Prab at 17:24, 18 March 2025

2025-03-18T17:24:04Z

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Deepika vegiraju at 07:56, 14 June 2023

2023-06-14T07:56:30Z

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== '''What is Epcoritamab?''' ==

* Epcoritamab ('''Epkinly'''), is '''a bispecific CD20-directed CD3 T-cell engager'''; it is '''a humanized bispecific IgG1 antibody'''.
* Epcoritamab-bysp is manufactured in [[Chinese hamster ovary cell|Chinese hamster ovary (CHO) cells]] using [[recombinant DNA technology]].

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== '''What are the uses of this medicine?''' ==

* Epcoritamab ('''Epkinly''')is a prescription medicine used to treat adults with certain types of [[diffuse large B-cell lymphoma]] (DLBCL) and high-grade [[B-cell lymphoma]] that has come back ([[relapsed]]) or that did not respond to previous treatment ([[refractory]]), and who have already received 2 or more treatments for their cancer.

== '''How does this medicine work?''' ==

* A '''bispecific monoclonal antibody''', with potential '''immunomodulating and antineoplastic activities'''.
* '''Epcoritamab contains two antigen-recognition sites: one for human CD3, a T-cell surface antigen''', and one for human CD20, a tumor-associated antigen (TAA) that is exclusively expressed on B-cells during most stages of B-cell development and is often overexpressed in B-cell malignancies.
* Upon administration, '''epcoritamab binds to both T-cells and CD20-expressing B-lineage tumor cells'''.
* The resulting cross-linkage may '''trigger a potent cytotoxic T-lymphocyte (CTL) response against the CD20-expressing tumor B-cells'''.

== '''Who Should Not Use this medicine ?''' ==

* This medicine have no usage limitations.

== '''What drug interactions can this medicine cause?''' ==

* Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
* Your doctor may need to change the doses of your medications or monitor you carefully for side effects.

Be sure to mention any of the following:
* CYP substrates

== '''Is this medicine FDA approved?''' ==

* Epcoritamab was approved for medical use in the United States in May 2023.

== '''How should this medicine be used?''' ==

* Administer Epkinly to well-hydrated patients.

'''Recommended dosage:'''
* The recommended dosage schedule for Epkinly is provided below.
* Administer Epkinly in 28-day cycles until disease progression or unacceptable toxicity.

'''Cycle 1:'''
* Days of treatment: 1, 8, 15 and 22
* Dose of Epkinly: 0.16mg, 0.8mg, 48mg, 48mg

'''Cycles 2 and 3:'''
* Days of treatment: 1, 8, 15 and 22
* Dose of Epkinly: 48mg

'''Cycles 4 to 9:'''
* Days of treatment: 1 and 15
* Dose of Epkinly: 48mg

'''Cycle 10 and beyond:'''
* Days of treatment:1
* Dose of Epkinly: 48mg

'''Administration:'''
* Epkinly will be given to you by your healthcare provider as an injection under your skin ([[subcutaneous]] injection), usually in the lower part of your stomach-area (abdomen) or thigh.
* Your Epkinly treatment schedule is divided into cycles that are usually 28 days (4 weeks) long.
* Epkinly is usually given every week during Cycles 1 to 3, every 2 weeks during Cycles 4 to 9, and every 4 weeks starting with Cycle 10.
* Your healthcare provider will decide how many treatment cycles you will receive.

== '''What are the dosage forms and brand names of this medicine?''' ==

This medicine is available in fallowing doasage form:
* As Injection: 4 mg/0.8 mL in a single-dose vial. Dilute prior to use.
* Injection: 48 mg/0.8 mL in a single-dose vial.

