Epkinly

Pronunciation: ep-KIN-lee
Generic name: epcoritamab-bysp
Dosage form: injection, for subcutaneous use
Drug class: Bispecific T-cell engagers (BiTE)

Medically reviewed by Carmen Pope, BPharm. Last updated on Jul 1, 2024.

What is Epkinly?

Epkinly is a T-cell engaging bispecific antibody that may be used to treat adults with certain types of diffuse large B-cell lymphoma (DLBCL), high-grade B-cell lymphoma, or follicular 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.

Epkinly contains epcoritamab-bysp, which is a bispecific CD20-directed CD3 T-cell engager that works by simultaneously binding to CD3 on T-cells and CD20 on B-cells, inducing T-cell mediated killing of CD20+ cells. CD20 is expressed on B-cells and is an important treatment target in many B-cell malignancies, including DLBCL. Epkinly directs cytotoxic T-cells selectively to tumors to induce T-cell mediated killing of lymphoma B cells.

Epkinly was FDA-approved on May 19, 2023, under the accelerated approval designation. The approval for follicular lymphoma was added on 26 June 2024 (also under the accelerated approval designation). Continued approval may be contingent upon continued clinical benefits being reported in further clinical trials.

What is Epkinly used to treat?

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

• DLBCL is the most common form of non-Hodgkin's lymphoma. DLBCL is an aggressive, fast-growing B-cell lymphoma characterized by rapidly growing tumors in the lymph nodes, spleen, liver, bone marrow, or other tissues and organs. It is caused by mutations in the B-cells, which are lymphocytes that make antibodies to fight infections in the body.

Epkinly may also be used to treat relapsed or refractory follicular lymphoma (FL) in adults who have already received 2 or more treatments for their cancer.

It is not known if this medicine is safe and effective in children.

Related/similar drugs

Rituxan, Truxima, Monjuvi, Yescarta, Breyanzi, Kymriah, Polivy

Epkinly side effects

The most common side effects of Epkinly include:

• tiredness
• muscle and bone pain
• injection site reactions
• fever
• stomach-area (abdominal) pain
• nausea
• diarrhea.

Serious side effects and warnings

Epkinly carries a Boxed Warning for cytokine release syndrome (CRS) and Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS).

Cytokine Release Syndrome (CRS) happens when your immune system responds to immunotherapy drugs more aggressively than it should. It is common during treatment and can also be serious or life-threatening. Tell your healthcare provider or get medical help right away if you develop any signs or symptoms of CRS, including:

• fever of 100.4°F (38°C) or higher
• dizziness or light-headedness
• trouble breathing
• chills
• fast heartbeat
• feeling anxious
• headache
• confusion
• shaking (tremors)
• problems with balance and movement, such as trouble walking

Due to the risk of CRS, you will receive treatment on a "step-up dosing schedule".

• The step-up dosing schedule is when you receive smaller "step-up" doses on Day 1 and Day 8 of your first cycle of treatment (Cycle 1).
• You will receive your first full dose on Day 15 of Cycle 1.
• If your dose is delayed for any reason, you may need to repeat the "step-up dosing schedule".
• Before each dose in Cycle 1, you will receive medicines to help reduce your risk of CRS. Your healthcare provider will decide if you need to receive medicine to help reduce your risk of CRS with future cycles.
• See How will I receive Epkinly? for more information about how you will receive this medicine.

Neurologic Problems (Immune Effector Cell-Associated Neurotoxicity Syndrome or ICANS). Epkinly can cause serious neurologic problems that can be life-threatening and lead to death. Neurologic problems may happen days or weeks after you receive this medicine. Your healthcare provider may refer you to a healthcare provider who specializes in neurologic problems. Tell your healthcare provider right away if you develop any signs or symptoms of neurologic problems, including:

• trouble speaking or writing
• confusion and disorientation
• drowsiness
• tiredness or lack of energy
• muscle weakness
• shaking (tremors)
• seizures
• memory loss.

Due to the risk of CRS and neurologic problems, you should be hospitalized for 24 hours after receiving your first full dose on Day 15 of Cycle 1. Your healthcare provider will monitor you for signs and symptoms of CRS and neurologic problems during treatment, as well as other side effects and treat you if needed. Your healthcare provider may temporarily stop or completely stop your treatment if you develop CRS, neurologic problems, or any other severe side effects.

