EPKINLY Dosage & Rx Info | Uses, Side Effects

Epkinly Generic Name & Formulations

Legal Class

General Description

Epcoritamab-bysp 4mg/0.8mL, 48mg/0.8mL; soln for SC inj; preservative-free.

Pharmacological Class

Bispecific CD20-directed CD3 T-cell engager.

How Supplied

Single-dose vial—1

Storage

Store refrigerated at 2°C to 8°C (36°F to 46°F). Keep in the original carton to protect from light. Do not freeze. Do not shake.

Manufacturer

Genmab US, Inc.

Generic Availability

Mechanism of Action

Epcoritamab-bysp is a T-cell engaging bispecific antibody that binds to the CD3 receptor expressed on the surface of T-cells and CD20 expressed on the surface of lymphoma cells and healthy B-lineage cells. In vitro, epcoritamab-bysp activated T-cells, caused the release of proinflammatory cytokines, and induced lysis of B-cells.

Epkinly Indications

Indications

In adults with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), including DLBCL arising from indolent lymphoma, and high-grade B-cell lymphoma after ≥2 lines of systemic therapy.

Epkinly Dosage and Administration

Adult

Premedicate with corticosteroid, antihistamine, and antipyretic prior to each dose in Cycle 1 (see full labeling). For SC inj only. Give in 28-day cycles until disease progression or unacceptable toxicity. Cycle 1: 0.16mg on Day 1, then 0.8mg on Day 8, then 48mg on Days 15 and 22. Cycles 2 and 3: 48mg on Days 1, 8, 15, and 22. Cycles 4–9: 48mg on Days 1 and 15. Cycle 10 and beyond: 48mg on Day 1. Should hospitalize patients for 24hrs after Cycle 1, Day 15 dosage. Restarting therapy after dose delay, dose modifications for adverse reactions: see full labeling.

Children

Not established.

Epkinly Contraindications

Not Applicable

Epkinly Boxed Warnings

Boxed Warning

Cytokine release syndrome (CRS). Immune effector cell-associated neurotoxicity syndrome (ICANS).

Epkinly Warnings/Precautions

Warnings/Precautions

Must be administered by a qualified healthcare professional. Have appropriate medical support available. Risk of CRS. Initiate Epkinly therapy with step-up dosing schedule and premedicate to reduce the risk of CRS. Ensure adequate hydration, monitor after administration. Monitor for ICANS, infections prior to and during treatment. Evaluate immediately if CRS or ICANS occurs; manage according to guidelines, and provide supportive care; withhold or discontinue based on severity (see full labeling). Active infections: avoid. Give PJP prophylaxis and consider herpes virus prophylaxis prior to initiation. Monitor CBCs during treatment. If cytopenias occur, temporarily withhold or permanently discontinue based on severity. Consider prophylactic granulocyte CSF as appropriate. Embryo-fetal toxicity. Advise females of reproductive potential to use effective contraception during and for 4 months after the last dose. Pregnancy: exclude status prior to initiation. Nursing mothers: not recommended (during and for 4 months after the last dose).

Epkinly Pharmacokinetics

Distribution

Apparent total volume of distribution: 25.6 L (82%).

Metabolism

Catabolic pathways.

Elimination

Half-life: ~22 days.

Epkinly Interactions

Interactions

May affect certain CYP substrates; monitor for toxicity or drug levels if concomitant use.

Epkinly Adverse Reactions

Adverse Reactions

Cytokine release syndrome, fatigue, musculoskeletal pain, inj site reactions, pyrexia, abdominal pain, nausea, diarrhea, lab abnormalities (decreased lymphocyte count, decreased neutrophil count, decreased WBC count, decreased hemoglobin, decreased platelets); ICANS, infections.

Epkinly Clinical Trials

Clinical Trials

The approval was based on data from the LBCL cohort of the open-label, multicenter phase 2 EPCORE NHL-1 trial (ClinicalTrials.gov Identifier: NCT03625037), which evaluated subcutaneous epcoritamab in patients with relapsed or refractory B-cell lymphoma.

The efficacy population included 148 patients with DLBCL, not otherwise specified, including DLBCL arising from indolent lymphoma, and high-grade B-cell lymphoma after 2 or more lines of systemic therapy, including an anti-CD20 monoclonal antibody-containing therapy.

Results showed an overall response rate (ORR; primary endpoint) of 61% (95% CI, 52.5-68.7), with 38% (95% CI, 30-46.2) of patients having a complete response and 23% (95% CI, 16.5-30.6) having a partial response. The median duration of response was 15.6 months (95% CI, 9.7, not reached).

Epkinly Note