Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Vyloy 300 mg powder for concentrate for solution for infusion
⚠ This medicine appears to have been discontinued
The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.
If you were prescribed this medicine, other products containing Zolbetuximab may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
What it is and what it is used for
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 take it
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).
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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. Vyloy contains polysorbate 80 This medicine contains 1.05 mg and 3.15 mg of polysorbate 80 in each 100 mg and 300 mg dose of Vyloy, respectively. Polysorbates may cause allergic reactions. Tell your doctor if you have any known allergies.
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3.
How to take it
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)
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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 it
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 (2oC to 8oC). 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 100 mg powder for concentrate for solution for infusion contains an extractable amount of 100 mg zolbetuximab.
- One vial of 300 mg powder for concentrate for solution for infusion contains an extractable amount of 300 mg zolbetuximab.
- After reconstitution, each ml of solution contains 20 mg of zolbetuximab. The other ingredients are arginine, phosphoric acid, sucrose, and polysorbate 80 (see section 2 "Vyloy contains 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 United Kingdom KT15 2NX
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Manufacturer Astellas Ireland Co. Limited Killorglin Co Kerry V93 FC86 Ireland This leaflet was last revised in 10/2025
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The following information is intended for healthcare professionals only: Traceability In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded. Instructions for preparation and administration Reconstitution in single-dose vial 1. Follow procedures for proper handling and disposal of anticancer drugs. 2. Use appropriate aseptic technique for reconstitution and preparation of dosing solutions. 3. Calculate the recommended dose based on the patient's body surface area to determine the number of vials needed. 4. Reconstitute each vial as follows. If possible, direct the stream of sterile water for injections (SWFI) along the walls of the vial and not directly onto the lyophilised powder: a. 100 mg vial: Slowly add 5.0 mL of SWFI, resulting in 20 mg/mL zolbetuximab. b. 300 mg vial: Slowly add 15.0 mL of SWFI, resulting in 20 mg/mL zolbetuximab. 5. Slowly swirl each vial until the contents are completely dissolved. Allow the reconstituted vial(s) to settle. Visually inspect the solution until the bubbles are gone. Do not shake the vial. 6. Visually inspect the solution for particulate matter and discolouration. The reconstituted solution should be clear to slightly opalescent, colourless to slight yellow and free of visible particles. Discard any vial with visible particles or discolouration. 7. Based upon the calculated dose amount, the reconstituted solution from the vial(s) should be added to the infusion bag immediately. This product does not contain a preservative. Dilution in infusion bag 8. Withdraw the calculated dose amount of reconstituted solution from the vial(s) and transfer into an infusion bag. 9. Dilute zolbetuximab with 0.9% Sodium Chloride Injection. The infusion bag size should allow enough diluent to achieve a final concentration of 2 mg/mL zolbetuximab. The diluted dosing solution of zolbetuximab is compatible with intravenous infusion bags composed of polyethylene (PE), polypropylene (PP), polyvinyl chloride (PVC) with either plasticiser [Di-(2-ethylhexyl) phthalate (DEHP) or Trioctyl trimellitate (TOTM)], ethylene propylene copolymer, ethylene-vinyl acetate (EVA) copolymer, polypropylene and styrene-ethylene-butylene-styrene copolymer, or glass (bottle for administration use), and infusion tubing composed of PE, polyurethane (PU), PVC with either plasticiser [DEHP, TOTM or Di(2-ethylhexyl) terephthalate], polybutadiene (PB), or elastomer modified polypropylene with in-line filter membranes (pore size 0.2 μm) composed of polyethersulfone or polysulfone. 10. Mix diluted solution by gentle inversion. Do not shake the bag. 11. Visually inspect the infusion bag for any particulate matter prior to use. The diluted solution should be free of visible particles. Do not use the infusion bag if particulate matter is observed. 12. Discard any unused portion left in the single-dose vials. Administration 13. Do not co-administer other medicinal products through the same infusion line. 6
