Epcoritamab: Drug information

For additional information see "Epcoritamab: Patient drug information"

For abbreviations, symbols, and age group definitions show table

ALERT: US Boxed Warning

Cytokine release syndrome:

Cytokine release syndrome (CRS), including serious or life-threatening reactions, can occur in patients receiving epcoritamab. Initiate treatment with the epcoritamab step-up dosage schedule to reduce the incidence and severity of CRS. Withhold epcoritamab until CRS resolves or permanently discontinue based on severity.

Immune effector cell-associated neurotoxicity syndrome:

Immune effector cell-associated neurotoxicity syndrome (ICANS), including life-threatening and fatal reactions, can occur with epcoritamab. Monitor patients for neurological signs or symptoms of ICANS during treatment. Withhold epcoritamab until ICANS resolves or permanently discontinue based on severity.

Brand Names: US

Epkinly

Brand Names: Canada

Epkinly

Pharmacologic Category

Antineoplastic Agent, Anti-CD20;
Antineoplastic Agent, Anti-CD3;
Antineoplastic Agent, Bispecific T Cell Engager;
Antineoplastic Agent, Monoclonal Antibody

Dosing: Adult

Dosage guidance:

Safety: Ensure patients are well-hydrated prior to epcoritamab initiation. Avoid administering epcoritamab to patients with active infection. Should only be administered by a qualified provider with appropriate medical support to manage severe reactions (eg, cytokine release syndrome and immune effector cell-associated neurotoxicity syndrome).

Pre- and postmedication: Premedicate prior to each dose in cycle 1; if patient experienced grade 2 or 3 cytokine release syndrome (CRS) with the previous dose, administer premedication in cycle 2 and beyond until epcoritamab is tolerated without subsequent grade 2 or higher CRS. See "Epcoritamab Recommended Pre- and Postmedications" tables below.

Clinical considerations : Provide prophylaxis for Pneumocystis jirovecii pneumonia prior to initiating epcoritamab. Consider initiating herpes virus prophylaxis prior to initiating epcoritamab to prevent herpes zoster reactivation. Consider prophylactic granulocyte colony-stimulating factor administration as appropriate.

Diffuse large B-cell lymphoma and high-grade B-cell lymphoma, relapsed or refractory

Diffuse large B-cell lymphoma and high-grade B-cell lymphoma, relapsed or refractory: SUBQ: Note: Hospitalization is recommended for 24 hours following administration of the first full 48 mg dose (cycle 1 day 15).

**Epcoritamab DLBCL^a and High-Grade B-cell Lymphoma Dosing Schedule^b, ^c (28-day Treatment Cycles)**
Cycle number	Day of treatment	Epcoritamab dose^c
^aDLBCL = diffuse large B-cell lymphoma.
^b Continue until disease progression or unacceptable toxicity.
^c Manufacturer's labeling, Thieblemont 2023.
^dFor patients with DLBCL or high-grade B-cell lymphoma, hospitalization is recommended for 24 hours following administration of the cycle 1 day 15 dose.
Cycle 1	Day 1	0.16 mg SUBQ (step-up dose 1)
	Day 8	0.8 mg SUBQ (step-up dose 2)
	Day 15^d	48 mg SUBQ (first full dose)
	Day 22	48 mg SUBQ
Cycles 2 and 3	Days 1, 8, 15, and 22	48 mg SUBQ
Cycles 4 to 9	Days 1 and 15	48 mg SUBQ
Cycles 10 and beyond^b	Day 1	48 mg SUBQ

**Recommendations for Restarting Epcoritamab After a Dosing Delay (DLBCL^aand High-Grade B-cell Lymphoma)**
Last dose administered	Time since last dose	Action for next epcoritamab dose(s)^a
^a DLBCL = Diffuse large B-cell lymphoma.
^b Administer premedications prior to epcoritamab dose and monitor appropriately.
Cycle 1, day 1 (0.16 mg)	>8 days	Repeat cycle 1 schedule starting at step-up dose 1 (0.16 mg SUBQ). Following the repeat of cycle 1 schedule, resume the planned treatment schedule.
Cycle 1, day 8 (0.8 mg)	≤14 days	Administer 48 mg SUBQ, then resume the planned treatment schedule.
Cycle 1, day 8 (0.8 mg)	>14 days	Repeat cycle 1 schedule starting at step-up dose 1 (0.16 mg SUBQ). Following the repeat of cycle 1 schedule, resume the planned treatment schedule.
Cycle 1, day 15 and beyond (48 mg)	≤6 weeks	Administer 48 mg SUBQ, then resume the planned treatment schedule.
Cycle 1, day 15 and beyond (48 mg)	>6 weeks	Repeat cycle 1 schedule starting at step-up dose 1 (0.16 mg SUBQ). Following the repeat of cycle 1 schedule, resume the planned treatment schedule.

**Epcoritamab Recommended Pre- and Postmedications for DLBCL^aand High-Grade B-cell Lymphoma**
Cycle	Patients requiring medication	Premedication	Administration schedule
^aDLBCL = diffuse large B-cell lymphoma.
^bDexamethasone is the preferred corticosteroid when available.
^cEpcoritamab should be permanently discontinued if grade 4 CRS occurs.
^d CRS = cytokine release syndrome.
Cycle 1	All patients	Dexamethasone^b 15 mg oral or IV or prednisolone 100 mg oral or IV (or equivalent)	30 to 120 minutes prior to each weekly epcoritamab dose and for 3 consecutive days following each weekly epcoritamab dose in cycle 1
		Diphenhydramine 50 mg oral or IV (or equivalent)	30 to 120 minutes prior to each weekly epcoritamab dose
		Acetaminophen 650 to 1,000 mg orally	30 to 120 minutes prior to each weekly epcoritamab dose
Cycle 2 and beyond	Patients who experienced grade 2 or 3^c CRS^d with the previous dose	Dexamethasone^b 15 mg oral or IV or prednisolone 100 mg oral or IV (or equivalent)	30 to 120 minutes prior to the next epcoritamab dose after a grade 2 or 3^c CRS event and for 3 consecutive days following the next epcoritamab dose until epcoritamab is administered and tolerated without subsequent ≥ grade 2 CRS.

