ENTYVIO 300 mg POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION

Introduction

Package Leaflet: Information for the Patient

Entyvio 300mg powder for concentrate for solution for infusion

vedolizumab

Read all of this leaflet carefully before you start using 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 or nurse.
• If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

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

1. What is Entyvio and what is it used for

What is Entyvio

Entyvio contains the active substance “vedolizumab”. Vedolizumab belongs to a group of biologic medicines called monoclonal antibodies (MAb).

How Entyvio works

Entyvio blocks a protein on the surface of white blood cells (leucocytes) that causes inflammation in ulcerative colitis, Crohn's disease, and pouchitis, so that inflammation is reduced.

What Entyvio is used for

Entyvio is used to treat signs and symptoms in adults with:

• moderate to severe active ulcerative colitis
• moderate to severe active Crohn's disease
• moderate to severe active chronic pouchitis

Ulcerative Colitis

Ulcerative colitis is a disease that causes inflammation of the large intestine. If you have ulcerative colitis, you will first be given other medicines. If you do not respond satisfactorily or cannot tolerate these medicines, your doctor may prescribe Entyvio to reduce the signs and symptoms of the disease.

Crohn's Disease

Crohn's disease is a disease that causes inflammation of the digestive tract. If you have Crohn's disease, you will first be given other medicines. If you do not respond satisfactorily or cannot tolerate these medicines, your doctor may prescribe Entyvio to reduce the signs and symptoms of the disease.

Pouchitis

Pouchitis is a disease that causes inflammation of the lining of the pouch created during surgery to treat ulcerative colitis. If you have pouchitis, you may first be given antibiotics. If you do not respond well enough to antibiotics, your doctor may prescribe Entyvio to reduce the signs and symptoms of the disease.

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

Do not use Entyvio:

• if you are allergic to vedolizumab or any of the other ingredients of this medicine (listed in section 6).
• if you have a severe active infection, such as tuberculosis, sepsis, severe vomiting and diarrhea (gastroenteritis) or infection of the nervous system.

Warnings and precautions

Talk to your doctor or nurse before receiving Entyvio.

Tell your doctor or nurse immediatelywhen you receive this medicine for the first time, during treatment, and between doses:

• if you experience double vision, blurred vision, or loss of vision, difficulty speaking, weakness in an arm or leg, a change in your walking, or balance problems, numbness, decreased or lost sensation, confusion, or memory loss. All these symptoms could correspond to a serious and potentially life-threatening brain complicationknown as progressive multifocal leukoencephalopathy (PML).

• if you have an infection, or think you have an infection - the signs may be shivering, persistent cough, or high fever. Some infections can be severe and even life-threatening if not treated.

• if you experience signs of an allergic reaction or other reactionto the infusion, such as wheezing, difficulty breathing, hives, itching, swelling, or dizziness. These may occur during or after the infusion. For more detailed information, see the section on infusion and allergic reactions in section 4.

• if you are going to receive any vaccineor have recently received one. Entyvio may affect how you respond to a vaccine.

• if you have cancer, tell your doctor. Your doctor will have to decide if it is possible to give you Entyvio.

• if you do not feel any better, as vedolizumab may take up to 14 weeks to work in some patients with very active Crohn's disease.

Children and adolescents

Entyvio is not recommended for use in children and adolescents (under 18 years of age) due to the lack of information on the use of this medicine in this age group.

Other medicines and Entyvio

Tell your doctor or nurse if you are taking, have recently taken, or might take any other medicines.

• Entyvio must not be given with other biologic medicines that suppress the immune system, as the effects that may occur are unknown.

Tell your doctor if you have previously been given:

• natalizumab (a medicine used to treat multiple sclerosis) or
• rituximab (a medicine used to treat certain types of cancer and rheumatoid arthritis).

Your doctor will have to decide if it is possible to give you Entyvio.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before taking this medicine.

Pregnancy

The effects of Entyvio in pregnant women are not known. Therefore, this medicine is not recommended during pregnancy. You and your doctor must decide if the benefit to you is clearly greater than the potential risk to you and your baby.

If you are a woman of childbearing age, it is recommended that you avoid becoming pregnant during treatment with Entyvio. You must use adequate contraceptive methods during treatment and for at least 4.5 months after receiving the last dose.

