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Entyvio (vedolizumab) – Package leaflet - L04AA

Updated on site: 06-Oct-2017

Medication nameEntyvio
ATC CodeL04AA
Substancevedolizumab
ManufacturerTakeda Pharma A/S

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

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 via 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.How to store Entyvio

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

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

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 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.

Reconsituted/diluted solution: Use immediately. If this is not possible, solutions 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 12 hours at room temperature and then for 12 hours in a refrigerator. Do not freeze.

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

Any unused product or waste material should be disposed of in accordance with local requirements.

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:

België/Belgique/Belgien

Lietuva

Takeda Belgium

Takeda, UAB

Tel./Tél.: +32 2 464 06 11

Tel.: +370 521 09 070

takeda-belgium@takeda.com

It-info@takeda.com

България

Luxembourg/Luxemburg

Такеда България

Takeda Belgium

Тел.: + 359 2 958 27 36

Tel/Tél: +32 2 464 06 11

 

takeda-belgium@takeda.com

Česká republika

Magyarország

Takeda Pharmaceuticals Czech Republic s.r.o.

Takeda Pharma Kft.

 

Tel.: +361 2707030

Tel: + 420 731 620 870

info-hu@takeda.com

Danmark

Malta

Takeda Pharma A/S

Takeda Italia S.p.A.

Tlf./Tel.: +45 46 77 11 11

Tel..: +39 06 502601

Deutschland

Nederland

Takeda GmbH

Takeda Nederland bv

Tel.: +49 (0) 800 825 3325

Tel.: +31 23 56 68 777

medinfo@takeda.de

nl.medical.info@takeda.com

Eesti

Norge

Takeda Pharma AS

Takeda AS

Tel.: +372 6177 669

Tlf.: +47 6676 3030

info@takeda.ee

infonorge@takeda.com

Ελλάδα

Österreich

TAKEDA ΕΛΛΑΣ Α.Ε.

Takeda Pharma Ges.m.b.H.

Τηλ.: +30 210 6387800

Tel.: +43 (0) 800 20 80 50

gr.info@takeda.com

 

España

Polska

Takeda Farmacéutica España S.A.

Takeda Polska Sp. z o.o.

Tel.: +34 917 14 99 00

Tel.: +48 22 608 13 00

spain@takeda.com

 

France

Portugal

Takeda France

Takeda Farmacêuticos Portugal, Lda.

Tel.: +33 1 46 25 16 16

Tel.: + 351 21 120 1457

Hrvatska

România

Takeda Pharmaceuticals Croatia d.o.o.

Takeda Pharmaceuticals SRL

Tel: +385 1 377 88 96

Tel.: +40 21 335 03 91

Ireland

Slovenija

Takeda Products Ireland Ltd.

Takeda GmbH, Podružnica Slovenija

Tel.: +353 (0) 1 6420021

Tel.: +386 (0) 59 082 480

Ísland

Slovenská republika

Vistor hf.

Takeda Pharmaceuticals Slovakia s.r.o.

Tel.: +354 535 7000

Tel.: +421 (2) 20 602 600

vistor@vistor.is

 

Italia

Suomi/Finland

Takeda Italia S.p.A

Takeda Oy

Tel.: +39 06 502601

Puh./Tel.: +358 20 746 5000

 

infoposti@takeda.com

Κύπρος

Sverige

Takeda Pharma A/S

Takeda Pharma AB

Τηλ: +45 46 77 11 11

Tel.: +46 8 731 28 00

 

infosweden@takeda.com

Latvija

United Kingdom

Takeda Latvia SIA

Takeda UK Ltd

Tel.: +371 67840082

Tel.: +44 (0)1628 537 900

This leaflet was last revised in

 

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.

-----------------------------------------------------------------------------------------------------------------------

The following information is intended for healthcare professionals only:

Instructions for reconstitution and infusion

Entyvio should be at room temperature (20°C-25°C) when reconstituted.

1.Use aseptic technique when preparing Entyvio solution for intravenous infusion. Remove flip-off cap from the vial and wipe with alcohol swab. Reconstitute vedolizumab with 4.8 ml of sterile water for injection, using a syringe with a 21-25 gauge needle.

2.Insert needle into the vial through the centre of the stopper and direct the stream of liquid to the wall of the vial to avoid excessive foaming.

3.Gently swirl the vial for at least 15 seconds. Do not vigorously shake or invert.

4.Let the vial sit for up to 20 minutes to allow for reconstitution and for any foam to settle; the vial can be swirled and inspected for dissolution during this time. If not fully dissolved after 20 minutes, allow another 10 minutes for dissolution.

5.Inspect the reconstituted solution visually for particulate matter and discoloration prior to administration. Solution should be clear or opalescent, colourless to light yellow and free of visible particulates. Reconstituted solution with uncharacteristic colour or containing particulates must not be administered.

6.Prior to withdrawing reconstituted solution from vial, gently invert vial 3 times.

7.Withdraw 5 ml (300 mg) of reconstituted Entyvio using a syringe with a 21-25 gauge needle.

8.Add the 5 ml (300 mg) of reconstituted Entyvio to 250 ml of sterile 0.9% sodium chloride solution, and gently mix the infusion bag (5 ml of 0.9% sodium chloride solution does not have to be withdrawn from the infusion bag prior to adding Entyvio). Do not add other

medicinal products to the prepared infusion solution or intravenous infusion set. Administer the infusion solution over 30 minutes.

Entyvio does not contain preservatives. Once reconstituted, the infusion solution should be used as soon as possible. However, if necessary, the infusion solution may be stored for up to 24 hours: this 24 hour hold may include up to 12 hours at 20-25°C; any additional hold time must be at 2-8°C. Do not freeze. Do not store any unused portion of the infusion solution for reuse.

Each vial is for single-use only.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

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