Epkinly Side Effects

Generic name: epcoritamab

Medically reviewed by Drugs.com. Last updated on Nov 13, 2024.

Note: This document provides detailed information about Epkinly Side Effects associated with epcoritamab. Some dosage forms listed on this page may not apply specifically to the brand name Epkinly.

Applies to epcoritamab: subcutaneous solution.

Precautions

It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly. Blood tests are needed to check for unwanted effects.

Using this medicine while you are pregnant can harm your unborn baby. If you are a woman who can get pregnant, your doctor may do tests to make sure you are not pregnant before starting treatment. Use an effective form of birth control to keep from getting pregnant during treatment and for 4 months after the last dose. If you think you have become pregnant while using this medicine, tell your doctor right away.

This medicine may cause cytokine release syndrome (CRS) and nervous system problems, including immune effector cell-associated neurotoxicity syndrome (ICANS). These may be life-threatening and require immediate attention. Tell your doctor right away if you have agitation, back pain, blurred vision, burning, throbbing, or stabbing pain, coma, confusion, double vision, drowsiness, feeling restless, fever, chills, hallucinations, headache, hearing loss, irritability, jerking movements, mood or mental changes, muscle spasms, nausea, lightheadedness, dizziness, fainting, rigid muscles, seizures, skin rash, stiff neck, tremor, trouble breathing, trouble speaking, unusual tiredness or weakness, or vomiting.

This medicine may cause serious infections. Check with your doctor right away if you have fever or chills, confusion, cough or hoarseness, lower back or side pain, or painful or difficult urination.

This medicine lowers the number of some types of blood cells in your body. Because of this, you may bleed or get infections more easily. To help with these problems, avoid being near people who are sick or have infections. Wash your hands often. Stay away from rough sports or other situations where you could be bruised, cut, or injured. Brush and floss your teeth gently. Be careful when using sharp objects, including razors and fingernail clippers.

This medicine may cause dizziness, confusion, or tremors. Do not drive or do anything else that could be dangerous after receiving this medicine until you know how this medicine affects you.

Serious side effects of Epkinly

Along with its needed effects, epcoritamab (the active ingredient contained in Epkinly) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur while taking epcoritamab:

Other side effects of Epkinly

Some side effects of epcoritamab may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

For healthcare professionals

Applies to epcoritamab: subcutaneous solution.

General adverse events

The most common adverse reactions were cytokine release syndrome (CRS), fatigue, musculoskeletal pain, injection site reactions, pyrexia, abdominal pain, nausea, and diarrhea. Serious adverse reactions include infections, CRS, pleural effusion, febrile neutropenia, fever, and immune effector cell-associated neurotoxicity syndrome (ICANS). Fatal adverse reactions leading to discontinuation occurred in 3.8% of patients. These fatal reactions include COVID-19, hepatotoxicity, ICANS, myocardial infarction, and pulmonary embolism.^[Ref]

Cardiovascular

• Very common (10% or more): Cardiac arrhythmias (includes bradycardia, sinus bradycardia, sinus tachycardia, supraventricular extrasystoles, supraventricular tachycardia, and tachycardia) (10%)
• Common (1% to 10%): Myocardial infarction^[Ref]

Dermatologic

• Very common (10% or more): Rash (includes dermatitis bullous, erythema, palmar erythema, penile erythema, rash erythematous, rash maculopapular, rash pustular, recall phenomenon, seborrheic dermatitis, and skin exfoliation) (15%)^[Ref]

Gastrointestinal

• Very common (10% or more): Abdominal pain (includes abdominal discomfort, pain, lower and upper abdominal pain, and tenderness) (23%), diarrhea (20%), nausea (20%), vomiting (12%)^[Ref]

Hematologic

• Very common (10% or more): Decreased lymphocyte count (87%), decreased hemoglobin (62%), decreased white blood cells (53%), decreased neutrophils (50%), decreased platelets (48%)^[Ref]

Immunologic

• Very common (10% or more): Cytokine release syndrome (51%)
• Common (1% to 10%): Immune effector cell-associated neurotoxicity syndrome^[Ref]

Local

• Very common (10% or more): Injection site reactions (includes erythema, hypertrophy, inflammation, mass, pain, pruritus, rash, swelling, and urticaria) (27%)^[Ref]

Metabolic

• Very common (10% or more): Decreased appetite (12%)^[Ref]

Musculoskeletal

• Very common (10% or more): Musculoskeletal pain (includes back pain, bone pain, flank pain, musculoskeletal pain, myalgia, neck pain, non-cardiac chest pain, pain, pain in extremity, and spinal pain) (28%)^[Ref]

Nervous system

• Very common (10% or more): Headache (13%)^[Ref]

Other

• Very common (10% or more): Fatigue (29%), pyrexia (24%), edema (14%), decreased sodium (56%), decreased phosphate (56%), increased aspartate aminotransferase (48%), increased alanine aminotransferase (45%), decreased potassium (34%), decreased magnesium (31%), increased creatinine (24%), increased potassium (21%)
• Frequency not reported: Infections (includes sepsis, COVID-19, pneumonia, and upper respiratory tract infections), febrile neutropenia^[Ref]

Respiratory

• Uncommon (0.1% to 1%): Pulmonary embolism
• Frequency not reported: Pleural effusion^[Ref]

Hepatic

• Common (1% to 10%): Hepatotoxicity^[Ref]

See also:

Frequently asked questions

• What are monoclonal antibodies?
• What is the success rate of Epkinly?

Further information

Epkinly side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.

Medical Disclaimer