Epcoritamab 48mg/0.8ml solution for injection vials
Requires a prescription from a doctor or prescriber
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Safety monitoring data
Yellow Card reports
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Data from the MHRA Yellow Card scheme. A reported reaction does not necessarily mean the medicine caused it. Contains public sector information licensed under the Open Government Licence v3.0.
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Suspected adverse reactions reported for Epcoritamab
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1 branded products available
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Tepkinly 48mg/0.8ml solution for injection vials
Therapeutically similar medicines
Similarity is based on WHO Anatomical Therapeutic Chemical (ATC) classification and on a factual NHS dm+d therapeutic-grouping code prefix. Source data: NHS dm+d via TRUD (OGL v3.0), WHO ATC/DDD Index.
NHS prescribing volume and spending trends
Guidelines from the National Institute for Health and Care Excellence
NICE clinical guidance(5)
Epcoritamab for treating relapsed or refractory diffuse large B-cell lymphoma after 2 or more systemic treatments (TA954)
Epcoritamab for treating relapsed or refractory follicular lymphoma after 2 or more lines of systemic treatment (TA1139)
Non-Hodgkin lymphoma: diagnosis and management (NG52)
Glofitamab with gemcitabine and oxaliplatin for treating relapsed or refractory diffuse large B-cell lymphoma (TA1113)
Lisocabtagene maraleucel for treating relapsed or refractory large B-cell lymphoma after first-line chemoimmunotherapy when a stem cell transplant is suitable (TA1048)
Source: National Institute for Health and Care Excellence (NICE). Contains public sector information licensed under the Open Government Licence v3.0.
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Pharmacy links redirect to the retailer's own search and do not represent real-time stock levels. Shortage and safety information sourced from MHRA drug safety updates (gov.uk, Crown Copyright under OGL v3.0).
Codes for healthcare professionals and prescribing systems
These codes are used by healthcare IT systems and prescribers to identify this medicine.
NHS UK identifiers
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SNOMED CT and dm+d codes from NHS TRUD (Technology Reference data Update Distribution), licensed under the Open Government Licence v3.0. ATC codes from the WHO Collaborating Centre for Drug Statistics Methodology (whocc.no).
Active and completed clinical studies from ClinicalTrials.gov
Source: ClinicalTrials.gov, a database of the U.S. National Library of Medicine (NLM), National Institutes of Health (NIH). Data accessed via ClinicalTrials.gov API v2. Trial information is provided for research purposes and does not constitute medical advice.
Academic studies and reviews for this medicine's active substance
Showing the 50 most relevant studies.
Reviews & meta-analyses: 6 · Randomised trials: 3 · 2022–2026
Showing the 50 most relevant studies, sorted by most relevant.
S. Naqvi, Sara Yousaf, A. Najafi, et al.
Clinical Lymphoma Myeloma and Leukemia, 2025
S. Naqvi, Sara Yousaf, A. Najafi, et al.
Clinical Lymphoma Myeloma and Leukemia, 2025
C. Thieblemont, T. Phillips, H. Ghesquières, et al.
Journal of Clinical Oncology, 2022
L. Falchi, M. Nijland, Huiqiang Huang, et al.
Lancet, 2025
- Lymphoma, Follicular
- Antineoplastic Combined Chemotherapy Protocols
- Antibodies, Bispecific
Umberto Vitolo, Juan Miguel Bergua Burgues, Johannes Duell, et al.
The Lancet Haematology, 2026
- Antineoplastic Combined Chemotherapy Protocols
- Lymphoma, Large B-Cell, Diffuse
- Antibodies, Monoclonal, Humanized
Sandeep S. Raj, Alli Bock, Sharmila Giri, et al.
Blood, 2025
C. Thieblemont, Yasmin H Karimi, H. Ghesquières, et al.
Leukemia, 2024
K. Linton, U. Vitolo, Wojciech Jurczak, et al.
The Lancet. Haematology, 2024
Atsushi Takahata, Tomohito Shimada, Kana Bando, et al.
