Neurologic toxicity, including ICANS, occurred in 55% of patients who received TALVEY® at the recommended dosages; Grade 3 or 4 events occurred in 6% of patients

  • Most frequent neurologic toxicities were headache (20%), encephalopathy (15%), sensory neuropathy (14%), and motor dysfunction, including ataxia/cerebellar ataxia (10%)

ICANS was reported in 9% of 265 patients where ICANS data were collected and who received TALVEY® at the recommended dosages

  • Recurrent ICANS occurred in 3% of patients
  • ICANS can occur concurrently with CRS, following resolution of CRS, or in the absence of CRS
  • Clinical signs and symptoms of ICANS may include but are not limited to confusional state, depressed level of consciousness, disorientation, somnolence, lethargy, and bradyphrenia
  • Advise patients to refrain from driving or operating heavy or potentially dangerous machinery during the step-up dosing schedule and for 48 hours after completion of the step-up dosing schedule, and in the event of new onset of any neurological symptoms, until symptoms resolve
Median time to onset of ICANS

2.5 days from the last dose

(range: 1–16 days)

Median duration of ICANS

2 days

(range: 1–22 days)

ICANS experienced after each dose of TALVEY® (n=265)

Q2WQW
Step-up dosing schedule
Step-up dose 1: 3%
Step-up dose 2: 3%
Step-up dose 3: 1.8%First treatment dose (n=156): 2.6%
First treatment dose (n=109): 3.7%N/A
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    1. TALVEY® [Prescribing Information]. Horsham, PA: Janssen Biotech, Inc.