14. Immediately administer the infusion over a minimum of 2 hours through an intravenous line. Do not administer as an IV push or bolus. If not administered immediately, the prepared infusion bag should be stored: • under refrigeration at 2°C to 8°C for no longer than 24 hours including infusion time from the end of the preparation of the infusion bag. Do not freeze. • at room temperature (≤30°C) for no longer than 8 hours including infusion time from when the prepared infusion bag is removed from the refrigerator. Do not expose to direct sunlight. Discard unused prepared infusion bags beyond the recommended storage time. No incompatibilities have been observed with closed system transfer device composed of PP, PE, stainless steel, silicone (rubber/oil/resin), polyisoprene, PVC or with plasticiser [TOTM], acrylonitrile-butadiene-styrene (ABS) copolymer, methyl methacrylate-ABS copolymer, thermoplastic elastomer, polytetrafluoroethylene, polycarbonate, polyethersulfone, acrylic copolymer, polybutylene terephthalate, PB, or EVA copolymer. No incompatibilities have been observed with central port composed of silicone rubber, titanium alloy or PVC with plasticiser [TOTM]. In-line filters (pore size of 0.2 μm with materials listed above) are recommended to be used during administration. Disposal Vyloy is for single use only. Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
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Frequently asked questions about Vyloy 300 mg powder for concentrate for solution for infusion
How do I take Vyloy 300 mg powder for concentrate for solution for infusion?
Vyloy 300 mg powder for concentrate for solution for infusion comes as infusion containing 300mg. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
What is the active substance in Vyloy 300 mg powder for concentrate for solution for infusion?
The active substance in Vyloy 300 mg powder for concentrate for solution for infusion is zolbetuximab.
Where does this information come from?
This leaflet reproduces the patient information leaflet approved for Vyloy 300 mg powder for concentrate for solution for infusion, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Can I get Vyloy 300 mg powder for concentrate for solution for infusion without a prescription?
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
About this leaflet
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
- Source: electronic medicines compendium (emc), Datapharm
- Active substance: zolbetuximab
- Official document: view the original leaflet on emc →
⚕For healthcare professionals — Summary of Product Characteristics (SmPC)Full SmPC: dosage, interactions, contraindications, warnings+
4.1. Therapeutic indications
Vyloy, in combination with fluoropyrimidine- and platinum-containing chemotherapy, is indicated for the first-line treatment of adult patients with locally advanced unresectable or metastatic human epidermal growth factor receptor 2 (HER2)-negative gastric or gastro-oesophageal junction (GEJ) adenocarcinoma whose tumours are Claudin (CLDN) 18.2 positive (see section 5.1).
4.2. Posology and method of administration
Treatment with Vyloy should be initiated and supervised by a physician experienced in the use of anticancer therapies.
Posology
Patient selection
Select patients with locally advanced unresectable or metastatic HER2-negative gastric or GEJ adenocarcinoma whose tumours are CLDN18.2 positive (defined as ≥75% of tumour cells demonstrating moderate to strong membranous CLDN18 immunohistochemical staining) as determined by a validated test, for treatment with Vyloy in combination with fluoropyrimidine- and platinum-containing chemotherapy (see section 5.1).
Prior to administration
If a patient is experiencing nausea and/or vomiting prior to administration of Vyloy, the symptoms should be resolved to Grade ≤1 before administering the first infusion.
Recommended pre-treatment
Prior to each infusion of Vyloy, premedicate patients with a combination of antiemetics (e.g., NK-1 receptor blockers and/or 5-HT3 receptor blockers, as well as other medicinal products as indicated), for the prevention of nausea and vomiting (see section 4.4).
Recommended dose
Table 1. Recommended Vyloy dosage based on body surface area
Single loading dose
Maintenance doses
Duration of therapy
800 mg/m2 intravenously,
Cycle 1, Day 1a
Administer Vyloy in combination with fluoropyrimidine- and platinum‑containing chemotherapy
(see section 5.1).b
600 mg/m2 intravenously
every 3 weeks
or
400 mg/m2 intravenously
every 2 weeksc
Administer Vyloy in combination with fluoropyrimidine- and platinum‑containing chemotherapy
(see section 5.1).b
Until disease progression or unacceptable toxicity.
a. The cycle duration of Vyloy is determined based on the respective chemotherapy backbone (see section 5.1).
b. Refer to the fluoropyrimidine- or platinum-containing chemotherapy prescribing information regarding the dosing information for chemotherapy.
c. Based on pharmacokinetic modelling exercise (see section 5.2).
