Prescription medicine
Epcoritamab Brand names: Epkinly
Epcoritamab (Epkinly) is a prescription medicine. No generic is listed in FDA's NDC Directory.
- No generic listed
- Boxed warning
Check it at the source: the epcoritamab FDA label on DailyMed (effective June 22, 2026); every epcoritamab label on DailyMed.
Highlights of the record
FDA label of June 22, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
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 [see Dosage and Administration (2.1 , 2.2 , 2.6) and Warnings and Precautions (5.1) ]. 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 [see Dosage and Administration (2.1 , 2.2 , 2.6) and Warnings and Precautions (5.2) ]. WARNING: CYTOKINE RELEASE SYNDROME and IMMUNE EFFECTOR CELL-ASSOCIATED NEUROTOXICITY SYNDROME See full prescribing information for complete boxed warning. 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. […]
Used for
From the label: indications and usageEPKINLY 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.
Forms and strengths
- 4 mg/.8ml
- 48 mg/.8ml
Injection (solution).
On the market
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 1,272 through July 30, 2026
What is epcoritamab used for?
From the label: indications and usageEPKINLY 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. ( 1.1 ) 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). […]
Conditions named in the indications of epcoritamab's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: Bispecific CD20-directed CD3 T Cell Engager.
Source: FDA drug label (EPKINLY), Genmab US, Inc., effective June 22, 2026 (SPL set d7836711-b677-412d-bf2d-0f7c8444103a), via openFDA; the full label on DailyMed
What does the patient leaflet for epcoritamab say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What is the most important information I should know about EPKINLY?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. […]
From the patient leaflet: What should I avoid while receiving EPKINLY?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. See " What is the most important information I should know about EPKINLY? " for more information about signs and symptoms of CRS and neurologic problems.
Source: FDA drug label (EPKINLY), Genmab US, Inc., effective June 22, 2026 (SPL set d7836711-b677-412d-bf2d-0f7c8444103a), via openFDA; the full label on DailyMed
Is there a generic for epcoritamab (Epkinly)?
No generic epcoritamab is approved (Drugs@FDA, October 8, 2026).
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What does the epcoritamab label say about other medicines?
The epcoritamab label names 2 other medicines in its interaction, contraindication or warning sections. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Lenalidomide | warnings and precautions | CRS occurred in 24% (32/131) of patients with FL receiving EPKINLY at the recommended dosage schedule in combination with lenalidomide and rituximab in EPCORE FL-1, with Grade 1 CRS occurring in 19%, Grade 2 in 5% of patients, and serious adverse reactions due to CRS in 12%. |
| Rituximab | warnings and precautions | CRS occurred in 24% (32/131) of patients with FL receiving EPKINLY at the recommended dosage schedule in combination with lenalidomide and rituximab in EPCORE FL-1, with Grade 1 CRS occurring in 19%, Grade 2 in 5% of patients, and serious adverse reactions due to CRS in 12%. |
Source: FDA drug label (EPKINLY), Genmab US, Inc., effective June 22, 2026 (SPL set d7836711-b677-412d-bf2d-0f7c8444103a), via openFDA; the full label on DailyMed
What do FAERS reports show for epcoritamab?
The FDA Adverse Event Reporting System holds 1,272 reports that list epcoritamab among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 422 are coded as a death and 295 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as epcoritamab?
7 other medicines are given the same way (subcutaneous) and in the same FDA class as epcoritamab or labeled mainly for the same use (leukemia, lymphoma and myeloma), the same class first. Leukemia, lymphoma and myeloma lists all 98 medicines labeled for it, by any route. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (subcutaneous) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Elranatamab | Leukemia, lymphoma and myeloma | none listed | n/a | No current entry |
| Hyaluronidase and rituximab | Leukemia, lymphoma and myeloma | none listed | n/a | No current entry |
| Mosunetuzumab | Leukemia, lymphoma and myeloma | none listed | n/a | No current entry |
| Talquetamab | Leukemia, lymphoma and myeloma | none listed | n/a | No current entry |
| Teclistamab | Leukemia, lymphoma and myeloma | none listed | n/a | No current entry |
| Daratumumab and hyaluronidase | Leukemia, lymphoma and myeloma | none listed | n/a | No current entry |
| Isatuximab | Leukemia, lymphoma and myeloma | none listed | n/a | No current entry |
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Other bispecific cd20-directed cd3 t cell engagers
- the pharmacologic class, with prices and generics
- Epcoritamab side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other