What are the precautions for zenidatumab for injection (zanidatamab-hrii)-Ziihera

In the clinical study of zenidatamab-hrii for injection (zanidatamab-hrii)-Ziihera in the treatment of HER2-positive (IHC 3+) biliary tract cancer (BTC), warnings and precautions such as embryo-fetal toxicity, left ventricular dysfunction, infusion-related reactions, and diarrhea have emerged. Discontinue and resume at reduced dose upon recovery, or permanently discontinue based on severity.

1. Embryo-fetal toxicity: According to the mechanism of action, zenidatuzumab for injection can cause harm to the fetus when used in pregnant women. There are no human or animal data regarding the use of this drug during pregnancy. In reports in the literature, use of HER2-directed antibodies during pregnancy resulted in cases of oligohydramnios and oligohydramnios sequences, manifested by pulmonary hypoplasia, skeletal abnormalities, and neonatal death.

Verify pregnancy status in females of reproductive potential before initiating zenidatuzumab injection. Inform pregnant women and women of reproductive potential that exposure to this drug during pregnancy or within 4 months before conception may cause fetal harm. Advise females of childbearing potential to use effective contraception during treatment and for 4 months after the last dose.

2. Left ventricular dysfunction: Injectable zenidatuzumab can cause a decrease in left ventricular ejection fraction (LVEF). In clinical studies, the median time to first onset of left ventricular dysfunction was 5.6 months, and left ventricular dysfunction disappeared in 70% of patients. Assess LVEF before starting zenidatuzumab injection and periodically during treatment. The safety of injectable zenidatuzumab has not been established in patients with baseline ejection fraction less than 50%.

3. Infusion-related reactions: Zenidatuzumab for injection can cause infusion-related reactions (IRRs). In clinical studies, 28% of patients experienced IRRs on the first day of dosing, and 97% of IRRs resolved within one day. Administer premedication before each dose of injectable zenidatuzumab to prevent potential IRRs. Monitor patients for signs and symptoms of IRR during administration of zenidatuzumab injection and after completion of the infusion as clinically indicated. Have medications and first aid equipment ready for immediate use to treat IRRs.

IfIRR occurs, slow or stop the infusion and initiate appropriate medical management. Before resuming treatment, monitor the patient until symptoms and signs have completely resolved. Zenidasumab for injection should be permanently discontinued in patients who experience recurrent serious or life-threatening infusion-related reactions.

4. Diarrhea: Zenidatuzumab for injection can cause severe diarrhea. If diarrhea occurs, administer antidiarrheal treatment as clinically indicated. Diagnostic testing is performed as clinically indicated to rule out other causes of diarrhea. Withhold or permanently discontinue zenidatuzumab for injection based on severity.

Therefore, physicians should carefully assess the patient's overall health status when prescribing this drug and conduct appropriate monitoring and management to ensure patient safety and maximize treatment effectiveness. At the same time, patients should maintain communication with medical staff while using the drug and report any discomfort in a timely manner so that measures can be taken quickly to ensure the safety and effectiveness of the treatment process.

Reference materials:https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=ae5d9425-fae5-4541-a158-150998343348##