Epkinly
Epkinly (epcoritamab or epcoritamab-bysp) is a medication used to treat adults with certain cancers that come back or don’t improve after at least two other treatments. These cancers include diffuse large B-cell lymphoma (DLBCL), high-grade B-cell lymphoma, and follicular lymphoma. It’s a bispecific antibody, which means it helps your immune system find and destroy cancer cells. The medication is given as an injection under the skin. Common side effects include low blood cell counts, diarrhea, tiredness, and a serious reaction called cytokine release syndrome (CRS).
What is Epkinly (epcoritamab)?
What is Epkinly (epcoritamab) used for?
Relapsed or refractory diffuse large B-cell lymphoma (DLBCL) and high-grade B-cell lymphoma in adults who've already tried at least two other therapies
Relapsed or refractory follicular lymphoma in adults who've already tried at least two other therapies
How Epkinly (epcoritamab) works
Epkinly (epcoritamab) is a bispecific T-cell engager (BiTE), which is a type of monoclonal antibody that’s designed to bind to two different targets. One side of the antibody attaches to CD20, a protein on cancer cells, while the other side binds to CD3, a protein on T-cells in your immune system. By connecting these two cells, Epkinly (epcoritamab) brings T-cells close to the cancer cells, helping the immune system attack and destroy the cancer cells.
Drug Facts
What are the side effects of Epkinly (epcoritamab)?
Common Side Effects
- Low white blood cells (up to 87%)
- Low red blood cells (62%)
- Cytokine release syndrome (51%)
- Electrolyte changes in blood (up to 56%)
- Higher liver enzymes in blood (up to 48%)
- Low platelets (48%)
- Tiredness (29%)
- Muscle pain (28%)
- Injection site reactions (27%)
- Fever (24%)
- Stomach pain (23%)
- Diarrhea (20%)
- Nausea (20%)
- Injection site reactions (58%)
- Cytokine release syndrome (49%)
- COVID-19 (40%)
- Tiredness (37%)
- Upper respiratory tract infection (29%)
- Muscle pain (28%)
- Rash (28%)
- Fever (26%)
- Diarrhea (26%)
- Nausea (20%)
- Cough (20%)
Other Side Effects
- Swelling
- Rash
- Headache
- Vomiting
- Lower appetite
- Swelling
- Pneumonia
- Urinary tract infection
- Herpes infection
- Joint pain
- Nausea
- Stomach pain
- Constipation
- Mouth sores
- Dizziness
- Trouble sleeping
Serious Side Effects
- Cytokine release syndrome (CRS): fever, chills, low blood pressure, fast heartbeat, trouble breathing, headache
- Nervous system problems: headache, numbness, dizziness, confusion, sleepiness
- Serious infection: fever, body aches, chills, feeling very tired or weak, very fast heartbeat, cough, chest pain, shortness of breath, rash, sore throat
Source: DailyMed
The following side effects have also been reported
Side effects that you should report to your care team as soon as possible:
- Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
- Fever, chills, unusual weakness or fatigue, loss of appetite, nausea, headache, dizziness, feeling faint or lightheaded, shortness of breath, fast or irregular heartbeat, which may be signs of cytokine release syndrome
- Infection—fever, chills, cough, sore throat, wounds that don't heal, pain or trouble when passing urine, general feeling of discomfort or being unwell
- Low red blood cell level—unusual weakness or fatigue, dizziness, headache, trouble breathing
- Pain, tingling, or numbness in the hands or feet, muscle weakness, change in vision, confusion or trouble speaking, loss of balance or coordination, trouble walking, seizures
- Unusual bruising or bleeding
Side effects that usually do not require medical attention (report these to your care team if they continue or are bothersome):
Pros and cons of Epkinly (epcoritamab)
Pros
Works in a more specific, targeted way than traditional chemotherapy
Given as a brief injection under the skin
Can lead to remission when other treatments haven’t worked
Cons
Frequent hospital visits for the first few cycles
Can cause serious side effects like CRS and nervous system problems
Commonly causes low blood cell counts, diarrhea, and tiredness
Pharmacist tips for Epkinly (epcoritamab)
Epkinly (epcoritamab) can cause cytokine release syndrome (CRS), a serious reaction where your immune system becomes overly activated. Let your oncologist know right away if you have symptoms like fever, chills, headache, trouble breathing, nausea, vomiting, or tiredness.