Follicular lymphoma, relapsed or refractory

Follicular lymphoma, relapsed or refractory: SUBQ:

**Epcoritamab Follicular Lymphoma Dosing Schedule^{a, b} (28-day Treatment Cycles)**
Cycle number	Day of treatment	Epcoritamab dose^b
^a Continue until disease progression or unacceptable toxicity.
^b Manufacturer's labeling, Linton 2024.
Cycle 1	Day 1	0.16 mg SUBQ (step-up dose 1)
	Day 8	0.8 mg SUBQ (step-up dose 2)
	Day 15	3 mg SUBQ (step-up dose 3)
	Day 22	48 mg SUBQ (first full dose)
Cycles 2 and 3	Days 1, 8, 15, and 22	48 mg SUBQ
Cycles 4 to 9	Days 1 and 15	48 mg SUBQ
Cycles 10 and beyond^a	Day 1	48 mg SUBQ

**Recommendations for Restarting Epcoritamab for Follicular Lymphoma After a Dosing Delay**
Last dose administered	Time since last dose	Action for next epcoritamab dose(s)^a
^a Administer premedications prior to epcoritamab dose and monitor appropriately.
Cycle 1, day 1 (0.16 mg)	>8 days	Repeat cycle 1 schedule starting at step-up dose 1 (0.16 mg SUBQ). Following the repeat of cycle 1 schedule, resume the planned treatment schedule.
Cycle 1, day 8 (0.8 mg)	>8 days	Repeat cycle 1 schedule starting at step-up dose 1 (0.16 mg SUBQ). Following the repeat of cycle 1 schedule, resume the planned treatment schedule.
Cycle 1, day 15 (3 mg)	≤14 days	Administer 48 mg SUBQ, then resume the planned treatment schedule.
Cycle 1, day 15 (3 mg)	>14 days	Repeat cycle 1 schedule starting at step-up dose 1 (0.16 mg SUBQ). Following the repeat of cycle 1 schedule, resume the planned treatment schedule.
Cycle 1, day 22 and beyond (48 mg)	≤6 weeks	Administer 48 mg SUBQ, then resume the planned treatment schedule.
Cycle 1, day 22 and beyond (48 mg)	>6 weeks	Repeat cycle 1 schedule starting at step-up dose 1 (0.16 mg SUBQ). Following the repeat of cycle 1 schedule, resume the planned treatment schedule.

**Epcoritamab Recommended Pre- and Postmedications for Follicular Lymphoma**
Cycle	Patients requiring medication	Premedication	Administration schedule
^aDexamethasone is the preferred corticosteroid when available.
^b Epcoritamab should be permanently discontinued if grade 4 CRS occurs.
^c CRS = cytokine release syndrome.
Cycle 1	All patients	Dexamethasone^a 15 mg oral or IV or prednisolone 100 mg oral or IV (or equivalent)	30 to 120 minutes prior to each weekly epcoritamab dose and for 3 consecutive days following each weekly epcoritamab dose in cycle 1
		Diphenhydramine 50 mg oral or IV (or equivalent)	30 to 120 minutes prior to each weekly epcoritamab dose
		Acetaminophen 650 to 1,000 mg orally	30 to 120 minutes prior to each weekly epcoritamab dose
Cycle 2 and beyond	Patients who experienced grade 2 or 3^b CRS^c with the previous dose	Dexamethasone^a 15 mg oral or IV or prednisolone 100 mg oral or IV (or equivalent)	30 to 120 minutes prior to the next epcoritamab dose after a grade 2 or 3^b CRS event and for 3 consecutive days following the next epcoritamab dose until epcoritamab is administered and tolerated without subsequent ≥ grade 2 CRS.

Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.

Dosing: Kidney Impairment: Adult

Note: Kidney function estimated using the Cockcroft-Gault equation.

CrCl 30 to <90 mL/minute: There are no dosage adjustments provided in the manufacturer's labeling; however, no clinically significant difference in epcoritamab pharmacokinetics was observed based on CrCl 30 to <90 mL/minute.

CrCl <30 mL/minute: There are no dosage adjustments provided in the manufacturer's labeling (effects on epcoritamab pharmacokinetics are unknown).

Dosing: Liver Impairment: Adult

Mild impairment (total bilirubin ≤ ULN with AST > ULN or total bilirubin >1 to 1.5 times ULN and any AST): There are no dosage adjustments provided in the manufacturer's labeling; however, no clinically significant difference in epcoritamab pharmacokinetics was observed based on mild hepatic impairment.

Moderate or severe impairment (total bilirubin >1.5 times ULN and any AST): There are no dosage adjustments provided in the manufacturer's labeling (effects on epcoritamab pharmacokinetics are unknown).

Dosing: Obesity: Adult

American Society of Clinical Oncology guidelines for appropriate systemic therapy dosing in adults with cancer with a BMI ≥30 kg/m²: The dosing in the FDA-approved prescribing information should be followed in all patients, regardless of obesity status. If a patient with a BMI ≥30 kg/m² experiences high-grade toxicity from systemic anticancer therapy, the same dosage modification recommendations should be followed for all patients, regardless of obesity status (Ref).

Dosing: Adjustment for Toxicity: Adult

Refer to "Dosing: Adult" for recommendations on restarting epcoritamab after dose delays.

Cytokine release syndrome: If cytokine release syndrome (CRS) is suspected, interrupt epcoritamab until CRS resolves; manage according to the table below and per clinical practice guidelines. Supportive therapy for CRS may include intensive care for severe or life-threatening CRS. Identify CRS based on the clinical presentation. Evaluate for other causes (eg, fever, hypotension, hypoxia) and manage appropriately.

