Dosage modifications & management guidance for EPKINLY1
Dosage modifications for adverse reactions
If CRS or ICANS is suspected, withhold EPKINLY until symptoms resolve. For ICANS, consider neurology evaluation and rule out other causes of neurologic symptoms. Administer supportive therapy, which may include intensive care.
Manage CRS and ICANS according to the recommendations in the EPKINLY Dosage and Administration Section 2.6 of the Prescribing Information. Consider further management per current practice guidelines and provide supportive therapy, which may include intensive care.
For infections, grades 1-4
- Withhold EPKINLY in patients with active infection, until the infection resolves‡
- For grade 4, consider permanent discontinuation of EPKINLY
For other adverse reactions, grade 3 or higher
- Withhold EPKINLY until the toxicity resolves to grade 1 or baseline‡
Neutropenia, absolute neutrophil count (ANC) <0.5 x 109/L
- Withhold EPKINLY until ANC ≥0.5 x 109/L‡
Thrombocytopenia, platelet count <50 x 109/L
- Withhold EPKINLY until platelet count ≥50 x 109/L‡
*Based on American Society for Transplantation and Cellular Therapy (ASTCT) 2019 grading for CRS and ICANS.
†Premedication may mask fever; therefore, if clinical presentation is consistent with CRS, follow these management guidelines.
‡Refer to Table 2 in Section 2.3 of the Prescribing Information for information on restarting EPKINLY after dose delays.
§Low-flow oxygen defined as oxygen delivered at <6 L/minute; high-flow oxygen defined as oxygen delivered at ≥6 L/minute.
¶If grade 2 or 3 CRS occurs with the second full dose (48 mg) or beyond, administer CRS premedications with each subsequent dose until an EPKINLY dose is given without subsequent CRS of any grade. Refer to Table 3 in Section 2.3 of the Prescribing Information for additional information on premedication.
||Management is determined by the most severe event, not attributable to any other cause.
#If patient is arousable and able to perform Immune Effector Cell-Associated Encephalopathy (ICE) Assessment, assess: Orientation (oriented to year, month, city, hospital = 4 points); Naming (names 3 objects, eg, point to clock, pen, button = 3 points); Following Commands (eg, “show me 2 fingers” or “close your eyes and stick out your tongue” = 1 point); Writing (ability to write a standard sentence = 1 point); and Attention (count backwards from 100 by ten = 1 point). If patient is unarousable and unable to perform ICE Assessment (grade 4 ICANS) = 0 points.
**Not attributable to any other cause.
††See Table 2 in Section 2.3 of the Prescribing Information for recommendations on restarting EPKINLY after dose delays.
‡‡All references to dexamethasone administration are dexamethasone or equivalent.
BiPAP=bilevel positive airway pressure; CPAP=continuous positive airway pressure; CRS=cytokine release syndrome; ICANS=immune effector cell-associated neurotoxicity syndrome; IV=intravenous; SC=subcutaneous.