Epkinly (epcoritamab) is given as an injection underneath the skin. If you have any redness or swelling at the injection site, your oncologist might recommend using an ice pack to manage it.
If you have DLBCL or high-grade B-cell lymphoma, you’ll need to stay in the hospital for 24 hours after getting your first full dose of Epkinly (epcoritamab) on Day 15 of Cycle 1. This is because there is a risk of CRS and nervous system problems, which need to be watched closely by your care team.
If you pause Epkinly (epcoritamab) treatment for more than 6 weeks, you might need to repeat some or all of the “step-up” doses. Stopping the medication can raise your risk of CRS, similar to when you first started. Your oncologist will decide if you need “step-up” doses and how many.
If your temperature reaches 100.4°F or higher, it means you have a fever. Call your oncologist or get medical help right away. A fever while taking Epkinly (epcoritamab) could be serious since it might mean you have an infection or it could be an early warning sign of CRS.
If you experience CRS or nervous system problems like headache or dizziness after receiving Epkinly (epcoritamab), avoid driving or using heavy or dangerous machinery until your symptoms go away.
Epkinly (epcoritamab) commonly causes low white blood cell counts. When your white blood cells are low, your body might not be able to fight infections as well. Be alert for symptoms like fever, chills, cough, or shortness of breath, and contact your oncologist if they occur.
Epkinly (epcoritamab) can cause harm to an unborn baby. If you can become pregnant, use birth control while taking this medication and for 4 months after your last dose. Let your oncologist know right away if you become pregnant during treatment.
Avoid breastfeeding while taking Epkinly (epcoritamab) and for 4 months after the last dose. It’s not known if this medication passes into breast milk, but it could potentially harm a nursing infant.
Frequently asked questions about Epkinly (epcoritamab)
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What are the risks and warnings for Epkinly (epcoritamab)?
Epkinly (epcoritamab) can cause some serious health issues. This risk may be even higher for certain groups. If this worries you, talk to your doctor or pharmacist about other options.
Cytokine release syndrome
Epkinly (epcoritamab) can cause cytokine release syndrome (CRS), which can be serious or even life-threatening. This happens when your body’s immune system overreacts to the medication. Symptoms of CRS include headache, chills, fever, low blood pressure, trouble breathing, fast heartbeat, and confusion. CRS is most likely to happen during the first cycle, usually starting within a few hours to a few days after the infusion.
To reduce your risk, you’ll take premedications and follow a “step-up” dosing process. Tell your care team right away if you notice any symptoms. If you develop mild CRS, you might be able to restart Epkinly (epcoritamab) after symptoms go away. But if the symptoms are severe, you might have to stop the medication altogether. Avoid driving or using heavy machinery until the symptoms go away.
Serious nervous system problems
Epkinly (epcoritamab) can cause a serious and life-threatening condition called immune effector cell-associated neurotoxicity syndrome (ICANS). In clinical studies, most cases started within the first few weeks of treatment, often about 3 days after a dose, and lasted around 2 to 4 days. Tell your care team immediately if you have symptoms like confusion, trouble speaking, shakiness, sleepiness, trouble writing, or seizures. ICANS can happen at the same time as CRS, after CRS, or on its own. If you have symptoms affecting your thinking or alertness, avoid driving or using heavy machinery until you get better.
Infections
Epkinly (epcoritamab) can cause serious and life-threatening infections, including opportunistic infections. Opportunistic infections are infections that happen in people with immune systems that don’t work as well, like those with cancer or HIV. Don’t take this medication if you have an active infection. Contact your oncologist right away if you have any signs or symptoms of an infection, such as fever, chills, cough, or body aches. Your oncologist might also prescribe preventive medications to help protect against certain infections. If a serious infection develops, your oncologist might pause or stop treatment depending on how severe it is.
