoring for CRS and neurologic events

On-site monitoring

Monitored at ATC for signs and symptoms of CRS, neurologic events, and other adverse reactions1

Day 8 to Day 28

post-discharge monitoring

Post-discharge monitoring

Patients instructed to remain within proximity of the ATC1

After Day 28

 
patient follow-up

Long-term follow-up

Patient returns to referring office for routine monitoring4

  • In the ZUMA-2 trial, patients with Grade >1 treatment-related CRS or neurologic events remained hospitalized until the adverse reaction resolved4
  • Post-discharge monitoring occurred at Weeks 2, 4, 8, and 12, then every 3 months through Month 184

Guidance for monitoring and management of CAR T-related adverse reactions (CRS and neurologic events)1

see full Prescribing Information see full Prescribing Information
Ensure that 2 doses of tocilizumab are available for each patient prior to infusion. For more information on CRS and neurologic events management, please see the full Prescribing Information for TECARTUS
Seek immediate medical attention for signs or symptoms of CRS or neurologic events. Seek immediate medical attention for signs or symptoms of CRS or neurologic events.
Counsel patients to seek immediate medical attention should signs or symptoms of CRS or neurologic events occur at any time
Monitor patients daily for at least 7 days and 4 weeks postinfusion at the ATC for signs and symptoms of CRS and neurologic events. Please see TECARTUS full Prescribing Information for detailed adverse event management guidelines.1

ATCs must ensure that healthcare providers who prescribe, dispense, or administer TECARTUS are trained about the management of CRS and neurologic toxicities.1

ATC=Authorized Treatment Center; CAR=chimeric antigen receptor; CRS=cytokine release syndrome; MCL=mantle cell lymphoma; R/R=relapsed or refractory.

References: 1. TECARTUS™ (brexucabtagene autoleucel). Prescribing information. Kite Pharma, Inc; 2020. 2. Data on file [1]. Kite Pharma, Inc; 2020. 3. Data on file [2]. Kite Pharma, Inc; 2020. 4. Wang M, Munoz J, Goy A, et al. KTE-X19 CAR T-cell therapy in relapsed or refractory mantle cell lymphoma – study protocol. N Engl J Med. 2020;1-47.