| DRUG INFORMATION |
| Classification | Bispecific CD20-directed CD3 T-cell engager |
| Mechanism of Action | As a T-cell–engaging bispecific antibody, epcoritamab-bysp binds to the CD3 receptor on T-cells and binds to the CD20 receptor on the surface of lymphoma cells and healthy B-cells. This causes the release of cytokines and induces lysis of B-cells. |
| Indications | Epcoritamab-bysp has accelerated approval for adult patients with relapsed or refractory FL after two or more lines of systemic therapy. Epcoritamab-bysp is also approved for relapsed or refractory DLBCL and high-grade B-cell lymphoma after two or more lines of systemic therapy. |
| ADMINISTRATION |
| Dosing, Frequency, and Administration | This drug follows a step-up dosing schedule. | Treatment Cycle | Treatment Day | Epcoritamab-Bysp Dose | | DLBL or high-grade B-cell lymphoma | Cycle 1 | 1 | Step-up dose 1 | 0.16 mg | | 8 | Step-up dose 2 | 0.8 mg | | 15* | Full dose | 48 mg | | 22 | 48 mg | | Cycles 2 and 3 | 1, 8, 15, and 22 | 48 mg | | Cycles 4–9 | 1 and 15 | 48 mg | | Cycles 10 and beyond | 1 | 48 mg | | *Monitor patients for 24 hours following administration to assess for signs of cytokine release syndrome (CRS) and neurotoxicities. | | FL | Cycle 1 | 1 | Step-up dose 1 | 0.16 mg | | 8 | Step-up dose 2 | 0.8 mg | | 15 | Step-up dose 3 | 3 mg | | 22 | First full dose | 48 mg | | Cycles 2 and 3 | 1, 8, 15, and 22 | 48 mg | | Cycles 4–9 | 1 and 15 | 48 mg | | Cycles 10 and beyond | 1 | 48 mg |
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| Route | Subcutaneous, preferably in the lower abdomen or the thigh. Alternate the injection site from left to right side. |
| Safe Handling | Epcoritamab-bysp is a potentially hazardous drug per the National Institute for Occupational Safety and Health definition. Follow safe handling precautions. |
| ADVERSE REACTIONS |
- The major side effects include infections, neutropenia, thrombocytopenias, and other adverse reactions include:
- CRS and infection
- Pain and fatigue
- Rash
- Nausea, diarrhea, constipation, abdominal pain, and mucositis
- Cough or dyspnea
- Headache, neurologic changes, peripheral neuropathy and paresthesias, and dizziness
- Insomnia
- Renal insufficiency
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| WARNINGS |
- Black box warnings: The package insert has a boxed warning for the risk of CRS and immune effector cell-associated neurotoxicity syndrome (ICANS).
- Other warnings: Epcoritamab-bysp may cause fetal harm when administered to a pregnant individual.
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| NURSING CONSIDERATIONS |
| Pretreatment | - Consider Pneumocystis jirovecii pneumonia and herpes virus prophylaxis.
- Ensure correct dose and premedication (as applicable) are ordered based on dosage schedules.
- Administer recommended premedications to prevent the risk for CRS:
| Cycle | Patients Requiring Premedication | Premedication | Administration | | Cycle 1 | All patients | - Prednisolone (100 mg, oral or IV) or dexamethasone (15 mg, oral or IV) or equivalent
| - 30–120 minutes prior to each weekly administration
- For 3 consecutive days following each weekly administration during cycle 1
| - Diphenhydramine (50 mg, oral or IV) or equivalent
- Acetaminophen (650–1,000 mg oral)
| - 30–120 minutes prior to each weekly administration
| | Cycle 2 and beyond | Patients who experienced grade 2 or 3 CRS with previous dose | - Prednisolone (100 mg, oral or IV) or dexamethasone (15 mg, oral or IV) or equivalent
| - 30–120 minutes prior next administration of this drug after a Grade 2 or 3 CRS event
- For 3 consecutive days following the next administration of this drug until it is given without subsequent CRS of grade 2 or higher
| | Note. Epcoritamab-bysp is permanently discontinued after grade 4 CRS. |
|
| Administration | - Because of the risk for CRS and ICANS, monitor patients for:
- Fever, hypotension, hypoxia, dyspnea, chills, and tachycardia
- Headache, confusion, tremors, dizziness, and ataxia
- Lethargy, tremor, dysgraphia, aphasia, and nonconvulsive status epilepticus
- If you suspect CRS or ICANS, administer supportive therapy, which may require intensive care.
- Because of the risk for CRS and neurotoxicities, monitor patients for 24 hours after administration of the first full dose of 48 mg on cycle 1, day 15.
- Monitor the injection site for signs of reaction, including redness, bruising, or tenderness.
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| Post-Treatment | - Observe and measure patients’ vital signs.
- Understand any new treatment modifications based on patient response and adverse reactions.
- Conduct a follow-up assessment for toxicities and manage any CRS and ICANS treatment according to grade.
- Ensure patients have prescriptions for home symptom management and understand how to use them.
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| PATIENT EDUCATION |
- Inform patients about the risk for CRS, ICANS, embryo-fetal toxicities, cytopenias, and infection.
- Teach patients about the symptoms associated with neurotoxicities and to avoid the operation of heavy machinery or driving until symptoms resolve.
- Educate patients about the signs and symptoms of infection and when to contact their healthcare professional.
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| RESOURCES |
| Patient Resources | Patient assistance program: Visit MyNavCare.com/patient or call 866-628-2271. |
| Healthcare Professional Resources | |
| Other Resources | National Cancer Institute’s page for epcoritamab-bysp |
