Entyvio 300 mg polvo para concentrado para solucion para perfusion

Patient Information Leaflet

Entyvio 300 mg powder for concentrate for solution for infusion

vedolizumab

Read this leaflet carefully before you start using this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or nurse.
• If you experience any side effects, ask your doctor or nurse, even if they are not listed in this leaflet. See section4.

1.What Entyvio is and what it is used for

2.What you need to know before you receive Entyvio

3.How you will receive Entyvio

4.Possible side effects

5.Storage of Entyvio

6. Contents of the pack and additional information.

What is Entyvio

Entyvio contains the active ingredient “vedolizumab”. Vedolizumab belongs to a group of biologic medications known as monoclonal antibodies (mAbs).

How Entyvio works

Entyvio blocks a protein on the surface of white blood cells (leukocytes) that causes inflammation in ulcerative colitis, Crohn's disease, and pyelonephritis, thereby reducing inflammation.

What Entyvio is indicated for

Entyvio is used to treat symptoms in adults with:

• moderate to severe active ulcerative colitis
• moderate to severe active Crohn's disease
• moderate to severe active pyelonephritis

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 medications. If you do not respond satisfactorily or cannot tolerate these medications, your doctor may prescribe Entyvio to reduce the symptoms of the disease.

Crohn's Disease

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

Pyelonephritis

Pyelonephritis is a disease that causes inflammation of the lining of the reservoir created during surgery to treat ulcerative colitis. If you have pyelonephritis, you may first be given antibiotics. If you do not respond sufficiently to antibiotics, your doctor may prescribe Entyvio to reduce the symptoms of the disease.

Do not use Entyvio:

• if you are allergic to vedolizumab or any of the other components of this medication (listed in section6).
• if you have an active severe infection, for example, tuberculosis, septicemia, severe vomiting and diarrhea (gastroenteritis) or central nervous system infection.

Warnings and precautions

Consult your doctor or nurse before receiving Entyvio.

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

• if you experience double vision, blurred vision or loss of vision, difficulty speaking, weakness in one arm or leg, a change in your gait or balance problems, persistent numbness, decreased or loss of sensitivity, confusion or memory loss. These symptoms may correspond to aserious and potentially life-threatening brain complication known as multifocal progressive leukoencephalopathy (LMP).

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

• if you experience signs ofan allergic reaction or otherreactionto theinfusion,such as hissing, difficulty breathing, wheezing, 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 section4.

• if you are to receive anyvaccineor have received one recently.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 administer Entyvio.

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

Children and adolescents

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

Other medications and Entyvio

Inform your doctor or nurse if you are taking, have taken recently or may need to take any other medication.

• Entyvio should not be administered with other biologic immunosuppressive medications, as the effects that may occur are unknown.

Inform your doctor if you have previously been administered:

• natalizumab (a medication indicated for treating multiple sclerosis) or
• rituximab (a medication indicated for treating certain types of cancer and rheumatoid arthritis).

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

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor before using this medication.

Pregnancy

The effects of Entyvio on pregnant women are unknown. Therefore, it is not recommended to use this medication during pregnancy. You and your doctor must decide if the benefit for you is clearly greater than the potential risk to you and your baby.

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

Breastfeeding

Inform your doctor if you are breastfeeding or intend to be. Entyvio passes into breast milk. There is not enough information about the effects this may have on your baby and milk production. It will be necessary to decide whether to interrupt breastfeeding or the Entyvio treatment, for which an evaluation of the benefits of breastfeeding for your baby and the benefits of treatment for you will be required.

Driving and operating machinery

The effects of this medication on the ability to drive and operate machinery or tools are small. A reduced number ofpatients have felt dizzy after receiving Entyvio. If you feel dizzy, do not drive or use tools or machinery.

How Much Entyvio Will Be Administered

The treatment with Entyvio is the same for ulcerative colitis, Crohn's disease, and sclerosing cholangitis.

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

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

• Your doctor or nurse will administer the medication through an intravenous infusion system with a drip in one of the veins of your arm (intravenous infusion) for about 30 minutes.
• In the first 2 infusions, your doctor or nurse will closely monitor you during the infusion and approximately 2 hours after completing it. For the rest of the infusions (after the first 2), you will be monitored during the infusion and approximately 1 hour after completing it.

What to Do If You Forget or Miss a Treatment Appointment for Entyvio

If you forget or miss a treatment appointment to receive the infusion, schedule another appointment as soon as possible.

