Patient Medication Information: uses, side effects, how to take - Vyloy
What VYLOY is used for:
Vyloy is used to treat adults with stomach (gastric) or gastro-esophageal junction cancer. The gastro-esophageal junction is the place where the oesophagus (gullet) joins the stomach.
This medicine is given to patients whose tumours are positive for the “Claudin18.2 (CLDN18.2)”, and negative for the “Human epidermal growth factor receptor 2 (HER2)” proteins. This medicine is given to patients whose gastric or gastro-esophageal junction cancer cannot be removed by surgery or has spread to other parts of the body.
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.
How VYLOY works:
Vyloy contains the active substance zolbetuximab, which is a monoclonal antibody that can recognise and attach to certain cancer cells. By attaching to these cancer cells, the medicine is intended to kill them.
The ingredients in VYLOY are:
Medicinal ingredient: zolbetuximab
Non-medicinal ingredients: arginine, phosphoric acid, polysorbate 80, sucrose
VYLOY comes in the following dosage form(s):
Vyloy comes in single-use vials containing an extractable amount of either 100 mg or 300 mg zolbetuximab for injection.
Do not use VYLOY if:
You are allergic to zolbetuximab or any of the other ingredients of this medicine.
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take VYLOY. Talk about any health conditions or problems you may have.
Other warnings you should know about:
During treatment, Vyloy may cause some side effects that require medical attention:
Allergic (drug hypersensitivity) reactions, including anaphylaxis. Serious allergic reactions can happen during or after you receive your infusion. Tell your doctor or get medical help right 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.
Infusion related reactions. Severe infusion reactions can happen during or after you receive your infusion. Tell your doctor or get medical help right away if you 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).
- Nausea and vomiting. Before you start this medicine, tell your doctor if you are currently feeling sick. Nausea and vomiting are very common during treatment and can sometimes be severe. Your doctor will give you medicine before each infusion to help relieve nausea and vomiting.
Tell your doctor immediately if you have any of these signs or symptoms or if they get worse. Your doctor may:
- give you other medicines in order to prevent complications and reduce your symptoms,
- slow the rate of your Vyloy infusion, or
- stop your treatment for a period of time (temporarily) or completely.
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 and for 8 months following your last dose.
- Tell your doctor if you are breast-feeding or plan to breastfeed.
- It is not known if Vyloy passes into your breast milk.
Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.
The following may interact with VYLOY:
No relevant interactions with other medicines are known.
How to take VYLOY:
You will receive Vyloy in a hospital or clinic under the supervision of a doctor experienced in cancer treatment.
Vyloy will be given to you by intravenous infusion in your vein over at least 2 hours.
Your healthcare provider will monitor you during infusion and for at least 2 hours afterwards.
Usual dose:
Your doctor will decide how much Vyloy you will receive.
You will usually receive 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.
Overdose:
If you think you, or a person you are caring for, have taken too much VYLOY, contact a healthcare professional, hospital emergency department, regional poison control centre or Health Canada’s toll-free number, 1-844 POISON-X (1-844-764-7669) immediately, even if there are no signs or symptoms.
Missed dose:
It is very important that you do not miss a dose of this medicine. If you miss an appointment, call your doctor to reschedule your appointment as soon as possible.
If you stop treatment with Vyloy
Do not stop treatment with Vyloy unless you have discussed this with your doctor. Stopping your treatment may stop the effect of the medicine.
Possible side effects from using VYLOY:
These are not all the possible side effects you may have when being treated with Vyloy. If you experience any side effects not listed here, tell your healthcare professional.
Very common side effects (may affect more than 1 in 10 people):
- Feeling sick (nausea)
- Being sick (vomiting)
- Decreased appetite
- Weight loss
- Dizziness
- High blood pressure
- Feeling unusually weak
- Feeling generally unwell
- Fever
- Swelling of the lower legs or hands (peripheral edema)
- Difficulty sleeping (insomnia)
Changes in test results:
- Decrease in the number of white blood cells
- Decreased level of albumin in the blood
- Decreased level of calcium in the blood
- Decreased level of potassium in the blood
- Decreased level of glucose in the blood
- Decreased level of sodium in the blood
- Increased level of sodium in the blood
- Decreased level of magnesium in the blood
- Increased level of magnesium in the blood
- Increased level of liver enzymes in the blood
Common side effects (may affect up to 1 in 10 people):
- Increased saliva (salivary hypersecretion)
- Indigestion
- Changes to your sense of taste
- Chills
- Urinary tract infection
- Cough
- Chest pain
- Abdominal pain
- Low blood pressure
- Blood clot in a deep vein, causing pain, swelling, redness and warmth (deep vein thrombosis)
- Increased number of infections
Changes in test results:
- Increased levels of potassium in the blood
Serious side effects and what to do about them
| Frequency/Side Effect/Symptom | Talk to your healthcare professional | Stop taking this drug and get immediate medical help | |
|---|---|---|---|
| Only if severe | In all cases | ||
| Common | |||
| Hypersensitivity reactions (including drug hypersensitivity and anaphylactic reactions): 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 | X | ||
| Infusion-related reactions: nausea, vomiting, stomach pain, increased saliva (salivary hypersecretion), fever, chest discomfort, chills or shaking, back pain, cough or high blood pressure (hypertension) | X | ||
| Feeling or being sick (nausea and vomiting) | X | ||
If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, tell your healthcare professional.
Reporting side effects
You can report any suspected side effects associated with the use of health products to Health Canada by:
- Visiting the Web page on Adverse Reaction Reporting (canada.ca/drug-device-reporting) for information on how to report online, by mail or by fax; or
- Calling toll-free at 1-866-234-2345.
NOTE: Contact your healthcare professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.
Storage:
Keep out of reach and sight of children.
Vyloy will be stored by the healthcare professional at the hospital or clinic. The storage details are as follows:
- Store under refrigeration (2°C to 8°C).
- Do not freeze.
- Store in the original package in order to protect from light.
If you want more information about VYLOY:
- Talk to your healthcare professional.
- Find the full product monograph that is prepared for healthcare professionals and includes the Patient Medication Information by visiting the Health Canada Drug Product Database website (Drug Product Database: Access the database); the manufacturer’s website http://www.astellas.ca; or by calling 1-888-338-1824.
Date of Authorization: 2024-12-13