Epkinly is a brand-name injection that’s prescribed for certain types of B-cell lymphoma. Epkinly contains the active drug epcoritamab-bysp. It’s a treatment that helps your body attack the cancer cells.

Epkinly (epcoritamab-bysp)* is FDA-approved to treat certain types of diffuse large B-cell lymphoma (DLBCL), which is a type of cancer that affects white blood cells called B-cells.

Epkinly is prescribed in adults who’ve had at least two past treatments for DLBCL. It’s used for DLBCL that’s refractory (hasn’t responded to or has stopped responding to past treatment) or has relapsed (came back after past treatment).

* The reason “-bysp” appears at the end of the drug’s name is to show that the drug is distinct from similar medications that may be created in the future.

Drug details

You’ll find key information about Epkinly below.

  • Drug class: bispecific T-cell engaging monoclonal antibody, which is a biologic treatment
  • Drug form: solution for subcutaneous injection in a single-dose vial
  • Generic or biosimilar available? no
  • Prescription required? yes
  • Controlled substance? no
  • Year of FDA approval: 2023
  • Accelerated approval? yes

Epkinly is a biologic drug that’s available only as a brand-name medication. It’s not currently available in generic or biosimilar form.

Most drugs are made using chemicals. It’s possible to make exact copies of brand-name chemical drugs. These are called generics. Generics are considered to be as safe and effective as the brand-name version. Generics usually cost less than brand-name drugs.

Biologic drugs are made using living cells. It’s not possible to make exact copies of biologic drugs. Instead, biosimilars can sometimes be made. Like generics, biosimilars are considered to be as safe and effective as the original brand-name drug. And like generics, they usually cost less.

Your doctor will gradually increase your Epkinly dosage after you start treatment. This is to help prevent cytokine release syndrome and immune effector cell-associated neurotoxicity syndrome, which are serious side effects of Epkinly. The drug has boxed warnings about these side effects. See the Epkinly precautions” section below for more information about these warnings.

The following information describes Epkinly dosages that are commonly used or recommended. However, your doctor will determine the best dosage to fit your needs.

Drug forms and strengths

Epkinly comes as a solution inside single-dose vials. 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.

A healthcare professional will administer Epkinly by subcutaneous injection in your lower abdomen or thigh. You’ll typically receive Epkinly injections in a hospital, infusion center, or in your doctor’s office or clinic.

Before each of your first four doses, your healthcare professional will give you medications to help prevent serious Epkinly side effects. If you have serious Epkinly side effects with any of these doses, you may also be given preventive medications before each further Epkinly dose.

Your third dose will usually be your first full dose of Epkinly. You’ll need to stay in the hospital for at least 24 hours after receiving this dose. This is so your doctor can monitor you for side effects and give treatment if needed.

Dosage for lymphoma

You’ll usually receive one injection of Epkinly once per week for the first 12 weeks of treatment. Then you’ll receive one injection once every 2 weeks for 24 weeks. After that, you’ll receive one injection once every 4 weeks.

The typical dosage schedule for diffuse large B-cell lymphoma (DLBCL) in adults is described below:

WeekDose
1 0.16 mg on day 1
2 0.8 mg on day 8
348 mg (first full dose) on day 15
4 to 12 48 mg once every week
13 to 36 48 mg once every 2 weeks
37 and beyond48 mg once every 4 weeks

About receiving Epkinly

Below you’ll find information about key dosage issues.

  • If you miss a dose. If you miss an appointment to receive your dose of Epkinly, call your doctor’s office right away to reschedule. Depending on where you are in your treatment schedule and how delayed your dose will be, your doctor may need to adjust your treatment schedule. Or they may need to restart your treatment with a lower dose.
  • Length of use. Epkinly is meant to be a long-term treatment. If you and your doctor determine that Epkinly is safe and effective for you, you’ll likely take it long term.

Epkinly can cause mild or serious side effects. The following lists contain some of the key side effects that may occur while taking Epkinly. These lists do not include all possible side effects.

For more information about the possible side effects of Epkinly, talk with your doctor or pharmacist. They can give you tips on how to manage any side effects that may be concerning or bothersome.

Note: The Food and Drug Administration (FDA) tracks side effects of drugs it has approved. If you would like to notify the FDA about a side effect you’ve had with Epkinly, you can do so through MedWatch.

