Active Ingredient: Epcoritamab
Tepkinly in combination with lenalidomide and rituximab is indicated for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL).
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, 3 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. Afterwards, subcutaneous, 48 milligrams epcoritamab, once every 2 weeks, over the duration of 4 weeks. Afterwards, subcutaneous, 48 milligrams epcoritamab, once every 4 weeks.
Epcoritamab should be administered according to 28-day cycles for a total of 12 cycles or until disease progression or unacceptable toxicity, whichever occurs first.
Table 1. Epcoritamab 3-step step-up dose schedule in combination with lenalidomide and rituximab for patients with follicular lymphoma:
| Dosing schedule | Cycle of treatment | Days | Epcoritamab dose (mg) |
| Weekly | Cycle 1 | 1 | 0.16 mg (Step-up dose 1) |
| 8 | 0.8 mg (Step-up dose 2) | ||
| 15 | 3 mg (Step-up dose 3) | ||
| 22 | 48 mg (First full dose) | ||
| Cycles 2 and 3 | 1, 8, 15, and 22 | 48 mg | |
| Every four weeks | Cycles 4 to 12 | 1 | 48 mg |
Epcoritamab should be administered in combination with lenalidomide 20 mg orally once daily (from Day 1 to Day 21) in Cycles 1-12 and rituximab 375 mg/m² intravenously every week in Cycle 1 (on Days 1, 8, 15, and 22) and every 4 weeks in Cycles 2-5 (on Day 1).
For additional information, refer to the Summary of Product Characteristics (SmPC) of the lenalidomide and rituximab products.
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-medicationa | Administration |
|---|---|---|---|
| Cycle 1 | All patients | Dexamethasone (15 mg oral or intravenous) or Prednisolone (100 mg oral or intravenous) or equivalent • Dexamethasone is the preferred corticosteroid for CRS prophylaxisc | • 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 3b CRS with previous dose | Dexamethasone (15 mg oral or intravenous) or Prednisolone (100 mg oral or intravenous) or equivalent • Dexamethasone is the preferred corticosteroid for CRS prophylaxisc | • 30-120 minutes prior to next administration of epcoritamab after a grade 2 or 3b CRS event • And for three consecutive days following the next administration of epcoritamab until epcoritamab is given without subsequent any grade of CRS |
a Premedication used for combination agents may serve as premedication for epcoritamab at the discretion of the treating physician, provided that the doses administered are at least equivalent.
b Patients will be permanently discontinued from epcoritamab after a Grade 4 CRS event.
c Based on the GCT3013-01 Optimisation study.
Prophylaxis against Pneumocystis jirovecii pneumonia (PCP) and herpes virus infections is strongly recommended during treatment with epcoritamab.
Epcoritamab should be administered to adequately hydrated patients.
It is strongly recommended that all patients adhere to the following fluid guidelines during Cycle 1, unless medically contraindicated:
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) and managed per current practice guidelines following epcoritamab administration. 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.
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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