Epcoritamab Side Effects

Medically reviewed by Drugs.com. Last updated on Oct 1, 2024.

Applies to epcoritamab: subcutaneous solution.

Important warnings This medicine can cause some serious health issues

Subcutaneous route (solution)

Warning: Cytokine Release Syndrome and Immune Effector Cell-Associated Neurotoxicity Syndrome. Cytokine release syndrome (CRS), including serious or life-threatening reactions, can occur in patients receiving epcoritamab-bysp.

Initiate treatment with the epcoritamab-bysp step-up dosing schedule to reduce the incidence and severity of CRS.

Withhold epcoritamab-bysp until CRS resolves or permanently discontinue based on severity.Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS), including life threatening and fatal reactions, can occur with epcoritamab-bysp.

Monitor patients for neurological signs or symptoms of ICANS during treatment.

Withhold epcoritamab-bysp until ICANS resolves or permanently discontinue based on severity.

Serious side effects of epcoritamab

Along with its needed effects, epcoritamab 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:

More common side effects

• back pain
• bloating or swelling of the face, arms, hands, lower legs, or feet
• chest pain or discomfort
• decreased appetite
• difficulty in moving
• dizziness
• fainting
• fast, slow, or irregular heartbeat
• headache
• joint pain
• lightheadedness
• muscle aches, cramps, or stiffness
• muscle or bone pain
• nausea
• neck pain
• pain in the arms or legs
• palpitations
• pounding or rapid pulse
• rapid weight gain
• rash with flat lesions or small raised lesions on the skin
• stomach pain
• swollen joints
• tingling of the hands or feet
• trembling and shaking of hands
• trouble breathing
• unusual tiredness or weakness
• unusual weight gain or loss
• vomiting

Less common side effects

• black, tarry stools
• bleeding gums
• blood in the urine or stools
• body aches or pain
• chest tightness
• chills
• confusion
• cough
• ear congestion
• fever
• loss of voice
• lower back or side pain
• painful or difficult urination
• pale skin
• pinpoint red spots on the skin
• problems with speech or speaking
• sneezing
• sore throat
• stuffy or runny nose
• ulcers, sores, or white spots in the mouth
• unusual bleeding or bruising
• unusual drowsiness, dullness, tiredness, weakness or feeling of sluggishness

Rare side effects

• anxiety
• dark urine
• pain or discomfort in the arms, jaw, back, or neck
• sweating
• yellow eyes or skin

Other side effects of epcoritamab

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:

More common side effects

• bleeding, blistering, burning, coldness, discoloration of skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site

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]

Further information

Epcoritamab 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.

Some side effects may not be reported. You may report them to the FDA.

Medical Disclaimer