**Epcoritamab-Related CRS Management^d**
CRS grade	Presenting symptoms	Actions
^aFever may be masked by premedications; if clinical presentation is consistent with CRS, follow CRS management recommendations.
^bRefer to "Dosing: Adult" for recommendations for restarting epcoritamab after a dosing delay.
^cIf grade 2 or 3 CRS occurs with the second full epcoritamab dose (48 mg) or beyond, administer CRS premedications with each subsequent dose until an epcoritamab dose is administered without subsequent ≥ grade 2 CRS. Refer to "Dosing: Adult" for recommended pre- and postmedications.
^d CRS = cytokine release syndrome; CPAP = continuous positive airway pressure; BiPAP = bilevel positive airway pressure.
Grade 1	Temperature ≥38°C (100.4°F)^a, attributed to CRS.	Withhold epcoritamab and manage per practice guidelines. Ensure CRS symptoms are resolved prior to the next epcoritamab dose^b.
Grade 2	Temperature ≥38°C (100.4°F)^awith: Hypotension not requiring vasopressors and/or Hypoxia requiring low-flow oxygen (<6 L/minute) via nasal cannula or blow-by.	Withhold epcoritamab and manage per practice guidelines. Ensure CRS symptoms are resolved prior to the next epcoritamab dose^b. Administer premedication^c prior to the next epcoritamab dose. For the next dose, monitor more frequently and consider hospitalization.
Grade 3	Temperature ≥38°C (100.4°F)^a with: Hypotension requiring a vasopressor (with or without vasopressin) and/or Hypoxia requiring high-flow oxygen (≥6 L/minute) via nasal cannula, face mask, non-rebreather mask, or Venturi mask.	Withhold epcoritamab and manage per practice guidelines, which may include intensive care. Ensure CRS symptoms are resolved prior to the next epcoritamab dose^b. Administer premedication^c prior to the next epcoritamab dose. Hospitalize for the next epcoritamab dose.
Grade 3, recurrent		Permanently discontinue epcoritamab. Manage CRS per practice guidelines and provide supportive therapy, which may include intensive care.
Grade 4	Temperature ≥38°C (100.4°F)^a with: Hypotension requiring multiple vasopressors (excluding vasopressin) and/or Hypoxia requiring oxygen via positive pressure (eg, CPAP, BiPAP, intubation, mechanical ventilation).	Permanently discontinue epcoritamab. Manage CRS per practice guidelines and provide supportive therapy, which may include intensive care.

Immune effector cell-associated neurotoxicity syndrome: Monitor for signs/symptoms of immune effector cell-associated neurotoxicity syndrome (ICANS). Interrupt epcoritamab at the first sign of neurologic toxicity, including ICANS, and consider neurology evaluation. Rule out other causes of neurologic symptoms. Manage ICANS according to the table below and consider further management according to current practice guidelines.

**Epcoritamab-Related ICANS Management^e**
Grade	Presenting symptoms^a	Actions
^aManagement is determined by the most severe event (not attributable to any other cause).
^bIf patient is arousable and able to perform Immune Effector Cell-Associated Encephalopathy (ICE) assessment: Orientation (oriented to year, month, city, hospital = 4 points) Naming (name 3 objects, eg, point to clock, pen, button = 3 points) Following commands (eg, “show me 2 fingers” or “close your eyes and stick out your tongue” = 1 point) Writing (ability to write a standard sentence = 1 point) Attention (count backwards from 100 by 10 = 1 point) If unarousable and unable to perform ICE assessment (grade 4 ICANS = 0 points).
^cNot attributable to any other cause.
^dRefer to "Dosing: Adult" for recommendations for restarting epcoritamab after a dosing delay.
^e ICANS = immune effector cell-associated neurotoxicity syndrome.
Grade 1	ICE score 7 to 9^b, or depressed level of consciousness^c(awakens spontaneously)	Withhold epcoritamab until ICANS resolves^d. Monitor neurologic symptoms and consider consultation with neurologist/other specialists for further evaluation and management (eg, consideration for initiating seizure prophylaxis with nonsedating, antiseizure medication).
Grade 2	ICE score 3 to 6^b, or depressed level of consciousness^c (awakens to voice)	Withhold epcoritamab until ICANS resolves^d. Administer dexamethasone 10 mg IV every 6 hours (or equivalent); continue dexamethasone until resolution to ≤ grade 1, then taper. Monitor neurologic symptoms and consider consultation with neurologist/other specialists for further evaluation and management (including consideration for initiating seizure prophylaxis with nonsedating, antiseizure medication).
Grade 3	ICE score 0 to 2^b, or depressed level of consciousness^c (awakens only to tactile stimulus), or seizures^c (either any clinical seizure, focal or generalized, that resolves rapidly, or nonconvulsive seizures on EEG that resolve with intervention), or raised intracranial pressure (focal/local edema on neuroimaging^c)	First occurrence of grade 3 ICANS: Withhold epcoritamab until ICANS resolves^d. Administer dexamethasone 10 mg IV every 6 hours (or equivalent); continue dexamethasone until resolution to ≤ grade 1, then taper. Monitor neurologic symptoms and consider consultation with neurologist/other specialists for further evaluation and management (including consideration for initiating seizure prophylaxis with nonsedating, antiseizure medication). Provide supportive therapy as clinically appropriate (may include intensive care).
Grade 3		Recurrent grade 3 ICANS: Permanently discontinue epcoritamab. Administer dexamethasone 10 mg IV every 6 hours (or equivalent); continue dexamethasone until resolution to ≤ grade 1, then taper. Monitor neurologic symptoms and consider consultation with neurologist/other specialists for further evaluation and management (including consideration for initiating seizure prophylaxis with nonsedating, antiseizure medication). Provide supportive therapy as clinically appropriate (may include intensive care).
Grade 4	ICE score 0^b, or depressed level of consciousness^c (either unarousable or requires vigorous/repetitive tactile stimuli to arouse, or stupor or coma), or seizures^c (either life-threatening prolonged seizure >5 minutes, or repetitive clinical or electrical seizures without return to baseline in between), or motor findings^c (deep focal motor weakness such as hemiparesis or paraparesis), or raised intracranial pressure/cerebral edema^c, with signs/symptoms such as diffuse cerebral edema on neuroimaging, or decerebrate or decorticate posturing, or cranial nerve VI palsy, or papilledema, or Cushing triad	Permanently discontinue epcoritamab. Administer dexamethasone 10 mg IV every 6 hours (or equivalent); continue dexamethasone until resolution to ≤ grade 1, then taper. Alternatively, consider methylprednisolone 1,000 mg IV daily for ≥2 days. Monitor neurologic symptoms and consider consultation with neurologist/other specialists for further evaluation and management (including consideration for initiating seizure prophylaxis with nonsedating, antiseizure medication). Provide supportive therapy as clinically appropriate (may include intensive care).

**Recom** **mended Epcoritamab Dosage Modifications for Other Adverse Reactions**
Adverse reaction	Severity	Actions
^aRefer to "Dosing: Adult" for recommendations for restarting epcoritamab after a dosing delay.
Hematologic toxicity	ANC <500/mm³	Withhold epcoritamab until ANC is ≥500/mm³.^a Consider prophylactic granulocyte colony-stimulating factor administration as appropriate.
	Platelets <50,000/mm³	Withhold epcoritamab until platelets are ≥50,000/mm³.^a
	Other cytopenias	Withhold or discontinue epcoritamab based on the severity.
Infections	Grades 1 to 4	Withhold epcoritamab or consider permanently discontinuing based on severity. Manage infection appropriately and as clinically indicated. Withhold epcoritamab in patients with active infection until infection resolves.^a For grade 4 infection, consider permanently discontinuing epcoritamab.
Other adverse reactions	Grade 3 or higher	Withhold epcoritamab until adverse reaction resolves to grade 1 or baseline.^a

Dosing: Older Adult

Refer to adult dosing.