Dose modifications
No dose reduction for Vyloy is recommended. Adverse reactions for Vyloy are managed by infusion rate reduction, interruption, and/or discontinuation as presented in Table 2.
Table 2. Dose modifications for Vyloy
Adverse reaction
Severitya
Dose modification
Hypersensitivity reactions (see section 4.4)
Anaphylactic reaction, suspected anaphylaxis, Grade 3 or 4
Immediately stop the infusion and permanently discontinue.
Grade 2
• Interrupt the infusion until Grade ≤1, then resume at a reduced infusion rate for the remaining infusion.
• For the next infusion, premedicate and administer per the infusion rates in Table 3.
Infusion related reaction (see section 4.4)
Grade 3 or 4
Immediately stop the infusion and permanently discontinue.
Grade 2
• Interrupt the infusion until Grade ≤1, then resume at a reduced infusion rate for the remaining infusion.
• For the next infusion, premedicate and administer per the infusion rates in Table 3.
Nausea (see section 4.4)
Grade 2 or 3
• Interrupt the infusion until Grade ≤1, then resume at a reduced infusion rate for the remaining infusion.
• For the next infusion, administer per the infusion rates in Table 3.
Vomiting (see section 4.4)
Grade 4
Permanently discontinue.
Grade 2 or 3
• Interrupt the infusion until Grade ≤1, then resume at a reduced infusion rate for the remaining infusion.
• For the next infusion, administer per the infusion rates in Table 3.
a. Toxicity was graded per National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.03 (NCI-CTCAE v4.03) where Grade 1 is mild, Grade 2 is moderate, Grade 3 is severe, Grade 4 is life-threatening.
Special populations
Elderly
No dose adjustment is required in patients ≥65 years of age (see section 5.2).
Renal impairment
No dose adjustment is required in patients with mild or moderate renal impairment (see section 5.2). Vyloy has only been evaluated in a limited number of patients with severe renal impairment.
Hepatic impairment
No dose adjustment is required in patients with mild hepatic impairment (see section 5.2). Vyloy has only been evaluated in a limited number of patients with moderate hepatic impairment and has not been evaluated in patients with severe hepatic impairment.
Paediatric population
The safety and efficacy of Vyloy in the paediatric population have not been established.
Method of administration
Vyloy is for intravenous use. The recommended dose is administered by intravenous infusion over a minimum of 2 hours. Vyloy must not be administered as an intravenous push or bolus injection.
If Vyloy and fluoropyrimidine- and platinum-containing chemotherapy are administered on the same day, Vyloy must be administered first.
To help minimise potential adverse reactions, it is recommended that each infusion should be started at a slower rate than the initially calculated rate for the entire infusion, and gradually increased as tolerated during the course of the infusion (see Table 3).
If the infusion time exceeds the recommended storage time at room temperature (8 hours from end of preparation of infusion solution), the infusion bag must be discarded and a new infusion bag prepared to continue the infusion (see section 6.3 for recommended storage times).
Table 3. Infusion rates recommended for each Vyloy infusion
Vyloy dose
Infusion Rate
First 30-60 minutes
Remaining infusion timeb
Single loading dose
(Cycle 1, Day 1)a
800 mg/m2
100 mg/m2/hr
200-400 mg/m2/hr
Maintenance doses
600 mg/m2 every 3 weeks
or
400 mg/m2 every 2 weeks
75 mg/m2/hr
or
50 mg/m2/hr
150-300 mg/m2/hr
or
100-200 mg/m2/hr
a. The cycle duration of Vyloy is determined based on the respective chemotherapy backbone (see section 5.1).
b. In the absence of adverse reactions after 30-60 minutes, the infusion rate can be increased as tolerated.
