VYLOY 100 mg POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION

Introduction

Package Leaflet: Information for the Patient

Vyloy 100mg powder for concentrate for solution for infusionVyloy 300mgpowder for concentrate for solution for infusion

zolbetuximab

This medicinal product is subject to additional monitoring, which will allow for quick identification of new safety information. You can help by reporting any side effects you may get. The last section of this leaflet includes information on how to report side effects.

Read all of this leaflet carefully before this medicine is administered to you 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 experience any side effects, talk to your doctor, even if they are not listed in this leaflet. See section 4.

Contents of the pack

1. What is Vyloy and what is it used for
2. What you need to know before you are given Vyloy
3. How Vyloy is administered
4. Possible side effects
5. Storage of Vyloy
6. Contents of the pack and further information

1. What is Vyloy and what is it used for

Vyloy contains the active substance zolbetuximab, which is a monoclonal antibody that can recognize and bind to certain cancer cells. By binding to these cancer cells, the medicine makes the immune system fight and eliminate them.

This medicine is used to treat adults with stomach cancer (gastric) or cancer of the gastroesophageal junction. The gastroesophageal junction is the place where the esophagus (throat) and stomach meet.

This medicine is given to patients whose tumors are positive for the protein Claudin18.2 (CLDN18.2)(meaning that the protein is produced in the cells) and negative for the proteins of the "Human Epidermal Growth Factor Receptor 2 (HER2)" (meaning that only small amounts of the protein or none are produced). It is given to patients whose gastric cancer or gastroesophageal junction cancer cannot be removed by surgery or has spread to other parts of the body.

This medicine is given in combination with other cancer medicines that contain fluoropyrimidine and/or platinum. It is important that you also read the package leaflets of the other medicines. If you have any questions about these medicines, ask your doctor.

2. What you need to know before you are given Vyloy

Vyloy must not be given to you

• 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 this medicine because it can cause:

• Allergic reactions (hypersensitivity), including anaphylaxis.Serious allergic reactions can occur during or after receiving the infusion. Tell your doctor or get medical attention immediately if you have any of the following symptoms of a serious allergic reaction:

• itching, pink swollen or red skin areas (hives),
• persistent cough,
• breathing problems such as wheezing or
• feeling of pressure in the throat/changes in the voice

• Infusion-related reactions.Serious infusion-related reactions can occur during or after receiving the infusion. Tell your doctor or get medical attention immediately if you have any of the following symptoms of an infusion-related reaction:

• nausea,
• vomiting,
• stomach pain,
• increased saliva production (hypersalivation),
• fever,
• chest discomfort,
• chills or shivering,
• back pain,
• cough or
• high blood pressure (hypertension)

• Nausea and vomiting.Tell your doctor if you feel unwell before starting the infusion. Nausea and vomiting are very common during treatment and can sometimes be severe. Your doctor may give you another medicine before each infusion to help relieve nausea and vomiting.

Tell your doctor immediatelyif you have any of these signs or symptoms or if they get worse. Your doctor may:

• give you other medicines to reduce your symptoms or prevent complications,
• slow down the infusion rate or
• stop your treatment for a while or completely.

Children and adolescents

The use of Vyloy in children and adolescents is not appropriate because it has not been studied in this age group for the treatment of stomach cancer (gastric) or cancer of the gastroesophageal junction.

Other medicines and Vyloy

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

Pregnancy

You should not use Vyloy if you are pregnant, unless your doctor has explicitly recommended it. It is not known whether this medicine will harm the baby. If you are pregnant, think you may be pregnant, or plan to become pregnant, consult your doctor before using this medicine.

Breast-feeding

Breast-feeding is not recommended during treatment with Vyloy. It is not known whether this medicine passes into breast milk. Tell your doctor if you are breast-feeding or plan to breast-feed.

Driving and using machines

Vyloy is unlikely to affect your ability to drive or use machines.

