Pronunciation: ep-cor-i-ta-mab
Generic name: epcoritamab-bysp
Brand name: Epkinly
Dosage form: injection, for subcutaneous use
Drug class: Bispecific T-cell engagers (BiTE)

Medically reviewed by Carmen Pope, BPharm. Last updated on Feb 28, 2025.

What is epcoritamab?

Epcoritamab (Epkinly) is prescribed for adult patients with specific B-cell lymphomas, including:

• Certain forms of diffuse large B-cell lymphoma (DLBCL)
• High-grade B-cell lymphoma
• Follicular lymphoma.

This medication is specifically for patients who:

• Have experienced disease recurrence after prior therapy
• Did not respond adequately to previous treatments
• Have undergone at least two different treatment regimens.

The treatment is administered as a subcutaneous injection (under the skin) with a dosing schedule that varies from weekly to monthly, depending on which phase of treatment the patient has reached.

The FDA granted accelerated approval for epcoritamab on May 19, 2023, under the brand name Epkinly. This special designation means the medication's continued approval may depend on additional confirmation of its benefits in ongoing clinical studies.

There is no generic for Epkinly.

How does epcoritamab work?

Epcoritamab (Epkinly) functions through an innovative dual-targeting approach in the immune system. The medication works by:

• Creating a bridge between two different immune cell types
• Attaching to CD20 proteins found on B cells (including cancerous B cells)
• Simultaneously binding to CD3 proteins present on T cells
• Facilitating direct contact between T cells and cancerous B cells
• Enhancing the T cells' ability to recognize and destroy the cancer cells.

This medication is classified as a Bispecific T-cell engager (BiTE), a newer category of immunotherapy that harnesses the body's immune system to target cancer more effectively by connecting cancer-fighting T cells directly to the cancerous B cells they need to eliminate.

Epcoritamab clinical trial summary

DLBCL Patient Outcomes

• Nearly two-thirds (61%) of participants showed positive treatment response.
• Benefits continued for approximately 1.3 years (15.6 months) median duration.
• Study focused on individuals whose cancer returned or resisted prior therapies.

Follicular Lymphoma Results

• Treatment effectiveness reached 82% among participating patients.
• The therapeutic effect persisted beyond 14.8 months for over half the participants.
• Participants had previously experienced treatment failure with standard approaches.

The EPCORE NHL-1 clinical investigation provided these efficacy findings for epcoritamab treatment in both lymphoma types.

See What is the success rate of Epkinly? for more information.

Epcoritamab side effects

The most common side effects of epcoritamab are:

• diarrhea
• fever
• injection site reactions
• muscle and bone pain
• nausea
• stomach-area (abdominal) pain
• tiredness.

Serious side effects and warnings

Epcoritamab carries a Boxed Warning for cytokine release syndrome (CRS) and Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS).

Cytokine Release Syndrome (CRS)

This immune system overreaction is common during treatment and can become serious or life-threatening. Seek immediate medical attention if you experience:

• Temperature of 100.4°F (38°C) or higher
• Dizziness or lightheadedness
• Breathing difficulties
• Chills or shaking (tremors)
• Accelerated heartbeat
• Feelings of anxiety
• Headache or confusion
• Balance or movement difficulties, including walking problems.

Special Dosing Approach for Safety:

• Treatment follows a gradual "step-up dosing schedule"
• You'll receive smaller initial doses on Day 1 and Day 8 of Cycle 1
• Your first full dose comes on Day 15 of Cycle 1
• Delayed doses may require repeating the step-up schedule
• Preventive medications will be given before doses in Cycle 1
• Your healthcare team will determine if preventive medications are needed in future cycles.

Neurologic Problems (ICANS)

Serious neurological issues may develop days or weeks after treatment, potentially becoming life-threatening. Alert your healthcare provider immediately if you notice:

• Speech or writing difficulties
• Disorientation or confusion
• Drowsiness or unusual fatigue
• Muscle weakness
• Tremors or seizures
• Memory issues.

Hospital Monitoring

Because of the risk of CRS and ICANS:

• 24-hour hospitalization follows your first full dose on Day 15 of Cycle 1
• Your healthcare team will monitor for CRS, neurologic problems, and other side effects
• Treatment may be temporarily or permanently discontinued if serious side effects occur.

Infections

Potentially fatal infections can occur. Report these symptoms immediately:

• Fever of 100.4°F (38°C) or higher
• Coughing or chest pain
• Unusual tiredness
• Breathing difficulties
• Painful rash
• Sore throat
• Painful urination
• General weakness or feeling unwell.

