CRS & ICANS events
CRS was primarily low grade, predictable, and manageable1
- CRS occurred in 51% of the patients. The majority of these patients experienced a grade 1 (37%) or grade 2 (17%) CRS event
- Most CRS events (92%) occurred during cycle 1
- In cycle 1, 9% occurred after the 0.16-mg dose (day 1), 16% after the 0.8-mg dose (day 8), 61% after the 48-mg dose (day 15), and 6% after the 48-mg dose (day 22)
- The median time to onset of CRS from the most recently administered dose of EPKINLY across all doses was 24 hours (range: 0-10 days)
- The median time to onset after the first full 48-mg dose was 21 hours (range: 0-7 days)
- CRS resolved in 98% of patients in a median of 2 days (range: 1-27 days)
Management of CRS may require supportive therapy, which may include intensive care as appropriate. Withhold or discontinue EPKINLY based on the severity of CRS. See CRS Management.
Most CRS events occurred following the first full dose
SELECT IMPORTANT SAFETY INFORMATION
- In patients who experienced CRS, the signs and symptoms included pyrexia, hypotension, hypoxia, dyspnea, chills, and tachycardia. Concurrent neurological adverse reactions associated with CRS occurred in 2.5% of patients and included headache, confusional state, tremors, dizziness, and ataxia.
- Administer pretreatment medications to reduce the risk of CRS. Following administration of the first 48 mg dose, patients should be hospitalized for 24 hours.
- Monitor patients for potential CRS. At the first signs or symptoms of CRS, manage per current practice guidelines and administer supportive care as appropriate.
The majority of ICANS cases occurred within cycle 11
- ICANS occurred in 6% (10/157) of patients: grade 1 (4.5%), grade 2 (1.3%), grade 5 (0.6%; 1 patient)
- The median time from initiation of therapy to first ICANS onset was 16.5 days (range: 8-141 days)
- ICANS resolved in 90% (9/10) of patients with supportive care
- The median duration of ICANS was 4 days (range: 0-8 days)
At the first signs or symptoms of ICANS, immediately evaluate patient and provide supportive therapy based on severity. Withhold or discontinue EPKINLY as recommended. See ICANS Management.
SELECT IMPORTANT SAFETY INFORMATION
- The onset of ICANS can be concurrent with CRS, following resolution of CRS, or in the absence of CRS. Clinical manifestations of ICANS included, but were not limited to, confusional state, lethargy, tremor, dysgraphia, aphasia, and non convulsive status epilepticus.
- Monitor patients for potential ICANS. At the first signs or symptoms of ICANS, manage per current practice guidelines and administer supportive care as appropriate.
CRS=cytokine release syndrome; ICANS=immune effector cell-associated neurotoxicity syndrome.