Adverse Reactions

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Reported adverse reactions are for adults treated for large B-cell lymphoma (LBCL) and follicular lymphoma (FL) unless otherwise noted.

>10%:

Cardiovascular: Edema (14% to 17%)

Dermatologic: Skin rash (FL: 28%; LBCL: 15%)

Endocrine & metabolic: Decreased serum magnesium (FL: 20%; LBCL: 31%), decreased serum phosphate (LBCL: 56%), decreased serum potassium (FL: 20%; LBCL: 34%), decreased serum sodium (51% to 56%), increased serum potassium (LBCL: 21%)

Gastrointestinal: Abdominal pain (17% to 23%), constipation (FL: 16%), decreased appetite (LBCL: 12%), diarrhea (20% to 26%; FL: grade 3: 2%), nausea (17% to 20%; LBCL: grade 3: 1%), stomatitis (FL: 12%), vomiting (FL: <10%; LBCL: 12%, grade 3: <1%)

Hematologic & oncologic: Decreased hemoglobin (59% to 62%; grades 3/4: 10% to 12%), decreased neutrophils (50% to 55%; grades 3/4: 30% to 32%), decreased platelet count (48% to 49%; grades 3/4: 8% to 12%), decreased white blood cell count (53% to 58%; grades 3/4: 19% to 22%), lymphocytopenia (87% to 94%; grades 3/4: 77% to 82%)

Hepatic: Increased serum alanine aminotransferase (45% to 47%), increased serum alkaline phosphatase (FL: 29%), increased serum aspartate aminotransferase (44% to 48%), increased serum bilirubin (FL: 28%)

Hypersensitivity: Cytokine release syndrome (49% to 51%)

Infection: Infection (including cellulitis [FL: <10%], herpes virus infection [FL: 12%], lower respiratory tract infections [FL: <10%], pneumonia [FL: 17%], upper respiratory tract infection [FL: 29%; LBCL: <10%], urinary tract infection [FL: 13%]), serious infection (FL: 40%; LBCL: 15%; including opportunistic infection [cytomegalovirus disease: FL: <10%], sepsis [FL: <1%; LBCL: 5%])

Local: Injection-site reaction (FL: 58%; LBCL: 27%)

Nervous system: Dizziness (FL: 11%), fatigue (29% to 37%), headache (13% to 20%), insomnia (FL: 13%), neurological signs and symptoms (FL: 13%; including amnesia, aphasia, balance impairment, confusion, encephalopathy, extrapyramidal reaction, hallucination, hypoacusis, mental status changes, neuralgia, tremor, vertigo, voice disorder), paresthesia (FL: ≤13%), peripheral neuropathy (FL: ≤13%)

Neuromuscular & skeletal: Arthralgia (FL: 14%), musculoskeletal pain (28%)

Renal: Increased serum creatinine (FL: 36%; LBCL: 24%)

Respiratory: Cough (FL: 20%), dyspnea (FL: 17%)

Miscellaneous: Fever (24% to 26%)

1% to 10%:

Cardiovascular: Cardiac arrhythmia (≤10%), heart failure (FL)

Dermatologic: Pruritus (FL)

Hematologic & oncologic: Febrile neutropenia (3%), secondary primary malignant neoplasm (FL), tumor flare (LBCL), tumor lysis syndrome (LBCL)

Hepatic: Hepatotoxicity (FL)

Nervous system: Neurotoxicity (immune effector cell-associated neurotoxicity syndrome [ICANS]: 6%)

Ophthalmic: Visual disturbance (FL)

Renal: Kidney impairment (FL: 10%)

Respiratory: Pleural effusion (LBCL), pneumonitis (FL)

Contraindications

There are no contraindications listed in the manufacturer's US labeling.

Canadian labeling: Additional contraindications (not in US labeling): Hypersensitivity to epcoritamab or any component of the formulation.

Warnings/Precautions

Concerns related to adverse effects:

• Cytokine release syndrome: Epcoritamab may cause cytokine release syndrome (CRS); may be serious or life-threatening. CRS occurred in approximately half of patients who received epcoritamab at the recommended dose. Grades 1, 2, and 3 CRS were reported. Recurrent CRS was also reported. Most CRS events occurred during cycle 1, predominantly with the full 48 mg dose in cycle 1, although CRS also occurred with the step-up doses. The median time to onset of CRS across all doses was 24 to 59 hours (range: up to 10 days) and the median time to CRS onset after the first full 48 mg dose was 21 to 61 hours (range: 14 days). CRS resolved in most patients and the median duration of CRS events was 2 days (range: 1 to 27 days). Signs/symptoms of CRS included pyrexia, chills, hypotension, hypoxia, dyspnea, and tachycardia. Concurrent neurological adverse reactions associated with CRS occurred in a small percentage of patients and included headache, confusion, tremors, dizziness, and ataxia. Patients who experience CRS (and/or other adverse reactions that impair consciousness) should be evaluated and advised not to drive and to refrain from operating heavy or potentially dangerous machinery until resolution.

• Cytopenias: Epcoritamab may cause serious or severe cytopenias, including neutropenia, anemia, and thrombocytopenia. Grade 3 and 4 cytopenias (neutropenia, anemia, and thrombocytopenia) and neutropenic fever have occurred.

• Immune effector cell-associated neurotoxicity syndrome: Epcoritamab may cause immune effector cell-associated neurotoxicity syndrome (ICANS), including life-threatening and fatal reactions. ICANS occurred in a small percentage of patients who received epcoritamab at the recommended dose. Grades 1 and 2 ICANS have been reported, along with one fatal ICANS case. Most ICANS events occurred during cycle 1 of epcoritamab treatment, with a median time to onset of ICANS of 16.5 to 21.5 days (range: 8 to 141 days) from the start of treatment in cycle 1. The median time to ICANS onset relative to the most recent dose was 3 days (range: 0.4 to 13 days). The median duration of ICANS was 2 to 4 days (range: up to 8 days) with ICANS resolving with supportive care in most patients. Clinical manifestations of ICANS included (although not limited to) confusion, lethargy, tremor, dysgraphia, aphasia, and nonconvulsive status epilepticus. The onset of ICANS may be concurrent with CRS, following resolution of CRS, or in the absence of CRS. Patients who experience signs/symptoms of ICANS or any other adverse reactions impairing cognition or consciousness should be evaluated, including potential neurology evaluation, and patients at increased risk should be advised not to drive and to refrain from operating heavy or potentially dangerous machinery until resolution.

