Patient Leaflet Updated 16-Aug-2024 | Astellas Pharma Ltd
Vyloy 100 mg powder for concentrate for solution for infusion - PIL
Vyloy 100 mg powder for concentrate for solution for infusion
zolbetuximab
▼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. See the end of section 4 for how to report side effects.
1. What Vyloy is and what it is used for
2. What you need to know before you are given Vyloy
3. How Vyloy is given
4. Possible side effects
5. How to store Vyloy
6. Contents of the pack and other information
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.
Vyloy is used to treat adults with stomach (gastric) or gastro-oesophageal junction cancer. The gastro-oesophageal 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. It is given to patients whose gastric or gastro-oesophageal 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.
Talk to your doctor before you are given Vyloy as it may cause:
Tell your doctor immediately if you have any of these signs or symptoms or if they get worse. Your doctor may:
This medicine should not be used in children and adolescents below 18 years of age.
Tell your doctor if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription.
Vyloy can cause side effects that may affect your ability to drive or use machines. Use caution when deciding to drive or use machines after you have been given Vyloy if you are feeling unwell.
You will receive Vyloy in a hospital or clinic under the supervision of a doctor experienced in cancer treatment.
Your doctor will decide how much of this medicine 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.
Vyloy will be given to you by intravenous infusion into your vein over at least 2 hours.
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.
Do not stop treatment with Vyloy unless you have discussed this with your doctor. Stopping your treatment may stop the effect of the medicine.
If you have any further questions on the use of this medicine, ask your doctor.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Some possible side effects may be serious:
Other possible side effects:
If these side effects become severe, tell your doctor.
Very common (may affect more than 1 in 10 people):
Common (may affect up to 1 in 10 people):
If you get any side effects, talk to your doctor. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
By reporting side effects you can help provide more information on the safety of this medicine.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton and vial label after EXP. The expiry date refers to the last day of that month.
Store in a refrigerator (2°C to 8°C). Do not freeze. Store in the original package in order to protect from light.
Do not store any unused portion of the single-dose vials for reuse. Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
The other ingredients are arginine, phosphoric acid, sucrose, and polysorbate 80.
Vyloy powder for concentrate for solution for infusion is a white to off-white lyophilised powder.
Vyloy is supplied in a carton containing 1 vial.
This leaflet was last revised in 07/2024
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