Epcoritamab is an active pharmaceutical ingredient in the Other Monoclonal Antibodies and Antibody Drug Conjugates group (L01FX). The information below is compiled per regulator from the product labels on record, with direct links to the original documents.
GBOfficial regulatory label· revised May 15, 2026[1]
Tepkinly (epcoritamab), as monotherapy, is indicated for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) after two or more lines of systemic therapy. Tepkinly as monotherapy is indicated for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) after two or more lines of systemic therapy.
How to take
CACanada· Health Canada
2 products
How to take
CAOfficial regulatory label· revised October 24, 2025[2]
). 5. Overdose In the event of overdose, monitor the patient for any signs or symptoms of adverse reactions and administer appropriate supportive treatment. For the most recent information in the management of a suspected drug overdose, contact your regional poison control centre or Health Canada’s toll-free number, 1-844 POISON-X (1-844-764- 7669).
6. Dosage Forms, Strengths, Composition, and Packaging Table 6. 8 mL (60 mg/mL) single dose vial The vial stopper is not made from natural rubber latex (made of bromobutyl rubber). 7. Warnings and Precautions Please see 3 SERIOUS WARNINGS AND PRECAUTIONS BOX.
Driving and Operating Machinery EPKINLY may have an influence on the ability to drive or operate machinery. , symptoms of CRS or ICANS, such as pyrexia, tachycardia, hypotension, chills, hypoxia, depressed level of consciousness) should be advised not to drive or use machines until symptoms resolve.
Endocrine and Metabolism Tumour Lysis Syndrome Tumour Lysis Syndrome (TLS) has been reported in patients receiving EPKINLY (see 8 ADVERSE REACTIONS). Patients at an increased risk for TLS are recommended to receive hydration and prophylactic treatment with a uric acid lowering agent.
EUEuropean Union· EMA
1 product
Uses
EUOfficial regulatory label· revised February 6, 2026[3]
Tepkinly as monotherapy is indicated for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) after two or more lines of systemic therapy. Tepkinly as monotherapy is indicated for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) after two or more lines of systemic therapy.
[1]MHRA (UK) · PLGB410420093 · revised May 15, 2026
[2]Health Canada (DPD) · 02542293 · revised October 24, 2025
[3]European Medicines Agency · EMEA/H/C/005985 · revised February 6, 2026
Information on this page is compiled from public regulatory records. Drugvu is not affiliated with any regulator or pharmaceutical manufacturer. This is not medical advice. Always consult a qualified healthcare professional.
4). Posology Recommended pre-medication and dose schedule Details on recommended premedication for cytokine release syndrome (CRS) are shown in Table 1. Table 1 - Epcoritamab premedication and CRS prophylaxis Cycle Patient requiring premedication Premedication Corticosteroid prophylaxis Cycle 1 All patients 30-120 minutes prior to each weekly administration of epcoritamab • Dexamethasoneb (15 mg oral or intravenous) or Prednisolone (100 mg oral or IV) or equivalent • Diphenhydramine (50 mg oral or IV) or equivalent • Paracetamol (1000 mg oral) Prednisolone (100 mg oral or IV) or equivalent for three consecutive days following each weekly administration of epcoritamab in Cycle 1 Cycle 2 and beyond Patients who experienced Grade 2 or 3a CRS with previous dose 30-120 minutes prior to next administration of epcoritamab after a grade 2 or 3a CRS event • Dexamethasone b (15 mg oral or intravenous) or Prednisolone (100 mg oral or Prednisolone (100 mg oral or IV) or equivalent for three consecutive days following the next administration of epcoritamab until epcoritamab is given without subsequent CRS of any grade IV) or equivalent a Patients will be permanently discontinued from epcoritamab after a Grade 4 CRS event.
bDexamethasone is the preferred corticosteroid for CRS prophylaxis based on the GCT3013-01 Optimisation study. Administer Tepkinly according to the step-up dose schedule in 28-day cycles outlined in Table 2 for patients with diffuse large B-cell lymphoma and Table 3 for patients with follicular lymphoma.
Tepkinly is for subcutaneous (SC) injection only. 8 mg is an intermediate dose and 48 mg is a full dose. Tepkinly should be administered until disease progression or unacceptable toxicity. e. an initial transient increase in tumour size or small new lesions within the first few months followed by tumour shrinkage) have been observed.
It is recommended to continue treatment for clinically stable patients with initial evidence of disease progression until disease progression is confirmed. Tepkinly should be administered to well hydrated patients. Prophylaxis against Pneumocystis jirovecii pneumonia (PCP) and herpes virus infections is strongly recommended especially during concurrent use of steroids.
