Epkinly (epcoritamab-bysp) is a prescription drug used to treat a certain type of B-cell lymphoma in adults when other treatments haven’t worked. Epkinly is given as an injection under your skin by a healthcare professional.

Epkinly basics

Epkinly contains the active ingredient epcoritamab-bysp. (An active ingredient is what makes a drug work.)

Epkinly is a biologic medication. A biologic is made from parts of living organisms. It’s available only as a brand-name drug. It isn’t available in a biosimilar form.

Biosimilars are like generic drugs. But unlike generics, which are made for non-biologic drugs, biosimilars are made for biologic drugs.

Note that “-bysp” appears at the end of the name of Epkinly’s active ingredient. This suffix is added to show that it’s distinct from biosimilars that may be developed in the future.

Epkinly is used to treat diffuse large B-cell lymphoma (DLBCL)* in adults. Specifically, the drug is prescribed for adults who’ve already tried at least two systemic treatments for DLBCL, but their cancer either didn’t respond or came back. (“Systemic” refers to a treatment that affects the whole body, such as medications that you swallow or inject.)

DLBCL is a type of non-Hodgkin’s lymphoma. It’s a blood cancer that affects a kind of white blood cell called B-cells. It may cause symptoms such as sudden weight loss, fever, and swelling in the armpit, neck, or groin.

Epkinly may be used to treat DLBCL that’s:

  • high grade (fast growing) or low grade (slow growing, also called indolent)
  • not otherwise specified (meaning it doesn’t have a known cause)

Epkinly works to treat DLBCL by activating certain cells in your immune system. This helps your immune system kill the cancerous cells. To learn more about how the drug works, talk with your doctor.

* Epkinly has received accelerated approval from the Food and Drug Administration (FDA) for this use. Accelerated approval is given based on data from early studies. Full approval of Epkinly will not be granted until additional studies have been completed.

Like most drugs, Epkinly may cause mild or serious side effects. The lists below describe some of the more common side effects that Epkinly may cause. These lists don’t include all possible side effects.

Keep in mind that side effects of a drug can depend on:

  • your age
  • other health conditions you have
  • other medications you take

Your doctor or pharmacist can tell you more about the potential side effects of Epkinly. They can also suggest ways to help reduce side effects.

Mild side effects

Here’s a list of some of the mild side effects that Epkinly can cause. To learn about other mild side effects, talk with your doctor or pharmacist, or read Epkinly’s prescribing information.

Mild side effects of Epkinly that have been reported include:

  • fatigue (low energy)
  • muscle ache
  • injection site reactions, such as pain or swelling, where you receive the injection
  • mild fever
  • abdominal pain
  • nausea
  • diarrhea
  • fluid buildup in your legs, arms, face, or other areas of your body
  • mild allergic reaction*

Mild side effects of many drugs may go away within a few days to a couple of weeks. But if they become bothersome, talk with your doctor or pharmacist.

* To learn more about this side effect, see the “Allergic reaction” section below.

Serious side effects

Serious side effects from Epkinly can occur, but they aren’t common. If you have serious side effects from Epkinly, call your doctor right away. But if you think you’re having a medical emergency, you should call 911 or your local emergency number.

Serious side effects of Epkinly that have been reported include:

* For more information, see the “What should be considered before taking Epkinly?” section below.
† To learn more about this side effect, see the “Allergic reaction” section below.

Allergic reaction

Some people may have an allergic reaction to Epkinly. But this side effect wasn’t reported in studies of the drug.

Symptoms of a mild allergic reaction can include:

  • skin rash
  • itchiness
  • flushing (temporary warmth, redness, or deepening of skin color)

A more severe allergic reaction is rare but possible. Symptoms of a severe allergic reaction can include swelling under your skin, usually in your eyelids, lips, hands, or feet. They can also include swelling of your tongue, mouth, or throat, which can cause trouble breathing.

Call your doctor right away if you have an allergic reaction to Epkinly. But if you think you’re having a medical emergency, call 911 or your local emergency number.

Your doctor will recommend the dosage of Epkinly that’s right for you. Below are commonly used dosages, but the dosage you receive will be determined by your doctor.

Form and strengths

Epkinly comes as a liquid solution that’s given as an injection under your skin by a healthcare professional.

It’s available in two strengths: 4 milligrams in 0.8 milliliters of solution (4 mg/0.8 mL) and 48 mg/0.8 mL.

Recommended dosages

Epkinly is given in cycles of 28 days.

