Zanidatamab-hrli Injection

Zanidatamab-hrli injection is used to treat certain type of biliary tract cancer that cannot be operated on, have failed to respond to other treatments or that has spread. Zanidatamab-hrli injection is in a class of medications called monoclonal antibodies. It works by stopping the growth of the tumor.

Zanitamab-hrli injection comes as a powder to be mixed with a liquid and to be given as an intravenous infusion (infusion into the vein) by a doctor or a nurse at a healthcare facility. It is usually given every 2 weeks. Your doctor will decide how long you should receive zanitamab-hrli injection. Your dose may need to be changed, delayed or held based on how you are tolerating the medicine.

Zanitamab-hrli injection can cause reactions during the infusion. Let your doctor know if you experience any of the following during your zanitamab-hrli infusion: itching, flushing, rash, fever, chills, muscle or joint pain, fast heartbeat, shortness of breath, cough, chest discomfort, dizziness or lightheadedness, or sudden anxiety. Your doctor will give you additional medicines before each dose of zanitamab-hrli to help prevent any reactions while receiving zanitamab-hrli.

Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient.

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

Before receiving zanitamab-hrli,

• tell your doctor and pharmacist if you are allergic to zanitamab-hrli, any other medications, or any of the ingredients in zanitamab-hrli injection. Ask your pharmacist or check the Medication Guide for a list of the ingredients.
• tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take.
• tell your doctor if you have or have ever had any heart problems.
• talk to your doctor about risks and benefits of breastfeeding while receiving zanitamab-hrli.

Unless your doctor tells you otherwise, continue your normal diet.

If you miss a scheduled infusion of zanitamab-hrli, call your doctor to set up an appointment to receive it right away. Then restart the infusion schedule so that zanitiamab=hrli is given every 2 weeks.

Zanitmaba-hrli injection may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• abdominal pain
• nausea
• vomiting
• fatigue
• reduced appetite

Some side effects can be serious. If you experience any of these symptoms, call your doctor immediately or get emergency medical treatment:

• diarrhea
• new or worsening shortness of breath, feeling more tired than usual, swelling of your ankles or feet, loss of consciousness, irregular heartbeat, sudden weight gain, dizziness or lightheadedness

Zanitiamab-hrli injection may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (https://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

Keep all appointments with your doctor and the laboratory. Your doctor may order certain lab tests to check your body's response to zanitamab-hrli injection.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.