It is strongly recommended that all patients adhere to the following fluid guidelines during Cycle 1, unless medically contraindicated: • 2-3 L of fluid intake during the 24 hours prior to each epcoritamab administration • Hold antihypertensive medications for 24 hours prior to each epcoritamab administration • Administer 500 ml isotonic intravenous (IV) fluids on the day of epcoritamab prior to dose administration; AND • 2-3 L of fluid intake during the 24 hours following each epcoritamab administration.
Patients at an increased risk for clinical tumour lysis syndrome (CTLS) are recommended to receive hydration and prophylactic treatment with a uric acid lowering agent. 4). 8 mg is an intermediate dose, 3 mg is a second intermediate dose and 48 mg is a full dose.
8 mg) and first full dose (48 mg), or • If there are more than 6 weeks between full doses (48 mg) After the re-priming cycle, the patient should resume treatment with Day 1 of the next planned treatment cycle (subsequent to the cycle during which the dose was delayed).
8 mg) and the second intermediate dose (3 mg), or • If there are more than 14 days between the second intermediate dose (3 mg) and first full dose (48 mg), or • If there are more than 6 weeks between any two full doses (48 mg) After the re-priming cycle, the patient should resume treatment with Day 1 of the next planned treatment cycle (subsequent to the cycle during which the dose was delayed).
Dosage modifications and management of adverse reactions Cytokine release syndrome (CRS) Patients treated with epcoritamab may develop CRS. Evaluate for and treat other causes of fever, hypoxia, and hypotension. If CRS is suspected, manage according to the recommendations in Table 4.
Patients who experience CRS should be monitored more frequently during next scheduled epcoritamab administration. Table 4 - CRS grading and […]
This is not medical advice. Consult a qualified healthcare professional.
Side effects & warnings
GBOfficial regulatory label· Adverse reactions· revised May 15, 2026[1]
Summary of the safety profile The safety of epcoritamab was evaluated in a non-randomised, single-arm GCT3013- 01 study in 382 patients with relapsed or refractory large B-cell lymphoma (N=167), follicular lymphoma (N=129) and follicular lymphoma (3-step step-up dose schedule N=86) after two or more lines of systemic therapy and included all the patients who enrolled to the 48 mg dose and received at least one dose of epcoritamab.
The following adverse reactions have been reported with epcoritamab during clinical studies and post marketing experience. 9 months (range: <1 to 30 months). The most common adverse reactions (≥20%) were CRS (56%), injection site reactions (40%), fatigue (32%), viral infection (28%), neutropenia (28%), muscoskeletal pain (27%), pyrexia (22%), and diarrhoea (21%).
4%). Serious adverse reactions occurred in 50% of patients. The most common serious adverse reaction (≥10%) was CRS (34%). 3%) patient). 8% of patients. 3%) patient each. Dose delays due to adverse reactions occurred in 42% of patients. 7%).
Tabulated list of adverse reactions Adverse reactions for epcoritamab from clinical studies (Table 7) are listed by MedDRA system organ class and are based on the following convention: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1 000 to < 1/100); rare (≥ 1/10 000 to < 1/1 000); and very rare (< 1/10 000).
0 a Viral infection includes COVID-19, cytomegalovirus chorioretinitis, cytomegalovirus colitis, cytomegalovirus infection, cytomegalovirus infection reactivation, gastroenteritis viral, herpes simplex, herpes simplex reactivation, herpes virus infection, herpes zoster, oral herpes, post- acute COVID-19 syndrome, and varicella zoster virus infection b Pneumonia includes COVID-19 pneumonia and pneumonia c Upper respiratory tract infection includes laryngitis, pharyngitis, respiratory syncytial virus infection, rhinitis, rhinovirus infection, and upper respiratory tract infection d Fungal infection includes candida infection, oesophageal candidiasis, oral candidiasis and oropharyngeal candidiasis e Sepsis includes bacteraemia, sepsis and septic shock f Neutropenia includes neutropenia and neutrophil count decreased g Anaemia includes anaemia and serum ferritin decreased h Thrombocytopenia includes platelet count decreased and thrombocytopenia i Lymphopenia includes lymphocyte count decreased and lymphopenia j Events graded using American Society for Transplantation and Cellular Therapy (ASTCT) consensus criteria k Clinical Tumour Lysis Syndrome was graded based on Cairo-Bishop l Cardiac arrhythmias include bradycardia, sinus bradycardia, sinus tachycardia, supraventricular tachycardia, and tachycardia m Abdominal pain includes abdominal discomfort, abdominal pain, abdominal pain lower, abdominal pain upper, and abdominal tenderness n Rash includes rash, rash erythematous, rash macular, rash maculo-papular, rash popular, rash prutitic, rash pustular and rash vesicular o Musculoskeletal pain includes back pain, bone pain, flank […]
GBOfficial regulatory label· Warnings and precautions· revised May 15, 2026[1]
Traceability In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded. 8). The most common signs and symptoms of CRS include pyrexia, hypotension and hypoxia.
