EPKINLY

Formula & Concentration

EPKINLY- epcoritamab-bysp injection, solution

Manufacturer

Genmab US, Inc.

Indications

EPKINLY is a bispecific CD20-directed CD3 T-cell engager indicated for the treatment of:

Diffuse Large B-cell Lymphoma and High-grade B-cell Lymphoma

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. (1.1)
Follicular Lymphoma

adult patients with relapsed or refractory follicular lymphoma (FL) after two or more lines of systemic therapy. (1.2)
These indications are approved under accelerated approval based on response rate and durability of response. Continued approval for these indications may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

Product Options

Package Size

NDC #

Presentation

4 mg

82705-0002-01

Vial

48 mg

82705-0010-01

Vial

Shelf Life and 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.