Epkinly, illustration of tablet bottle form (not a photo of the actual pack)

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Epkinly

Epcoritamab

Prescription required

$1240.00

4mg/0.8ml · 1 bottle

BrandBranded medicine· By Abbvie

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4mg/0.8ml

48mg/0.8ml

FDA boxed warningCytokine release syndrome and immune effector cell-associated neurotoxicity syndrome

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.

Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS), including life-threatening and fatal reactions, can occur with EPKINLY. Monitor patients for neurological signs or symptoms of ICANS during treatment. Withhold EPKINLY until ICANS resolves or permanently discontinue based on severity.

Read this with the rest of the clinical information

About Epkinly

Overview

Epkinly (epcoritamab-bysp) is an antibody medicine given by injection under the skin. It treats adults with certain forms of diffuse large B-cell lymphoma (including disease arising from slow-growing lymphoma) or high-grade B-cell lymphoma that has returned or not responded after at least two previous systemic treatments. It also treats follicular lymphoma that has returned or not responded to treatment, either with lenalidomide and rituximab or on its own after at least two previous systemic treatments. It works by binding to CD3 on T cells and CD20 on lymphoma cells and healthy B cells, activating T cells to attack these B cells.

What it treats

- Relapsed or refractory diffuse large B-cell lymphoma (DLBCL), not otherwise specified, including DLBCL arising from indolent lymphoma, and high-grade B-cell lymphoma in adults after two or more lines of systemic therapy. This indication has accelerated approval; continued approval may depend on confirmation of clinical benefit. - Relapsed or refractory follicular lymphoma in adults, in combination with lenalidomide and rituximab. - Relapsed or refractory follicular lymphoma in adults, used alone after two or more lines of systemic therapy.

Safety information

Side effects

Common side effects of Epkinly used alone include cytokine release syndrome (CRS), injection-site reactions, tiredness, muscle and bone pain, fever, diarrhea, COVID-19, rash and abdominal pain. When used with lenalidomide and rituximab, common side effects include rash, upper respiratory tract infections, tiredness, injection-site reactions, constipation, diarrhea, CRS, pneumonia, COVID-19 and fever. Serious side effects that warrant contacting a doctor include CRS, immune effector cell-associated neurotoxicity syndrome (a nervous system reaction), infections and low blood cell counts. Infections can be serious or fatal; contact your doctor if you develop signs or symptoms of infection. Severe decreases in certain white blood cells and platelets can occur. Severe decreases in hemoglobin can also occur when Epkinly is used alone. Blood cell counts must be monitored during treatment. Epkinly may harm an unborn baby. If you can become pregnant, use effective contraception and contact your doctor if you become pregnant during treatment.

FDA boxed warning

Cytokine release syndrome and immune effector cell-associated neurotoxicity syndrome

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.

Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS), including life-threatening and fatal reactions, can occur with EPKINLY. Monitor patients for neurological signs or symptoms of ICANS during treatment. Withhold EPKINLY until ICANS resolves or permanently discontinue based on severity.

A boxed warning is the strongest warning the US Food and Drug Administration requires on a medicine label. Text is taken from the official label, with internal section references removed.

When to call your doctor

- Seek medical attention immediately for fever or other signs of infection. - Seek medical attention immediately for new or worsening symptoms affecting brain or nerve function.

If symptoms are severe or getting worse quickly, seek emergency care rather than waiting.

Before taking this medicine

The label lists no contraindications for Epkinly. However, it can cause serious or fatal infections, including opportunistic infections. Patients should be monitored for signs of infection and treated as needed. Complete blood cell counts should also be monitored during treatment because of the risk of low blood cell counts. Epkinly may harm an unborn baby. Women who could become pregnant should use effective contraception. Do not breastfeed during treatment.

Interactions

Epkinly can increase blood levels of some medicines broken down by liver enzymes called CYP enzymes. For certain medicines, even small increases can cause serious side effects. Tell your doctor about other medicines you take; they may need to monitor drug levels or signs of toxicity. This interaction is more likely early in treatment and during and after cytokine release syndrome (CRS).

Using Epkinly

Dosing

Dosing is set by your prescriber. Each health care professional may prescribe medication differently according to a patient's medical history and condition, so follow the directions on your prescription label and speak to your doctor or pharmacist before changing anything.

Storage

Store below 25°C in a dry place with the bottle tightly closed, away from direct light and moisture. Keep all medicines out of the sight and reach of children.

Clinical information on this page is summarised from the US FDA label EPKINLY (EPCORITAMAB-BYSP) INJECTION, SOLUTION [GENMAB US, INC.] (DailyMed, retrieved 19 September 2026).

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