Mild side effects

Below is a partial list of mild side effects of Epkinly. To learn about other mild side effects, talk with your doctor or pharmacist, or view Epkinly’s prescribing information.

Mild side effects of Epkinly can include:

Most of these side effects may go away within a few days to a couple of weeks. However, if they become more severe or don’t go away, talk with your doctor or pharmacist.

* For more information about allergic reaction and Epkinly, see “Allergic reaction” below.

Serious side effects

Serious side effects from Epkinly aren’t common, but they can occur. Call your doctor right away if you have serious side effects. Call 911 or your local emergency number if your symptoms feel life threatening or if you think you’re having a medical emergency.

Serious side effects and their symptoms can include:

  • Low white blood cell count. Symptoms can include:
    • fever
  • Low red blood cell count. Symptoms can include:
    • shortness of breath
    • tiredness
    • skin, gums, or nailbeds that look paler than usual
  • Low platelet count. Symptoms can include:
    • bruising easily
    • bleeding, such as nosebleeds or bleeding gums
  • Serious infections that can be life threatening or even fatal. Symptoms can include:
    • fever
    • cough
    • shortness of breath
    • sore throat
    • sore, hot, swollen area of skin
    • pain when urinating
    • chest pain
    • feeling tired, weak, or generally unwell
  • Risk of cytokine release syndrome.*
  • Risk of immune effector cell-associated neurotoxicity syndrome.*
  • Severe allergic reaction.†

* Epkinly has a boxed warning for this side effect. This is the most serious warning from the FDA. To learn more, see the “Epkinly precautions” section below.
† For details about allergic reaction and Epkinly, see “Allergic reaction” below.

ALLERGIC REACTION

As with most drugs, some people can have an allergic reaction after receiving Epkinly. This side effect wasn’t reported in clinical trials of this drug but can still occur.

Symptoms of a mild allergic reaction can include:

A more severe allergic reaction is rare but possible. Symptoms of a severe allergic reaction can include:

  • swelling under your skin, typically in your eyelids, lips, hands, or feet
  • swelling of your tongue, mouth, or throat
  • trouble breathing

Call your doctor right away if you have an allergic reaction to Epkinly, as the reaction could become severe. Call 911 or your local emergency number if your symptoms feel life threatening or if you think you’re having a medical emergency.

The Food and Drug Administration (FDA) approves prescription drugs such as Epkinly to treat certain conditions.

Epkinly for lymphoma

Epkinly is FDA-approved to treat certain types of diffuse large B-cell lymphoma (DLBCL). These include DLBCL not otherwise specified (NOS) and high-grade B-cell lymphoma.

DLBCL is a type of cancer that affects white blood cells called B-cells. B-cells usually make antibodies that help your body fight infections.

With DLBCL, you have faulty B-cells that multiply faster than usual and grow larger than usual. These cancerous B-cells crowd out healthy blood cells. They build up in your lymph nodes, causing the lymph nodes to swell. Other symptoms of DLBCL can include night sweats, fever, and unintentional weight loss.

Epkinly is a type of immunotherapy (treatment that helps your immune system attack the cancerous B-cells). It’s prescribed to adults who’ve had at least two past treatments for DLBCL. It’s used when the cancer is refractory (hasn’t responded to or has stopped responding to past treatment) or has relapsed (came back after past treatment).

To find out more about your condition and its treatment, you can visit our cancer hub.

Epkinly and children

Epkinly is not FDA-approved for use in children. It hasn’t been studied in children under 18 years old, and it’s not known if the drug is safe or effective in this age group.

The manufacturer of Epkinly didn’t look at interactions in clinical trials of the drug. Epkinly is not known to interact with herbs, supplements, or foods. However, it might interact with certain other medications.

Epkinly causes cytokines (immune system proteins) to be released in your body. These cytokines may reduce the action of enzymes (proteins that help chemical reactions happen) that help clear certain drugs from your body. As a result, Epkinly treatment may cause certain drugs to build up in your body. This can increase the risk of side effects.

Interactions are most likely to occur:

  • after your first Epkinly dose
  • up to 14 days after your third Epkinly dose (your first full dose)
  • if you have a serious Epkinly side effect called cytokine release syndrome*

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.

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

* Epkinly has a boxed warning for this side effect. This is the most serious warning from the FDA. To learn more, see the “Epkinly precautions” section below.

Alcohol interaction

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

If you have questions about how much alcohol is safe to drink while taking Epkinly, talk with your doctor or pharmacist.

