epcoritamab

medtigo

epcoritamab

Brand Name :

epcoritamab-bysp, Epkinly

Synonyms :

epcoritamab

Class :

Antineoplastics, Anti-CD20 Monoclonal Antibodies

Action and Spectrum

Actions and Spectrum

epcoritamab belongs to the class of bispecific antibodies, which are engineered to simultaneously bind to two distinct epitopes. Specifically, drug is designed to target both CD3 on T cells and CD20 on B cells. This dual binding mechanism enables epcoritamab to redirect the immune system’s cytotoxic response towards malignant B cells, leading to their destruction.

The spectrum of activity of this drug extends to various subtypes of NHL, including diffuse large B-cell lymphoma (DLBCL), follicular lymphoma (FL), and mantle cell lymphoma (MCL). Additionally, drug has shown promising results in CLL, a common form of leukemia characterized by the accumulation of mature B cells.

Dosing & Uses

Drug Interaction

Adverse Reaction

Frequency defined

>10%

(All grades)

Sodium decreased (56%)

Neutrophil count decreased (50%)

AST increased (48%)

Cytokine release syndrome (51%)

ALT increased (45%)

Lymphocyte count decreased (87%)

Platelet count decreased (48%)

Phosphate decreased (56%)

Magnesium decreased (31%)

White blood cell count decreased (53%)

Hemoglobin decreased (62%)

Fatigue (29%)

Potassium decreased (34%)

(Grade 3 or 4)

White blood cell count decreased (22%)

Neutrophil count decreased (32%)

Lymphocyte count decreased (77%)

Hemoglobin decreased (12%)

Platelet count decreased (12%)

1-10%

(All grades)

Cardiac arrhythmias (10%)

(Grade 3 or 4 H4)

Potassium increased (1.3%)

Potassium decreased (5.3%)

Creatinine increased (3.3%)

Cytokine release syndrome (2.5%)

Sodium decreased (2.6%)

ALT increased (5.3%)

Edema (1.9%)

Abdominal pain (1.9%)

AST increased (4.6%)

Nausea (1.3%)

Fatigue (2.5%)

Musculoskeletal pain (1.3%)

<1%

(Grade 3 or 4)

Headache (0.6%)

Cardiac arrhythmias (0.6%)

Rash (0.6%)

Vomiting (0.6%)

Decreased appetite (0.6%)

Black Box Warning

Black Box Warning:

Cytokine release syndrome

Neurotoxicity syndrome associated with immune effector cells

Contraindication / Caution

Contraindication/Caution:

Hypersensitivity: The drug is contraindicated in individuals with a known hypersensitivity or allergic reaction to the active substance or any of the excipients present in the formulation. Hypersensitivity reactions may manifest as rash, itching, swelling, or severe anaphylaxis.

Active Infections: The use of this drug is contraindicated in patients with active severe infections. epcoritamab therapy may suppress the immune system, rendering the patient more susceptible to infections. Precautionary measures should be taken to evaluate the patient’s infection status, and appropriate treatment should be initiated before considering the use of this drug.

Severe Organ Dysfunction: Patients with severe hepatic or renal impairment may experience altered metabolism or excretion of this drug, leading to potential safety concerns.

Vaccinations: The administration of live vaccines should be avoided during the drug treatment due to the potential risk of increased infection susceptibility. Vaccination with live vaccines should be completed before initiating epcoritamab therapy.

Pregnancy / Lactation

Pregnancy warnings:   

Pregnancy category: N/A

Lactation: Excreted into human milk is unknown

Pregnancy Categories:        

Category A: Studies that were well-controlled and met expectations revealed no risk to the fetus in either the first or second trimester.

Category B: There were a lack of studies on pregnant women and no evidence of risk to the fetus in animal experiments.  

Category C: there was evidence of risk of adverse effects in animal reproduction studies, and no adequate evidence in human studies must take care of potential risks in pregnant women.   

Category D: adequate data with sufficient evidence of human fetal risk from various platforms, but despite the potential risk, and used only in emergency cases for potential benefits.  

Category X: Drugs listed in this category outweigh the risks over benefits. Hence these categories of drugs need to be avoided by pregnant women.   