Breast-feeding

Tell your doctor if you are breast-feeding or plan to breast-feed. Entyvio passes into breast milk. There is not enough information on the effects this may have on your baby and on milk production. A decision must be made whether to discontinue breast-feeding or to discontinue/discontinue Entyvio therapy, taking into account the benefit of breast-feeding for the child and the benefit of therapy for you.

Driving and using machines

The effects of this medicine on the ability to drive and use machines or tools are small. A small number of patients have felt dizzy after receiving Entyvio. If you feel dizzy, do not drive or use tools or machines.

3. How Entyvio is given

How much Entyvio will you be given

Treatment with Entyvio is the same for ulcerative colitis, Crohn's disease, and pouchitis.

The recommended dose is 300 mg of Entyvio, which will be given to you as follows (see table):

Your doctor may decide to change this treatment schedule based on how you respond to treatment with Entyvio.

• Your doctor or nurse will give you the medicine through a drip into one of the veins in your arm (intravenous infusion) over about 30 minutes.
• During the first 2 infusions, your doctor or nurse will closely monitor you during the infusion and for about 2 hours after completing it. For the rest of the infusions (after the first 2), you will be monitored during the infusion and for about 1 hour after completing it.

If you miss or miss a scheduled infusion of Entyvio

If you miss or miss a scheduled infusion, make another appointment as soon as possible.

If you stop treatment with Entyvio

Do not stop using Entyvio without talking to your doctor first.

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

4. Possible side effects

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

Serious side effects

Tell your doctor immediatelyif you notice any of the following symptoms:

• allergic reactions (may affect up to 1 in 100 people) - with signs such as wheezing or difficulty breathing, hives, itching, swelling, feeling unwell, pain at the infusion site, redness of the skin, and
• infections (may affect up to 1 in 10 people) - with signs such as chills or shivering, high fever or rash

Other side effects

Tell your doctor as soon as possibleif you notice any of the following symptoms:

Very common side effects(may affect more than 1 in 10 patients)

• common cold
• joint pain
• headache

Common side effects(may affect up to 1 in 10 patients)

• pneumonia
• bacterial infection of the colon by Clostridium difficile
• fever
• respiratory infection
• changes in liver function, increased liver enzymes (shown in blood tests)
• fatigue
• cough
• flu
• back pain
• sore throat
• sinusitis
• itching/pruritus
• rash and redness
• limb pain
• muscle cramps
• muscle weakness
• throat infection
• stomach flu
• anal infection
• anal pain
• hard stools
• bloating
• gas
• high blood pressure
• numbness or tingling
• heartburn
• hemorrhoids
• stuffy nose
• eczema

• night sweats
• acne (pimples)
• rectal bleeding
• chest discomfort
• shingles

Uncommon side effects(may affect up to 1 in 100 patients)

• redness and sensitivity of hair follicles
• infection of the mouth and throat by yeast
• vaginal infection
• blurred vision (loss of visual acuity)

Rare side effects(may affect up to 1 in 10,000 patients)

• sudden and severe allergic reaction that can cause difficulty breathing, swelling, rapid heartbeat, sweating, low blood pressure, dizziness, loss of consciousness, and fainting (anaphylactic reaction and anaphylactic shock)
• inflammation of the liver (hepatitis). The signs and symptoms of hepatitis may include abnormal liver function tests, yellowing of the eyes or skin (jaundice), pain in the right upper abdomen or bruising

Frequency not known(frequency cannot be estimated from the available data)

• lung disease that causes difficulty breathing (interstitial lung disease)

Reporting of side effects

If you experience any side effects, talk to your doctor or nurse, even if it is possible side effects 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. Storing Entyvio

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 on the label after 'EXP'. The expiry date refers to the last day of the month shown.

Entyvio is given by a doctor or nurse. Patients must not store or handle it.

Entyvio is for single use only.

Closed vial:Store in a refrigerator (between 2°C and 8°C). Keep the vial in the original carton to protect it from light.