Other signs and symptoms of CRS include chills, tachycardia, headache and dyspnoea. Most CRS events occurred in Cycle 1 and were associated with the first full dose of epcoritamab. 2). Patients should be monitored for signs and symptoms of CRS following epcoritamab administration.
2, Table 4). Counsel patients on the signs and symptoms associated with CRS and instruct patients to contact their healthcare professional and seek immediate medical attention should signs or symptoms occur at any time. 2). Patients with DLBCL should be hospitalised for 24 hours after administration of the Cycle 1 Day 15 dose of 48 mg to monitor for signs and symptoms of CRS.
Haemophagocytic lymphohistiocytosis (HLH) Haemophagocytic lymphohistiocytosis (HLH), including fatal cases, have been reported in patients receiving epcoritamab. HLH is a life-threatening syndrome characterised by fever, skin rash, lymphadenopathy, hepato- and/or splenomegaly and cytopenias.
HLH should be considered when the presentation of CRS is atypical or prolonged. Patients should be monitored for clinical signs and symptoms of HLH. For suspected HLH, epcoritamab must be interrupted for diagnostic workup and treatment for HLH initiated.
If HLH is confirmed, administration of Tepkinly should be discontinued. 8). ICANS may manifest as aphasia, altered level of consciousness, impairment of cognitive skills, motor weakness, seizures, and cerebral oedema. The majority of cases of ICANS occurred within the Cycle 1 of epcoritamab treatment, however some occurred with delayed onset.
Patients should be monitored for signs and symptoms of ICANS following epcoritamab administration. 2. Table 5). Patients with DLBCL should be hospitalised for 24 hours after administration of the Cycle 1 Day 15 dose of 48 mg to monitor for signs and symptoms of ICANS.
Counsel patients on the signs and symptoms of ICANS and that the onset of events may be delayed. Instruct patients to contact their healthcare professional and seek immediate medical attention should signs or symptoms occur at any time.
This is not medical advice. Consult a qualified healthcare professional.
Who should not take it
GBOfficial regulatory label· Contraindications· revised May 15, 2026[1]
1.
This is not medical advice. Consult a qualified healthcare professional.
Patients should be monitored for signs or symptoms of TLS, especially patients with high tumour burden or rapidly proliferative tumours, and patients with reduced renal function. Patients should be monitored for blood chemistries and abnormalities should be managed promptly.
3 Pharmacokinetics, Special Populations and Conditions). Immune Cytokine Release Syndrome Cytokine Release Syndrome (CRS), which may be life-threatening or fatal, occurred in patients receiving EPKINLY. The most common signs and symptoms of CRS include pyrexia, hypotension and hypoxia.
Other signs and symptoms of CRS in greater than two patients include chills, tachycardia, headache and dyspnea. The median time to onset of CRS from the most recent administered EPKINLY dose was 2 days (range: 1 to 11 days). 2 to 7 days).
Most CRS events occurred in Cycle 1 and were associated with the first full dose of EPKINLY. Median duration of CRS was 3 Days (range: 1 to 27 days). Administer prophylactic medications including corticosteroids to mitigate the risk of CRS (see 4 DOSAGE AND ADMINISTRATION).
In addition to EPKINLY (epcoritamab injection / epcoritamab for injection) Page 15 of 42 corticosteroids use, tocilizumab was used to manage CRS event in 15% of patients. Monitor patients for CRS following EPKINLY administrations during Cycle 1 and in subsequent cycles as needed at the discretion of the health professional.
For 24 hours following administration of the first full dose of 48 mg, patients should remain within proximity of a healthcare facility and be monitored for signs and symptoms of CRS, or alternatively consider hospitalization. At the first signs or symptoms of CRS, institute treatment of supportive care with tocilizumab and/or corticosteroids as per institutional guidelines considering the recommendations listed in Table 7.
Counsel patients on the signs and symptoms associated with CRS and instruct patients to contact their health professional and seek immediate medical attention should signs or symptoms occur at any time. Management of CRS may require either temporary delay or discontinuation of EPKINLY based on the severity of CRS as per recommendations in Table 7.
Patients who experience CRS should be monitored more frequently during the next scheduled EPKINLY administration. Withhold or discontinue EPKINLY as indicated in Table 3 (see 4 DOSAGE AND ADMINISTRATION). Haemophagocytic lymphohistiocytosis (HLH), including fatal cases, have been reported in patients receiving EPKINLY, and in some instances HLH has been reported independently of CRS.
HLH should be considered when the presentation of CRS is atypical or unresponsive and/or when clinical manifestations of HLH present such as prolonged fever, cytopenias, hyperferritinemia, coagulopathy and elevated liver enzymes. If HLH is suspected, withhold EPKINLY and initiate treatment for HLH per current practice guidelines.