For instructions on reconstitution and dilution of the medicinal product before administration, see section 6.6.
4.3. Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
4.4. Special warnings and precautions for use
Traceability
In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded.
Hypersensitivity reactions
Hypersensitivity reactions in patients treated with Vyloy in combination with fluoropyrimidine and platinum-containing chemotherapy during clinical studies were characterised by anaphylactic reactions and drug hypersensitivity (see section 4.8).
Monitor patients during and after infusion with Vyloy (at least 2 hours, or longer if clinically indicated) for hypersensitivity reactions with symptoms and signs that are highly suggestive of anaphylaxis (urticaria, repetitive cough, wheeze and throat tightness/change in voice).
If an anaphylactic reaction occurs, administration of Vyloy should be immediately and permanently discontinued and appropriate medical therapy administered.
For any Grade 3 or 4 hypersensitivity reaction or hypersensitivity reaction with features of anaphylaxis, administration of Vyloy should be immediately and permanently discontinued and appropriate medical therapy instituted based on the type of reaction.
For any Grade 2 hypersensitivity reaction, interrupt the Vyloy infusion until Grade ≤1, then resume the infusion at a reduced infusion rate for the remaining infusion. Pre-medicate the patient with antihistamines for the next infusion, administer per the infusion rates in Table 3, and closely monitor the patient for symptoms and signs of a hypersensitivity reaction. The infusion rate may be gradually increased as tolerated (see section 4.2).
Infusion-related reaction
Infusion-related reaction (IRR) has occurred during clinical studies with Vyloy in combination with fluoropyrimidine and platinum-containing chemotherapy (see section 4.8).
Monitor patients for signs and symptoms of infusion-related reaction including nausea, vomiting, abdominal pain, salivary hypersecretion, pyrexia, chest discomfort, chills, back pain, cough and hypertension. These signs and symptoms are usually reversible with the interruption of the infusion.
For Grade 3 or 4 IRRs, administration of Vyloy should be immediately and permanently discontinued and appropriate medical therapy instituted.
For Grade 2 IRRs, interrupt the Vyloy infusion until Grade ≤1, then resume the infusion at a reduced infusion rate for the remaining infusion. Pre-medicate the patient with antihistamines for the next infusion, administer per the infusion rates in Table 3, and closely monitor the patient for symptoms and signs of an IRR. The infusion rate may be gradually increased as tolerated (see section 4.2).
Nausea and vomiting
During clinical studies, nausea and vomiting were the most frequently observed gastrointestinal adverse reactions with Vyloy in combination with fluoropyrimidine and platinum-containing chemotherapy treatment (see section 4.8).
Nausea and vomiting occurred more often during the first cycle of treatment but decreased in incidence with subsequent cycles of treatment.
To prevent nausea and vomiting, pre-treatment with antiemetics is recommended prior to each infusion of Vyloy (see section 4.2).
During and after infusion, patients should be monitored and managed using standard of care, including antiemetics or fluid replacement, as clinically indicated.
For Grade 4 vomiting, permanently discontinue treatment with Vyloy.
For Grade 2 or 3 nausea or vomiting, interrupt the Vyloy infusion until Grade ≤1, then resume at a reduced infusion rate for the remaining infusion. For the next infusion, administer per the infusion rates in Table 3, and closely monitor the patient for symptoms and signs of nausea or vomiting. The infusion rate may be gradually increased as tolerated (see section 4.2).
Excipient information
This medicinal product contains 1.05 mg and 3.15 mg of polysorbate 80 in each 100 mg and 300 mg vial, respectively. Polysorbates may cause allergic reactions.
4.5. Interaction with other medicinal products and other forms of interaction
No in vitro or in vivo drug-drug interaction or transporter studies have been conducted (see section 5.2).
4.6. Fertility, pregnancy and lactation
Pregnancy
There are no data on the use of zolbetuximab in pregnant women. No adverse effects were observed in an animal reproductive and developmental study with intravenous administration of zolbetuximab to pregnant mice during organogenesis. Based on AUC, the doses administered in this study were up to approximately 1.8 times higher than human exposure at the recommended therapeutic dose of 600 mg/m2 (see section 5.3). Vyloy should only be given to a pregnant woman if the benefit outweighs the potential risk.
