Prescribing Information

Medication Guide

WHAT IS ZIIHERA?

ZIIHERA 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.

ZIIHERA targets HER2, which is a biomarker on some cancer cells. Too much HER2 can make the cancer grow.

Biomarker: a target in your cancer cells that helps your doctor choose the right treatment for you; short for "biological marker"
GEA: gastroesophageal adenocarcinoma
GEJ: gastroesophageal junction
HER2+: human epidermal growth factor receptor 2-positive
IHC: immunohistochemistry
ISH: in situ hybridization

Authored text wrapper: a target in your cancer cells that helps your doctor choose the right treatment for you; short for "biological marker"

Biomarker: a target in your cancer cells that helps your doctor choose the right treatment for you; short for "biological marker"
Two paragraphs in one text block: a target in your cancer cells that helps your doctor choose the right treatment for you; short for "biological marker"
Biomarker: a target in your cancer cells that helps your doctor choose the right treatment for you; short for "biological marker"
GEA: gastroesophageal adenocarcinoma
GEJ: gastroesophageal junction

No sign-up or enrollment needed. It starts with a conversation with your doctor.
Once you and your doctor have decided that Wegovy^{^®} is right for you, your doctor and pharmacist handle the submission and approval process.

WHAT IS ZIIHERA?

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.

ZIIHERA targets HER2, which is a biomarker on some cancer cells. Too much HER2 can make the cancer grow.

Biomarker: a target in your cancer cells that helps your doctor choose the right treatment for you; short for "biological marker"
GEA: gastroesophageal adenocarcinoma
GEJ: gastroesophageal junction
HER2+: human epidermal growth factor receptor 2-positive
IHC: immunohistochemistry
ISH: in situ hybridization

Authored text wrapper: a target in your cancer cells that helps your doctor choose the right treatment for you; short for "biological marker"

Biomarker: a target in your cancer cells that helps your doctor choose the right treatment for you; short for "biological marker"
Two paragraphs in one text block: a target in your cancer cells that helps your doctor choose the right treatment for you; short for "biological marker"
Biomarker: a target in your cancer cells that helps your doctor choose the right treatment for you; short for "biological marker"
GEA: gastroesophageal adenocarcinoma
GEJ: gastroesophageal junction

No sign-up or enrollment needed. It starts with a conversation with your doctor.
Once you and your doctor have decided that Wegovy^{^®} is right for you, your doctor and pharmacist handle the submission and approval process.

Learn more about ZIIHERA, including what to expect during treatment and possible side effects, with a treatment brochure.

Sign up to get the treatment brochure and receive ongoing emails with helpful information about ZIIHERA.

Please see additional Important Safety Information below, and full Prescribing Information, including BOXED WARNINGS and Medication Guide, and discuss with your doctor.

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

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.

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

ZIIHERA can cause serious side effects, including:

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.

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.

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

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.

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

What is ZIIHERA?

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.

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