Table 7. , advanced age, high tumour burden, circulating tumour cells, fever refractory to antipyretics): Tocilizumab 8 mg/kg IV over 1 hour (not to exceed 800 mg per dose). Repeat tocilizumab after at least 8 hours as needed. Maximum of 2 doses in a 24-hour period.
, siltuximab, anakinra). […]
This is not medical advice. Consult a qualified healthcare professional.
Side effects & warnings
CAOfficial regulatory label· Adverse reactions· revised October 24, 2025[2]
5 x 109/L or higher. 5 Missed Dose for how to properly resume treatment. Thrombocytopenia1 (see 8 ADVERSE REACTIONS) Platelet count less than 50 x 109/L • Withhold EPKINLY until platelet count is 50 x 109/L or higher. 5 Missed Dose for how to properly resume treatment.
Other adverse reactions1 (see 8 ADVERSE REACTIONS) Grade 3 or higher • Withhold EPKINLY until the toxicity resolves to Grade ≤ 1. • For events associated with severe outcomes, consider permanent discontinuation of therapy. CRS and ICANS graded according to ASTCT consensus criteria.
1. 0. Dosing in Special Populations Pediatrics (< 18 years of age) EPKINLY is not indicated in the pediatric population, as the safety and efficacy of EPKINLY in pediatric patients less than 18 years of age have not been evaluated. Geriatric (≥ 65 years of age) In the EPCORE NHL-1 study, 48 (31%) patients were ≥ 65 to < 75 years of age and 29 (18%) patients were ≥ 75 years of age.
No clinically meaningful differences in safety or efficacy were observed between patients ≥ 65 years of age compared with younger adult patients. EPKINLY (epcoritamab injection / epcoritamab for injection) Page 10 of 42 Renal impairment Dose adjustments are not considered necessary in patients with mild to moderate renal impairment.
Patients with severe renal impairment were excluded from clinical studies with EPKINLY and no dose recommendations can be made for these patients. Hepatic impairment Dose adjustments are not considered necessary in patients with mild hepatic impairment.
Patients with moderate or severe hepatic impairment were excluded from clinical studies with EPKINLY and no dose recommendations can be made for these patients. 3. Reconstitution Dose Preparation Use aseptic techniques to prepare EPKINLY.
Filtration of the diluted solution is not recommended because of potential loss of active ingredient. The following table outlines the materials needed for preparation of the step-up doses. Table 4. 16 mg) Preparation Instructions – (2 dilutions required): Use an appropriately sized syringe, vial and needle for each transfer step.
8 mL (5 mg/mL) EPKINLY (epcoritamab for injection) vial with the light blue cap from the refrigerator. b) Allow the vial to come to room temperature for no more than 1 hour. c) Gently swirl the EPKINLY vial. DO NOT invert, vortex, or vigorously shake the vial.
2) Perform first dilution a) Label an appropriately sized empty vial as “Dilution A”. 8 mL of EPKINLY into the Dilution A vial. 9% Sodium Chloride Injection, sterile solution, into the Dilution A vial. d) Gently swirl the Dilution A vial for 30 – 45 seconds.
8 mg/mL. 3) Perform second dilution a) Label an appropriately sized empty vial as “Dilution B”. 0 mL of solution from the Dilution A vial into the Dilution B vial. The Dilution A vial is no longer needed. 9% Sodium Chloride Injection, sterile solution, into the Dilution B vial.
d) Gently swirl the Dilution B vial for 30 – 45 seconds. 16 mg/mL. 4) Withdraw dose a) Using a 1 mL syringe for SC injection, withdraw 1 mL of EPKINLY from the Dilution B vial. 16 mg and include the time of day. Discard the vial and any unused portions of EPKINLY in accordance with local requirements.
Use prepared EPKINLY immediately or store EPKINLY solution in a refrigerator and protect from light up to 24 hours from the time of preparation (see 11 STORAGE, STABILITY AND DISPOSAL). 8 mg) Preparation Instructions – (1 dilution required): Use an appropriately sized syringe, vial and needle for each transfer step.
8 mL (5 mg/mL) EPKINLY (epcoritamab for injection) vial with the light blue cap from the refrigerator. b) Allow the vial to come to room temperature for no more than 1 hour. c) Gently swirl the EPKINLY vial. DO NOT invert, vortex, or vigorously shake the vial.
2) Perform dilution a) Label an appropriately sized empty vial as “Dilution A”. 8 mL of EPKINLY into the Dilution A vial. 9% Sodium Chloride Injection, sterile solution, into the Dilution A vial. d) Gently swirl the Dilution A vial for 30 – 45 seconds.
