Active Ingredient: Epcoritamab
Epcoritamab as monotherapy is indicated for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) after two or more lines of systemic therapy.
For this indication, competent medicine agencies globally authorize below treatments:
For:
Subcutaneous, 0.16 milligrams epcoritamab, one dose, over the duration of 1 week. Afterwards, subcutaneous, 0.8 milligrams epcoritamab, one dose, over the duration of 1 week. Afterwards, subcutaneous, 48 milligrams epcoritamab, one dose, over the duration of 1 week. Afterwards, subcutaneous, 48 milligrams epcoritamab, one dose, over the duration of 1 week. Afterwards, subcutaneous, 48 milligrams epcoritamab, once weekly, over the duration of 4 weeks. This step is repeated 2 times. Afterwards, subcutaneous, 48 milligrams epcoritamab, once every 2 weeks, over the duration of 4 weeks. This step is repeated 6 times. Afterwards, subcutaneous, 48 milligrams epcoritamab, once every 4 weeks.
Epcoritamab should be administered according to the following dosing schedule in 28-day cycles which is outlined in Table 1.
Table 1. Dosing schedule:
| Dosing schedule | Cycle of treatment | Days | Epcoritamab dose (mg)a |
|---|---|---|---|
| Weekly | Cycle 1 | 1 | 0.16 mg (Step-up dose 1) |
| 8 | 0.8 mg (Step-up dose 2) | ||
| 15 | 48 mg (First full dose) | ||
| 22 | 48 mg | ||
| Weekly | Cycles 2 – 3 | 1, 8, 15, 22 | 48 mg |
| Every two weeks | Cycles 4 – 9 | 1, 15 | 48 mg |
| Every four weeks | Cycles 10 + 1 | 48 | mg |
a 0.16 mg is a priming dose, 0.8 mg is an intermediate dose and 48 mg is a full dose.
Epcoritamab should be administered until disease progression or unacceptable toxicity.
Details on recommended pre-medication for cytokine release syndrome (CRS) are shown in Table 2.
Table 2. Epcoritamab pre-medication:
| Cycle | Patient requiring pre-medication | Pre-medication | Administration |
|---|---|---|---|
| Cycle 1 | All patients | Prednisolone (100 mg oral or intravenous) or dexamethasone (15 mg oral or intravenous) or equivalent | • 30-120 minutes prior to each weekly administration of epcoritamab • And for three consecutive days following each weekly administration of epcoritamab in Cycle 1 |
| • Diphenhydramine (50 mg oral or intravenous) or equivalent • Paracetamol (650 to 1 000 mg oral) | • 30-120 minutes prior to each weekly administration of epcoritamab | ||
| Cycle 2 and beyond | Patients who experienced Grade 2 or 3a CRS with previous dose | Prednisolone (100 mg oral or intravenous) or dexamethasone (15 mg oral or intravenous) or equivalent | • 30-120 minutes prior to next administration of epcoritamab after a grade 2 or 3a CRS event • And for three consecutive days following the next administration of epcoritamab until epcoritamab is given without subsequent CRS of Grade 2 or higher |
a Patients will be permanently discontinued from epcoritamab after a Grade 4 CRS event.
Prophylaxis against Pneumocystis jirovecii pneumonia (PCP) and herpes virus infections is strongly recommended especially during concurrent use of steroids.
Epcoritamab should be administered to adequately hydrated patients. Patients at an increased risk for clinical tumour lysis syndrome (CTLS) are recommended to receive hydration and prophylactic treatment with a uric acid lowering agent.
Patients should be monitored for signs and symptoms of CRS and/or immune effector cell-associated neurotoxicity syndrome (ICANS) following epcoritamab administration. Patients should be hospitalised for 24 hours after administration of the Cycle 1 Day 15 dose of 48 mg to monitor for signs and symptoms of CRS and/or ICANS. Patients should be counselled on the signs and symptoms associated with CRS and ICANS and on seeking immediate medical attention should signs or symptoms occur at any time.
A re-priming Cycle (identical to Cycle 1 with standard CRS prophylaxis) is required:
After the re-priming cycle, the patient should resume treatment with Day 1 of the next planned treatment cycle (subsequent to the cycle during which the dose was delayed).
It should be administered by subcutaneous injection only, preferably in the lower part of the abdomen or the thigh. Change of injection site from left to right side or vice versa is recommended especially during the weekly administration schedule (i.e., Cycles 1-3).
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