What is a Patient Information Leaflet and why is it useful?

The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.

Black triangle. This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information.

Below is a text only representation of the Patient Information Leaflet. The original can be viewed in PDF format using the link above.

The text only version may be available from RNIB in large print, Braille or audio CD. For further information call RNIB Medicine Leaflet Line on 0800 198 5000. The product code(s) for this leaflet is: EU/1/14/923/001.

Entyvio 300mg powder for concentrate for solution for infusion

Package leaflet: Information for the patient

Entyvio 300 mg powder for concentrate for solution for infusion

vedolizumab

▼This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See the end of section 4 for how to report side effects.

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.
  • Your doctor will also give you a Patient Alert Card for you to keep with you at all times.

What is in this leaflet

1. What Entyvio is and what it is used for
2. What you need to know before you are given Entyvio
3. How Entyvio will be given
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

Entyvio contains the active substance vedolizumab. Vedolizumab belongs to a group of biological medicines called monoclonal antibodies (MAbs). Vedolizumab blocks a protein on the surface of white blood cells that cause the inflammation in ulcerative colitis and Crohn’s disease, and so the amount of inflammation is reduced.

Entyvio is used to treat the signs and symptoms in adults of:

  • moderately to severely active ulcerative colitis
  • moderately to severely active Crohn’s disease.

Ulcerative colitis

Ulcerative colitis is an inflammatory disease of the large bowel. If you have ulcerative colitis, you will first be given other medicines. If you do not respond well enough or are intolerant to these medicines, your doctor may give you Entyvio to reduce the signs and symptoms of your disease.

Crohn’s disease

Crohn’s disease is an inflammatory disease of the gastrointestinal tract. If you have Crohn’s disease you will first be given other medicines. If you do not respond well enough or are intolerant to these medicines, your doctor may give you Entyvio to reduce the signs and symptoms of your disease.

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

You must not be given Entyvio if you:

  • are allergic to vedolizumab or any of the other ingredients of this medicine (listed in section 6).
  • have an active severe infection, for example, tuberculosis, blood poisoning, severe gastroenteritis, nervous system infection

Warnings and precautions

When you first receive this medicine and during the course of the treatment, also between doses, tell your doctor or nurse immediately if you:

  • experience blurred, loss of or double vision, difficulty speaking, weakness in an arm or a leg, a change in the way you walk or problems with your balance, persistent numbness, decreased sensation or loss of sensation, memory loss or confusion. These may all be symptoms of a serious and potentially fatal brain condition known as progressive multifocal leukoencephalopathy (PML).
  • have an infection, or think you have an infection, if you develop chills, shivering, persistent cough or a high fever. Some infections may become serious and possibly even life-threatening if left untreated.
  • experience signs of an allergic reaction or other reaction to the infusion such as wheezing, difficulty breathing, hives, itching, swelling or dizziness. These could occur during or after the infusion. For more detailed information, see infusion and allergic reactions in section 4.
  • are going to receive any vaccination or have recently had a vaccination. Entyvio may affect the way you respond to a vaccination.
  • have cancer, tell your doctor. Your doctor will have to decide if you can still be given Entyvio.
  • are not feeling 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 or adolescents (under 18 years of age) due to the lack of information regarding 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 start taking any other medicines.

Entyvio should not be given with other biologic medicines that suppress your immune system as the effect of this is not known.

If you have previously taken natalizumab (a medicine used to treat multiple sclerosis) or rituximab (a medicine used to treat certain types of cancer and rheumatoid arthritis), tell your doctor, who will decide if you can be given Entyvio.

Pregnancy and breast-feeding

If you are pregnant, think you may be pregnant or are planning to have a baby, discuss this with your doctor before starting treatment with Entyvio.

The effects of Entyvio in pregnant women are not known. Therefore, this medicine is not recommended for use during pregnancy unless you and your doctor decide that the benefit to you clearly outweighs the potential risk to yourself and your baby.

If you are a woman of childbearing potential, 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 the last treatment.

Tell your doctor if you are breast-feeding or planning to breast-feed. It is not known whether Entyvio passes into breast milk and if so what effect this may have on your baby.

Driving and using machines

This medicine may have a minor influence on your ability to drive or use tools or machines. 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 will be given

  • The infusion will be given to you, by your doctor or nurse, through a drip in one of the veins in your arm (intravenous infusion) over about 30 minutes.
  • For your first 2 infusions, your doctor or nurse will monitor you closely during the infusion and for approximately 2 hours after you have completed the infusion. For all subsequent infusions (after the first two), you will be monitored during the infusion and for approximately 1 hour after you have completed the infusion.