8 mg/mL. 3) Withdraw dose a) Using a 1 mL syringe for SC injection, withdraw 1 mL of EPKINLY from the Dilution A vial. 8 mg and include the time of day. Discard the vial and any unused portions of EPKINLY in accordance with local requirements.
Use prepared EPKINLY immediately or store EPKINLY solution in a refrigerator and protect from light up to 24 hours from the time of preparation (see 11 STORAGE, STABILITY AND DISPOSAL). EPKINLY (epcoritamab injection / epcoritamab […]
CAOfficial regulatory label· Warnings and precautions· revised October 24, 2025[2]
3 Pharmacokinetics, Special Populations and Conditions). 2. Contraindications • EPKINLY is contraindicated in patients who are hypersensitive to this drug or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container.
For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING. 3. Serious Warnings and Precautions Box Serious Warnings and Precautions • Cytokine Release Syndrome (CRS), which may be serious or life-threatening occurred in patients receiving EPKINLY.
Initiate treatment with EPKINLY step-up dosing schedule to reduce the risk of CRS. Withhold EPKINLY until CRS resolves, provide supportive care and treatment as needed, or permanently discontinue based on severity (see 7 WARNINGS AND PRECAUTIONS).
• Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS), which include life- threatening and fatal events have occurred in patients receiving EPKINLY. ICANS can be concurrent with CRS, occur following resolution of CRS, or occur in the absence of CRS.
Withhold EPKINLY until ICANS resolves or permanently discontinue based on severity (see 7 WARNINGS AND PRECAUTIONS). • Progressive Multifocal leukoencephalopathy (PML), which include life-threatening and fatal events have occurred in patients receiving EPKINLY.
Withhold EPKINLY if PML is suspected and permanently discontinue if PML is confirmed (see 7 WARNINGS AND PRECAUTIONS). EPKINLY (epcoritamab injection / epcoritamab for injection) Page 6 of 42 • Haemophagocytic lymphohistiocytosis (HLH), including fatal cases, have been reported in patients receiving EPKINLY, and in some instances HLH has been reported independently of CRS (see 7 WARNINGS AND PRECAUTIONS).
Patients should be monitored in proximity to a healthcare facility for 24 hours after the first full dose of EPKINLY for signs and symptoms of CRS and ICANS. 4. 1. Dosing Considerations • Counsel patients on the risks associated with EPKINLY and distribute the Patient Card prior to administration of the first step-up dose.
• EPKINLY should only be administered under the supervision of a health professional experienced in the treatment of cancer patients and who has access to appropriate medical support to manage severe reactions such as cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS).
This is not medical advice. Consult a qualified healthcare professional.
Tepkinly must only be administered under the supervision of a healthcare professional qualified in the use of anti-cancer therapy. At least 1 dose of tocilizumab for use in the event of CRS should be available prior to epcoritamab administration for Cycle 1.
Access to an additional dose of tocilizumab within 8 hours of use of the previous tocilizumab dose should be available. Posology Recommended pre-medication and dose schedule Tepkinly should be administered according to the following step-up dose schedule in 28-day cycles which is outlined in Table 1 for patients with diffuse large B-cell lymphoma and Table 2 for patients with follicular lymphoma.
3 Table 1 Tepkinly 2-step step-up dose schedule for patients with diffuse large B-cell lymphoma Table 2 Tepkinly 3-step step-up dose schedule for patients with follicular lymphoma Tepkinly should be administered until disease progression or unacceptable toxicity.
Details on recommended pre-medication for cytokine release syndrome (CRS) are shown in Table 3. 8 mg is an intermediate dose and 48 mg is a full dose. 8 mg is an intermediate dose, 3 mg is a second intermediate dose and 48 mg is a full dose.
4 administration of epcoritamab until epcoritamab is given without subsequent any grade of CRS aPatients will be permanently discontinued from epcoritamab after a Grade 4 CRS event. bDexamethasone is the preferred corticosteroid for CRS prophylaxis based on the GCT3013-01 Optimisation study.
Prophylaxis against Pneumocystis jirovecii pneumonia (PCP) and herpes virus infections is strongly recommended especially during concurrent use of steroids. Tepkinly should be administered to adequately hydrated patients. It is strongly recommended that all patients adhere to the following fluid guidelines during Cycle 1, unless medically contraindicated: • 2-3 L of fluid intake during the 24 hours prior to each epcoritamab administration • Hold antihypertensive medications for 24 hours prior to each epcoritamab administration • Administer 500 ml isotonic intravenous (IV) fluids on the day of epcoritamab prior to dose administration; AND • 2-3 L of fluid intake during the 24 hours following each epcoritamab administration.
