Entyvio 108 mg solution for injection in pre-filled pen

Patient Information Leaflet

Introduction

Entyvio 108mg injectable solution in a prefilled pen

vedolizumab

Read this entire 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, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, since it may harm them.
• If you experience any adverse reactions, consult your doctor, pharmacist, or nurse, even if they are adverse reactions not listed in this leaflet. See section 4.

Contents of the leaflet

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

1. What Entyvio is and what it is used for

What Entyvio is

Entyvio contains the active substance "vedolizumab". Vedolizumab belongs to a group of biological medicines 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 and Crohn's disease, thereby reducing inflammation.

What Entyvio is indicated 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.

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 adequately or do not tolerate these medications, your doctor may prescribe Entyvio to reduce the signs and symptoms of the disease.

Crohn's disease

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

2. What you need to know before using 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 serious active infection, for example, tuberculosis, septicemia, severe vomiting or diarrhoea (gastroenteritis), or a nervous system infection.

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before you start using Entyvio.

Tell your doctor, pharmacist, or nurse immediately when you use 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 one arm or leg, a change in your way of walking, balance problems, persistent numbness, reduced or loss of sensation, confusion, or memory loss. All these symptoms could be due to a serious and potentially fatal brain condition known as progressive multifocal leukoencephalopathy (PML).

• if you have an infection, or think you may have an infection — signs may include chills, shaking, persistent cough, or high fever. Some infections may be serious and even potentially life-threatening if not treated.

• if you experience signs of an allergic reaction such as wheezing, difficulty breathing, hives, itching, swelling, or dizziness. For more detailed information, see the section on allergic reactions in section 4.

• if you are due to receive any vaccination or have recently received one. Entyvio may affect how you respond to a vaccine.

• if you have cancer, tell your doctor. Your doctor will need to decide whether it is safe for you to receive 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 lack of information on the use of this medicine in this age group.

Other medicines and Entyvio

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

• Entyvio should not be given together with other biological immunosuppressive medicines, as the effects of such combinations are unknown.

Tell your doctor if you have previously received:

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

Your doctor will need to decide whether it is safe for you to receive Entyvio.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, talk to your doctor before using this medicine.

Pregnancy

The effects of Entyvio in pregnant women are unknown. Therefore, use of this medicine during pregnancy is not recommended. You and your doctor should decide whether the benefit to you clearly outweighs the potential risk to you and your baby.

If you are a woman of childbearing age, you are advised to avoid becoming pregnant while using Entyvio. You should use adequate contraception during treatment and for at least 4.5 months after receiving the last dose.

Breastfeeding

Tell your doctor if you are breastfeeding or plan to breastfeed. Entyvio passes into breast milk. There is insufficient information about the effects this may have on your baby and on milk production. A decision must be made whether to discontinue breastfeeding or discontinue treatment with Entyvio, taking into account the benefits of breastfeeding for your baby and the benefits of treatment for you.

Driving and using machines

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

Entyvio 108 mg solution for injection contains sodium

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

Entyvio contains polysorbate 80

This medicine contains 1.48 mg of polysorbate 80 in each Entyvio 108 mg pre-filled pen. Polysorbates may cause allergic reactions. Inform your doctor if you have any known allergy.

3. How to use Entyvio

Follow exactly the instructions for administration of this medicine given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

You or your caregiver will receive training on how to use the subcutaneous injections (injections under the skin) of Entyvio.

How much Entyvio will be administered to you

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

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

• At the beginning of treatment, your doctor will administer the initial doses of Entyvio via intravenous infusion (through a vein in your arm) over approximately 30 minutes.
• After at least 2 intravenous infusions, you may start treatment with Entyvio via subcutaneous injection. The first subcutaneous injection is given at the time of the next scheduled intravenous infusion, and then every 2 weeks thereafter.

How to inject Entyvio

You may self-administer the subcutaneous injections, or a caregiver may do it, after proper training. Instructions on how to perform the subcutaneous injection are provided at the end of this leaflet.

If you forget or miss an injection of Entyvio

If you forget or miss a dose, administer the next dose as soon as possible, and then continue every 2 weeks from that point.

If you stop treatment with Entyvio

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

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

4. Possible adverse effects

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

Serious adverse effects

Inform your doctor immediately if you notice any of the following symptoms:

• allergic reactions (may affect up to 1 in 100 patients), with signs such as wheezing or difficulty breathing, hives, skin itching, swelling, feeling unwell, skin redness
• infections (may affect up to 1 in 10 patients), with signs such as chills or shivering, high fever, or rashes

Other adverse effects

Inform your doctor as soon as possible if you notice any of the following symptoms:

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

• common cold
• joint pain
• headache

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

• pneumonia
• bacterial infection of the large intestine due to Clostridium difficile
• fever
• respiratory infection
• changes in liver function, increased liver enzymes (shown in blood tests)
• fatigue
• cough
• influenza
• back pain
• sore throat
• sinusitis
• itching/pruritus
• rash and redness
• pain in limbs
• muscle cramps
• muscle weakness
• throat infection
• stomach flu
• anal infection
• anal pain
• hard stools
• bloated stomach
• flatulence
• high blood pressure
• numbness or tingling
• heartburn
• haemorrhoids
• stuffy nose
• eczema
• night sweats
• acne (pimples)
• reactions at the injection site (pain, swelling, erythema, or itching)
• shingles (herpes zoster)

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

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

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

• sudden and severe allergic reaction which may 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). Signs and symptoms of hepatitis may include abnormal liver function tests, yellowing of the eyes or skin (jaundice), pain in the right side of the stomach area, or bruising

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

• lung disease causing difficulty breathing (interstitial lung disease)

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly through the national reporting system listed in Appendix V. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Entyvio

• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date stated on the carton and label, following "EXP". The expiry date refers to the last day of the month indicated.
• Entyvio is for single use only.
• Store in a refrigerator (between 2 °C and 8 °C). Keep the pre-filled pen(s) in the original carton to protect them from light. If necessary, a single pre-filled pen may be stored outside the refrigerator, protected from light, at room temperature (up to 25 °C) for a maximum of 7 days. Do not use the pen if it has been kept outside the refrigerator for more than 7 days.
• Do not freeze. Do not expose directly to sunlight.
• Do not use this medicine if particles are visible in the liquid or if discoloration occurs (the solution should be clear and colourless or may have a yellowish tint) prior to administration.
• Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Entyvio

• The active substance is vedolizumab. Each pre-filled pen contains 108 mg of vedolizumab.
• The other components are monohydrate citric acid (E 330), disodium citrate dihydrate (E 331), L-histidine, L-histidine monohydrochloride, L-arginine hydrochloride, polysorbate 80 (E 433) and water for injections. See section 2 "Entyvio 108 mg solution for injection contains sodium" and "Entyvio contains polysorbate 80".

Appearance of the product and contents of the pack

• Entyvio is a colourless or yellowish injectable solution supplied in a pre-filled glass pen with an automatic safety mechanism that protects and locks the needle after removing the device from the injection site.
• Entyvio is available in cartons containing 1 or 2 pre-filled pens and in multiple packs containing 6 (6 × 1) pre-filled pens. Only certain 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-Straße 25

A-4020 Linz

Austria

For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:

Date of the most recent review of this leaflet:

Other sources of information

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

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

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 administered medicinal product must be clearly documented.

Instructions for use:

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

Your single-use, pre-filled Entyvio pen