Vyloy contains polysorbate 80

This medicine contains 1.05 mg and 3.15 mg of polysorbate 80 per 100 mg and 300 mg dose of Vyloy, respectively. Polysorbates can cause allergic reactions. Tell your doctor if you have any known allergy.

The Vyloy infusion contains sodium

This medicine does not contain sodium; however, a saline solution is used for dilution of this product before infusion. Talk to your doctor if you are on a low-salt diet.

3. How Vyloy is administered

You will be given Vyloy in a hospital or clinic, under the supervision of a doctor with experience in cancer treatment. This medicine will be given to you into a vein, through an intravenous infusion (drip) over at least 2 hours.

How much Vyloy you will be given

Your doctor will decide the amount of this medicine you will be given. You will usually receive this medicine every 2 or 3 weeks, depending on the other cancer medicines chosen by your doctor. Your doctor will decide how many infusions you need.

If you miss a dose of Vyloy

It is very important that you do not miss any dose of this medicine. If you miss an appointment, contact your doctor to reschedule the appointment as soon as possible.

If you stop treatment with Vyloy

Do notstop treatment with this medicine unless you have discussed it with your doctor. Stopping treatment may stop the effect of the medicine.

If you have any other questions about 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 of the possible side effects can be serious:

• Hypersensitivity reactions (allergic reactions) (including hypersensitivity and anaphylactic reaction) – frequent(may affect up to 1 in 10 people). Tell your doctor or get medical attention immediately if you have any of these symptoms of a serious allergic reaction: itching, pink swollen or red skin areas (hives), persistent cough, breathing problems such as wheezing or feeling of pressure in the throat/changes in the voice.

• Infusion-related reaction – frequent(may affect up to 1 in 10 people). Tell your doctor or get medical attention immediately if you have any of these symptoms of an infusion-related reaction: nausea, vomiting, stomach pain, increased saliva production (hypersalivation), fever, chest discomfort, chills or shivering, back pain, cough or high blood pressure (hypertension).

• Nausea and vomiting – very frequent(may affect more than 1 in 10 people). Tell your doctor if these symptoms do not go away or get worse.

Other possible side effects:

Talk to your doctor if these side effects become serious.

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

• decreased appetite
• low white blood cell count
• low albumin levels in the blood (hypoalbuminemia)
• swelling of the lower parts of the legs or hands (peripheral edema)
• weight loss
• fever (pyrexia)

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

• indigestion (dyspepsia)

• increased saliva production (hypersalivation)
• high blood pressure (hypertension)
• chills

Reporting of side effects

If you experience any side effects, talk to your doctor, even if they are not listed in this leaflet. You can also report side effects directly through the national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Vyloy

Your doctor, pharmacist, or nurse is responsible for storing this medicine and disposing of any unused product correctly. This information is intended only for healthcare professionals.

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 label of the vial after EXP. The expiry date is the last day of the month shown.

Store in a refrigerator (between 2°C and 8°C). Do not freeze. Keep in the original packaging to protect from light.

Do not store any leftover contents of the single-dose vials for reuse. Disposal of unused medicine and all materials that have come into contact with it should be done according to local regulations.

6. Container contents and additional information

Vyloy composition

• The active ingredient is zolbetuximab.
• A 100 mg vial of powder for concentrate for solution for infusion contains 100 mg of zolbetuximab.

• A 300 mg vial of powder for concentrate for solution for infusion contains 300 mg of zolbetuximab.
• After reconstitution, each ml of solution contains 20 mg of zolbetuximab.

• The other components are arginine, phosphoric acid (E 338), sucrose, and polysorbate 80 (E 433) (see section 2 "Vyloy contains polysorbate 80").

Appearance and container contents of the product

Vyloy powder for concentrate for solution for infusion is a white to off-white lyophilized powder.

Vyloy is supplied in a carton containing 1 or 3 glass vials.

Not all pack sizes may be marketed.

Marketing authorisation holder

Astellas Pharma Europe B.V.

