epcoritamab

High Alert

Relapsed or refractory diffuse large B-cell lymphoma, not otherwise specified, including diffuse large B-cell lymphoma arising from indolent lymphoma, and high-grade B-cell lymphoma after ≥2 lines of systemic therapy.
Relapsed or refractory follicular lymphoma after ≥2 lines of systemic therapy.

Contraind./Precautions ⬆ ⬇

Contraindicated in:

Active infection;
OB: Pregnancy;
Lactation: Lactation.

Use Cautiously in:

Rep: Women of reproductive potential;
Pedi: Safety and effectiveness not established in children.

Adv. Reactions/Side Effects ⬆ ⬇

CV: bradycardia, edema, tachycardia

Derm: rash

F and E: hyperkalemia, hypokalemia, hypomagnesemia, hyponatremia, hypophosphatemia

GI: ↑liver enzymes, abdominal pain, diarrhea, nausea, vomiting

GU: ↑serum creatinine

Hemat: anemia, leukopenia, lymphopenia, neutropenia, thrombocytopenia

Local: injection site reactions

Metab: ↓appetite

MS: pain

Neuro: fatigue, headache, aphasia, confusion, dysgraphia, IMMUNE EFFECTOR CELL-ASSOCIATED NEUROTOXICITY SYNDROME (ICANS), sedation, tremor

Resp: pleural effusion

Misc: cytokine release syndrome (CRS), fever, infection, tumor flare, tumor lysis syndrome

Interactions ⬆ ⬇

Drug-drug:

May suppress activity of CYP450 drug-metabolizing enzymes (especially after the first dose on Cycle 1, Day 1; up to 14 days after the first 48-mg dose on Cycle 1, Day 15; and then during/after onset of cytokine release syndrome); careful monitoring of CYP450 substrates is recommended.

Availability ⬆ ⬇

Solution for injection: 4 mg/0.8 mL; 48 mg/0.8 mL

Route/Dosage ⬆ ⬇

To be administered in 28-day cycles.

Diffuse Large B-Cell Lymphoma and High-Grade B-Cell Lymphoma

SC (Adults ): Cycle 1, Day 1: 0.16 mg as single dose (step-up dose 1); Cycle 1, Day 8: 0.8 mg as single dose (step-up dose 2); Cycle 1, Day 15: 48 mg as single dose; Cycle 1, Day 22: 48 mg as single dose; Cycles 2 and 3, Days 1, 8, 15, and 22: 48 mg as single dose on each of these days; Cycles 4–9, Days 1 and 15: 48 mg as single dose on each of these days; Cycles 10 and beyond, Day 1: 48 mg as single dose on each of these days. Continue therapy until disease progression or unacceptable toxicity.

Follicular Lymphoma

SC (Adults ): Cycle 1, Day 1: 0.16 mg as single dose (step-up dose 1); Cycle 1, Day 8: 0.8 mg as single dose (step-up dose 2); Cycle 1, Day 15: 3 mg as single dose (step-up dose 3); Cycle 1, Day 22: 48 mg as single dose; Cycles 2 and 3, Days 1, 8, 15, and 22: 48 mg as single dose on each of these days; Cycles 4–9, Days 1 and 15: 48 mg as single dose on each of these days; Cycles 10 and beyond, Day 1: 48 mg as single dose on each of these days. Continue therapy until disease progression or unacceptable toxicity.

US Brand Names ⬆ ⬇

Action ⬆ ⬇

Acts as a T-cell engager, binding to CD20 expressed on the surface of B cells and lymphoma cells and to the CD3 receptor on the surface of T cells, resulting in facilitated lysis of malignant cells.

Therapeutic effects:

Slowed progression of diffuse large B-cell and follicular lymphoma.

Classifications ⬆ ⬇

Therapeutic Classification: antineoplastics

Pharmacologic Classification: T-cell engagers

Pharmacokinetics ⬆ ⬇

Absorption: Extent of absorption following SUBQ administration unknown.

Distribution: Well distributed to tissues.

Metabolism/Excretion: Metabolized into small peptides by catabolic pathways.

Half-Life: 22 days.

Time/Action Profile ⬆ ⬇

(plasma concentrations)

ROUTE	ONSET	PEAK	DURATION
SUBQ	unknown	0.3–7 days	unknown

Patient/Family Teaching ⬆ ⬇

Explain purpose and side effects of medication to patient. Advise patient to read Patient Information before starting therapy.
Advise patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and to consult health care professional before taking other medications.
Inform patient of the risk of CRS and to immediately contact health care professional of any signs and symptoms of fever, hypotension, hypoxia, chills, tachycardia, headache, or dyspnea. Advise patients with diffuse large B-cell lymphoma or high-grade B-cell lymphoma that they should be hospitalized for 24 hr after administration of the Cycle 1, Day 15, dosage of 48 mg.
Advise patient of the risk of ICANS; to immediately contact health care professional if signs and symptoms of confusion, lethargy, tremor, dysgraphia, aphasia, or nonconvulsive status epilepticus occur; and that the onset of events may be delayed.
Advise patients who experience symptoms of CRS or ICANS not to drive and refrain from operating heavy or potentially dangerous machinery until events resolve.
Advise patient of the risk of serious infections and to contact their health care professional for signs or symptoms of serious infection.
Educate patient on the signs and symptoms associated with cytopenias, including neutropenia and febrile neutropenia, anemia, and thrombocytopenia.
Rep: May cause fetal harm. Advise women of reproductive potential to inform their health care professional if pregnancy is suspected or planned or if breastfeeding. Advise patient not to breastfeed during treatment and for 4 mo after last dose. Advise patient who could become pregnant to use effective contraception during therapy and for 4 mo after the last dose.

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Indications ⬇