Annals of Hematology, 2025
- Pleural Effusion, Malignant
- Pleural Effusion
- Antibodies, Bispecific
Epcoritamab, a bispecific T-cell engager (BiTE) antibody targeting CD3 and CD20, has shown significant efficacy in treating refractory diffuse large B-cell lymphoma (DLBCL). However, its use can lead to severe side effects, such as tumor flare. Here, we report the case of an 84-year-old male with relapsed DLBCL who developed fatal unilateral pleural effusion following Epcoritamab treatment. Initially, the patient showed a favorable response, but later developed significant pleural effusion with elevated interleukin-6 (IL-6) levels, indicating a severe inflammatory response. This suggests that Epcoritamab directly affected the pleural lesions and caused a local cytokine release syndrome (L-CRS). Despite aggressive management, including Tocilizumab and Dexamethasone, the patient’s condition worsened, leading to his death. This case underscores the importance of regular lab tests and imaging follow-ups to monitor and manage severe inflammatory reactions based on tumor location. Comprehensive monitoring protocols are needed to mitigate risks associated with novel immunotherapies. To our knowledge, this is the first reported case of fatal unilateral pleural effusion in a patient with relapsed DLBCL following Epcoritamab treatment.
Abstract licence: CC BY-NC-ND 4.0
Atsushi Takahata, Kaori Akita, Tomohito Shimada, et al.
Journal of Clinical and Experimental Hematopathology, 2025
- Neurotoxicity Syndromes
- Interleukin-6
- Antibodies, Bispecific
Immune effector cell-associated neurotoxicity syndrome (ICANS) is a serious complication observed in patients receiving advanced immunotherapies such as bispecific antibodies and CAR-T cell therapies. Although the Immune Effector Cell-Associated Encephalopathy (ICE) score is commonly used to assess ICANS severity, its diagnostic accuracy can be compromised by factors such as concomitant medications, underlying comorbidities, and other external influences. This case report discusses a patient with diffuse large B-cell lymphoma who developed ICANS while receiving Epcoritamab. Notably, elevated interleukin-6 (IL-6) levels in the cerebrospinal fluid (CSF) correlated with the patient’s clinical course of neurotoxicity. In contrast to conventional scoring systems, which can be affected by unrelated factors, CSF IL-6 levels appeared to more directly reflect the severity and progression of ICANS. These findings are consistent with similar reports from patients treated with CAR-T cells, suggesting that CSF IL-6 may serve as a reliable marker for ICANS progression. Further research that systematically measures CSF IL-6 in diverse clinical contexts could help validate its role as a biomarker, enhancing diagnostic precision and guiding optimal management strategies for ICANS.
Abstract licence: CC BY-NC-SA
Sources: aggregated from Europe PMC (EMBL-EBI), OpenAlex, Crossref, PubMed and other open scholarly databases. Retracted articles are excluded. Study information is provided for research purposes and does not constitute medical advice.
Pharmacology and chemical data from DrugBank
Key facts
Drug status
Approved
Major interactions
None known
Half-life
22 days
Mechanism
Epcoritamab is a humanized bispecific IgG1 antibody that targets CD20 on B-cells and CD3 on T-cells.
Food interactions
None known
Human targets
2 targets
Data: DrugBank · CC BY-NC 4.0
Pharmacokinetics at a glance
Absorption
1.5 to 60 mg
Half-life
48 mg
[L46516]
Protein binding
Volume of distribution
25.6 L
[L46516]
Metabolism
[L46516]
Elimination
Clearance
48 mg
[L46516]
Pharmacokinetic data: DrugBank · CC BY-NC 4.0
The use of epcoritamab may lead to cytokine release syndrome and immune effector cell-associated neurotoxicity syndrome.[L46516] It is administered subcutaneously and is currently being evaluated as a monotherapy and in combination for the treatment of a variety of hematologic malignancies. In May 2023, epcoritamab was approved by the FDA under accelerated approval for the treatment of relapsed or refractory DLBCL. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).[L46516][L46556] In September 2023, epcoritamab was also approved in the EU for the same indication.[L49464] In November 2025, epcoritamab in combination with rituximab and lenalidomide was approved by the FDA for adult patients with relapsed or refractory follicular lymphoma.[L54713]
[L46516][L49459]
Epcoritamab is also indicated for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) after two or more lines of systemic therapy.
[L51214]
These indications are approved under accelerated approval based on response rate and durability of response. Their continued approval may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).
