Consumer Medicine Information (CMI) summary
The
full CMI on the next page has more details. If you are worried about being given this medicine,
speak to your doctor or pharmacist.
This medicine is new or being used differently. Please report side effects. See the
full CMI for further details.
1. Why am I being given VYLOY?
VYLOY contains the active ingredient zolbetuximab. VYLOY is used in combination with
other anti-cancer medicines to treat people with a kind of cancer called stomach (gastric)
or gastro-oesophageal junction cancer.
2. What should I know before I am given VYLOY?
VYLOY should not be given if you have ever had an allergic reaction to zolbetuximab
or any of the ingredients listed at the end of the CMI.
Talk to your doctor if you have any other medical conditions, take any other medicines,
or are pregnant or plan to become pregnant or are breastfeeding. VYLOY is not used in children and adolescents.
3. What if I am taking other medicines?
Some medicines may interfere with VYLOY and affect how it works.
4. How am I given VYLOY?
Your doctor will give you VYLOY through an infusion (a drip) into a vein (intravenously)
over at least 2 hours.
You will get VYLOY every 2 or 3 weeks based on the other anti-cancer medicines chosen
by your doctor. Your doctor will decide how many treatments you need.
5. What should I know while being given VYLOY?
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Things you should do
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Remind any doctor, dentist or pharmacist you visit that you are being given VYLOY.
Call your doctor straight away or go to the Emergency Department at the nearest hospital
if you have any symptoms of serious allergic reactions, infusion related reactions,
nausea and vomiting.
Tell your doctor if you are taking any other medicines, including medicines obtained
without a prescription.
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Things you should not do
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It is very important that you do not miss a dose of this medicine (call your doctor
if you cannot make it to your appointment to receive your next dose).
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Driving or using machines
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Be careful before you drive or use any machines or tools until you know how VYLOY
affects you.
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Looking after your medicine
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You will not be asked to store VYLOY. It will usually be stored in the pharmacy or
on the ward. Any unused portion of the solution will be disposed of by your doctor.
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6. Are there any side effects?
Some possible side effects may be serious, and can include serious allergic reactions
such as itchy, swollen pink or red areas of the skin, breathing problems like wheezing,
or throat tightness, infusion related reactions, nausea and vomiting.
This medicine is subject to additional monitoring. This will allow quick identification
of new safety information. You can help by reporting any side effects you may get.
You can report side effects to your doctor, or directly at www.tga.gov.au/reporting-problems .
Active ingredient:
zolbetuximab
Full Consumer Medicine Information (CMI)
This leaflet provides important information about using VYLOY. You should also speak to your doctor or pharmacist if you would like further information
or if you have any concerns or questions about using VYLOY.
Where to find information in this leaflet:
1. Why am I being given VYLOY?
VYLOY contains the active ingredient zolbetuximab.
VYLOY is used in combination with other anti-cancer medicines to treat people with
stomach (gastric) or gastro-oesophageal junction cancer. VYLOY is given to people whose tumours are positive for the "Claudin18.2 (CLDN18.2)",
and negative for the "Human epidermal growth factor receptor 2 (HER2)" proteins. People
get VYLOY when their cancer has spread or cannot be taken out by surgery. This medicine
is given in combination with other anti-cancer medicines. It is important that you
also read the package leaflets for these other medicines. If you have any questions
about these medicines, ask your doctor.
2. What should I know before I am given VYLOY?
Warnings
Do not use VYLOY if:
you are allergic to zolbetuximab, or any of the ingredients listed at the end of this
leaflet.
always check the ingredients to make sure you can be given this medicine.
Check with your doctor if you:
are currently experiencing nausea and/or vomiting. Nausea and vomiting could be common
during treatment and can sometimes be severe. Your doctor may give you medicine before
each infusion to help relieve nausea and vomiting.
During treatment, you may be at risk of developing certain side effects. It is important
you understand these risks and how to monitor for them. See additional information
under Section
6. Are there any side effects?
Pregnancy and breastfeeding
Check with your doctor if you are pregnant or intend to become pregnant.
Talk to your doctor if you are breastfeeding or intend to breastfeed.
Pregnancy
VYLOY should not be used if you are pregnant unless your doctor specifically recommends
it.
If you are pregnant, think you may be pregnant or are planning to have a baby, ask
your doctor for advice before taking this medicine.
It is not known if VYLOY will harm your unborn baby.
Breast-feeding
Breast-feeding is not recommended during treatment with VYLOY.
Tell your doctor if you are breast-feeding or plan to breastfeed.
It is not known if VYLOY passes into your breast milk.
3. What if I am taking other medicines?
Tell your doctor or pharmacist if you are taking any other medicines, including any
medicines, vitamins or supplements that you buy without a prescription from your pharmacy,
supermarket or health food shop.
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins
or supplements you are taking and if these affect VYLOY.
4. How am I given VYLOY?
How much to receive VYLOY
You will receive VYLOY in a hospital or clinic under the supervision of a doctor experienced
in cancer treatment.
Your doctor will give you VYLOY through an infusion (a drip) into a vein (intravenously)
over at least 2 hours.
