How will you receive ZIIHERA?

ZIIHERA is given as an intravenous () .

Your infusions will be given at a clinic or infusion center every 2 or 3 weeks. Your doctor will decide how many treatments you need and what schedule is right for you.

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Chemotherapy is given with ZIIHERA at the beginning of treatment. Your doctor will decide how much chemotherapy is needed.

  • You may also be given tislelizumab () if your healthcare provider decides it is right for your treatment plan
  • If you miss a dose, call your care team as soon as possible to reschedule your appointment

Knowing what to expect helps you feel in control

You will receive some medicines 30 to 60 minutes before each treatment to help reduce the risk of infusion-related reactions or make them less severe. Your care team will also direct you to take an over-the-counter medicine called loperamide (Imodium®) to help manage diarrhea.

  • It is important you take loperamide before your infusion and as instructed by your care team, which could be throughout your treatment journey

Plan for your ZIIHERA infusions to take some time. Your first treatment will likely take the longest.

  • You may want to bring a book, download a podcast, or plan to watch a TV show during your infusions

Your healthcare provider:

  • May slow down your infusion, temporarily stop, or permanently stop your treatment with ZIIHERA if you have certain side effects
  • May do certain tests to check you for some side effects

Starting a new therapy can feel overwhelming, but there are some steps you can take to make your experience better:

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During your infusion

Your infusion could take a few hours, so think of it as time to rest or do something you never have time for, like watching a show you've been meaning to see or starting a new book

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Eating well

Try to eat small, frequent meals throughout the day. Soft, moist, high-protein foods like eggs and fish can help keep your strength up

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Staying hydrated and managing swallowing

Staying hydrated is important. Sip fluids throughout the day. Blending or pureeing foods like smoothies, soups, and soft-cooked options can make eating more comfortable

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Daily planning

Prep meals and write down questions for your doctor on days when you are feeling well. Lean on friends and family for help when you need it

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Emotional health

It is okay to feel scared or overwhelmed. Talking to someone you trust, or connecting with a support group, can help you feel less alone

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Staying active

Exercise can help you feel better and keep your energy up. Ask your doctor what level of activity is right for you

What is ZIIHERA?

ZIIHERA (zanidatamab-hrii) 50 mg/mL is a prescription medicine used to treat adults with gastroesophageal cancer (GEA) including gastric cancer, esophageal cancer, and gastroesophageal junction (GEJ) cancer. ZIIHERA is used in combination with fluoropyrimidine- and platinum-containing chemotherapy with or without tislelizumab-jsgr as the first treatment when your GEA:

  • cannot be removed by surgery or has spread to other parts of your body (metastatic); and
  • your tumor tests positive for human epidermal growth factor receptor 2 (HER2 IHC 3+ or IHC 2+/ISH+).

Your healthcare provider will perform a test to make sure ZIIHERA is right for you.

It is not known if ZIIHERA is safe and effective in children.

IMPORTANT SAFETY INFORMATION

ZIIHERA can cause serious side effects, including:

  • Diarrhea. Diarrhea during treatment with ZIIHERA can be severe, life threatening, and can lead to death. Diarrhea may cause loss of fluids and body salts (electrolytes). To help prevent or reduce diarrhea during treatment with ZIIHERA, your healthcare provider:
    • will tell you to drink more fluids.
    • start you on an antidiarrheal medicine such as loperamide or other treatment, as needed.
    • may temporarily stop, reduce your dose or permanently stop treatment with ZIIHERA, or other medicines you take.

If you get new or worsening diarrhea, tell your healthcare provider right away and take antidiarrheal medicine as prescribed. Follow all of your healthcare providers instructions to help with your diarrhea.

  • Harm to your unborn baby. Taking ZIIHERA during pregnancy or within 4 months before pregnancy can harm your unborn baby. Tell your healthcare provider right away if you become pregnant or think you may be pregnant during treatment with ZIIHERA.

Females who are able to become pregnant:

  • Your healthcare provider should do a pregnancy test before you start treatment with ZIIHERA.
  • Use effective birth control (contraception) during treatment with ZIIHERA and for 4 months after the last dose.

  • Heart problems that may affect how well your heart pumps blood. Your healthcare provider will check your heart function before and during treatment with ZIIHERA. Tell your healthcare provider right away if you get any of the following signs and symptoms of a heart problem:

    • 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 feeling light-headed

  • Infusion-related reactions. Your healthcare provider will check for side effects during your infusions. Tell your healthcare provider right away if you get any of the following symptoms during or after your infusions of ZIIHERA:

    • shortness of breath or trouble breathing
    • fever
    • chills
    • rash
    • flushing
    • nausea or vomiting
    • dizziness or feeling light-headed
    • chest discomfort

Before receiving ZIIHERA, tell your healthcare provider about all of your medical conditions, including if you:

  • have or have had any heart problems.
  • are breastfeeding or plan to breastfeed. It is not known if ZIIHERA passes into your breastmilk. Talk to your healthcare provider about the best way to feed your baby if you receive treatment with ZIIHERA.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Other common side effects when ZIIHERA is given in combination with chemotherapy and tislelizumab-jsgr include:

  • diarrhea
  • nausea
  • decreased appetite
  • low levels of blood potassium
  • vomiting
  • feeling tired
  • numbness, pain, tingling, or burning in your hands or feet
  • rash
  • infusion-related reactions

Other common side effects when ZIIHERA is given in combination with chemotherapy include:

  • diarrhea
  • nausea
  • vomiting
  • numbness, pain, tingling, or burning in your hands or feet
  • decreased appetite
  • feeling tired
  • low levels of blood potassium
  • infusion-related reactions
  • rash

These are not all the possible side effects of ZIIHERA. Call your doctor for medical advice about side effects.

Tell your healthcare provider if you have any side effect that bothers you or that does not go away. You may report side effects to FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

Please see the full Prescribing Information, including BOXED WARNINGS and Medication Guide, and discuss with your doctor.