Low blood cells
Epkinly (epcoritamab) commonly causes low blood cell counts, including white blood cells, red blood cells, and platelets. Low white blood cells make it harder to fight infections, low red blood cells can make you feel tired, and low platelets raise your risk of bleeding. If you have any unexplained bruising, blood in your urine, blood in your stool, or nosebleeds contact your care team right away.
Your oncologist will monitor your blood counts during treatment. If your blood cell levels drop too much, they might pause or stop Epkinly (epcoritamab). You might also receive medications to help your body make more white blood cells.
Harm to unborn baby
Based on the way Epkinly (epcoritamab) works, it might cause harm to an unborn baby. If you’re able to get pregnant, use birth control while taking this medication and for 4 months after the last dose. Let your oncologist know if you’re pregnant or thinking about becoming pregnant while taking Epkinly (epcoritamab).
Epkinly (epcoritamab) dosage forms
Typical dosing for Epkinly (epcoritamab)
The recommended dose follows a step-up schedule. Each dose is given as an injection under the skin, starting with a low dose and increasing to the highest dose. The typical maintenance dose is 48 mg. Each treatment cycle lasts 28 days.
DLBCL or high-grade B-cell lymphoma:
Cycle 1
Day 1: 0.16 mg, Day 8: 0.8 mg, Day 15: 48 mg, Day 22: 48 mg
Cycles 2 and 3
Day 1: 48 mg, Day 8: 48 mg, Day 15: 48 mg, Day 22: 48 mg
Cycles 4 to 9
Day 1: 48 mg, Day 15: 48 mg
Cycles 10 and beyond:
Day 1: 48 mg
Follicular lymphoma:
Cycle 1
Day 1: 0.16 mg, Day 8: 0.8 mg, Day 15: 3 mg, Day 22: 48 mg
Cycles 2 and 3
Day 1: 48 mg, Day 8: 48 mg, Day 15: 48 mg, Day 22: 48 mg
Cycles 4 to 9
Day 1: 48 mg, Day 15: 48 mg
Cycles 10 and beyond
Day 1: 48 mg
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References
Best studies we foundAmerican Cancer Society. (n.d.). Targeted therapy.
American Cancer Society. (2024). Fevers.
American Cancer Society. (2024). Neutropenia (low white blood cell counts).
American Cancer Society. (2024). Why are people with cancer more likely to get infections?
American Cancer Society. (n.d.). Chemotherapy.
Clinical Info HIV.gov. (n.d.). Opportunistic infection (OI).
Genmab US, Inc. (2024). Epkinly- epcoritamab-bysp injection, solution [package insert]. DailyMed.
Kröger, N., et al. (2022). Chapter 27 Management of immune effector cell-associated neurotoxicity syndrome (ICANS). The EMBT/EHA CAR-T Cell Handbook.
Linton, K. M., et al. (2024). Epcoritamab monotherapy in patients with relapsed or refractory follicular lymphoma (EPCORE NHL-1): A phase 2 cohort of a single-arm, multicentre study. The Lancet Haematology.
Lymphoma Research Foundation. (n.d.). Diffuse large B-cell lymphoma.
Lymphoma Research Foundation. (n.d.). Follicular lymphoma.
Lymphoma Research Foundation. (n.d.). High-grade B-cell lymphoma.
Lymphoma Research Foundation. (n.d.). Relapsed and refractory lymphoma.
Menon, A. P., et al. (2023). Modulating T cell responses by targeting CD3. Cancers.
National Cancer Institute. (n.d.). CD20.
National Cancer Institute. (n.d.). T cell.
National Comprehensive Cancer Network. (2021). Anemia and neutropenia: Low red and white blood cell counts.
Shimabukuro-Vornhagen, A., et al. (2018). Cytokine release syndrome. Journal for Immunotherapy of Cancer.
Thieblemont, C., et al. (2022). Epcoitamab, a novel, subcutaneous CD3xCD20 bispecific T-cell–engaging antibody, in relapsed or refractory large B-cell lymphoma: Dose expansion in a Phase I/II trial. Journal of Clinical Oncology.
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