Epcoritamab

What it is used for

EPKINLY is a bispecific CD20-directed CD3 T-cell engager 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). In combination with lenalidomide and rituximab for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL). As monotherapy for the treatment of adult patients with relapsed or refractory FL after two or more lines of systemic therapy.

1.1 DLBCL and High-grade B-cell Lymphoma 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). 1.2 Follicular Lymphoma EPKINLY is indicated in combination with lenalidomide and rituximab for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL). EPKINLY is indicated as monotherapy for the treatment of adult patients with relapsed or refractory FL after two or more lines of systemic therapy.

The most important thing to know

EPKINLY can cause serious side effects, including: Cytokine Release Syndrome (CRS). CRS is common during treatment with EPKINLY and can also be serious or lead to death. Tell your healthcare provider or get medical help right away if you develop any signs or symptoms of CRS, including: fever of 100.4°F (38°C) or higher dizziness or light-headedness trouble breathing chills fast heartbeat feeling anxious headache confusion shaking (tremors) problems with balance and movement, such as trouble walking Due to the risk of CRS, you will receive EPKINLY on a "step-up dosing schedule".

The step-up dosing schedule is when you receive 2 or 3 smaller "step-up" doses of EPKINLY during your first cycle of treatment (Cycle 1). You will receive your first full dose of EPKINLY a week after your last step-up dose (this will be Day 15 or Day 22 of Cycle 1). If your dose of EPKINLY is delayed for any reason, you may need to repeat the "step-up dosing schedule".

Before each dose in Cycle 1, you will receive medicines to help reduce your risk of CRS. You will also receive medicine for 3 days after each dose in Cycle 1. Your healthcare provider will decide if you need to receive medicine to help reduce your risk of CRS with future cycles. See " How will I receive EPKINLY? " for more information about how you will receive EPKINLY.

Neurologic problems. EPKINLY can cause serious neurologic problems that can be life-threatening and lead to death. Neurologic problems may happen days or weeks after you receive EPKINLY. Your healthcare provider may refer you to a healthcare provider who specializes in neurologic problems. Tell your healthcare provider right away if you develop any signs or symptoms of neurologic problems, including: trouble speaking or writing confusion and disorientation drowsiness tiredness or lack of energy muscle weakness shaking (tremors) seizures memory loss Your healthcare provider will monitor you for signs and symptoms of CRS and neurologic problems during treatment with EPKINLY, as well as other side effects and treat you if needed.

Your healthcare provider may temporarily stop or completely stop your treatment with EPKINLY if you develop CRS, neurologic problems, or any other side effects that are severe. People with diffuse large B-cell lymphoma (DLBCL) or high-grade B-cell lymphoma may be hospitalized after receiving their first full dose of EPKINLY on Day 15 of Cycle 1 due to the risk of CRS and neurologic problems.

People with follicular lymphoma (FL) may be hospitalized after receiving their first full dose of EPKINLY on Day 22 of Cycle 1 due to the risk of CRS and neurologic problems. See "

Side effects, and when to stop

" for more information about side effects. What is EPKINLY? EPKINLY is a prescription medicine used to treat adults with: certain types of DLBCL or high-grade B-cell lymphoma that has come back (relapsed) or that did not respond (refractory), after 2 or more treatments. follicular lymphoma that has come back or that did not respond to previous treatment, together with lenalidomide and rituximab.

follicular lymphoma that has come back or that did not respond after 2 or more treatments. It is not known if EPKINLY is safe and effective in children. Before receiving EPKINLY, tell your healthcare provider about all of your medical conditions, including if you: have an infection. are pregnant or plan to become pregnant.

EPKINLY may harm your unborn baby. Females who are able to become pregnant: Your healthcare provider should do a pregnancy test before you start treatment with EPKINLY. You should use effective birth control (contraception) during treatment and for 4 months after your last dose of EPKINLY. Tell your healthcare provider if you become pregnant or think that you may be pregnant during treatment with EPKINLY.

are breastfeeding or plan to breastfeed. It is not known if EPKINLY passes into your breast milk. Do not breastfeed during treatment and for 4 months after your last dose of EPKINLY. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

How will I receive EPKINLY? EPKINLY will be given to you by your healthcare provider as an injection under your skin (subcutaneous injection), usually in the lower part of your stomach-area (abdomen) or thigh. Your EPKINLY treatment schedule is divided into cycles that are usually 28 days (4 weeks) long. Your healthcare provider will decide how many treatment cycles you will receive and how often you will receive EPKINLY in each cycle.

for more information about how you will receive EPKINLY.

What to avoid

Do not drive, operate heavy machinery, or do other dangerous activities if you develop dizziness, confusion, tremors, sleepiness, or any other symptoms that impair consciousness until your signs and symptoms go away. These may be signs and symptoms of CRS or neurologic problems. for more information about signs and symptoms of CRS and neurologic problems.

What are the possible side effects of EPKINLY? EPKINLY can cause serious side effects, including: Infections. EPKINLY can cause serious infections that may lead to death. Your healthcare provider will check you for signs and symptoms of infection before and during treatment with EPKINLY. Your healthcare provider should prescribe medicines before you start treatment to help prevent infection and treat you as needed if you develop an infection during treatment with EPKINLY.

Tell your healthcare provider right away if you develop any signs or symptoms of infection during treatment with EPKINLY, including: fever of 100.4°F (38°C) or higher cough chest pain tiredness shortness of breath painful rash sore throat pain during urination feeling weak or generally unwell confusion Low blood cell counts.

EPKINLY can cause low blood cell counts which can be serious or severe. Your healthcare provider will check your blood cell counts during treatment with EPKINLY. EPKINLY may cause the following low blood cell counts: low white blood cell counts (neutropenia and lymphopenia). Low white blood cells can increase your risk for infection.

low red blood cell counts (anemia). Low red blood cells can cause tiredness and shortness of breath. low platelet counts (thrombocytopenia). Low platelet counts can cause bruising or bleeding problems. Your healthcare provider may temporarily stop or completely stop treatment with EPKINLY if you develop certain side effects.

The most common side effects of EPKINLY when used alone in DLBCL or high-grade B-cell lymphoma or FL include: CRS injection site reactions tiredness muscle and bone pain fever diarrhea COVID-19 rash stomach area (abdominal pain) The most common severe abnormal laboratory test results with EPKINLY when used alone in DLBCL or high-grade B-cell lymphoma or FL include: decreased white blood cells, decreased red blood cells, and decreased platelets.

The most common side effects of EPKINLY when used together with lenalidomide and rituximab in follicular lymphoma include: rash upper respiratory tract infections tiredness injection site reactions constipation diarrhea CRS pneumonia COVID-19 fever The most common severe abnormal laboratory test results with EPKINLY when used together with lenalidomide and rituximab in follicular lymphoma include: decreased white blood cells and decreased platelets.

These are not all of the possible side effects of EPKINLY. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. General information about safe and effective use of EPKINLY. Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide.

You can ask your pharmacist or healthcare provider for information about EPKINLY that is written for health professionals. What are the ingredients in EPKINLY? Active ingredient: epcoritamab-bysp Inactive ingredients: acetic acid, polysorbate 80, sodium acetate, sorbitol and Water for Injection. Manufactured by: Genmab US, Inc., Plainsboro, NJ 08536 U.S.

License Number: 2293 Marketed by: Genmab US, Inc., Plainsboro, NJ 08536 and AbbVie Inc., North Chicago, IL 60064 EPKINLY is a registered trademark owned by Genmab A/S ©2026 Genmab A/S For more information, go to www.EPKINLY.com or call 1-855-4GENMAB (1-855-443-6622)