This medicine is available in fallowing brand namesː
* '''Epkinly'''

=='''What side effects can this medication cause?'''==

The most common side effects of this medicine include:
* tiredness
* muscle and bone pain
* [[injection site reactions]]
* fever
* stomach-area (abdominal) pain
* nausea
* [[diarrhea]]

Less common, but serious side effects may include:
* [[Cytokine Release Syndrome]] (CRS)
* [[Neurologic]] problems
* Infections
* Low blood cell counts

==''' What special precautions should I follow?''' ==

* Epkinly can cause CRS, including serious or life-threatening reactions. Inform patients of the risk of CRS, and to immediately contact their healthcare provider should signs and symptoms associated with CRS (e.g., [[pyrexia]], [[hypotension]], [[hypoxia]], [[chills]], [[tachycardia]], headache, and [[dyspnea]]) occur at any time. Advise patients that they should be hospitalized for 24 hours after administration of the Cycle 1 Day 15 dosage of 48 mg. Advise patients who experience symptoms that impair consciousness not to drive and refrain from operating heavy or potentially dangerous machinery until events resolve.
* Epkinly can cause life-threatening and fatal [[Immune effector cell encephalopathy|immune effector cell-associated neurotoxicity syndrome]] (ICANS). Advise patients of the risk of ICANS, to immediately contact their healthcare provider for signs and symptoms associated with ICANS, which may manifest, for example, as confusional state, lethargy, [[tremor]], [[dysgraphia]], [[aphasia]], and non-convulsive [[status epilepticus]], and that the onset of events may be delayed. Advise patients who experience symptoms of ICANS that impair consciousness to refrain from driving or operating heavy or potentially dangerous machinery until symptoms of ICANS resolve.
* Epkinly can cause serious and fatal infections. Advise patients of the risk of serious infections, and to contact their healthcare professional for signs or symptoms of serious infection.
* Epkinly can cause serious or severe [[cytopenia]]s, including [[neutropenia]], [[anemia]], and [[thrombocytopenia]]. Discuss the signs and symptoms associated with cytopenias, including neutropenia and [[febrile neutropenia]], anemia, and thrombocytopenia.
* Based on its mechanism of action, Epkinly may cause fetal harm when administered to a pregnant woman. Advise pregnant women of the potential risk to the fetus. Advise females of reproductive potential to use effective [[contraception]] during treatment with Epkinly and for 4 months after the last dose.
* It is not known if Epkinly passes into your breast milk. Do not breastfeed during treatment and for 4 months after your last dose of Epkinly.

== '''What to do in case of emergency/overdose?''' ==

* {{overdose}}

== '''Can this medicine be used in pregnancy?''' ==

* Based on the mechanism of action, Epkinly may cause fetal harm when administered to a pregnant woman.
* Epkinly may harm your unborn baby.

Females who are able to become pregnant:
* Your healthcare provider should do a pregnancy test before you start treatment with Epkinly.
* You should use effective birth control ([[contraception]]) during treatment and for 4 months after your last dose of Epkinly.
* Tell your healthcare provider if you become pregnant or think that you may be pregnant during treatment with Epkinly.

=='''Can this medicine be used in children?'''==

* The safety and efficacy of Epkinly in pediatric patients have not been established.

== '''What are the active and inactive ingredients in this medicine?''' ==

* '''Active ingredient:''' epcoritamab-bysp
* '''Inactive ingredients:''' acetic acid, polysorbate 80, sodium acetate, sorbitol and Water for Injection.

== '''Who manufactures and distributes this medicine?''' ==

'''Manufactured by:'''
* [[Genmab US Inc|Genmab US, Inc]].
* Plainsboro, NJ, USA

'''Marketed by:'''
* Genmab US, Inc.
* Plainsboro, NJ
* and
* [[AbbVie Inc.]]
* North Chicago, IL

* Epkinly is a trademark owned by Genmab A/S

== '''What should I know about storage and disposal of this medication?''' ==

* Store refrigerated at 2°C to 8°C (36°F to 46°F).
* Keep in the original carton to protect from light.
* Do not freeze.
* Do not shake.

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[[Category:Monoclonal antibodies for tumors]]

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Epcoritamab - Revision history

Prab at 17:24, 18 March 2025

Prab: CSV import

Prab: CSV import

Deepika vegiraju at 07:56, 14 June 2023