Sylviusweg 62

2333 BE Leiden

Netherlands

Manufacturer

Astellas Ireland Co. Limited

Killorglin

Co Kerry

V93 FC86

Ireland

For further information on this medicinal product, please contact the local representative of the marketing authorisation holder:

Date of last revision of this prospectus: MM/YYYY

Other sources of information

Detailed information on this medicinal product is available on the European Medicines Agency website: https://www.ema.europa.eu.

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This information is intended only for healthcare professionals:

Traceability

In order to improve the traceability of biological medicinal products, the name and batch number of the administered product should be clearly recorded.

Instructions for preparation and administration

Reconstitution in a single-dose vial

• Follow the procedures for the proper handling and disposal of anticancer medications.
• Use the appropriate aseptic technique for reconstitution and preparation of solutions.
• Calculate the recommended dose based on the patient's body surface area to determine the number of vials needed.
• Reconstitute each vial as follows. If possible, direct the flow of sterile water for injection (SWFI) towards the vial walls and not directly onto the lyophilized powder:

1. 100 mg vial: slowly add 5 ml of SWFI to obtain 20 mg/ml of zolbetuximab.
2. 300 mg vial: slowly add 15 ml of SWFI to obtain 20 mg/ml of zolbetuximab.

• Slowly rotate each vial until the contents are completely dissolved. Allow the reconstituted vials to settle. Visually inspect the solution until the bubbles disappear. Do not shake the vials.
• Visually inspect the solution for particulate matter or discoloration. The reconstituted solution should be clear to slightly opalescent, colorless to slightly yellow, and free of visible particles. Discard any vial with visible particles or discoloration.
• The reconstituted solution from the vials, based on the calculated dose, should be added to the infusion bag immediately. This product does not contain preservatives.

Dilution in infusion bag

• Remove the calculated dose of reconstituted solution from the vials and transfer it to an infusion bag.
• Dilute with a 9 mg/ml (0.9%) sodium chloride solution for infusion. The size of the infusion bag should allow sufficient diluent to achieve a final concentration of 2 mg/ml of zolbetuximab.

The diluted zolbetuximab solution for administration is compatible with intravenous infusion bags made of polyethylene (PE), polypropylene (PP), polyvinyl chloride (PVC) with plasticizer [di-(2-ethylhexyl) phthalate (DEHP) or trioctyl trimellitate (TOTM)], ethylene propylene copolymer, ethylene vinyl acetate copolymer (EVA), PP and styrene-ethylene-butylene-styrene copolymer, or glass (administration vial) and infusion lines made of PE, polyurethane (PU), PVC with plasticizer [DEHP, TOTM, or di-(2-ethylhexyl) terephthalate], polybutadiene (PB), or PP modified with elastomer with in-line filters (pore size 0.2 μm) made of polyethersulfone (PES) or polysulfone.

• Mix the diluted solution by gently inverting. Do not shake the bag.
• Visually inspect the infusion bag for particulate matter before use. The diluted solution should not contain visible particles. Do not use the infusion bag if particulate matter is observed.
• Discard any unused contents of the single-dose vials.

Administration

• Do not administer other medications simultaneously through the same infusion line.
• Administer the infusion immediately over at least 2 hours via an intravenous route. Do not administer as a rapid infusion or intravenous bolus.

No incompatibilities have been observed with closed drug transfer devices made of PP, PE, stainless steel, silicone (rubber/oil/resin), polyisoprene, PVC, or plasticizer [TOTM], acrylonitrile-butadiene-styrene copolymer (ABS), methyl methacrylate and ABS copolymer, thermoplastic elastomer, polytetrafluoroethylene, polycarbonate, PES, acrylic copolymer, polybutylene terephthalate, PB, or EVA copolymer.

No incompatibilities have been observed with the central port made of silicone rubber, titanium alloy, or PVC with plasticizer [TOTM].

• During administration, it is recommended to use in-line filters (pore size 0.2 μm with the materials listed above).

Disposal

Vyloy is for single use.

Disposal of unused medicinal product and all materials that have come into contact with it should be done in accordance with local regulations.