Breastfeeding
There are no data on the presence of zolbetuximab in human milk, the effects on the breastfed child, or the effects on milk production. Because many drugs, including antibodies are excreted in human milk and because of the potential for serious adverse reactions in a breastfed child, breastfeeding is not recommended during treatment with Vyloy.
Fertility
Studies to evaluate the effect of zolbetuximab on fertility have not been performed. Thus, the effect of Vyloy on male and female fertility is unknown.
4.7. Effects on ability to drive and use machines
No studies with Vyloy and the effects on the ability to drive or use machines have been performed. Based on reported adverse reactions, Vyloy may influence the ability to drive and use machines. Caution should be exercised when driving or operating machines.
4.8. Undesirable effects
Summary of the safety profile
The safety of Vyloy was evaluated in the integrated safety population from two phase 2 studies (FAST, ILUSTRO) and two phase 3 studies (SPOTLIGHT, GLOW) in 631 patients who received at least one dose of Vyloy 800 mg/m2 as a loading dose followed by 600 mg/m2 maintenance doses every 3 weeks in combination with fluoropyrimidine and platinum-containing chemotherapy. The median duration of exposure to zolbetuximab was 174 days (range: 1 to 1791 days).
Serious adverse events occurred in 45% of patients treated with Vyloy and/or fluoropyrimidine and platinum‑containing chemotherapy. The most common serious adverse reactions (≥2%) were vomiting (6.8%) and nausea (4.9%).
Thirty-seven percent of patients permanently discontinued Vyloy and/or fluoropyrimidine and platinum‑containing chemotherapy for adverse events; the most common adverse reactions (≥2%) leading to dose discontinuation were vomiting (5.4%) and nausea (4.3%).
Adverse events leading to dose interruption of Vyloy and/or fluoropyrimidine and platinum‑containing chemotherapy occurred in 73% of patients; the most common adverse reactions (≥2%) leading to dose interruption were vomiting (29.3%), nausea (28.4%) and decreased appetite (3.6%).
The most common adverse reactions (≥2%) leading to dose rate reduction of the Vyloy and/or fluoropyrimidine and platinum-containing chemotherapy infusion were nausea (9.7%) and vomiting (7.8%).
Tabulated list of adverse reactions
Adverse reactions observed during clinical studies are listed in this section by frequency category. Frequency categories are defined as follows: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000); not known (cannot be estimated from the available data). Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
Table 4. Adverse reactions
Immune system disorders
Common
Drug hypersensitivity
Uncommon
Anaphylactic reaction
Metabolism and nutrition disorders
Very common
Hypoalbuminemia, decreased appetite
Gastrointestinal disorders
Very common
Vomiting, nausea, abdominal pain upper
Common
Salivary hypersecretion
General disorders and administration site conditions
Very common
Oedema peripheral
Common
Malaise
Investigations
Very common
Weight decreased
Injury, poisoning and procedural complications
Common
Infusion related reaction
Description of selected adverse reactions
Hypersensitivity reactions
In the integrated safety analysis, all grade anaphylactic reaction and drug hypersensitivity occurred in the Vyloy in combination with fluoropyrimidine and platinum‑containing chemotherapy arm [0.5% (3/631), 1.6% (10/631)] compared with the placebo in combination with fluoropyrimidine and platinum-containing chemotherapy arm [0.8% (5/611), 1.6% (10/611)]. Severe (Grade 3) anaphylactic reaction and drug hypersensitivity occurred at a similar frequency in the Vyloy in combination with fluoropyrimidine and platinum-containing chemotherapy arm [0.5% (3/631), 0.2% (1/631)] compared with the placebo in combination with fluoropyrimidine and platinum-containing chemotherapy arm [0.3% (2/611), 0.2% (1/611)]. The median time to first onset of anaphylactic reaction or drug hypersensitivity with Vyloy and/or fluoropyrimidine and platinum-containing chemotherapy was 22 days or 113 days, respectively.