• Infection: Epcoritamab may cause serious and fatal infections. Serious infections (≥ grade 3), including opportunistic infections have been reported with the recommended epcoritamab dose (following step-up doses). The most common ≥ grade 3 infections were sepsis, COVID-19, urinary tract infection, pneumonia, and upper respiratory tract infection.

Special populations:

• Older adult: Patients with follicular lymphoma ≥65 years of age experienced a higher rate of fatal adverse reactions, primarily infections (including COVID-19), compared to patients <65 years of age.

Dosage form specific issues:

• Polysorbate 80: Some dosage forms may contain polysorbate 80 (also known as Tweens). Hypersensitivity reactions, usually a delayed reaction, have been reported following exposure to pharmaceutical products containing polysorbate 80 in certain individuals (Isaksson 2002; Lucente 2000; Shelley 1995). Thrombocytopenia, ascites, pulmonary deterioration, and renal and hepatic failure have been reported in premature neonates after receiving parenteral products containing polysorbate 80 (Alade 1986; CDC 1984). See manufacturer's labeling.

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Solution, Subcutaneous [preservative free]:

Epkinly: Epcoritamab-bysp 4 mg/0.8 mL (0.8 mL); Epcoritamab-bysp 48 mg/0.8 mL (0.8 mL) [contains polysorbate 80]

Generic Equivalent Available: US

Pricing: US

Solution (Epkinly Subcutaneous)

4 mg/0.8 mL (per 0.8 mL): $1,615.72

48 mg/0.8 mL (per 0.8 mL): $19,388.59

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Dosage Forms: Canada

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Solution, Subcutaneous:

Epkinly: Epcoritamab-bysp 4 mg/0.8 mL (0.8 mL); Epcoritamab-bysp 48 mg/0.8 mL (0.8 mL) [contains polysorbate 80]

Prescribing and Access Restrictions

Epcoritamab is available through specialty distributors. Distribution information is available at https://www.epkinlyhcp.com/order.

Administration: Adult

SUBQ: Inject required dose volume into the tissue of the lower part of the abdomen (preferred site) or the thigh. Rotate injection site from left to right (or vice versa), particularly during the weekly administrations (in cycles 1 to 3). Do not inject into tattoos or scars, or areas where the skin is red, bruised, tender, hard, or not intact.

Epcoritamab should be prepared and administered by a health care provider. If refrigerated, allow epcoritamab solution to equilibrate to room temperature for no more than 1 hour before administration. Discard unused epcoritamab solution beyond the allowable storage time.

Medication Guide and/or Vaccine Information Statement (VIS)

An FDA-approved patient medication guide, which is available with the product information and as follows, must be dispensed with this medication:

Epkinly: https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761324s000lbl.pdf#page=26

Use: Labeled Indications

Diffuse large B-cell lymphoma and high-grade B-cell lymphoma, relapsed or refractory: Treatment of relapsed or refractory diffuse large B-cell lymphoma (DLBCL), not otherwise specified, including DLBCL arising from indolent lymphoma, and high-grade B-cell lymphoma in adults after 2 or more lines of systemic therapy.

Follicular lymphoma, relapsed or refractory: Treatment of relapsed or refractory follicular lymphoma in adults after 2 or more lines of systemic therapy.

Medication Safety Issues

Sound-alike/look-alike issues:

Epcoritamab may be confused with elotuzumab, mosunetuzumab, teclistamab.

High alert medication:

The Institute for Safe Medication Practices (ISMP) includes this medication among its list of drug classes (chemotherapeutic agent, parenteral and oral) which have a heightened risk of causing significant patient harm when used in error (High-Alert Medications in Acute Care, Community/Ambulatory Care, and Long-Term Care Settings).

Metabolism/Transport Effects

None known.

Drug Interactions

Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the drug interactions program by clicking on the “Launch drug interactions program” link above.

5-Aminosalicylic Acid Derivatives: May increase myelosuppressive effects of Myelosuppressive Agents. Risk C: Monitor

Abrocitinib: May increase immunosuppressive effects of Immunosuppressants (Miscellaneous Oncologic Agents). Risk X: Avoid

Antithymocyte Globulin (Equine): Anti-CD20 B-Cell Depleting Therapies may increase adverse/toxic effects of Antithymocyte Globulin (Equine). Specifically, these effects may be unmasked if the dose of anti-CD20 B-cell depleting therapy is reduced. Anti-CD20 B-Cell Depleting Therapies may increase immunosuppressive effects of Antithymocyte Globulin (Equine). Specifically, infections may occur with greater severity and/or atypical presentations. Risk C: Monitor

Antithymocyte Globulin (Equine): Immunosuppressants (Miscellaneous Oncologic Agents) may increase adverse/toxic effects of Antithymocyte Globulin (Equine). Specifically, these effects may be unmasked if the dose of immunosuppressive therapy is reduced. Immunosuppressants (Miscellaneous Oncologic Agents) may increase immunosuppressive effects of Antithymocyte Globulin (Equine). Specifically, infections may occur with greater severity and/or atypical presentations. Risk C: Monitor

Antithyroid Agents: Myelosuppressive Agents may increase neutropenic effects of Antithyroid Agents. Risk C: Monitor

Baricitinib: Immunosuppressants (Miscellaneous Oncologic Agents) may increase immunosuppressive effects of Baricitinib. Risk X: Avoid

BCG Products: Anti-CD20 B-Cell Depleting Therapies may increase adverse/toxic effects of BCG Products. Specifically, the risk of vaccine-associated infection may be increased. Anti-CD20 B-Cell Depleting Therapies may decrease therapeutic effects of BCG Products. Risk X: Avoid

Brincidofovir: Immunosuppressants (Miscellaneous Oncologic Agents) may decrease therapeutic effects of Brincidofovir. Risk C: Monitor

Brivudine: May increase adverse/toxic effects of Immunosuppressants (Miscellaneous Oncologic Agents). Risk X: Avoid

Chikungunya Vaccine (Live): Anti-CD20 B-Cell Depleting Therapies may decrease therapeutic effects of Chikungunya Vaccine (Live). Anti-CD20 B-Cell Depleting Therapies may increase adverse/toxic effects of Chikungunya Vaccine (Live). Specifically, the risk of vaccine-associated infection may be increased. Risk X: Avoid

