Zolbetuximab Side Effects

Medically reviewed by Drugs.com. Last updated on Dec 10, 2024.

Applies to zolbetuximab: intravenous powder for injection.

Important warnings This medicine can cause some serious health issues

Tell your doctor if you use other medicines or have other medical conditions or allergies.

Get emergency medical help if you have signs of an allergic reaction: hives, difficult breathing, swelling of your face, lips, tongue, or throat.

Some side effects may occur during or after the injection with zolbetuximab, including life-threatening allergic reactions and serious infusion-related reactions, which can be fatal.

Call your doctor if you have:

• severe nausea and vomiting.

Common side effects may include:

• tiredness;

• loss of appetite and weight loss;

• diarrhea, constipation, stomach pain;

• fever;

• numbness, tingling, or burning pain in your hands or feet; or

• abnormal lab tests.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

For healthcare professionals

Applies to zolbetuximab: intravenous powder for injection.

General adverse events

The most frequently reported side effects were nausea, vomiting, fatigue, decreased appetite, diarrhea, peripheral sensory neuropathy, abdominal pain, constipation, decreased weight, hypersensitivity reactions, and pyrexia.

The most frequently reported laboratory abnormalities were decreased neutrophil count, decreased leucocyte count, decreased albumin, increased creatinine, decreased hemoglobin, increased glucose, decreased lymphocyte count, increased AST, decreased platelets, increased alkaline phosphatase, increased ALT, decreased glucose, decreased sodium, increased phosphate, decreased potassium, and decreased magnesium.

The most common side effect resulting in discontinuation were nausea and vomiting.^[Ref]

Hematologic

• Very common (10% or more): Neutropenia (76%), decreased leukocytes (66%)
• Common (1% to 10%): Decreased platelet count, febrile neutropenia
• Uncommon (0.1% to 1%): Disseminated intravascular coagulation
• Frequency not reported: Anemia, decreased lymphocyte count, thrombocytopenia^[Ref]

Hypersensitivity

• Very common (10% or more): Hypersensitivity reactions (18%)^[Ref]

Hypersensitivity reactions included anaphylaxis and infusion related reactions.^[Ref]

Metabolic

• Very common (10% or more): Decreased appetite (47%), decreased glucose (45%)^[Ref]

Hepatic

• Uncommon (0.1% to 1%): Acute hepatic failure
• Frequency not reported: Increased AST, increased ALT^[Ref]

Respiratory

• Common (1% to 10%): Pneumonia, pulmonary embolism, respiratory failure
• Uncommon (0.1% to 1%): Acute respiratory distress syndrome, dyspnea^[Ref]

Other

• Very common (10% or more): Decreased albumin (78%), decreased sodium (29%), decreased potassium (28%), decreased weight (20%)
• Common (1% to 10%): Pyrexia, sepsis
• Uncommon (0.1% to 1%): Death, procedural complication
• Frequency not reported: Decreased magnesium, fatigue, infusion-related reaction, increased alkaline phosphatase, increased phosphate^[Ref]

Nervous system

• Uncommon (0.1% to 1%): Cerebral hemorrhage, encephalopathy, syncope
• Frequency not reported: Peripheral sensory neuropathy^[Ref]

Renal

• Frequency not reported: Increased creatinine^[Ref]

Cardiovascular

• Very common (10% or more): Peripheral edema (18%)
• Uncommon (0.1% to 1%): Acute myocardial infarction, cardio-respiratory arrest
• Frequency not reported: Hypertension^[Ref]

Gastrointestinal

• Very common (10% or more): Nausea (82%), vomiting (67%)
• Common (1% to 10%): Diarrhea, intestinal obstruction, upper gastrointestinal hemorrhage
• Uncommon (0.1% to 1%): Abdominal infection, gastric perforation, hemorrhagic ascites
• Frequency not reported: Abdominal pain, constipation^[Ref]

Further information

Zolbetuximab 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