Epkinly Epcoritamab Application Scope

Epkinly is indicated for the treatment of adult patients with relapsed or refractory B-cell non-Hodgkin lymphoma, including:

Diffuse Large B-Cell Lymphoma (DLBCL), not otherwise specified, after ≥2 lines of systemic therapy
Follicular Lymphoma (FL), relapsed or refractory, after prior systemic therapies

Epcoritamab Characteristics

Ingredients: The active ingredient is epcoritamab-bysp with standard pharmaceutical excipients used for formulation stability.
Properties: Epcoritamab is a sterile, clear to slightly opalescent, colorless to pale yellow solution for subcutaneous injection.
Packaging Specification: Epcoritamab is supplied in single-dose vials containing 4 mg/0.8 mL or 48 mg/0.8 mL solution.
Storage: Epcoritamab should be stored refrigerated at 2°C–8°C and protected from light without freezing or shaking.
Expiry Date: The shelf life is typically 18–24 months depending on the labeled expiration date of each batch.
Executive Standard: Epkinly is manufactured under ICH, FDA/EMA, and NMPA biologics quality standards.
Approval Number: Epkinly was approved by the FDA under BLA 761291 for relapsed or refractory B-cell lymphomas.
Date of Revision: The most recent label updates were issued between 2024 and 2025 depending on regional regulatory authorities.
Manufacturer: Genmab A/S and AbbVie Inc.

Dosage and Administration:
- Recommended Dose: The recommended dosing begins with step-up doses followed by weekly or extended maintenance dosing depending on treatment response.
- Administration: Epkinly is administered by subcutaneous injection under medical supervision, especially during initial doses.
- Missed Dose: If a dose is missed, it should be given as soon as possible and the dosing schedule should be adjusted accordingly without doubling doses.
Adverse Reactions:
- Common Adverse Reactions: Common adverse reactions include cytokine release syndrome, fatigue, fever, and hematologic abnormalities.
- Serious Adverse Reactions: Serious adverse reactions may include severe cytokine release syndrome, infections, cytopenias, and rare neurologic toxicities.
Contraindications: Epkinly is contraindicated in patients with known hypersensitivity to epcoritamab or its excipients.
Precautions:
- Risk of Cytokine Release Syndrome (CRS)
- Infection monitoring required
- Hepatitis B reactivation screening recommended
- Avoid live vaccines during treatment
- Monitor blood counts regularly
- Administer step-up dosing under medical supervision

Immunosuppressants may reduce T-cell mediated efficacy
Caution with:
- Corticosteroids (high-dose systemic use)
- Other immunomodulatory therapies
No major CYP enzyme interactions expected (biologic drug)

Note:

If there is a new packaging for the drug, the new packaging shall prevail. The above information is sourced from DengYue Medicine.
This content is for reference only. Prescription drugs must be used under a doctor’s guidance and purchased from authorized sources.