Zanidatamab Side Effects

Applies to zanidatamab: intravenous powder for injection.

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 infusion. Tell your medical caregiver if you feel dizzy, nauseated, light-headed, itchy, sweaty, or have a headache, chest tightness, back pain, trouble breathing, or swelling in your face.

Call your doctor at once if you have:

• new or worsening shortness of breath;

• feeling very tired;

• loss of consciousness;

• a new or a worsening irregular heartbeat pattern;

• dizziness, feeling light-headed;

• swelling or rapid weight gain; or

• severe diarrhea.

Your cancer treatments may be delayed, changed, or permanently discontinued if you have certain side effects.

Common side effects may include:

• infusion related reaction;

• diarrhea;

• stomach pain; or

• feeling tired.

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 zanidatamab: intravenous powder for injection.

General adverse events

The most common adverse reactions were diarrhea, infusion-related reaction, abdominal pain, and fatigue.^[Ref]

Cardiovascular

• Common (1% to 10%): Decreased ejection fraction/left ventricular ejection fraction (LVEF)
• Frequency not reported: Left ventricular dysfunction

LVEF declined by greater than 10% and decreased to less than 50% in 4.3% of patients (n=233). Left ventricular dysfunction (LVD) led to permanent discontinuation of this drug in 0.9% of patients. The median time to first occurrence of LVD was 5.6 months (range: 1.6 to 18.7 months); LVD resolved in 70% of patients.

Dermatologic

• Very common (10% or more): Rash (up to 19%)

Rash included dermatitis, acneiform dermatitis, palmar-plantar erythrodysesthesia syndrome, rash, maculopapular rash, and pustular rash.

Gastrointestinal

• Very common (10% or more): Diarrhea (up to 50%), abdominal pain (up to 29%), nausea (up to 18%), vomiting (up to 15%)
• Common (1% to 10%): Gastric obstruction

In clinical studies, diarrhea was reported in 48% of treated patients (n=233), including grade 3 (6%) and grade 2 (17%).

Diarrhea included diarrhea and enteritis.

Abdominal pain included abdominal pain and upper abdominal pain.

Hematologic

• Very common (10% or more): Decreased hemoglobin (up to 88%), decreased lymphocytes (up to 44%)

Hepatic

• Very common (10% or more): Increased AST (up to 47%), increased ALT (up to 46%), biliary obstruction (up to 15%)
• Common (1% to 10%): Biliary tract infection, cholangitis
• Frequency not reported: Hepatic failure

Metabolic

• Very common (10% or more): Decreased appetite (up to 16%)

Other

• Very common (10% or more): Increased LDH (up to 55%), decreased albumin (up to 53%), increased alkaline phosphatase (up to 41%), decreased sodium (up to 35%), infusion-related reaction (up to 35%), decreased potassium (up to 34%), fatigue (up to 24%)
• Common (1% to 10%): Sepsis, decreased weight

In clinical studies using this drug as a single agent, an infusion-related reaction (IRR) was reported in 31% of treated patients (n=233), including grade 3 (0.4%) and grade 2 (25%). IRRs led to permanent discontinuation of this drug in 0.4% of patients. IRRs occurred on the first day of dosing in 28% of patients, and 97% of IRRs resolved within 1 day.

Fatigue included asthenia and fatigue.

Renal

• Common (1% to 10%): Increased blood creatinine

Respiratory

• Common (1% to 10%): Pneumonia, pneumonitis

See also:

Further information

Zanidatamab 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