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VYLOY FAQs and Glossary

Frequently Asked Questions

You may have questions about stomach cancer and treatment. Here are some of the most common questions and answers that people look for.

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Stomach cancer is also known as gastric cancer. It forms in the cells lining the stomach or in the gastroesophageal junction (GEJ). The GEJ is the place where the esophagus connects to the stomach. Often the biomarker claudin 18.2 becomes exposed on the surface of the stomach cancer cell.

Learn more about claudin 18.2

VYLOY is a prescription medicine used to treat adults with cancer of the stomach (gastric cancer) or cancer located where the esophagus joins the stomach (gastroesophageal junction cancer). VYLOY is used in combination with chemotherapy that contains fluoropyrimidine and platinum as the first treatment when your gastric or gastroesophageal junction cancer:

  • cannot be removed with surgery or has spread to other parts of the body,
  • is HER2-negative, and
  • your tumor tests positive for claudin (CLDN)18.2.

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

Discover more about VYLOY

VYLOY is different than chemotherapy. It is a treatment that targets the biomarker claudin 18.2 that is found on the surface of the cancer tumor in many cases of advanced stomach/GEJ cancer.

See how VYLOY is thought to work

VYLOY was studied in 2 clinical trials. Individual results may vary.

See the results from the clinical trials

You will receive VYLOY for as long as you continue to respond to treatment or until side effects become intolerable. Your healthcare professional will work with you to determine your therapy schedule and treatment duration.

Discover the dosing schedule

You will receive VYLOY in the hospital or infusion center:

  • As an intravenous infusion (through your vein)
  • Followed by chemotherapy that contains fluoropyrimidine and platinum
  • Every 2 or 3 weeks, depending on the chemotherapy chosen by your healthcare team
  • Your first VYLOY infusion will last a minimum of 3.5 hours. Subsequent VYLOY infusions may take less time

Learn more about starting treatment with VYLOY

VYLOY may cause serious side effects, including:

  1. Allergic reactions, including anaphylaxis and infusion-related reactions. Allergic reactions are common during treatment with VYLOY and can sometimes be serious. Serious allergic reactions can happen during or after your VYLOY infusion, including life-threatening allergic reactions and serious infusion-related reactions that may lead to death. Your healthcare provider will monitor you during your infusion and for 2 hours after or longer if needed. Tell your healthcare provider or get emergency medical help right away if you get any of the following symptoms of a serious allergic reaction during or after your infusion of VYLOY:
    • itchy, raised bumps on the skin (hives)
    • coughing that does not go away
    • nausea or vomiting
    • stomach (abdominal) pain
    • increased saliva
    • breathing problems such as wheezing
    • throat tightness or change in voice
    • fever
    • chest discomfort
    • chills or shaking
    • back pain
  1. Severe nausea and vomiting. Nausea and vomiting are common during treatment with VYLOY and can sometimes be severe. Nausea and vomiting happened more often during the first treatment cycle. Before you receive each VYLOY infusion, your healthcare provider will give you medicines to help prevent nausea and vomiting. Tell your healthcare provider right away if nausea or vomiting does not go away or gets worse.

Learn more about the most common side effects that may happen with VYLOY treatment

VYLOY Support SolutionsTM offers access and reimbursement support to help people like you, who have been prescribed VYLOY, access their medication.

Call VYLOY Support Solutions at
1-855-272-6609 Monday-Friday,
8:00 AM to 8:00 PM ET
if you have any questions or need assistance.

Discover more here

Glossary

BIOMARKER

A biological molecule found in blood, other body fluids, or tissues that is a sign of a normal or abnormal process, or of a condition or disease

CAPOX

A chemotherapy combination regimen used to treat gastric/GEJ cancer. It consists of the drugs capecitabine and oxaliplatin

CLAUDIN 18.2

A protein usually found between the cells that line the stomach wall. It may be exposed on the surface of some stomach cancer cells

ESOPHAGUS

The muscular tube through which food passes from the throat to the stomach

mFOLFOX6

A chemotherapy combination regimen used to treat gastric/GEJ cancer. It consists of the drugs fluorouracil (5-FU), leucovorin calcium (folinic acid), and oxaliplatin

GASTRIC

Having to do with the stomach

GASTROESOPHAGEAL JUNCTION (GEJ)

The place where the esophagus connects to the stomach

HER2 (human epidermal growth factor receptor 2)

A protein involved in normal cell growth. It may be found in some types of cancers, and may cause the cancer to grow more quickly and spread to other parts of the body

IMMUNE SYSTEM

A network of cells, tissues, and organs that helps the body fight infections and other diseases

MEDIAN OVERALL SURVIVAL

The length of time from the start of treatment for a disease, such as cancer, that half of the patients in a group of patients diagnosed with the disease are still alive

MEDIAN PROGRESSION-FREE SURVIVAL

The length of time from the start of treatment for a disease, such as cancer, that half of the patients in a group of patients diagnosed with the disease live with the disease but it does not get worse

OVERALL SURVIVAL

The length of time from either the date of diagnosis or the start of treatment for a disease, such as cancer, that patients diagnosed with the disease are still alive

PROGRESSION-FREE SURVIVAL

The length of time from the start of treatment that a patient lives with the cancer without their disease getting worse

TARGETED THERAPY

A type of treatment that uses medicines to target specific molecules that cancer cells need to survive and spread. Targeted therapies work in different ways to treat cancer

IMPORTANT SAFETY INFORMATION

WHAT IS VYLOY?