Category N: There is no data available for the drug under this category

Pharmacology

Pharmacology:

epcoritamab is a novel therapeutic agent classified as a bispecific antibody targeting CD3 and CD20 antigens.

Pharmacodynamics:

It exhibits a mechanism of action that combines the potent cytotoxic effects of T-cell engagement via CD3 with the targeted elimination of CD20-expressing B cells. This unique design enables epcoritamab to selectively redirect T cells towards malignant B cells, resulting in the potentiation of antitumor activity.

The drug binds to CD3 epsilon (CD3ε) chains on T cells and simultaneously engages CD20 molecules on B cells. This dual-binding interaction leads to the formation of a cytolytic synapse between the T and B cells, triggering the activation of T-cell effector functions, including the release of perforin and granzymes. Consequently, the targeted B cells undergo apoptosis, leading to their depletion.  

Pharmacokinetics:

Absorption

The drug is administered intravenously, bypassing the need for absorption considerations. By directly infusing the drug into the systemic circulation, maximum bioavailability is achieved, resulting in immediate and predictable therapeutic levels.

Distribution

epcoritamab exhibits a distribution pattern typical of monoclonal antibodies. It predominantly distributes within the intravascular compartment and extravascular tissues that express the target antigen, such as malignant B-cell infiltrated lymphoid organs and tumor sites. Distribution into other tissues and organs is limited, as epcoritamab primarily targets malignant B cells in specific locations.

Metabolism

Monoclonal antibodies, including epcoritamab, are not significantly metabolized by metabolic enzymes. Therefore, metabolism is not a major route of elimination for this drug. However, non-specific catabolism by proteolytic enzymes may occur, leading to the breakdown of the monoclonal antibody into smaller peptides and amino acids.

Excretion and Elimination

The primary route of elimination for the drug is via non-specific catabolism and clearance through the reticuloendothelial system (RES). The RES, consisting of macrophages and other phagocytic cells, clears epcoritamab from the systemic circulation. Elimination half-life is dependent on the rate of clearance, typically ranging from several days to weeks.

Adminstartion

Administration: 

Preparation: The drug is supplied as a sterile, concentrated solution in single-dose vials. Prior to administration, the healthcare professional should visually inspect the vial for any particulate matter or discoloration. If any abnormalities are observed, the vial should be discarded.

To prepare the infusion, the required dose of epcoritamab is withdrawn from the vial and diluted in [appropriate diluent], following aseptic techniques. The diluted solution should be prepared immediately before administration to maintain its stability and sterility.

Patient Information Leaflet

Patient information leaflet

Generic Name: epcoritamab

Why do we use epcoritamab?

Hematological Malignancies:

Non-Hodgkin Lymphoma (NHL): The drug demonstrates efficacy in the treatment of relapsed or refractory diffuse large B-cell lymphoma (DLBCL), follicular lymphoma (FL), and mantle cell lymphoma (MCL).

Chronic Lymphocytic Leukemia (CLL):

The drug shows potential as a therapeutic option for patients with CLL who have relapsed or are refractory to standard treatments. It offers an alternative approach to address the unmet medical need in this patient population.

Solid Tumors:

Multiple Myeloma (MM):

The drug demonstrates encouraging results in the treatment of relapsed or refractory multiple myeloma, particularly in patients who have exhausted available treatment options. It presents a new avenue for targeted therapy in this challenging disease.

Other Solid Tumors:

The drug holds promise in the management of solid tumors expressing CD20, such as ovarian cancer and breast cancer. Clinical studies are underway to evaluate its efficacy and safety in these indications.

epcoritamab

No data available for drug.

DRUG INTERACTION

epcoritamab

&

epcoritamab +

Contraindicated

Serious Use Alternative

Monitor Closely

Minor

epcoritamab

No data available for drug.

DRUG INTERACTION

epcoritamab

&

epcoritamab +

Contraindicated

Serious Use Alternative

Monitor Closely

Minor

medtigo

epcoritamab

Brand Name :

Synonyms :

Class :

Action and Spectrum

Dosing & Uses

Drug Interaction

Adverse Reaction

Black Box Warning

Contraindication / Caution

Pregnancy / Lactation

Pharmacology

Adminstartion

Patient Information Leaflet

CONTACT INFORMATION

ADDRESS

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