Three patients (0.5%) permanently discontinued Vyloy and/or fluoropyrimidine and platinum‑containing chemotherapy due to anaphylactic reaction. Dose interruption of Vyloy and/or fluoropyrimidine and platinum‑containing chemotherapy was experienced due to drug hypersensitivity in six patients (1.0%). The infusion rate was reduced for Vyloy and/or fluoropyrimidine and platinum‑containing chemotherapy in one patient (0.2%) due to drug hypersensitivity.
Infusion related reaction
In the integrated safety analysis, all grade IRR occurred in the Vyloy in combination with fluoropyrimidine and platinum-containing chemotherapy arm at 3.2% (20/631) compared with the placebo in combination with fluoropyrimidine and platinum-containing chemotherapy arm at 1.1% (7/611). Severe (Grade 3) IRRs occurred more frequently in the Vyloy in combination with fluoropyrimidine and platinum-containing chemotherapy arm [0.5% (3/631)] compared with the placebo in combination with fluoropyrimidine and platinum-containing chemotherapy arm [0% (0/611)]. The median time to first onset of infusion-related reaction with Vyloy in combination with fluoropyrimidine and platinum-containing chemotherapy was 22 days.
An IRR led to permanent discontinuation of Vyloy and/or fluoropyrimidine and platinum‑containing chemotherapy in 4 (0.6%) patients and dose interruption in 10 (1.6%) patients. The infusion rate was reduced for Vyloy and/or fluoropyrimidine and platinum‑containing chemotherapy in 2 patients (0.3%) due to an IRR.
Nausea and vomiting
In the integrated safety analysis, all grade nausea and vomiting occurred more frequently in the Vyloy in combination with fluoropyrimidine and platinum-containing chemotherapy arm [77.2% (487/631), 66.9% (422/631)] compared with the placebo in combination with fluoropyrimidine and platinum‑containing chemotherapy arm [58.9% (360/611), 36.8% (225/611)]. Severe (Grade 3) nausea and vomiting in the Vyloy in combination with fluoropyrimidine and platinum‑containing chemotherapy and placebo in combination with fluoropyrimidine and platinum-containing chemotherapy arms occurred at the following frequencies: nausea [11.6% (73/631) and 4.7% (29/611)] and vomiting [13.6% (86/631) and 4.7% (29/611)]. The median time to first onset of nausea or vomiting with Vyloy in combination with fluoropyrimidine and platinum-containing chemotherapy was 1 day or 1 day, respectively.
Nausea led to permanent discontinuation of Vyloy and/or fluoropyrimidine and platinum‑containing chemotherapy in 27 (4.3%) patients and dose interruption in 179 (28.4%) patients. Vomiting led to permanent discontinuation of Vyloy and/or fluoropyrimidine and platinum‑containing chemotherapy in 34 (5.4%) patients and dose interruption in 185 (29.3%) patients. The infusion rate was reduced for Vyloy and/or fluoropyrimidine and platinum-containing chemotherapy in 61 patients (9.7%) due to nausea and in 49 patients (7.8%) due to vomiting.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions 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.
4.9. Overdose
In case of overdose, the patient should be closely monitored for adverse reactions, and supportive treatment should be administered, as appropriate.
🇷🇴 Known in Romania as
Medicines sold in Romania with the same active substance: Cunoscut în România ca
- VYLOY 100 mg prescriptionZOLBETUXIMABUM · injection / infusion
- VYLOY 300 mg prescriptionZOLBETUXIMABUM · injection / infusion
Same active substance. The strength, the form and whether you need a prescription can differ. Always ask a pharmacist before you switch. Romanian medicines in the UK →
🇵🇱 Known in Poland as
Medicines sold in Poland with the same active substance: W Polsce znany jako
- VyloyZolbetuximab · injection / infusion
Same active substance. The strength, the form and whether you need a prescription can differ. Always ask a pharmacist before you switch. Polish medicines in the UK →
💬 Ask about this leaflet
Ask anything about Vyloy 300 mg powder for concentrate for solution for infusion. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.
Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.