Entyvio 108 mg solucion inyectable en pluma precargada

Entyvio 108mg pre-filled syringe injectable solution

vedolizumab

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

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only, and you must not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor, pharmacist 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 start using Entyvio

3.How to use 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 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 and Crohn's disease, thereby reducing inflammation.

What is Entyvio used for

Entyvio is used to treat symptoms in adults with:

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

Ulcerative Colitis

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

No 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 or diarrhea (gastroenteritis) or central nervous system infection.

Warnings and precautions

Consult your doctor, pharmacist or nurse before using Entyvio.

Inform your doctor, pharmacist or nurse immediatelywhen you first use this medication, 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. All these symptoms may correspond to aserious and potentially fatal brain complication known as progressive multifocal leukoencephalopathy (LMP).

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

• if you experience signs ofan allergic reactionsuch as wheezing, difficulty breathing, hives, itching, swelling or dizziness. For more detailed information, see the section on 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, pharmacist 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 multiple sclerosis)or
• rituximab (a medication indicated for 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. You will need to decide whether to interrupt breastfeeding or the Entyvio treatment, which will require evaluating the benefits of breastfeeding for your baby and the benefits of treatment for you.

Driving and operating machinery

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

Entyvio 108mg injectable solution contains sodium

This medication contains less than 1mmol of sodium (23mg) per dose unit; it is essentially “sodium-free”.

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. If in doubt, consult them again.

You or your caregiver will receive training on the use of subcutaneous injections of Entyvio.

How much Entyvio will be administered

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

The recommended dose is 108mg of Entyvio administered via subcutaneous injection once every 2weeks.

• At the beginning of treatment, your doctor will administer the initial doses of Entyvio through an infusion system with drip in one of the veins of the arm (intravenous infusion) for about 30minutes.
• After at least 2intravenous infusions, you can start the treatment with Entyvio via subcutaneous injection. The first subcutaneous injection is administered at the time of the next scheduled intravenous infusion, and every 2weeks thereafter.

How to inject Entyvio

You can administer the subcutaneous injections yourself, or have a caregiver do it after receiving training on how to do so. At the end of this prospectus, you will find instructions on how to proceed with the subcutaneous injection.

If you forgot or omitted an Entyvio injection

If you forget or omit a dose, inject the next dose as soon as possible and then every 2weeks.

If you interrupt treatment with Entyvio

You should not stop using Entyvio without first talking to your doctor.

If you have any other questions about the use of this medication, ask your doctor, pharmacist, or nurse.

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

Severe side effects

Inform your doctorimmediatelyif you notice any of the following symptoms:

• allergic reactions (may affect up to 1 in 100patients), with signs such as hissing or difficulty breathing, hives, skin itching, swelling, feeling unwell, pain at the infusion site, skin redness
• infections (may affect up to 1 in 10patients), 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(may affect more than 1 in 10patients)

• common cold
• joint pain
• headache

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

• pneumonia
• 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)
• reactions at the injection site (pain, swelling, erythema or itching)
• shingles

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

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

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

• sudden and severe allergic reaction that may cause difficulty breathing, inflammation, rapid heart rate, 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 abdominal area or cardinals

Unknown frequency(the frequency cannot be estimated from the 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, pharmacist, 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 about the safety of this medicine.

• Keep this medication out of the sight and reach of children.
• Do not use this medication after the expiration date that appears on the packaging, and on the label, after "CAD". The expiration date is the last day of the month indicated.
• Entyvio is for single use.
• Store in refrigerator (between 2°C and 8°C).Store the preloaded pen(s) in the original packaging to protect them from light. If necessary, a single preloaded pen can be stored outside the refrigerator, protected from light at room temperature (up to 25°C) for 7 days, maximum. Do not use the pen if it has been out of the refrigerator for more than 7 days.
• Do not freeze. Do not expose directly to sunlight.
• Do not use this medication if you observe the presence of particles in the liquid or discoloration (it should be colorless or have a yellowish tint) before administration.
• Medicines should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the packaging and the medication that you no longer need. This will help protect the environment.

Composition of Entyvio

• Theactive principleis vedolizumab. Each pre-filled syringe contains 108mg of vedolizumab.
• Theother componentsare citric acid monohydrate, sodium citrate dihydrate, L‑histidine, monohydrochloride of L‑histidine, hydrochloride of L‑arginine, polisorbate80 and water for injection.

Appearance of the product and contents of the pack

• Entyvio is a colourless or yellowish solution for injection provided in a pre-filled syringe of glass with an automatic safety mechanism that protects and blocks the needle after the device is removed from the injection site
• Entyvio is available in packs with 1 or 2pre-filled syringes and in multiple packs with 6(6×1)pre-filled syringes. Only some pack sizes may be marketed.

Marketing Authorisation Holder

Takeda Pharma A/S

Delta Park 45

2665 Vallensbaek Strand

Denmark

Manufacturer

Takeda Austria GmbH

St. Peter‑Straβe 25

A‑4020Linz

Austria

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

Last update of the summary of product characteristics: 03/2025

Other sources of information

This summary of product characteristics is available in a format suitable for patients with visual impairments or reduced vision and can be requested from the local representative of the marketing authorisation holder.

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

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This information is intended for healthcare professionals only:

Traceability

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

Instructions for use:

Read and follow these instructions before proceeding with the injection. Your doctor, nurse or pharmacist must show you how to use the Entyvio pre-filled syringe before you use it for the first time.

Your single-use Entyvio pre-filled syringe