Patients at an increased risk for clinical tumour lysis syndrome (CTLS) are recommended to receive hydration and prophylactic treatment with a uric acid lowering agent. Patients should be monitored for signs and symptoms of CRS and/or immune effector cell-associated neurotoxicity syndrome (ICANS) and managed per current practice guidelines following epcoritamab administration.
4). Dose modifications and management of adverse reactions Cytokine release syndrome (CRS) Patients treated with epcoritamab may develop CRS. Evaluate for and treat other causes of fever, hypoxia, and hypotension. If CRS is suspected, manage according to the recommendations in Table 4.
Patients who experience CRS should be monitored more frequently during next scheduled epcoritamab administration. Table 4 CRS grading and management guidance Gradea Recommended therapy Epcoritamab dose modification Grade 1 • Fever (temperature ≥ 38 °C) Provide supportive care such as antipyretics and intravenous hydration Dexamethasoneb may be initiated In cases of advanced age, high tumour burden, circulating tumour cells, fever refractory to antipyretics Hold epcoritamab until resolution of CRS event 5 Gradea Recommended therapy Epcoritamab dose modification • Anti-cytokine therapy, tocilizumabd, should be considered For CRS with concurrent ICANS refer to Table 5 Grade 2 • Fever (temperature ≥ 38 °C) and • Hypotension not requiring vasopressors and/or • Hypoxia requiring low-flow oxygene by nasal cannula or blow-by Provide supportive care such as antipyretics and intravenous hydration Dexamethasoneb should be considered Anti-cytokine therapy, tocilizumabd, is recommended If CRS is refractory to dexamethasone and tocilizumab: • Alternative immunosuppressantsg and methylprednisolone 1 000 mg/day intravenously should be administered until clinical improvement For CRS with concurrent ICANS refer to Table 5 Hold epcoritamab until resolution of CRS event Grade 3 • Fever (temperature ≥ 38 °C) and • Hypotension requiring a vasopressor with or without vasopressin and/or • Hypoxia requiring high-flow oxygenf by […]
This is not medical advice. Consult a qualified healthcare professional.
Side effects & warnings
EUOfficial regulatory label· Adverse reactions· revised February 6, 2026[3]
Summary of the safety profile The safety of epcoritamab was evaluated in a non-randomised, single-arm GCT3013-01 study in 382 patients with relapsed or refractory large B-cell lymphoma (N=167), follicular lymphoma (N=129) and follicular lymphoma (3-step step-up dose schedule N=86) after two or more lines of systemic therapy and included all the patients who enrolled to the 48 mg dose and received at least one dose of epcoritamab.
The following adverse reactions have been reported with epcoritamab during clinical studies and post marketing experience. 9 months (range: <1 to 30 months). The most common adverse reactions (≥ 20%) were CRS, injection site reactions, fatigue, viral infection, neutropenia, musculoskeletal pain, pyrexia, and diarrhoea.
Serious adverse reactions occurred in 50% of patients. The most frequent serious adverse reaction (≥ 10%) was cytokine release syndrome (34%). 3%) patient). 8% of patients. 3%) patient each. Dose delays due to adverse reactions occurred in 42% of patients.
7%). Tabulated list of adverse reactions Adverse reactions for epcoritamab from clinical studies (Table 7) are listed by MedDRA system organ class and are based on the following convention: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1 000 to < 1/100); rare (≥ 1/10 000 to < 1/1 000); and very rare (< 1/10 000).
Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness. 0 aViral infection includes COVID-19, cytomegalovirus chorioretinitis, cytomegalovirus colitis, cytomegalovirus infection, cytomegalovirus infection reactivation, gastroenteritis viral, herpes simplex, herpes simplex reactivation, herpes virus infection, herpes zoster, oral herpes, post-acute COVID- 19 syndrome, and varicella zoster virus infection bPneumonia includes COVID-19 pneumonia and pneumonia cUpper respiratory tract infection includes laryngitis, pharyngitis, respiratory syncytial virus infection, rhinitis, rhinovirus infection, and upper respiratory tract infection dFungal infection includes candida infection, oesophageal candidiasis, oral candidiasis and oropharyngeal candidiasis eSepsis includes bacteraemia, sepsis, and septic shock fNeutropenia includes neutropenia and neutrophil count decreased gAnaemia includes anaemia and serum ferritin decreased hThrombocytopenia includes platelet count decreased and thrombocytopenia iLymphopenia includes lymphocyte count decreased and lymphopenia j Events graded using American Society for Transplantation and Cellular Therapy (ASTCT) consensus criteria k Clinical Tumour Lysis Syndrome was graded based on Cairo-Bishop lCardiac arrhythmias include bradycardia, sinus bradycardia, sinus tachycardia, supraventricular tachycardia, and tachycardia mAbdominal pain includes abdominal discomfort, abdominal pain, abdominal pain lower, abdominal pain upper, and abdominal tenderness nRash includes rash, rash erythematous, rash macular, rash maculo-papular, rash papular, rash pruritic, rash pustular, and rash vesicular oMusculoskeletal pain includes back pain, bone pain, flank pain, musculoskeletal chest pain, musculoskeletal pain, myalgia, neck pain, non-cardiac chest pain, pain, pain in extremity, and spinal pain pInjection site reactions include […]
EUOfficial regulatory label· Warnings and precautions· revised February 6, 2026[3]
Traceability In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded. Cytokine release syndrome (CRS) CRS, which may be life-threatening or fatal, occurred in patients receiving epcoritamab.