Reconstituted and diluted solutions:Use immediately. If this is not possible, the reconstituted solution in the vial can be stored for up to 8 hours between 2°C and 8°C. The diluted solution in a sodium chloride 9 mg/ml (0.9%) solution for injection can be stored for up to 12 hours at a temperature not above 25°C, up to 24 hours in a refrigerator (between 2°C and 8°C), or up to 12 hours at room temperature in the refrigerator (between 2°C and 8°C). The 24-hour period may include up to 8 hours for the reconstituted solution in the vial between 2°C and 8°C and up to 12 hours for the diluted solution in the infusion bag at a temperature between 20°C and 25°C. However, the infusion bag must be stored in the refrigerator (between 2°C and 8°C) for the remainder of the 24-hour period. The time the reconstituted solution is stored in the vial must be subtracted from the time the solution is stored in the infusion bag.

Do not freeze.

Do not use this medicine if you notice particles in the liquid or discoloration (the solution should be clear or slightly opalescent, colorless or with a yellowish tint) before administration.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Container Contents and Additional Information

Composition of Entyvio

• The active substanceis vedolizumab. Each vial contains 300 mg of vedolizumab.
• The other componentsare L-histidine, L-histidine monohydrochloride, L-arginine hydrochloride, sucrose, and polysorbate 80.

Appearance of the Product and Container Contents

• Entyvio is a white or off-white powder for concentrate for solution for infusion, which is provided in a glass vial with a rubber stopper and a plastic cap.
• Each Entyvio container contains one vial.

Marketing Authorization Holder

Takeda Pharma A/S

Delta Park 45

2665 Vallensbaek Strand

Denmark

Manufacturer

Takeda Austria GmbH

St. Peter-Straße 25

A-4020 Linz

Austria

You can request more information about this medicinal product by contacting the local representative of the marketing authorization holder:

Date of Last Revision of this Leaflet: 03/2025

Other Sources of Information

This leaflet is available in a format suitable for blind or partially sighted patients and can be requested from the local representative of the marketing authorization holder.

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

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This information is intended solely for healthcare professionals:

Traceability

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

Instructions for Reconstitution and Infusion

1. Use aseptic technique to prepare the Entyvio solution for intravenous infusion.

1. Remove the easy-open cap from the vial and clean the top with a cotton swab moistened with alcohol. Reconstitute vedolizumab with 4.8 ml of sterile water for injection at room temperature between 20 °C and 25 °C, using a syringe with a 21-25 gauge needle.

1. Insert the needle into the vial through the center of the rubber stopper and direct the liquid towards the vial wall to avoid excessive foam formation.

1. Gently move the vial in circles for at least 15 seconds. Do not shake vigorously or invert.

1. Allow the vial to stand for about 20 minutes at room temperature between 20 °C and 25 °C to allow reconstitution and eliminate any remaining foam; during this time, you can move the vial in circles and check the dissolution. If it has not dissolved completely after 20 minutes, let it stand for another 10 minutes.

1. Prior to dilution, inspect for particles and discoloration in the reconstituted solution. The solution should be clear or opalescent, colorless to pale yellow, and free of visible particles. The reconstituted solution that presents a non-characteristic color or contains particles should not be administered.

1. Once dissolved, gently invert 3 times.

1. Immediately withdraw 5 ml (300 mg) of reconstituted Entyvio using a syringe with a 21-25 gauge needle.

1. Add the 5 ml (300 mg) of reconstituted Entyvio to 250 ml of sodium chloride 9 mg/ml (0.9%) solution for injection and gently mix in the infusion bag (do not withdraw 5 ml of sodium chloride 9 mg/ml (0.9%) solution for injection from the infusion bag before adding Entyvio). Do not add other medicinal products to the prepared infusion solution or to the intravenous infusion equipment. Administer the infusion solution over 30 minutes.

Once reconstituted, the infusion solution should be used as soon as possible.

1 In the case of reconstitution, up to 30 minutes are allowed.

2 This time assumes that the reconstituted solution is immediately diluted in the sodium chloride 9 mg/ml (0.9%) solution for injection and stored only in the infusion bag. The time during which the reconstituted solution is stored in the vial should be subtracted from the time during which the solution can be stored in the infusion bag.

3 This period may include up to 12 hours at 20 °C and 25 °C.

Do not freeze. Do not store unused quantities of the reconstituted solution or the infusion solution for reuse.

Each vial is for single use only.

Disposal of unused medicinal products and all materials that have come into contact with them should be carried out in accordance with local regulations.