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Epcoritamab Side Effects

Medically reviewed by Drugs.com. Last updated on Jun 21, 2023.

Applies to epcoritamab: subcutaneous solution.

Warning

Subcutaneous route (Solution)

Warning: Cytokine Release Syndrome and Immune Effector Cell-Associated Neurotoxicity SyndromeCytokine 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

Less common

Rare

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

For Healthcare Professionals

Applies to epcoritamab: subcutaneous solution.

General

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]

References

1. Product Information. Epkinly (epcoritamab). Genmab US, Inc. 2023.

Further information

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.