Dose and frequency

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

The recommended dose is 300 mg of Entyvio given as follows (see table below):

Treatment (infusion) number: Timing of treatment (infusion)

Treatment 1: 0 weeks

Treatment 2: 2 weeks after Treatment 1

Treatment 3: 6 weeks after Treatment 1

Further treatments: Every 8 weeks

Your doctor may decide to alter this treatment schedule depending on how well Entyvio works for you.

If you forget or miss your Entyvio infusion

If you forget or miss an appointment to receive the infusion, make another appointment as soon as possible.

If you stop using Entyvio

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

If you have any questions on 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.

Possible serious side effects include infusion reactions or allergic reactions (may affect up to 1 in 100 people) and infections (may affect up to 1 in 10 people).

Tell your doctor immediately if you notice any of the following:

  • wheezing or difficulty breathing
  • hives
  • itching of the skin
  • swelling
  • rapid heart rate
  • feeling sick
  • pain at the infusion site
  • redness of skin
  • chills or shivering
  • high fever or rash

Other side effects that you may experience while taking Entyvio are listed below. Tell your doctor as soon as possible if you notice any of the following:

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

  • common cold
  • joint pain
  • headache

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

  • fever
  • chest infection
  • tiredness
  • cough
  • flu (influenza)
  • back pain
  • throat pain
  • sinus infection
  • itching / itchiness
  • rash and redness
  • pain in the limb
  • muscle cramps
  • muscle weakness
  • throat infection
  • stomach flu
  • anal infection
  • anal sore
  • hard faeces
  • bloated stomach
  • passing gas
  • high blood pressure
  • prickling or tingling
  • heart burn
  • haemorrhoids
  • blocked nose
  • eczema
  • night sweats
  • acne (pimples)

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

  • redness and tenderness of hair follicle
  • throat and mouth yeast infection
  • vaginal infection

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

  • pneumonia
  • blurred vision (loss of sharpness of eyesight)
  • sudden, severe allergic reaction which can cause breathing difficulty, swelling, fast heartbeat, sweating, drop in blood pressure, light-headedness, loss of consciousness and collapse (anaphylactic reaction and anaphylactic shock)

Reporting of side effects

If you get any side effects, talk to your doctor, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to:

Ireland
HPRA Pharmacovigilance
Earlsfort Terrace
IRL - Dublin 2
Tel: +353 1 6764971
Fax: +353 1 6762517
Website: www.hpra.ie
E-mail: medsafety@hpra.ie
United Kingdom
Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard

or search for MHRA Yellow Card in the Google Play or Apple App Store.

By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store 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 after ”EXP”. The expiry date refers to the last day of that month.

Entyvio is given by a doctor or nurse and patients should not need to store or handle Entyvio.

Entyvio is for single-use only.

Unopened vial: Store in a refrigerator (2°C-8°C). Keep the vial in the original carton in order to protect from light.

Reconstituted and diluted solutions: Use immediately. If this is not possible, reconstituted solution in the vial can be stored for up to 8 hours at 2°C-8°C. Diluted solution in 0.9% sodium chloride solution can be stored up to 12 hours at a room temperature of not above 25°C or up to 24 hours in a refrigerator (2°C-8°C), or for up to 12 hours at room temperature and in a refrigerator (2°C-8°C), up to a combined total of 24 hours. A 24 hour period may include up to 8 hours at 2°C-8°C for reconstituted solution in the vial and up to 12 hours at 20°C - 25°C for diluted solution in the infusion bag but the infusion bag must be stored in the refrigerator (2°C-8°C) for the rest of the 24 hour period Any time that the reconstituted solution was held in the vial should be subtracted from the time the solution may be held in the infusion bag.

Do not freeze.

Do not use this medicine if you notice any particles in the liquid or discolouration prior to administration.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Entyvio contains

The active substance is vedolizumab. Each vial contains 300 mg of vedolizumab.

The other ingredients are L-histidine, L-histidine monohydrochloride, L-arginine hydrochloride, sucrose, and polysorbate 80.

What Entyvio looks like and contents of the pack

Entyvio is a white to off-white powder for concentrate for solution for infusion provided in a glass vial with a rubber stopper and a plastic cap.

Each pack of Entyvio consists of one vial.

Marketing Authorisation Holder

Takeda Pharma A/S
Dybendal Alle 10
2630 Taastrup
Denmark

Manufacturer

Delpharm Novara S.r.l.
Via Crosa, 86
28065 Cerano (NO)
Italy

Takeda Austria GmbH
St. Peter-Straße 25
4020 Linz
Austria

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

United Kingdom
Takeda UK Ltd
Tel.: +44 (0)1628 537 900

This leaflet was last revised in 08/2018.

Other sources of information

This leaflet is available in formats suitable for the blind or partially sighted patient and can be requested from respective local representative of the Marketing Authorisation Holder.

Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.