Low Blood Cell Counts

Regular blood tests will monitor for:

• Low white blood cells (neutropenia), increasing infection risk
• Low red blood cells (anemia), causing fatigue and shortness of breath
• Low platelets (thrombocytopenia), leading to bruising or bleeding problems.

Additional Information

• Safety and effectiveness in children has not been established
• This list doesn't include all possible side effects
• Report side effects to FDA at 1-800-FDA-1088
• Contact your doctor for medical advice about side effects.

Related/similar drugs

Before receiving epcoritamab

Before you receive treatment, tell your healthcare provider about all of your medical conditions, including if you:

• have an infection
• are pregnant or intend to become pregnant
• are breastfeeding.

Pregnancy

This medicine may cause harm to your unborn baby. Females who can become pregnant:

• Your healthcare provider should do a pregnancy test before you start treatment
• You should use effective birth control (contraception) during treatment, and for 4 months after your last dose
• Tell your healthcare provider if you become pregnant or think that you may be pregnant during treatment.

Breastfeeding

Do not breastfeed during treatment and for 4 months after your last dose of epcoritamab.

How is epcoritamab administered?

Epcoritamab will be given as an injection under your skin (subcutaneous injection) by your healthcare provider.

• It is usually given in the lower part of your stomach area (abdomen) or the upper, outer, thigh.
• Your treatment schedule is divided into cycles that are usually 28 days (4 weeks) long.
• Epcoritamab is usually given 1 time a week during Cycles 1 to 4, every 2 weeks from Cycle 4 to 9, and every 4 weeks starting with Cycle 10.
• Your healthcare provider will decide how many treatment cycles you will receive.

Your healthcare provider may hospitalize you for 24 hours after administration of the Cycle 1 Day 15 dosage of 48 mg.

Before administering epcoritamab, you may receive premedications to decrease the risk of CRS.

• These premedications may include a steroid such as prednisolone or dexamethasone or equivalent, an antihistamine such as diphenhydramine or equivalent, and acetaminophen.
• Premedications for the remaining cycles include prednisolone or dexamethasone or equivalent.

Dosing information

Adult Dose for Diffuse Large B-cell Lymphoma (DLBCL) or High-grade B-cell Lymphoma

The dose of epcoritamab for DLBCL or high-grade B-cell lymphoma depends on the Cycle and day of treatment. Your healthcare provider will calculate the dosage.

Adult Dose for Follicular Lymphoma (FL)

The dose of epcoritamab for FL depends on the Cycle and day of treatment. Your healthcare provider will calculate the dosage.

What should I avoid while receiving epcoritamab?

Epcoritamab may cause dizziness, confusion, tremors, sleepiness, or other symptoms that may impair your ability to drive or operate heavy machinery, and you should not do these tasks if you are impaired.

• These may be symptoms of CRS or neurologic problems and you should tell your healthcare provider right away.

What other drugs will affect this medication?

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Epcoritamab may cause small changes in the concentration of other medications that are metabolized by the CYP hepatic enzyme system. Monitor for any increase in side effects.

Epcoritamab causes the release of cytokines that may suppress the activity of CYP enzymes, and enhance the concentration of CYP substrates. This is more likely to occur after the first dose of epcoritamab and up to 14 days after the 48 mg dose.

Ingredients

Active ingredient: epcoritamab-bysp
Inactive ingredients (Epkinly): acetic acid, polysorbate 80, sodium acetate, sorbitol, and Water for Injection.

Who makes epcoritamab?

Epcoritamab is manufactured under the brand name Epkinly by Genmab, a Danish biotechnology company headquartered in Copenhagen, Denmark, in collaboration with AbbVie, an American biopharmaceutical company based in North Chicago, Illinois. Other notable drugs by these companies include:

• Genmab:
  • Darzalex - for multiple myeloma
  • Kesimpta - for multiple sclerosis
  • Tivdak - for cervical cancer.
• AbbVie:
  • Humira - for various autoimmune conditions
  • Rinvoq - for rheumatoid arthritis
  • Skyrizi - for psoriasis
  • Venclexta - for certain leukemias
  • Vraylar - for schizophrenia and bipolar disorder.

Epcoritamab Biosimilars

Biosimilar and interchangeable products are biological products that are highly similar to and have no clinically meaningful differences from the reference product.

Reference products

These are biological products that have already been approved by the FDA, against which biosimilar products are compared. There is 1 for epcoritamab.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Medical Disclaimer