Your doctor will decide how much VYLOY you will receive.
When to receive VYLOY
You will get VYLOY every 2 or 3 weeks based on the other anti-cancer medicines chosen
by your doctor.
Your doctor will decide how many treatments you need.
If you forget to receive VYLOY
If you miss a dose, call your doctor right away to reschedule your appointment. It
is very important that you do not miss a dose of this medicine.
If you are given too much VYLOY
As VYLOY is given to you under the supervision of your doctor, it is unlikely that
you will be given too much. However, if you experience any side effects after being
given VYLOY, tell your doctor immediately.
You should immediately:
phone the Poisons Information Centre
(by calling 13 11 26), or
contact your doctor, or
go to the Emergency Department at your nearest hospital.
You should do this even if there are no signs of discomfort or poisoning.
5. What should I know while being given VYLOY?
Things you should do
Call your doctor straight away if you:
have any of the following symptoms of a serious allergic reaction: itchy, swollen
pink or red areas of the skin (hives), coughing that doesn’t go away, breathing problems
such as wheezing, or throat tightness/change in voice. These can happen during or
after you receive your infusion.
have any of the following symptoms of an infusion related reaction: nausea, vomiting,
stomach pain, increased saliva (salivary hypersecretion), fever, chest discomfort,
chills or shaking, back pain, cough, or high blood pressure (hypertension). These
can happen during or after you receive your infusion.
are currently experiencing nausea and/or vomiting and/or bleeding in the digestive
tract: nausea and vomiting could be common during treatment and can sometimes be severe.
Your doctor may give you medicine before each infusion to help relieve nausea and
vomiting.
have any of the following symptoms of a rare, reversible condition involving the brain
called Posterior Reversible Encephalopathy Syndrome (PRES): seizure, worsening headache,
confusion, blindness or other vision problems.
Remind any doctor, dentist or pharmacist you visit that you are being given VYLOY.
Driving or using machines
Be careful before you drive or use any machines or tools until you know how VYLOY
affects you.
Drinking alcohol
Tell your doctor if you drink alcohol.
Looking after your medicine
You will not be asked to store VYLOY. It will usually be stored in the fridge (at
2°C to 8°C) at the pharmacy or on the ward. Unused portion of the infusion solution
will not be stored for reuse.
Getting rid of any unwanted medicine
Any unused medicine or waste material will be disposed of by your doctor in accordance
with local requirements.
6. Are there any side effects?
All medicines can have side effects. If you do experience any side effects, most of
them are minor and temporary. However, some side effects may need medical attention.
See the information below and, if you need to, ask your doctor or pharmacist if you
have any further questions about side effects.
Less serious side effects
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Less serious side effects
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What to do
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General:
swelling of the lower legs or hands (oedema peripheral)
low levels of albumin in the blood (hypoalbuminaemia)
Eating related:
decreased appetite
increased saliva (salivary hypersecretion)
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Speak to your doctor if you have any of these less serious side effects and they worry
you.
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Serious side effects
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Serious side effects
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What to do
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Hypersensitivity (allergic) reactions (including hypersensitivity and anaphylactic
reactions) – common (may affect up to 1 in 10 people):
Tell your doctor or get medical help right away if you have any of these symptoms
of a serious allergic reaction:
itchy, swollen pink or red areas of the skin (hives)
coughing that doesn’t go away, breathing problems such as wheezing, or throat tightness/change
in voice.
Infusion related reaction – common (may affect up to 1 in 10 people):
Tell your doctor or get medical help right away if you have any of these symptoms
of an infusion related reaction:
nausea, vomiting
stomach pain
increased saliva (salivary hypersecretion)
fever
chest discomfort
chills or shaking
back pain
cough
high blood pressure (hypertension).
Nausea and vomiting – very common (may affect more than 1 in 10 people):
Tell your doctor if these symptoms do not go away or become worse.
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Call your doctor straight away, or go straight to the Emergency Department at your
nearest hospital if you notice any of these serious side effects.
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Tell your doctor or pharmacist if you notice anything else that may be making you
feel unwell.
Other side effects not listed here may occur in some people.
Reporting side effects
After you have received medical advice for any side effects you experience, you can
report side effects to the Therapeutic Goods Administration online at
www.tga.gov.au/reporting-problems . By reporting side effects, you can help provide more information on the safety of
this medicine.
Always make sure you speak to your doctor or pharmacist before you decide to stop
taking any of your medicines.
7. Product details
This medicine is only available with a doctor's prescription.
What VYLOY contains
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Active ingredient
(main ingredient)
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zolbetuximab
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Other ingredients
(inactive ingredients)
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arginine,
phosphoric acid,
sucrose, and
polysorbate 80
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Do not take this medicine if you are allergic to any of these ingredients.
What VYLOY looks like
VYLOY powder for concentrate for solution for infusion is a white to off-white lyophilised
powder.
AUST R 428330
Who distributes VYLOY
Astellas Pharma Australia Pty Ltd
Suite 2.01, 2 Banfield Road
Macquarie Park NSW 2113
Tel: 1800 751 755 (Medical Information)
This leaflet was prepared in March 2025.