Chikungunya Vaccine (Live): Immunosuppressants (Miscellaneous Oncologic Agents) may increase adverse/toxic effects of Chikungunya Vaccine (Live). Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Miscellaneous Oncologic Agents) may decrease therapeutic effects of Chikungunya Vaccine (Live). Risk X: Avoid

Chloramphenicol (Ophthalmic): May increase adverse/toxic effects of Myelosuppressive Agents. Risk C: Monitor

Chloramphenicol (Systemic): Myelosuppressive Agents may increase myelosuppressive effects of Chloramphenicol (Systemic). Risk X: Avoid

Cladribine: Immunosuppressants (Miscellaneous Oncologic Agents) may increase immunosuppressive effects of Cladribine. Risk X: Avoid

CloZAPine: Myelosuppressive Agents may increase adverse/toxic effects of CloZAPine. Specifically, the risk for neutropenia may be increased. Risk C: Monitor

Coccidioides immitis Skin Test: Coadministration of Immunosuppressants (Miscellaneous Oncologic Agents) and Coccidioides immitis Skin Test may alter diagnostic results. Management: Consider discontinuing these oncologic agents several weeks prior to coccidioides immitis skin antigen testing to increase the likelihood of accurate diagnostic results. Risk D: Consider Therapy Modification

COVID-19 Vaccines: Anti-CD20 B-Cell Depleting Therapies may decrease therapeutic effects of COVID-19 Vaccines. Management: Administer COVID-19 vaccine 2 to 4 weeks prior to the next scheduled dose of anti-CD20 therapy, if used chronically for the treatment of autoimmune disease. Revaccinate 6 months after completion of anti-CD20 therapy if used over a limited period. Risk D: Consider Therapy Modification

CYP Substrates (Narrow Therapeutic Index/Sensitive with Inhibitors): Epcoritamab may increase serum concentration of CYP Substrates (Narrow Therapeutic Index/Sensitive with Inhibitors). Risk C: Monitor

Deferiprone: Myelosuppressive Agents may increase neutropenic effects of Deferiprone. Management: Avoid the concomitant use of deferiprone and myelosuppressive agents whenever possible. If this combination cannot be avoided, monitor the absolute neutrophil count more closely. Risk D: Consider Therapy Modification

Dengue Tetravalent Vaccine (Live): Anti-CD20 B-Cell Depleting Therapies may increase adverse/toxic effects of Dengue Tetravalent Vaccine (Live). Specifically, the risk of vaccine-associated infection may be increased. Anti-CD20 B-Cell Depleting Therapies may decrease therapeutic effects of Dengue Tetravalent Vaccine (Live). Risk X: Avoid

Denosumab: May increase immunosuppressive effects of Immunosuppressants (Miscellaneous Oncologic Agents). Management: Consider the risk of serious infections versus the potential benefits of coadministration of denosumab and immunosuppressants. If combined, monitor patients for signs/symptoms of serious infections. Risk D: Consider Therapy Modification

Deucravacitinib: May increase immunosuppressive effects of Immunosuppressants (Miscellaneous Oncologic Agents). Risk X: Avoid

Efgartigimod Alfa: May decrease therapeutic effects of Fc Receptor-Binding Agents. Risk C: Monitor

Etrasimod: May increase immunosuppressive effects of Immunosuppressants (Miscellaneous Oncologic Agents). Risk X: Avoid

Fexinidazole: Myelosuppressive Agents may increase myelosuppressive effects of Fexinidazole. Risk X: Avoid

Filgotinib: May increase immunosuppressive effects of Immunosuppressants (Miscellaneous Oncologic Agents). Risk X: Avoid

Inebilizumab: Immunosuppressants (Miscellaneous Oncologic Agents) may increase immunosuppressive effects of Inebilizumab. Risk C: Monitor

Influenza Virus Vaccines: Anti-CD20 B-Cell Depleting Therapies may decrease therapeutic effects of Influenza Virus Vaccines. Management: Administer influenza vaccines 2 weeks prior to starting anti-CD20 B-cell depleting therapies. Vaccination of patients treated with these agents in the past 6 months is not recommended. Risk D: Consider Therapy Modification

Leflunomide: Immunosuppressants (Miscellaneous Oncologic Agents) may increase immunosuppressive effects of Leflunomide. Management: Increase the frequency of chronic monitoring of platelet, white blood cell count, and hemoglobin or hematocrit to monthly, instead of every 6 to 8 weeks, if leflunomide is coadministered with immunosuppressive agents. Risk D: Consider Therapy Modification

Linezolid: May increase myelosuppressive effects of Myelosuppressive Agents. Risk C: Monitor

Mumps- Rubella- or Varicella-Containing Live Vaccines: Anti-CD20 B-Cell Depleting Therapies may increase adverse/toxic effects of Mumps- Rubella- or Varicella-Containing Live Vaccines. Specifically, the risk of vaccine-associated infection may be increased. Anti-CD20 B-Cell Depleting Therapies may decrease therapeutic effects of Mumps- Rubella- or Varicella-Containing Live Vaccines. Risk X: Avoid

Nadofaragene Firadenovec: Immunosuppressants (Miscellaneous Oncologic Agents) may increase adverse/toxic effects of Nadofaragene Firadenovec. Specifically, the risk of disseminated adenovirus infection may be increased. Risk X: Avoid

Natalizumab: Immunosuppressants (Miscellaneous Oncologic Agents) may increase immunosuppressive effects of Natalizumab. Risk X: Avoid

Nipocalimab: May decrease therapeutic effects of Fc Receptor-Binding Agents. Risk C: Monitor

Ocrelizumab: Immunosuppressants (Miscellaneous Oncologic Agents) may increase immunosuppressive effects of Ocrelizumab. Risk C: Monitor

Ofatumumab: Immunosuppressants (Miscellaneous Oncologic Agents) may increase immunosuppressive effects of Ofatumumab. Risk C: Monitor

Olaparib: Myelosuppressive Agents may increase myelosuppressive effects of Olaparib. Risk C: Monitor

Pidotimod: Immunosuppressants (Miscellaneous Oncologic Agents) may decrease therapeutic effects of Pidotimod. Risk C: Monitor

Pimecrolimus: May increase immunosuppressive effects of Immunosuppressants (Miscellaneous Oncologic Agents). Risk X: Avoid

Poliovirus Vaccine (Live/Trivalent/Oral): Anti-CD20 B-Cell Depleting Therapies may increase adverse/toxic effects of Poliovirus Vaccine (Live/Trivalent/Oral). Specifically, the risk of vaccine-associated infection may be increased. Anti-CD20 B-Cell Depleting Therapies may decrease therapeutic effects of Poliovirus Vaccine (Live/Trivalent/Oral). Risk X: Avoid