The most common signs and symptoms of CRS include pyrexia, hypotension and hypoxia. Other signs and symptoms of CRS in more than two patients include chills, tachycardia, headache and dyspnoea. Most CRS events occurred in Cycle 1 and were associated with the first full dose of epcoritamab.
2). Patients should be monitored for signs and symptoms of CRS following epcoritamab administration. 2, Table 4). Patients should be counselled on the signs and symptoms associated with CRS and patients should be instructed to contact their healthcare professional and seek immediate medical attention should signs or symptoms occur at any time.
2). Haemophagocytic lymphohistiocytosis (HLH) Haemophagocytic lymphohistiocytosis (HLH), including fatal cases, have been reported in patients receiving epcoritamab. HLH is a life-threatening syndrome characterised by fever, skin rash, lymphadenopathy, hepato- and/or splenomegaly and cytopenias.
HLH should be considered when the presentation of CRS is atypical or prolonged. Patients should be monitored for clinical signs and symptoms of HLH. For suspected HLH, epcoritamab must be interrupted for diagnostic workup and treatment for HLH initiated.
If HLH is confirmed, administration of Tepkinly should be discontinued. Immune effector cell-associated neurotoxicity syndrome (ICANS) ICANS, including fatal events, have occurred in patients receiving epcoritamab. ICANS may manifest as aphasia, altered level of consciousness, impairment of cognitive skills, motor weakness, seizures, and cerebral oedema.
The majority of cases of ICANS occurred within Cycle 1 of epcoritamab treatment, however some occurred with delayed onset. 11 Patients should be monitored for signs and symptoms of ICANS following epcoritamab administration. 2, Table 5).
Patients should be counselled on the signs and symptoms of ICANS and that the onset of events may be delayed. Patients should be instructed to contact their healthcare professional and seek immediate medical attention should signs or symptoms occur at any time.
This is not medical advice. Consult a qualified healthcare professional.
Who should not take it
EUOfficial regulatory label· Contraindications· revised February 6, 2026[3]
1.
This is not medical advice. Consult a qualified healthcare professional.
2). 8). Epcoritamab must not be administered in patients with active infections. 2). Caution should be exercised when considering the use of epcoritamab in patients with a history of recurring or chronic infections, with underlying conditions that may predispose to infections or who have had significant prior immunosuppressive treatment.
Patients should be monitored for signs and symptoms of infection before and after epcoritamab, and treated appropriately. In the event of febrile neutropenia, patients should be evaluated for infection and managed with antibiotics, fluids and other supportive care, according to local guidelines.
8). Immunoglobulin (Ig) levels should be monitored prior to and during treatment. Patients should be treated according to local institutional guidelines, including infection precautions and antimicrobial prophylaxis. Cases of progressive multifocal leukoencephalopathy (PML), including fatal cases, have been reported in patients treated with epcoritamab who have also received prior treatment with other immunosuppressive medications.
If neurological symptoms suggestive of PML occur during epcoritamab therapy, treatment with epcoritamab should be discontinued and appropriate diagnostic measures initiated. 8). Patients at an increased risk for TLS are recommended to receive hydration and prophylactic treatment with a uric acid lowering agent.
Patients should be monitored for signs or symptoms of TLS, especially patients with high tumour burden or rapidly proliferative tumours, and patients with reduced renal function. Patients should be monitored for blood chemistries and abnormalities should be managed promptly.
8). Manifestations could include localised pain and swelling. Consistent with the mechanism of action of epcoritamab, tumour flare is likely due to the influx of T-cells into tumour sites following epcoritamab administration. There are no specific risk factors for tumour flare that have been identified; however, there is a heightened risk of compromise and morbidity due to mass effect secondary to tumour flare in patients with bulky tumours located in close proximity to airways and/or a vital organ.
Patients treated with epcoritamab should be monitored and evaluated for tumour […]
• EPKINLY should not be administered to patients with active infections. • EPKINLY should not be administered to patients who have recently (within 4 weeks) received a live or live-attenuated vaccine (see 7 WARNINGS AND PRECAUTIONS).