VYLOY is a prescription medicine used to treat adults with cancer of the stomach (gastric cancer) or cancer located where the esophagus joins the stomach (gastroesophageal junction cancer). VYLOY is used in combination with chemotherapy that contains fluoropyrimidine and platinum as the first treatment when your gastric or gastroesophageal junction cancer:

  • cannot be removed with surgery or has spread to other parts of the body,
  • is HER2-negative, and
  • your tumor tests positive for “claudin (CLDN)18.2.”

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

IMPORTANT SAFETY INFORMATION

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

  • have nausea or vomiting.
  • are pregnant or plan to become pregnant. It is not known if VYLOY will harm your unborn baby.
  • are breastfeeding or plan to breastfeed. It is not known if VYLOY passes into your breast milk. Do not breastfeed during treatment with VYLOY and for 8 months after the last dose.
     

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

What are the possible side effects of VYLOY?

VYLOY may cause serious side effects, including:

  • Allergic reactions, including anaphylaxis and infusion-related reactions. Allergic reactions are common during treatment with VYLOY and can sometimes be serious. Serious allergic reactions can happen during or after your VYLOY infusion, including life-threatening allergic reactions and serious infusion-related reactions that may lead to death. Your healthcare provider will monitor you during your infusion and for 2 hours after or longer if needed. Tell your healthcare provider or get emergency medical help right away if you get any of the following symptoms of a serious allergic reaction during or after your infusion of VYLOY:
  • itchy, raised bumps on the skin (hives)
  • coughing that does not go away
  • nausea or vomiting
  • stomach (abdominal) pain
  • increased saliva
  • breathing problems such as wheezing
  • throat tightness or change in voice
  • fever
  • chest discomfort
  • chills or shaking
  • back pain
  • Severe nausea and vomiting. Nausea and vomiting are common during treatment with VYLOY and can sometimes be severe. Nausea and vomiting happened more often during the first treatment cycle. Before you receive each VYLOY infusion, your healthcare provider will give you medicines to help prevent nausea and vomiting. Tell your healthcare provider right away if nausea or vomiting does not go away or gets worse.

The most common side effects of VYLOY include:

  • tiredness
  • decreased appetite
  • diarrhea
  • tingling or numbness of the arms or legs
  • stomach (abdominal) pain
  • constipation
  • decreased weight
  • fever
  • decreased white blood cells, red blood cells and platelets
  • decreased protein (albumin) in the blood
  • changes in kidney function tests
  • changes in blood sugar (glucose)
  • changes in liver functions tests
  • changes in body salts (electrolytes) in your blood
     

Your healthcare provider may slow the rate of your infusion, temporarily stop, or completely stop treatment with VYLOY if you have certain side effects. These are not all of the possible side effects of VYLOY. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
 

Please see full Prescribing Information, including Patient Information.

IMPORTANT SAFETY INFORMATION

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

  • have nausea or vomiting.1
  • are pregnant or plan to become pregnant. It is not known if VYLOY will harm your unborn baby.
  • are breastfeeding or plan to breastfeed. It is not known if VYLOY passes into your breast milk. Do not breastfeed during treatment with VYLOY and for 8 months after the last dose.
     

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

What are the possible side effects of VYLOY?

VYLOY may cause serious side effects, including:

  • Allergic reactions, including anaphylaxis and infusion-related reactions. Allergic reactions are common during treatment with VYLOY and can sometimes be serious. Serious allergic reactions can happen during or after your VYLOY infusion, including life-threatening allergic reactions and serious infusion-related reactions that may lead to death. Your healthcare provider will monitor you during your infusion and for 2 hours after or longer if needed. Tell your healthcare provider or get emergency medical help right away if you get any of the following symptoms of a serious allergic reaction during or after your infusion of VYLOY:
  • itchy, raised bumps on the skin (hives)
  • coughing that does not go away
  • nausea or vomiting
  • stomach (abdominal) pain
  • increased saliva
  • breathing problems such as wheezing
  • throat tightness or change in voice
  • fever
  • chest discomfort
  • chills or shaking
  • back pain
  • Severe nausea and vomiting. Nausea and vomiting are common during treatment with VYLOY and can sometimes be severe. Nausea and vomiting happened more often during the first treatment cycle. Before you receive each VYLOY infusion, your healthcare provider will give you medicines to help prevent nausea and vomiting. Tell your healthcare provider right away if nausea or vomiting does not go away or gets worse.

The most common side effects of VYLOY include:

  • tiredness
  • decreased appetite
  • diarrhea
  • tingling or numbness of the arms or legs
  • stomach (abdominal) pain
  • constipation
  • decreased weight
  • fever
  • decreased white blood cells, red blood cells and platelets
  • decreased protein (albumin) in the blood
  • changes in kidney function tests
  • changes in blood sugar (glucose)
  • changes in liver functions tests
  • changes in body salts (electrolytes) in your blood
     

Your healthcare provider may slow the rate of your infusion, temporarily stop, or completely stop treatment with VYLOY if you have certain side effects. These are not all of the possible side effects of VYLOY. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
 

Please see full Prescribing Information, including Patient Information.