Polymethylmethacrylate: Immunosuppressants (Miscellaneous Oncologic Agents) may increase hypersensitivity effects of Polymethylmethacrylate. Management: Use caution when considering use of bovine collagen-containing implants such as the polymethylmethacrylate-based Bellafill brand implant in patients who are receiving immunosuppressants. Consider use of additional skin tests prior to administration. Risk D: Consider Therapy Modification

Promazine: May increase myelosuppressive effects of Myelosuppressive Agents. Risk C: Monitor

Rabies Vaccine: Anti-CD20 B-Cell Depleting Therapies may decrease therapeutic effects of Rabies Vaccine. Management: Complete rabies vaccination at least 2 weeks before initiation of immunosuppressant therapy if possible. If combined, check for rabies antibody titers, and if vaccination is for post exposure prophylaxis, administer a 5th dose of the vaccine. Risk D: Consider Therapy Modification

Ritlecitinib: Immunosuppressants (Miscellaneous Oncologic Agents) may increase immunosuppressive effects of Ritlecitinib. Risk X: Avoid

Ropeginterferon Alfa-2b: Myelosuppressive Agents may increase myelosuppressive effects of Ropeginterferon Alfa-2b. Management: Avoid coadministration of ropeginterferon alfa-2b and other myelosuppressive agents. If this combination cannot be avoided, monitor patients for excessive myelosuppressive effects. Risk D: Consider Therapy Modification

Rozanolixizumab: May decrease therapeutic effects of Fc Receptor-Binding Agents. Risk C: Monitor

Ruxolitinib (Topical): Immunosuppressants (Miscellaneous Oncologic Agents) may increase immunosuppressive effects of Ruxolitinib (Topical). Risk X: Avoid

Sipuleucel-T: Immunosuppressants (Miscellaneous Oncologic Agents) may decrease therapeutic effects of Sipuleucel-T. Management: Consider reducing the dose or discontinuing the use of immunosuppressants prior to initiating sipuleucel-T therapy. Risk D: Consider Therapy Modification

Sphingosine 1-Phosphate (S1P) Receptor Modulators: May increase immunosuppressive effects of Immunosuppressants (Miscellaneous Oncologic Agents). Risk C: Monitor

Tacrolimus (Topical): Immunosuppressants (Miscellaneous Oncologic Agents) may increase immunosuppressive effects of Tacrolimus (Topical). Risk X: Avoid

Talimogene Laherparepvec: Immunosuppressants (Miscellaneous Oncologic Agents) may increase adverse/toxic effects of Talimogene Laherparepvec. Specifically, the risk of infection from the live, attenuated herpes simplex virus contained in talimogene laherparepvec may be increased. Risk X: Avoid

Tertomotide: Immunosuppressants (Miscellaneous Oncologic Agents) may decrease therapeutic effects of Tertomotide. Risk X: Avoid

Tofacitinib: Immunosuppressants (Miscellaneous Oncologic Agents) may increase immunosuppressive effects of Tofacitinib. Risk X: Avoid

Typhoid Vaccine: Anti-CD20 B-Cell Depleting Therapies may increase adverse/toxic effects of Typhoid Vaccine. Specifically, the risk of vaccine-associated infection may be increased. Anti-CD20 B-Cell Depleting Therapies may decrease therapeutic effects of Typhoid Vaccine. Risk X: Avoid

Ublituximab: Immunosuppressants (Miscellaneous Oncologic Agents) may increase immunosuppressive effects of Ublituximab. Risk C: Monitor

Upadacitinib: Immunosuppressants (Miscellaneous Oncologic Agents) may increase immunosuppressive effects of Upadacitinib. Risk X: Avoid

Vaccines (Live): Anti-CD20 B-Cell Depleting Therapies may increase adverse/toxic effects of Vaccines (Live). Specifically, the risk of vaccine-associated infection may be increased. Anti-CD20 B-Cell Depleting Therapies may decrease therapeutic effects of Vaccines (Live). Risk X: Avoid

Vaccines (Non-Live/Inactivated/Non-Replicating): Anti-CD20 B-Cell Depleting Therapies may decrease therapeutic effects of Vaccines (Non-Live/Inactivated/Non-Replicating). Management: Give non-live/inactivated/non-replicating vaccines at least 2 weeks prior to initiation or 6 months after anti-CD20 B-cell depleting therapies. If vaccinated prior to B cell recovery, consider assessing immune response to vaccination. Risk D: Consider Therapy Modification

Yellow Fever Vaccine: Anti-CD20 B-Cell Depleting Therapies may increase adverse/toxic effects of Yellow Fever Vaccine. Specifically, the risk of vaccine-associated infection may be increased. Anti-CD20 B-Cell Depleting Therapies may decrease therapeutic effects of Yellow Fever Vaccine. Risk X: Avoid

Zoster Vaccine (Live/Attenuated): Anti-CD20 B-Cell Depleting Therapies may increase adverse/toxic effects of Zoster Vaccine (Live/Attenuated). Specifically, the risk of vaccine-associated infection may be increased. Anti-CD20 B-Cell Depleting Therapies may decrease therapeutic effects of Zoster Vaccine (Live/Attenuated). Risk X: Avoid

Zoster Vaccine (Live/Attenuated): Immunosuppressants (Miscellaneous Oncologic Agents) may increase adverse/toxic effects of Zoster Vaccine (Live/Attenuated). Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Miscellaneous Oncologic Agents) may decrease therapeutic effects of Zoster Vaccine (Live/Attenuated). Risk X: Avoid

Reproductive Considerations

Verify pregnancy status prior to treatment initiation in patients who could become pregnant.

Patients who could become pregnant should use effective contraception during therapy and for 4 months after the last epcoritamab dose.

Pregnancy Considerations

Epcoritamab is a humanized bispecific antibody (IgG₁). Human IgG crosses the placenta. Fetal exposure is dependent upon the IgG subclass, maternal serum concentrations, placental integrity, newborn birth weight, and gestational age, generally increasing as pregnancy progresses. The lowest exposure would be expected during the period of organogenesis and the highest during the third trimester (Clements 2020; Palmeira 2012; Pentsuk 2009).

Animal reproduction studies have not been conducted. Based on the mechanism of action, in utero exposure to epcoritamab may cause fetal harm. In addition, newborns exposed to epcoritamab in utero may develop B-cell lymphocytopenia.

