Zanidatamab Side Effects

Applies to zanidatamab: intravenous powder for injection.

Important warnings This medicine can cause some serious health issues

May harm an unborn baby.

Do not use if you are pregnant.

Use effective birth control while using zanidatamab and for at least 4 months after your last dose.

Tell your doctor if you become pregnant.

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

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