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Vyloy 100 mg powder for concentrate for solution for infusion {equilateral_black_triangle}

Active Ingredient:
zolbetuximab
Company:  
Astellas Pharma Ltd See contact details
ATC code: 
L01FX31
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About Medicine
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Prescription only medicine
Healthcare Professionals (SmPC) Patient Leaflet (PIL) HCP Med Info
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The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine.
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Last updated on emc: 16 Aug 2024

{equilateral_black_triangle} This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information.

{pdf} View or print the patient leaflet as PDF

Below is a text only representation of the Patient Information Leaflet (ePIL).

The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on {phone} 0800 198 5000. The product code(s) for this leaflet is: PLGB 00166/0439.

{printer} Print patient leaflet as text only

Vyloy 100 mg powder for concentrate for solution for infusion - PIL

Package leaflet: Information for the patient

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.

Read all of this leaflet carefully before you are given this medicine because it contains important information for you.
  • Keep this leaflet. You may need to read it again.
  • If you have any further questions, ask your doctor.
  • If you get any side effects, talk to your doctor. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

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

1. What Vyloy is and what it is used for

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.

2. What you need to know before you are given Vyloy
You must not be given Vyloy
  • if you are allergic to zolbetuximab or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Talk to your doctor before you are given Vyloy as it may cause:

  • Allergic (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 reaction. 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 experiencing nausea and/or vomiting. Nausea (feeling sick) and vomiting (being sick) 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.

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.

Children and adolescents

This medicine should not be used in children and adolescents below 18 years of age.

Other medicines and Vyloy

Tell your doctor if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription.

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.

Breastfeeding
  • Breastfeeding is not recommended during treatment with Vyloy.
  • Tell your doctor if you are breastfeeding or plan to breastfeed.
  • It is not known if Vyloy passes into your breast milk.

Driving and using machines

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.

3. How Vyloy is given

You will receive Vyloy in a hospital or clinic under the supervision of a doctor experienced in cancer treatment.

How much Vyloy you will receive

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.

How you will receive Vyloy

Vyloy will be given to you by intravenous infusion into your vein over at least 2 hours.

If you miss a dose of Vyloy

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.

If you have any further questions on the use of this medicine, ask your doctor.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Some possible side effects may be serious:

  • Hypersensitivity (allergic) reactions (including hypersensitivity and anaphylactic reaction). 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 (may affect up to 1 in 10 people).
  • Infusion related reaction. 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, or high blood pressure (hypertension) (may affect up to 1 in 10 people).
  • Nausea and vomiting. Tell your doctor if these symptoms do not go away or become worse (may affect more than 1 in 10 people).

Other possible side effects:

If these side effects become severe, tell your doctor.

Very common (may affect more than 1 in 10 people):

  • decreased appetite
  • pain in the upper abdomen
  • decreased weight
  • low levels of albumin in the blood (hypoalbuminaemia)
  • swelling of the lower legs or hands (oedema peripheral)

Common (may affect up to 1 in 10 people):

  • increased saliva (salivary hypersecretion)
  • generally feeling unwell

Reporting of side effects

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.

5. How to store Vyloy

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.

6. Contents of the pack and other information
What Vyloy contains
  • The active substance is zolbetuximab.
  • One vial of powder for concentrate for solution for infusion contains an extractable amount of 100 mg zolbetuximab.
  • After reconstitution, each ml of solution contains 20 mg of zolbetuximab.

The other ingredients are arginine, phosphoric acid, sucrose, and polysorbate 80.

What Vyloy looks like and contents of the pack

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.

Marketing Authorisation Holder
Astellas Pharma Ltd.
300 Dashwood Lang Road
Bourne Business Park
Addlestone
KT15 2NX
United Kingdom

Manufacturer
Astellas Ireland Co. Limited
Killorglin
Co Kerry
V93 FC86
Ireland

This leaflet was last revised in 07/2024

Astellas Pharma Ltd
Company image
Address
300 Dashwood Lang Road, Bourne Business Park, Addlestone, KT15 2NX, UK
Telephone
+44 (0) 203 379 8700
Medical Information Direct Line
0800 783 5018
Medical Information e-mail
[email protected]
Stock Availability
+44 (0) 203 379 8721