Epcoritamab, in combination with lenalidomide and rituximab, is also indicated for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL).
[L54713]
Known interactions with other medicines. Always consult a healthcare professional.
Showing 50 of 993 interactions
[L46516]
Symptomatic and supportive measures are recommended. The carcinogenicity or genotoxicity of epcoritamab has not been evaluated.
No dedicated fertility studies have been conducted with epcoritamab.
[L46516]
The use of epcoritamab can cause cytokine release syndrome as well as life-threatening and fatal immune effector cell-associated neurotoxicity syndrome. It may also cause infections, cytopenias and embryo-fetal toxicity.[L46516]
How the body processes this drug — absorption, distribution, metabolism, and elimination
[L46516]
[L46516]
[L46516]
[L46516]
[L46516]
Proteins and enzymes this drug interacts with in the body
PMID:12920111 PMID:3925015 PMID:7684739
Functions as a store-operated calcium (SOC) channel component promoting calcium influx after activation by the B-cell receptor/BCR PMID:12920111 PMID:18474602 PMID:7684739
Upon TCR engagement, these motifs become phosphorylated by Src family protein tyrosine kinases LCK and FYN, resulting in the activation of downstream signaling pathways .
PMID:2470098
In addition of this role of signal transduction in T-cell activation, CD3E plays an essential role in correct T-cell development. Initiates the TCR-CD3 complex assembly by forming the two heterodimers CD3D/CD3E and CD3G/CD3E. Also participates in internalization and cell surface down-regulation of TCR-CD3 complexes via endocytosis sequences present in CD3E cytosolic region .
PMID:10384095 PMID:26507128
In addition to its role as a TCR coreceptor, it serves as a receptor for ITPRIPL1.
Ligand recognition inhibits T-cell activation by promoting interaction with NCK1, which prevents CD3E-ZAP70 interaction and blocks the ERK-NFkB signaling cascade and calcium influx PMID:38614099
ATC L01FX27
Chemical identifiers
CAS, UNII, InChI Key and database cross-references
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Chemical identifiers
CAS, UNII, InChI Key and database cross-references
Linked compound data from DrugBank Open Data (CC BY-NC 4.0)
Epcoritamab
Additional database identifiers
Drugs Product Database (DPD)
23879
HUGO Gene Nomenclature Committee (HGNC)
HGNC:7315
GenAtlas
MS4A1
GeneCards
MS4A1
GenBank Gene Database
X12530
GenBank Protein Database
29774
Guide to Pharmacology
2628
UniProt Accession
CD20_HUMAN
HUGO Gene Nomenclature Committee (HGNC)
HGNC:1674
GenAtlas
CD3E
GeneCards
CD3E
GenBank Gene Database
X03884
GenBank Protein Database
469945
Guide to Pharmacology
2742
UniProt Accession
CD3E_HUMAN
DrugBank citations
If you use DrugBank data in your research, please cite:
- DrugBank 6.02024Recommended citationKnox C., Wilson M., Klinger C.M., et alDrugBank 6.0: the DrugBank Knowledgebase for 2024Nucleic Acids Res. 2024 Jan 552(D1):D1265-D1275
- DrugBank 5.02018Wishart D.S., Feunang Y.D., Guo A.C., et alDrugBank 5.0: a major update to the DrugBank database for 2018Nucleic Acids Res. 2017 Nov 846(D1):D1074-D1082
- DrugBank 4.02014Law V., Knox C., Djoumbou Y., et alDrugBank 4.0: shedding new light on drug metabolismNucleic Acids Res. 2014 Jan 142(1):D1091-7
- DrugBank 3.02011Knox C., Law V., Jewison T., et alDrugBank 3.0: a comprehensive resource for 'omics' research on drugsNucleic Acids Res. 2011 Jan39(Database issue):D1035-41
- DrugBank 2.02008Wishart D.S., Knox C., Guo A.C., et alDrugBank: a knowledgebase for drugs, drug actions and drug targets.Nucleic Acids Research2008 Jan36(Database issue):D901-6
- DrugBank 1.02006Wishart D.S., Knox C., Guo A.C., et alDrugBank: a comprehensive resource for in silico drug discovery and exploration.Nucleic Acids Research2006 Jan 134(Database issue):D668-72