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.
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.
About Advanced Stomach/GEJ Cancer
A diagnosis of advanced stomach or GEJ cancer can leave you feeling overwhelmed. You should remember you are not alone in dealing with this disease.
Stomach and GEJ cancer have symptoms that can be similar to other conditions, making them difficult to diagnose.
Most cases of stomach and GEJ cancer in the United States are not caught until they are in the advanced stages. This means the cancer is either:
Locally advanced unresectable
It has spread from where it started to nearby tissues or lymph nodes and is unable to be removed with surgery
-or-
Metastatic
It has spread from where it started to other places in the body
It is estimated that there will be approximately 26,500* new cases of stomach cancer in the United States in 2023.
*The Surveillance, Epidemiology, and End Results Program of the National Cancer Institute does not have a separate classification for GEJ cancer apart from esophageal cancer; therefore, true GEJ cancer projections are unknown. This makes it difficult to project an estimated number of new cases of GEJ cancer.
Understanding Biomarkers
Each of us is unique, and so is each case of advanced stomach/GEJ cancer.
One of the things that can differentiate your case of advanced stomach/GEJ cancer is the presence or absence of certain biomarkers.
A biomarker is a molecule that is found in the body. In some cases of cancer, it can be a protein found on the surface of a tumor.
Biomarker testing is used to gather more information about the specific type of cancer. These results help doctors understand the different features of the cancer.
If your cancer tests positive for a specific biomarker, this information can help you and your doctor choose a treatment that may be more appropriate for you.
Targeted therapy is a type of treatment that uses medicines to target specific molecules on cancer cells. Targeted therapies work in different ways to treat cancer. Targeted therapies, while specific, can also affect other tissues in the body.
Understanding Claudin 18.2
The protein claudin 18.2 is a biomarker that has been estimated to be present in more than a third of advanced stomach/GEJ cancer patients.
It is one of the most common biomarkers in stomach and GEJ cancers. Claudin 18.2 is typically found in the stomach lining. When cancer develops, claudin 18.2 may become more exposed at the surface of the cancer cell.
If you test positive for a biomarker like claudin 18.2, it means there is a targeted therapy that may be able to help treat your cancer.
VYLOY targets claudin 18.2 in advanced stomach/GEJ cancer
How has VYLOY helped others?
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.
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.