Premedication and Prophylaxis • Consider initiating prophylaxis against Pneumocystis jirovecii pneumonia (PJP) and herpes virus infections prior to starting treatment with EPKINLY. • EPKINLY should be administered to adequately hydrated patients.
Details on recommended premedication for CRS is detailed in Table 1. Table 1. Epcoritamab Premedication for CRS Cycle Patient requiring premedication Premedication Administration Cycle 1 All patients • Prednisolone (100 mg oral or IV) or equivalent • 30-120 minutes prior to each weekly administration of EPKINLY • And for three consecutive days following each weekly administration of EPKINLY in Cycle 1 EPKINLY (epcoritamab injection / epcoritamab for injection) Page 7 of 42 • Diphenhydramine (50 mg oral or IV) or equivalent • Acetaminophen (650 to 1000 mg oral) • 30-120 minutes prior to the administration of EPKINLY Cycle 2 and beyond Patients who experienced Grade 2 or 3a CRS with previous dose • Prednisolone (100 mg oral or IV) or equivalent • 30-120 minutes prior to next administration of EPKINLY after a grade 2 or 3a CRS event • And for three consecutive days following the next administration of EPKINLY until EPKINLY is given without subsequent CRS of Grade 2 or higher a.
Patients will be permanently discontinued from EPKINLY after a Grade 4 CRS event. Monitoring Monitor patients for potential CRS and immune effector cell-associated neurotoxicity syndrome (ICANS) following EPKINLY administrations during Cycle 1 and in subsequent cycles as needed at the discretion of the health professional.
For 24 hours following administration of the first full dose of 48 mg (Day 15 of Cycle 1), patients should remain within proximity of a healthcare facility and be monitored for signs and symptoms of CRS and ICANS, or alternatively consider hospitalization.
Counsel patients on the signs and symptoms associated with CRS and ICANS and on seeking immediate medical attention should signs or symptoms occur at any time (see 7 WARNINGS AND PRECAUTIONS). 2. Recommended Dose and Dosage Adjustment • EPKINLY is administered by subcutaneous (SC) injection only in 28-day cycles.
4 Administration). 4 Administration). • Weekly 48 mg doses of EPKINLY continue for Cycles 2 and 3 using the EPKINLY vial with the orange cap. • Starting in Cycle 4 and continuing through Cycle 9, the 48 mg EPKINLY doses are administered once every two weeks (Days 1 and 15 only of each cycle).
• Starting in Cycle 10, the 48 mg EPKINLY dose is taken once every 4 weeks (Day 1 only of each 28-day cycle). • EPKINLY is taken according to the following schedule until disease progression or unacceptable toxicity. EPKINLY (epcoritamab injection / epcoritamab for injection) Page 8 of 42 Table 2.
2). Serious infections Treatment with epcoritamab may lead to an increased risk of infections. 8). Administration of epcoritamab should be avoided in patients with clinically significant active systemic infections. 2). Patients should be monitored for signs and symptoms of infection, before and after epcoritamab administration, and treated appropriately.
In the event of febrile neutropenia, patients should be evaluated for infection and managed with antibiotics, fluids and other supportive care, according to local guidelines. 8). Immunoglobulin (Ig) levels should be monitored prior to and during treatment.
Patients should be treated according to local institutional guidelines, including infection precautions and antimicrobial prophylaxis. Cases of progressive multifocal leukoencephalopathy (PML), including fatal cases, have been reported in patients treated with epcoritamab who have also received prior treatment with other immunosuppressive medications.
If neurological symptoms suggestive of PML occur during epcoritamab therapy, treatment with epcoritamab should be discontinued and appropriate diagnostic measures initiated. 8). Patients at an increased risk for TLS are recommended to receive hydration and prophylactic treatment with a uric acid lowering agent.
Patients should be monitored for signs or symptoms of TLS, especially patients with high tumour burden or rapidly proliferative tumours, and patients with reduced renal function. Patients should be monitored for blood chemistries and abnormalities should be managed promptly.
8). Manifestations could include localised pain and swelling. Consistent with the mechanism of action of epcoritamab, tumour flare is likely due to the influx of T-cells into tumour sites following epcoritamab administration. There are no specific risk factors for tumour flare that have been identified; however, there is a heightened risk of compromise and morbidity due to mass effect secondary to tumour flare in patients with bulky tumours located in close proximity to airways and/or a vital organ.
Patients treated with epcoritamab should be monitored and evaluated for tumour flare at critical anatomical sites. CD20-negative disease There are limited data available on patients with CD20-negative DLBCL and patients with CD20- negative FL treated with epcoritamab and it is possible that patients with CD20-negative DLBCL and patients with CD20-negative FL may have less benefit compared to patients with CD20-positive DLBCL 12 and patients […]