As with all medications, the cost of Epkinly can vary. The actual price you’ll pay depends on your insurance plan, your location, and the pharmacy you use.

Drug coupons. You can visit Optum Perks for price estimates of Epkinly. These estimates are based on the use of Optum Perks coupons. Note: Optum Perks coupons cannot be used with any insurance copays or benefits.

Financial and insurance assistance. If you need financial support to pay for Epkinly, or if you need help understanding your insurance coverage, help is available.

A program called MyNavCare is available for Epkinly. For more information and to find out if you’re eligible for support, call 866-628-2271 or visit the program website.

Biosimilar form. Epkinly is a biologic drug that’s not available in a biosimilar form. A biologic drug is made using living cells. A biosimilar drug is similar to the active drug in a brand-name biologic medication. It’s considered to be as safe and effective as the brand-name drug. Biosimilars tend to cost less than brand-name drugs.

To learn more about saving money on prescriptions, check out this article.

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Other drugs are available that can treat your condition. Some may be a better fit for you than others. If you’re interested in finding an alternative to Epkinly, talk with your doctor. They can tell you about other medications that may work well for you.

The following drugs are possible alternatives to Epkinly:

  • CAR T-cell therapy, such as axicabtagene ciloleucel (Yescarta) or tisagenlecleucel (Kymriah)
  • monoclonal antibodies, such as tafasitamab-cxix (Monjuvi) or rituximab (Rituxan, others)
  • antibody-drug conjugates, such as polatuzumab vedotin-piiq (Polivy) or brentuximab vedotin (Adcetris)
  • T-cell engaging bispecific antibodies, such as glofitamab-gxbm (Columvi)
  • targeted therapies, such as selinexor (Xpovio)

If you can become pregnant, consider the following information about pregnancy, birth control, and breastfeeding.

Epkinly and pregnancy

Epkinly should not be used during pregnancy. If you’re planning a pregnancy or can become pregnant, talk with your doctor before having treatment with this medication. Your doctor may suggest birth control options to use during treatment with Epkinly.

Epkinly and birth control

Epkinly is not safe to take during pregnancy. If you’re sexually active and you or your partner can become pregnant, talk with your doctor about your birth control needs while you’re using Epkinly.

Note: Sex and gender exist on spectrums. Use of the terms “female” and “male” in this article refers to sex assigned at birth.

For females using Epkinly

If you can become pregnant, you should use birth control during your Epkinly treatment and for 4 months after your last dose.

For males using Epkinly

Epkinly’s manufacturer doesn’t give recommendations on birth control for males who receive the drug. If you have a sexual partner who could become pregnant, talk with your doctor about your birth control needs.

Epkinly and breastfeeding

You should not breastfeed while receiving Epkinly and for 4 months after your last dose. If you’re currently breastfeeding or planning to do so, talk with your doctor before starting treatment with this medication. Your doctor may recommend other ways to feed your child during treatment with Epkinly.

Here are answers to some frequently asked questions about Epkinly.

How does Epkinly work?

Epkinly is prescribed to treat certain types of diffuse large B-cell lymphoma (DLBCL), which is a type of cancer that affects your white blood cells. Specifically, it affects a type of white blood cell called B-cells. Epkinly helps your immune system attack the cancerous B-cells.

Epkinly is a type of drug called a bispecific T-cell engaging monoclonal antibody. It works by “showing” the cancerous B-cells to another type of white blood cell called T-cells. T-cells help your immune system attack foreign, abnormal, and diseased cells in your body.

Epkinly attaches to a specific protein on the surface of B-cells. It also attaches to a specific protein on the surface of T-cells. This brings the cancerous B-cells and the T-cells close together. This activates the T-cells, which helps your immune system kill the cancerous B-cells.

If you have questions about how Epkinly works, talk with your doctor.

Does Epkinly cause long-term side effects?

Yes, Epkinly can cause some long-term side effects. For example, it can cause low white blood cell counts that may last for as long as you continue treatment with the drug. It may take a long time for your white blood cell counts to increase after stopping Epkinly.

White blood cells help your body fight infections. So you may have a raised risk of infections during treatment with Epkinly. You may still be at risk of infections for a while after stopping this treatment.

Your doctor will order frequent blood tests to monitor your white blood cell counts while you’re receiving Epkinly. If your white blood cells become too low, your doctor may pause or permanently stop your Epkinly treatment. They may also prescribe granulocyte colony stimulating factor to help your white blood cells recover.