For the first cycle (cycle 1), you’ll receive low doses of Epkinly: 0.16 mg on day 1, then 0.8 mg on day 8. This dosing schedule helps prevent certain serious side effects, such as cytokine release syndrome.*

After the first cycle, you’ll receive full doses of the drug: 48 mg on days 15 and 22. The first time you receive the full dose, you’ll need to stay in the hospital so that your body’s response to the drug can be monitored.

After this, you’ll continue to receive full doses (48 mg) of Epkinly. The typical dosing schedule is:

  • Cycles 2–3: one dose once weekly
  • Cycles 4–9: one dose every 2 weeks
  • Cycle 10 and after: one dose every 4 weeks

Your doctor may pause, change, or stop the doses of Epkinly during your current cycle, depending on how your body responds to the drug. If you have questions about your dosing schedule, talk with your doctor.

* Epkinly has a boxed warning for this side effect. To learn more, see the “What should be considered before taking Epkinly?” section below.

How it’s given

Your doctor will explain how Epkinly will be given to you. They’ll also explain how much you’ll be given and how often.

Epkinly is available as a liquid solution that’s given as an injection under your skin. A healthcare professional will give your dose as an injection in your thigh or lower abdomen. You’ll receive these injections at a hospital, treatment center, or at your doctor’s office.

Questions about using Epkinly

Below are some common questions about using Epkinly.

  • What if I miss a dose of Epkinly? If you miss an appointment to receive an Epkinly injection, call your doctor’s office as soon as possible to reschedule.
  • Will I need to use Epkinly long term? Epkinly is typically used as a long-term treatment. If you and your doctor determine that it’s safe and effective for your condition, you’ll likely receive it long term.

Below is important information you should consider before starting Epkinly.

Interactions

Taking a drug with certain medications, vaccines, foods, and other things can affect how the drug works. These effects are called interactions.

Before starting Epkinly treatment, talk with your doctor and pharmacist. Tell them about all prescription, over-the-counter, and other drugs you take. Also, tell them about any vitamins, herbs, and supplements you take. Sharing this information can help you avoid potential interactions.

Epkinly isn’t known to interact with specific supplements or foods. It’s not known whether Epkinly may interact with other medications, but it may be possible based on how the drug works.

Epkinly causes your body to release cytokines (immune system proteins), which can make your body break down other drugs more slowly than usual. This could lead to other medications building up in your body, which may increase the risk or severity of side effects from the other drugs.

Before taking Epkinly, talk with your doctor and pharmacist. Tell them about all prescription, over-the-counter, and other drugs you take. Also tell them about any vitamins, herbs, and supplements you use. Sharing this information can help you avoid potential interactions.

If you have questions about drug interactions that may affect you, talk with your doctor or pharmacist.

Epkinly and alcohol

Alcohol is not known to interact with Epkinly. But Epkinly and alcohol can cause some of the same side effects, such as nausea, headache, and diarrhea. So you may be more likely to experience these side effects if you drink alcohol during your Epkinly treatment.

If you drink alcohol, talk with your doctor about how much may be safe to consume during your Epkinly treatment.

Pregnancy and breastfeeding

Epkinly is not safe to receive during pregnancy or while breastfeeding. You should not breastfeed a child during your Epkinly treatment and for 4 months after your last dose.

Birth control

If you’re able to become pregnant, you should use birth control throughout your Epkinly treatment and for 4 months after your last dose. If you have questions, talk with your doctor.

Boxed warnings

Epkinly has boxed warnings about the risk of two serious side effects. A boxed warning is the most serious warning from the Food and Drug Administration (FDA) about drug effects that may be dangerous.

Boxed warnings for Epkinly include:

Risk of cytokine release syndrome (CRS): Some people may experience CRS during treatment with Epkinly. With CRS, your immune system releases large amounts of proteins called cytokines.

Symptoms of CRS can include:

CRS is a common side effect of Epkinly and occurred in more than half of the people who took the drug in studies. In most cases, CRS from Epkinly is mild. But in rare cases, it can be severe or even life threatening.

To help prevent CRS, doctors typically prescribe a low dose of Epkinly for the first two doses. They’ll also monitor you in the hospital for at least 1 day after you receive your third dose (which is the first full dose). Medications such as corticosteroids, antihistamines, and acetaminophen (Tylenol) may also be prescribed to help prevent CRS.

If you experience symptoms of CRS, tell your doctor right away. They may pause or stop your Epkinly treatment, depending on how severe your symptoms are. Your doctor may also prescribe other medications to help manage your symptoms.

Risk of immune effector cell-associated neurotoxicity syndrome (ICANS): This serious side effect may occur during Epkinly treatment. With ICANS, you have symptoms that affect your nerves and brain.