Other serious side effects of Epkinly include:

Infections. Epkinly can cause serious infections that may lead to death. Your healthcare provider will check you for signs and symptoms of infection before and during treatment with Epkinly. Tell your healthcare provider right away if you develop any signs or symptoms of infection during treatment, including:

• fever of 100.4°F (38°C) or higher
• cough
• chest pain
• tiredness
• shortness of breath
• painful rash
• sore throat
• pain during urination
• feeling weak or generally unwell.

Low blood cell counts. Low blood cell counts are common during treatment, and can also be serious or severe. Your healthcare provider will check your blood cell counts during treatment.
Epkinly may cause the following low blood cell counts:

• low white blood cell counts (neutropenia). Low white blood cells can increase your risk for infection
• low red blood cell counts (anemia). Low red blood cells can cause tiredness and shortness of breath
• low platelet counts (thrombocytopenia). Low platelet counts can cause bruising or bleeding problems.

Your healthcare provider may temporarily stop or completely stop treatment if you develop certain side effects.

It is not known if Epkinly is safe and effective in children.

These are not all the possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Before receiving Epkinly

Before you receive treatment, tell your healthcare provider about all of your medical conditions, including if you:

• have an infection
• are pregnant or intend to become pregnant
• are breastfeeding.

Pregnancy

This medicine may cause harm to your unborn baby. Females who can become pregnant:

• Your healthcare provider should do a pregnancy test before you start treatment
• You should use effective birth control (contraception) during treatment, and for 4 months after your last dose
• Tell your healthcare provider if you become pregnant or think that you may be pregnant during treatment.

Breastfeeding

Do not breastfeed during treatment and for 4 months after your last dose.

How will I receive Epkinly?

• 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 treatment schedule is divided into cycles that are usually 28 days (4 weeks) long.
• Epkinly is usually given every week during Cycles 1 to 4, every 2 weeks from Cycle 4 to 9, and every 4 weeks starting with Cycle 10.
• Your healthcare provider will decide how many treatment cycles you will receive.

What should I avoid while receiving Epkinly?

Do not drive, operate heavy machinery, or do other dangerous activities if you develop dizziness, confusion, tremors, sleepiness, or any other symptoms that impair consciousness until your signs and symptoms go away. These may be signs and symptoms of CRS or neurologic problems.

Epkinly Dosing information

Usual Epkinly Adult Dose for Diffuse Large B-cell Lymphoma (DLBCL) or High-grade B-cell Lymphoma

* Cycle = 28 days

Comments:

• Patients should be hospitalized for 24 hours after administration of the Cycle 1 Day 15 dosage of 48 mg.
• Administer premedications and prophylaxis as recommended. Premedications for the first cycle include prednisolone or dexamethasone or equivalent, diphenhydramine or equivalent, and acetaminophen. Premedications for the remaining cycles include prednisolone or dexamethasone or equivalent.
• Dosages of 0.16 mg and 0.8 mg require dilution before administration.

Usual Epkinly Adult Dose for Follicular Lymphoma (FL)

* Cycle = 28 days

Comments

• Monitor all patients for signs and symptoms of CRS and ICANS.
• Administer premedications and prophylaxis as recommended. Premedications for the first cycle include prednisolone or dexamethasone or equivalent, diphenhydramine or equivalent, and acetaminophen. Premedications for the remaining cycles include prednisolone or dexamethasone or equivalent.
• Dosages of 0.16 mg and 0.8 mg require dilution before administration.

What other drugs will affect Epkinly?

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Epkinly may cause small changes in the concentration of other medications that are metabolized by the CYP hepatic enzyme system. Monitor for any increase in side effects .

Epkinly causes the release of cytokines that may suppress the activity of CYP enzymes, and enhance the concentration of CYP substrates. This is more likely to occur after the first dose of Epkinly and up to 14 days after the 48 mg dose.

Storage

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

What are the ingredients in Epkinly?

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

Who makes Epkinly?

Genmab US, Inc. makes Epkinly

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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