If you have questions or concerns about long-term side effects with Epkinly, talk with your doctor.

Will Epkinly cure my lymphoma?

In clinical trials, some people who received Epkinly had partial remission of their lymphoma. This means the signs and symptoms of their cancer were reduced. Some other people who received Epkinly had their lymphoma go into complete remission. This means all signs and symptoms of their cancer went away.

Complete remission is not necessarily considered a cure. It’s still possible for signs and symptoms of the cancer to come back at a later stage. However, some doctors may consider cancer to be cured if it stays in complete remission for at least 5 years. At this time, it’s not known how long the effects of Epkinly may last.

Keep in mind that not everyone will have the same experience with Epkinly. The results you may have with this treatment may be different from those seen in clinical trials.

To learn more about what you can expect from Epkinly treatment, talk with your doctor.

This drug comes with several precautions.

FDA warnings

This drug has boxed warnings. A boxed warning is the most serious warning from the Food and Drug Administration (FDA). It alerts doctors and patients about drug effects that may be dangerous.

Risk of cytokine release syndrome.

Epkinly can cause a serious side effect called cytokine release syndrome (CRS). This side effect occurs when large amounts of cytokines (immune system proteins that cause inflammation) are released in your body.

In clinical trials, CRS was common with Epkinly. Most cases were mild. But on rare occasions, this side effect can be severe or even life threatening.

CRS typically occurs within 24 hours of receiving a dose of Epkinly. It can cause various symptoms throughout your body. These usually get better within a few days. Symptoms of CRS may include:

  • fever
  • chills
  • shortness of breath
  • dizziness
  • increased heart rate
  • headache
  • confusion
  • tremor
  • problems with balance and coordination

To help prevent CRS, your doctor will likely prescribe a low dose of Epkinly for your first two doses. Your third dose will usually be your first full dose. CRS is most likely to occur with this dose, so you’ll need to stay in the hospital for at least 24 hours after receiving this dose. This allows healthcare professionals to monitor you for symptoms of CRS and provide treatment if needed.

Your doctor will likely prescribe medications to help prevent CRS before each of your first four Epkinly doses. If you have CRS with any of these doses, your doctor may also prescribe preventive medications before further Epkinly doses. Preventive medications will usually include a corticosteroid such as prednisolone or dexamethasone, an antihistamine such as diphenhydramine (Benadryl), and acetaminophen (Tylenol).

If you have symptoms of CRS after receiving any dose of Epkinly, tell your doctor right away. Your doctor will determine if you need to be treated in the hospital. You should not drive or operate dangerous machinery until your symptoms are managed.

If you have CRS, your doctor may pause your Epkinly treatment until your symptoms get better. But if you have severe CRS, your doctor may recommend stopping treatment with Epkinly altogether.

Risk of immune effector cell-associated neurotoxicity syndrome.

Epkinly can cause a serious side effect called immune effector cell-associated neurotoxicity syndrome (ICANS). ICANS causes symptoms that involve your brain and nerves.

In clinical trials, ICANS wasn’t common with Epkinly. Most cases were mild. But on rare occasions, this side effect can be severe or even life threatening.

ICANS can occur up to 2 weeks after receiving a dose of Epkinly. It can cause various symptoms that usually get better in a few days with supportive treatment. Symptoms of ICANS may include:

  • confusion
  • sleepiness
  • tiredness or low energy
  • memory problems
  • muscle weakness
  • tremor
  • problems with speech or writing
  • seizures

If you have symptoms of ICANS while receiving Epkinly, tell your doctor right away. Your doctor will determine if you need to be treated in a hospital. You should not drive or operate dangerous machinery until your symptoms are managed.

If you have ICANS, your doctor may pause your Epkinly treatment until your symptoms get better. But if you have severe ICANS, your doctor may recommend stopping treatment with Epkinly altogether.

Other precautions

Before taking Epkinly, discuss your health history with your doctor. Epkinly may not be right for you if you have certain medical conditions or other factors affecting your health. Be sure to talk with your doctor if any of the following apply to you:

  • current infections or past infections that keep coming back
  • severe liver or kidney problems
  • previous allergic reaction to this or a similar drug
  • pregnancy
  • breastfeeding

Note: For more information about the potential negative effects of Epkinly, see the “Epkinly side effects” section above.

Disclaimer: Medical News Today 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.