Epcoritamab

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 (CHO) cells using recombinant DNA technology.

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-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 cytopenias, 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?

• In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.

• Overdose related information is also available online at poisonhelp.org/help.
• In the event that the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services. In the United States, call 911.

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.
• 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.

• Dailymed label info on Epcoritamab
• FDA Epcoritamab

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