Ziihera 300 mg intravenous solution

Generic name:
Zanidatamab - injection

Brand name(s)
Ziihera

Zanidatamab may cause severe (possibly fatal) diarrhea. Tell your doctor right away if you have new or worsening diarrhea. Diarrhea that doesn't stop may result in dehydration. Contact your doctor promptly if you notice any symptoms of dehydration, such as unusual decreased urination, unusual dry mouth/thirst, fast heartbeat, or dizziness/lightheadedness. Your doctor may prescribe other medications before or during treatment to treat the diarrhea. Carefully follow your doctor's directions for all your medications.

This medication can cause serious (possibly fatal) harm to an unborn baby if used during pregnancy. Discuss the use of reliable forms of birth control with your doctor.

This medication is used to treat certain types of cancer (biliary tract, esophageal, stomach). Zanidatamab belongs to a class of drugs known as monoclonal antibodies. Zanidatamab works by slowing or stopping the growth of cancer cells.

Read the Medication Guide provided by your pharmacist before you start using zanidatamab and each time you get a treatment. If you have any questions, ask your doctor or pharmacist.

This medication is given by a health care professional. It is injected slowly into a vein over 60 to 120 minutes. It is given as directed by your doctor, usually once every 2 or 3 weeks. The dosage is based on your medical condition, weight, and response to treatment.

Infusion reactions may happen during the infusion of this drug. Your doctor may prescribe other medications (such as acetaminophen, antihistamines, corticosteroids) before each treatment to help prevent these side effects. Tell your doctor right away if you have any symptoms of infusion reactions such as fever, chills, flushing, shortness of breath, nausea, vomiting, chest pain, or dizziness. Your doctor may give you other medications to help with these side effects or may slow down or stop your treatment for some time.

Use this medication regularly to get the most benefit from it. To help you remember, mark your calendar with a reminder.

See also Warning and How to Use sections.

Tiredness or abdominal pain may occur. If either of these effects lasts or gets worse, tell your doctor or pharmacist promptly.

Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including:

• signs of heart problems (such as shortness of breath, swelling ankles/feet, unusual tiredness, unusual/sudden weight gain)

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including:

• rash
• itching/swelling (especially of the face/tongue/throat)
• severe dizziness
• trouble breathing

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Before using zanidatamab, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of:

• heart disease (such as heart failure)

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Older adults may be at greater risk for side effects such as diarrhea.

Tell your doctor if you are pregnant or plan to become pregnant. You should not become pregnant while using zanidatamab. Zanidatamab may harm an unborn baby. Your doctor should order a pregnancy test before you start this medication. Ask about the use of reliable forms of birth control during treatment and for 4 months after the last dose. If you become pregnant, talk to your doctor right away about the risks and benefits of this medication. See also Warning section.

It is unknown if this medication passes into breast milk. Consult your doctor before breastfeeding.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call 1-800-222-1222. Canada residents can call 1-844-764-7669.

Lab and/or medical tests (such as heart function) should be done before you start using this medication and while you are using it. Keep all medical and lab appointments. Consult your doctor for more details.

It is important to get each dose of this medication as scheduled. If you miss a dose, ask your doctor or pharmacist right away for a new dosing schedule.

Not applicable. This medication is given in a hospital or clinic and will not be stored at home.

HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.