Breastfeeding Considerations

It is not known if epcoritamab is present in breast milk.

Epcoritamab is a humanized bispecific antibody (IgG₁). Human IgG is present in breast milk; concentrations are dependent upon IgG subclass and postpartum age (Anderson 2021).

Due to the potential for serious adverse reactions in the breastfed infant, breastfeeding is not recommended by the manufacturer during therapy and for 4 months after the last epcoritamab dose.

Monitoring Parameters

CBC (throughout treatment). Verify pregnancy status prior to treatment (in patients who could become pregnant). Monitor for signs/symptoms of CRS (eg, pyrexia, chills, hypotension, hypoxia, dyspnea, tachycardia); at the first signs or symptoms, immediately evaluate patients for hospitalization. Monitor for neurological signs/symptoms of immune effector cell-associated neurotoxicity syndrome (ICANS) during treatment; evaluate patient immediately at the first signs/symptoms of ICANS. Monitor hydration status. Monitor for signs/symptoms of infection (including opportunistic infections) prior to and during epcoritamab treatment.

The American Society of Clinical Oncology hepatitis B virus (HBV) screening and management provisional clinical opinion (ASCO [Hwang 2020]) recommends HBV screening with hepatitis B surface antigen, hepatitis B core antibody, total Ig or IgG, and antibody to hepatitis B surface antigen prior to beginning (or at the beginning of) systemic anticancer therapy; do not delay treatment for screening/results. Detection of chronic or past HBV infection requires a risk assessment to determine antiviral prophylaxis requirements, monitoring, and follow-up.

Mechanism of Action

Epcoritamab is a bispecific T-cell engaging antibody that targets CD3 and CD20 (Thieblemont 2023). Epcoritamab binds to the CD3 receptor expressed on the surface of T-cells and CD20 expressed on the surface of lymphoma cells and healthy B-lineage cells. Epcoritamab activates T-cells resulting in the release of proinflammatory cytokines, and induces B-cell lysis.

Pharmacokinetics (Adult Data Unless Noted)

Onset: Circulating B cells decreased to undetectable levels (in patients who had detectable B cells at treatment initiation) following the approved recommended epcoritamab dose by cycle 1, day 15.

Duration: B cell depletion was sustained throughout treatment.

Distribution: V_d: 25.6 L.

Metabolism: Metabolized into small peptides via catabolic pathways.

Half-life elimination: ~22 days (after the end of cycle 3).

Time to peak: Following the first full (48 mg) dose in cycle 1: 4 days; following the end of cycle 3: 2.3 days.

Excretion: Clearance: 0.53 L/day (after the end of cycle 3).

Pharmacokinetics: Additional Considerations (Adult Data Unless Noted)

Body weight: In patients who received the recommended epcoritamab dose, cycle 1 median average concentration was 31% lower in a group of patients weighing 85 to 172 kg and 13% higher in a group of patients weighing 39 to 65 kg, compared to patients weighing 65 to <85 kg.

Brand Names: International

International Brand Names by Country

For country code abbreviations (show table)

(QA) Qatar: Tepkinly

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Anderson PO. Monoclonal antibodies during breastfeeding. Breastfeed Med. 2021;16(8):591-593. doi:10.1089/bfm.2021.0110 [PubMed 33956488]
Centers for Disease Control and Prevention (CDC). Unusual syndrome with fatalities among premature infants: association with a new intravenous vitamin E product. MMWR Morb Mortal Wkly Rep. 1984;33(14):198-199. [PubMed 6423951]
Clements T, Rice TF, Vamvakas G, et al. Update on transplacental transfer of IgG subclasses: impact of maternal and fetal factors. Front Immunol. 2020;11:1920. doi:10.3389/fimmu.2020.01920 [PubMed 33013843]
Epkinly (epcoritamab) [prescribing information]. Plainsboro, NJ: Genmab US Inc; August 2024.
Epkinly (epcoritamab) [product monograph]. St-Laurent, Quebec, Canada: AbbVie Corporation; April 2024.
Griggs JJ, Bohlke K, Balaban EP, et al. Appropriate systemic therapy dosing for obese adult patients with cancer: ASCO guideline update. J Clin Oncol. 2021:39(18):2037-2048. doi:10.1200/JCO.21.00471 [PubMed 33939491]
Hwang JP, Feld JJ, Hammond SP, et al. Hepatitis B virus screening and management for patients with cancer prior to therapy: ASCO provisional clinical opinion update. J Clin Oncol. 2020;38(31):3698-3715. doi:10.1200/JCO.20.01757 [PubMed 32716741]
Isaksson M, Jansson L. Contact allergy to Tween 80 in an inhalation suspension. Contact Dermatitis. 2002;47(5):312-313. doi:10.1034/j.1600-0536.2002.4705104.x [PubMed 12534540]
Linton KM, Vitolo U, Jurczak W, et al. Epcoritamab monotherapy in patients with relapsed or refractory follicular lymphoma (EPCORE NHL-1): a phase 2 cohort of a single-arm, multicentre study. Lancet Haematol. Published online June 13, 2024. doi:10.1016/S2352-3026(24)00166-2 [PubMed 38889737]
Lucente P, Iorizzo M, Pazzaglia M. Contact sensitivity to Tween 80 in a child. Contact Dermatitis. 2000;43(3):172. [PubMed 10985636]
Palmeira P, Quinello C, Silveira-Lessa AL, Zago CA, Carneiro-Sampaio M. IgG placental transfer in healthy and pathological pregnancies. Clin Dev Immunol. 2012;2012:985646. doi:10.1155/2012/985646 [PubMed 22235228]
Pentsuk N, van der Laan JW. An interspecies comparison of placental antibody transfer: new insights into developmental toxicity testing of monoclonal antibodies. Birth Defects Res B Dev Reprod Toxicol. 2009;86(4):328-344. doi:10.1002/bdrb.20201 [PubMed 19626656]
Shelley WB, Talanin N, Shelley ED. Polysorbate 80 hypersensitivity. Lancet. 1995;345(8960):1312-1313. doi:10.1016/s0140-6736(95)90963-x [PubMed 7746084]
Thieblemont C, Phillips T, Ghesquieres H, et al. Epcoritamab, a novel, subcutaneous CD3xCD20 bispecific T-cell-engaging antibody, in relapsed or refractory large b-cell lymphoma: dose expansion in a phase I/II trial. J Clin Oncol. 2023;41(12):2238-2247. doi:10.1200/JCO.22.01725 [PubMed 36548927]

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Epcoritamab: Drug information