Possible symptoms of ICANS include:

  • drowsiness
  • weakness
  • fatigue (low energy)
  • confusion
  • memory issues
  • difficulty communicating
  • seizures

In studies, ICANS was a rare side effect. And in most cases, people recovered quickly. But in some cases, this side effect can be severe. In rare cases, it can lead to coma or be life threatening.

If you experience symptoms of ICANS during your Epkinly treatment, tell your doctor right away. They may pause or stop your treatment, depending on how severe your symptoms are. In some cases, you may need care in the hospital to help manage your symptoms.

Other warnings

Epkinly can sometimes cause harmful effects in people who have certain conditions. This is known as a drug-condition interaction. Other factors may also affect whether Epkinly is a good treatment option for you.

Talk with your doctor about your health history before you take Epkinly. Be sure to tell them if any of the following factors apply to you:

Find answers to some commonly asked questions about Epkinly.

Does Epkinly cause long-term side effects?

It’s possible. Examples of long-term side effects reported in Epkinly’s studies include infections such as pneumocystis pneumonia and shingles.

Because of these risks, your doctor may prescribe certain treatments to help prevent these infections.

Talk with your doctor to learn more about possible side effects of Epkinly and how long they may last.

Is Epkinly used for other types of cancer?

Epkinly is not approved to treat other types of cancer. But your doctor may prescribe it off-label for this use. (With off-label use, doctors prescribe a drug for a purpose other than what it’s approved for.)

Currently, Epkinly is approved* to treat diffuse large B-cell lymphoma in certain adults who’ve already tried other treatments for this condition.

Several studies are ongoing to learn more about the drug’s possible effectiveness for treating other types of cancer. So far, some evidence suggests that Epkinly treatment may be beneficial for follicular lymphoma in certain situations.

To learn more about treatment options for other types of cancer, talk with your doctor.

*Epkinly has received accelerated approval from the FDA for this use. Accelerated approval is given based on data from early studies. Full approval of Epkinly will not be granted until additional studies have been completed.

How does Epkinly compare with Monjuvi?

Both Epkinly and tafasitamab-cxix (Monjuvi) are used to treat certain types of B-cell lymphoma.

They belong to different groups of drugs, so they work differently to treat this condition.

These drugs also come in different forms. Epkinly is given as an injection under your skin. Monjuvi is given as an intravenous (IV) infusion, which is an injection into a vein over a period of time. Both drugs are given by a healthcare professional, typically at a hospital or treatment center.

If you have other questions about how Epkinly and Monjuvi compare, talk with your doctor. They can help determine whether one of these drugs is right for you.

Whether you have health insurance or not, cost may be a factor when you’re considering Epkinly. What you’ll pay for Epkinly may depend on several things, such as your location and treatment plan.

If you have questions about how to pay for your prescription, talk with your doctor or pharmacist. A program called MyNavCare may also be available.

You can also check out this article to learn more about saving money on prescriptions.

Other drugs are available that can treat your condition. If you’d like to explore an alternative to Epkinly, talk with your doctor. They can tell you about other medications that might work well for you.

Similar to Epkinly, the following drugs may be used to treat diffuse large B-cell lymphoma:

  • other bispecific T-cell engaging (BiTE) antibodies, such as glofitamab-gxbm (Columvi)
  • antibody-drug conjugates, such as brentuximab vedotin (Adcetris) or polatuzumab vedotin-piiq (Polivy)
  • CAR T-cell therapy, such as axicabtagene ciloleucel (Yescarta), lisocabtagene melaleuca (Breyanzi), or tisagenlecleucel (Kymriah)
  • chemotherapy, such as cyclophosphamide (Cytoxan) or doxorubicin (Doxil)
  • monoclonal antibodies, such as tafasitamab-cxix (Monjuvi) or rituximab (Rituxan, others)
  • targeted therapies, such as ibrutinib (Imbruvica)

If you have questions about taking Epkinly, talk with your doctor or pharmacist. Questions you may want to ask include:

  • How is Epkinly different from other treatments I’ve already tried for my cancer?
  • How should I prepare for my appointments to receive Epkinly injections?
  • When and how will we be able to determine how well Epkinly is working for me?

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Disclaimer: Healthline has made every effort to make certain that all information is factually correct, comprehensive, and up to date. However, this article should not be used as a substitute for the knowledge and expertise of a licensed healthcare professional. You should always consult your doctor or another healthcare professional before taking any medication. The drug information contained herein is subject to change and is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. The absence of warnings or other information for a given drug does not indicate that the drug or drug combination is safe, effective, or appropriate for all patients or all specific uses.