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Epkinly (epcoritamab-bysp)
epcoritamab
Black Box Warnings .
Cytokine Release Syndrome
incl. serious or life-threatening rxn occurred in 51% of pts; initiate tx according to step-up dosing schedule to decr. CRS risk; monitor pts x24h in hospital after first 48 mg dose (day 15 of cycle 1); manifestations may incl. fever, hypotension, hypoxia, dyspnea, chills, tachycardia; provide supportive care as needed; withhold tx until s/sx resolve or permanently D/C, based on severity
Immune Effector Cell-Associated Neurotoxicity Syndrome
which may be fatal or life-threatening, occurred in 6% of pts, incl. concurrently w/ CRS, after CRS resolution, or in the absence of CRS; monitor pts x24h in hospital after first 48 mg dose (day 15 of cycle 1); provide supportive care as needed; withhold tx until s/sx resolve or permanently D/C, based on severity
Adult Dosing .
Dosage forms: INJ
Special Note
- [formulation clarification]
- Info: nonproprietary name = epcoritamab-bysp
- [uses, dosing may vary]
- Info: refer to institution protocols and pkg insert prior to prescribing for uses, premeds, postmeds, prophylactic meds, and dosing incl. toxicity-related dose adjustments
large B-cell lymphoma, relapsed or refractory
- [0.16 mg SC x1 on day 1, then 0.8 mg SC x1 on day 8 as part of step-up dosing schedule, then 48 mg SC x1 on days 15, 22 of 28-day cycle for cycle 1, then 48 mg SC x1 on days 1, 8, 15, 22 of 28-cycle for cycles 2-3, then 48 mg SC x1 on days 1, 15 of 28-day cycle for cycles 4-9, then 48 mg SC x1 on day of 1 of 28-day cycle starting cycle 10]
- Info: for pts w/ diffuse large B-cell lymphoma (DLBCL) not otherwise specified, DLBCL arising from indolent lymphoma, or high-grade B-cell lymphoma who have received at least 2 lines of tx
follicular lymphoma, relapsed or refractory
- [0.16 mg SC x1 on day 1, then 0.8 mg SC x1 on day 8, then 3 mg SC x1 on day 15 as part of step-up dosing schedule, then 48 mg SC x1 on day 22 of 28-day cycle for cycle 1, then 48 mg SC x1 on days 1, 8, 15, 22 of 28-cycle for cycles 2-3, then 48 mg SC x1 on days 1, 15 of 28-day cycle for cycles 4-9, then 48 mg SC x1 on day of 1 of 28-day cycle starting cycle 10]
- Info: for pts who have received at least 2 lines of tx
renal dosing
- [see below]
- CrCl >30: no adjustment; CrCl <30: not defined
- HD/PD: not defined
hepatic dosing
- [see below]
- bilirubin 1-1.5x ULN or AST >ULN: no adjustment; bilirubin >1.5x ULN: not defined
Peds Dosing .
Peds dosing is currently unavailable or not applicable for this drug.