What to Do If You Interrupt Entyvio Treatment

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

If you have any other questions about using this medication, ask your doctor or nurse.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Severe side effects

Inform your doctorimmediatelyif you notice any of the following symptoms:

• allergic reactions (can affect 1 in 100 people) – with signs such as: hissing or difficulty breathing, hoarseness, skin itching, swelling, feeling unwell, pain at the infusion site, skin redness, and
• infections (can affect 1 in 10 people) – with signs such as: chills or tremors, high fever or rashes

Other side effects

Inform your doctoras soon as possibleif you notice any of the following symptoms:

Frequent side effects(can affect more than 1 in 10 patients)

• common cold
• joint pain
• headache

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

• bronchitis
• intestinal bacterial infection byClostridium difficile
• fever
• respiratory infection
• liver function changes, increased liver enzymes (shown in blood tests)
• fatigue
• cough
• flu
• back pain
• throat pain
• sinusitis
• itching/ pruritus
• eruption and redness
• limb pain
• muscle cramps
• muscle weakness
• throat infection
• stomach flu
• anal infection
• anal pain
• hard stools
• swollen stomach
• flatulence
• high blood pressure
• numbness or tingling
• heartburn
• hemorrhoids
• stuffy nose
• eczema

• nocturnal sweating
• acne (pimples)
• rectal bleeding
• chest discomfort
• herpes zoster

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

• redness and sensitivity of hair follicles
• oral and throat infection by fungi
• vaginal infection
• blurred vision (loss of visual acuity)

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

• sudden and severe allergic reaction that can cause difficulty breathing, inflammation, rapid heart rate, sweating, low blood pressure, dizziness, loss of consciousness, and fainting (anaphylactic reaction and anaphylactic shock)
• liver inflammation (hepatitis). Signs and symptoms of hepatitis may include abnormal liver function tests, yellowing of the eyes or skin (jaundice), pain in the right upper abdominal area or cardinals

Unknown frequency(frequency cannot be estimated from available data)

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

Reporting side effects

If you experience any type of side effect, consult your doctor or nurse,even if it is a possible side effect that does not appear in this leaflet.You can also report them directly through thenational notification system included in theAppendix V. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the reach and sight of children.

Do not use this medication after the expiration date that appears on the carton and on the label, after "CAD." The expiration date is the last day of the month indicated.

Entyvio is administered by a doctor or nurse. Patients should not store or handle it.

Entyvio is for single use only.

Sealed vial:Store in the refrigerator (between 2°C and 8°C).Store 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 room temperature equal to or below 25°C, for up to 24 hours in the refrigerator (between 2°C and 8°C), or for 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 in the case of the reconstituted solution in the vial between 2°C and 8°C and up to 12 hours in the case of the diluted solution in the infusion bag at a temperature between 20°C and 25°C.However, the infusion bag should 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 maintained in the vial should be subtracted from the time the solution is maintained in the infusion bag.

Do not freeze.

Do not use this medication if you observe the presence of particles in the liquid or discoloration (the solution should be transparent or opalescent, colorless, or with a yellowish tint) before administration.

Medicines should not be disposed of through the drains or in the trash. Ask your pharmacist how to dispose of the containers and medicines that you no longer need. This will help protect the environment.

Composition of Entyvio

• Theactive principleis vedolizumab. Each vial contains 300mg of vedolizumab.
• Theother componentsare L‑histidina, monohydrochloride of L‑histidina, hydrochloride of L‑arginina, sacarosa and polisorbate80.

Aspect of the product and content of the packaging

• Entyvio is a powder for concentrate for solution for intravenous infusion of white or off-white color that is provided in a glass vial with a rubber stopper and a plastic cap.
• Each package of Entyvio contains a vial.

Holder of the marketing authorization

Takeda Pharma A/S

Delta Park 45

2665 Vallensbaek Strand

Denmark

Responsible for manufacturing

Takeda Austria GmbH

St. Peter‑Straße 25

A‑4020Linz

Austria

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

Last review date of this leaflet: 03/2025

Other sources of information

This leaflet is available in a format suitable for patients who are blind or have reduced vision and can be requested from the local representative of the marketing authorization holder.

The detailed information about this medication is available on the website of the European Medicines Agency: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 medicines, the name and batch number of the administered medicine must be clearly recorded.

Instructions for reconstitution and infusion

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

1. Remove the easy-open cap from the vial and clean the top with an alcohol-moistened cotton swab. Reconstitute vedolizumab with 4.8ml of sterile water for injection at a temperature between 20°Cand25°C, using a syringe with a 21‑25gauge needle.

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

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

1. Leave the vial to stand for 20minutes at a temperature between 20°Cand25°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 20minutes, leave it for another 10minutes.

1. Before dilution, inspect the presence of particles and discoloration in the reconstituted solution. The solution must be transparent or opalescent, colorless to pale yellow, and without visible particles. The reconstituted solution that presents an unusual color or contains particles should not be administered.

1. Once dissolved, invert it 3times gently.

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

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

The reconstituted solution should be used as soon as possible.

1This time is allowed for reconstitution, up to 30minutes.

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

3This period of time may include up to 12hours at 20°Cand25°C.

Do not freeze. Do not store unused solution for reutilization.

Each vial is for single use.

The disposal of unused medication and all materials that have come into contact with it will be carried out in accordance with local regulations.