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Drugs & Devices

EPKINLY

epcoritamab

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Primary source: US · Source publication:
Source checked:

EPKINLY · US package-label artwork; supplied packaging may differ.
US package-label artwork; supplied packaging may differ.
PRINCIPAL DISPLAY PANEL - 48 mg/0.8 mL Vial Carton

Clinical source excerpts are in English. Review the original label with your clinician.

What is it used for?

EPKINLY is indicated for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), not otherwise specified, including DLBCL arising from indolent lymphoma, and high-grade B-cell lymphoma after two or more lines of systemic therapy. This indication is approved under accelerated approval based on response rate and durability of response . Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). EPKINLY is indicated in combination with lenalidomide and rituximab for the treatment of adult patients with relapsed or refractory follicular lymphoma …

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This source does not establish current stock, import permission or personal eligibility in China. The treating clinician and provider must confirm these separately.

Product details

Active ingredient
epcoritamab
Form and strength
INJECTION, SOLUTION · 48 mg / 0.8 mL; INJECTION, SOLUTION · 4 mg / 0.8 mL
Manufacturer / applicant
GENMAB US, INC.

EPKINLY is a clear to slightly opalescent, colorless to slightly yellow solution for subcutaneous injection: Injection: 4 mg/0.8 mL in a single-dose vial Injection: 48 mg/0.8 mL in a single-dose vial

Safety and clinical review

Cytokine release syndrome (CRS), including serious or fatal reactions, can occur in patients receiving EPKINLY. Initiate treatment with the EPKINLY step-up dosage schedule to reduce the incidence and severity of CRS. Withhold EPKINLY until CRS resolves or permanently discontinue based on severity …

  • Cytokine Release Syndrome
  • Immune Effector Cell-Associated Neurotoxicity Syndrome
  • Infections
  • Cytopenias
  • Embryo-Fetal Toxicity

Ask your clinician to review the complete label, medical history, other medicines, allergies, pregnancy or breastfeeding and any required monitoring. Do not start, stop or change treatment from this page.

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Prepare your enquiry

Include the brand or generic name, strength, dosage form, requested quantity and country where care is needed. You can attach a prescription when you continue.

Questions patients ask

What is EPKINLY used for?

EPKINLY is indicated for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), not otherwise specified, including DLBCL arising from indolent lymphoma, and high-grade B-cell lymphoma after two or more lines of systemic therapy. This indication is approved under accelerated approval based on response rate and durability of response . Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). EPKINLY is indicated in combination with lenalidomide and rituximab for the treatment of adult patients with relapsed or refractory follicular lymphoma …

This source does not establish current stock, import permission or personal eligibility in China. The treating clinician and provider must confirm these separately.

Which formulation of EPKINLY should I ask about?

INJECTION, SOLUTION · 48 mg / 0.8 mL; INJECTION, SOLUTION · 4 mg / 0.8 mL

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What determines the price of EPKINLY?

A current quote depends on the exact presentation, quantity, provider and access arrangements. A catalogue entry is not a stock or delivery promise. Medical charges are paid to the provider, separately from coordination fees.

What should I check before using EPKINLY?

Ask your clinician to review the complete label, medical history, other medicines, allergies, pregnancy or breastfeeding and any required monitoring. Do not start, stop or change treatment from this page.

Sources and review scope

FDA prescribing information

Read the primary source

EPKINLY (EPCORITAMAB-BYSP) INJECTION, SOLUTION [GENMAB US, INC.]

Primary source: US · Source publication:
Source checked:

This source does not establish current stock, import permission or personal eligibility in China. The treating clinician and provider must confirm these separately.

More catalogue entries

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