Entyvio
vedolizumab
vedolizumab
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 Entyvio is and what it is used for
What you need to know before you are given Entyvio
How Entyvio will be given
Possible side effects
How to store Entyvio
Contents of the pack and other information
Entyvio contains the active substance ‘vedolizumab’. Vedolizumab belongs to a group of biological medicines called monoclonal antibodies (MAbs).
Entyvio works by blocking a protein on the surface of white blood cells that cause the inflammation in ulcerative colitis,Crohn’s disease and pouchitis. This reduces the amount of inflammation.
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
moderately to severely active chronic pouchitis
Ulcerativecolitis
Ulcerative colitis is a disease that causes inflammation of the large bowel. If you have ulcerative
colitis, you will first be given other medicines. If you do not respond well enough or cannot tolerate these medicines, your doctor may give you Entyvio to reduce the signs and symptoms of your disease.
Crohn’sdisease
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 medicines. If you do not respond well enough or cannot tolerate these medicines, your doctor may give you Entyvio to reduce the signs and symptoms of your disease.
Pouchitis
Pouchitis is a disease that causes inflammation of the lining of the pouch, which was created during
surgery to treat ulcerative colitis. If you have pouchitis, you may first be given antibiotics. If you do not respond well enough to the antibiotics, your doctor may give you Entyvio to reduce the signs and symptoms of your disease.
if you are allergic to vedolizumab or any of the other ingredients of this medicine (listed in section 6).
if you have an active severe infection - such as TB (tuberculosis), blood poisoning, severe diarrhoea and vomiting (gastroenteritis), nervous system infection.
Talk to your doctor or nurse before being given Entyvio.
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).
if you have an infection, or think you have an infection - signs include chills, shivering, persistent cough or a high fever. Some infections may become serious and possibly even life-threatening if left untreated.
if you 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.
if you are going to receive any vaccination or have recently had a vaccination. Entyvio may affect the way you respond to a vaccination.
if you have cancer, tell your doctor. Your doctor will have to decide if you can still be given Entyvio.
if you are not feeling any better as vedolizumab may take up to 14 weeks to work in some patients with very active Crohn’s disease.
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.
Tell your doctor or nurse if you are taking, have recently taken or might take 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.
Tell your doctor if you have previously taken:
natalizumab (a medicine for multiple sclerosis) or
rituximab (a medicine for certain types of cancer and rheumatoid arthritis). Your doctor will decide if you can be given Entyvio.
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.
Pregnancy
The effects of Entyvio in pregnant women are not known. Therefore, this medicine is not recommended for use during pregnancy. You and your doctor should decide if 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.
Breast-feeding
Tell your doctor if you are breast-feeding or planning to breast-feed. Entyvio passes into breast milk.
There is not enough information on what effect this may have on your baby and on milk production. A decision must be made whether to stop breast-feeding or to stop using Entyvio therapy taking into account the benefit of breast-feeding for your child and the benefit of therapy for you.
This medicine has a minor effect 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.
Treatment with Entyvio is the same for ulcerative colitis, Crohn’s disease and pouchitis..
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.
The infusion will be given to you, by your doctor or nurse, through a drip in 1 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 2), you will be monitored during the infusion and for approximately 1 hour after you have completed the infusion.
If you forget or miss an appointment to receive the infusion, make another appointment as soon as possible.
Do not stop using Entyvio without talking with your doctor first.
If you have any further questions on the use of this medicine, ask your doctor or nurse.
Like all medicines, this medicine can cause side effects although not everybody gets them.
Tell your doctor immediately if you notice any of the following:
allergic reactions (may affect up to 1 in 100 people) - the signs may include: wheezing or difficulty breathing, hives, itching of the skin, swelling, feeling sick, pain at the infusion site, redness of skin and
infections (may affect up to 1 in 10 people) - the signs may include: chills or shivering, high fever or rash
Tell your doctor as soon as possible if you notice any of the following:
common cold
joint pain
headache
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)
rectal bleeding
chest discomfort
redness and tenderness of hair follicle
throat and mouth yeast infection
vaginal infection
shingles (herpes zoster)
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)
lung disease causing shortness of breath (interstitial lung disease)
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 viathenationalreportingsystemlistedin AppendixV. By reporting side effects you can help provide more information on the safety of this medicine.
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.
(0.9%) solution for injection 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 (solution should be clear or opalescent, colourless to light yellow) 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.
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.
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.
Takeda Pharma A/S Delta Park 45
2665 Vallensbaek Strand Denmark
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:
Takeda Belgium
Tél./Tel.: +32 2 464 06 11
Takeda, UAB
Tel.: +370 521 09 070
Такеда България
Тел.: +359 2 958 27 36
Takeda Belgium
Tél/Tel: +32 2 464 06 11
Takeda Pharmaceuticals Czech Republic s.r.o.
Tel: +420 234 722 722
Takeda Pharma A/S
Tlf./Tel.: 00 800 6683 8470
Drugsales Ltd.
Tel.: +356 21 419070
Takeda GmbH
Tel.: +49 (0) 800 825 3325
Takeda Nederland bv
Tel.: +31 20 203 5492
Takeda Pharma AS
Tel.: +372 6177 669
Takeda AS
Tlf.: +47 6676 3030
TAKEDA ΕΛΛΑΣ Α.Ε.
Τηλ.: +30 210 6387800
Takeda Pharma Ges.m.b.H.
Tel.: +43 (0) 800 20 80 50
Takeda Farmacéutica España S.A.
Tel.: +34 917 90 42 22
Takeda Pharma sp. z o.o.
Tel.: +48 22 608 13 00
Takeda France SAS
Tel.: +33 1 40 67 33 00
Takeda Farmacêuticos Portugal, Lda.
Tel.: +351 21 120 1457
Takeda Pharmaceuticals Croatia d.o.o.
Tel: +385 1 377 88 96
Takeda Pharmaceuticals SRL
Tel.: +40 21 335 03 91
Takeda Products Ireland Ltd.
Tel.: 1800 937 970
Takeda Pharmaceuticals farmacevtska družba d.o.o.
Tel.: +386 (0) 59 082 480
Vistor hf.
Tel.: +354 535 7000
Takeda Pharmaceuticals Slovakia s.r.o.
Tel.: +421 (2) 20 602 600
Takeda Italia S.p.A
Tel.: +39 06 502601
Takeda Oy
Puh./Tel.: +358 20 746 5000
otamitis Medicare Ltd
Tηλ: +357 22583333
Takeda Pharma AB
Tel.: +46 8 731 28 00
Takeda Latvia SIA
Tel.: +371 67840082
Takeda UK Ltd
Tel.: +44 (0) 283 064 0902
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.
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The following information is intended for healthcare professionals only: Traceability
In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded
Instructionsforreconstitutionandinfusion
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 injections at room temperature (20 °C-25 °C), using a syringe with a 21-25 gauge needle.
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.
Gently swirl the vial for at least 15 seconds. Do not vigorously shake or invert.
Let the vial sit for up to 20 minutes at room temperature (20 °C-25 °C), 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.
Inspect the reconstituted solution visually for particulate matter and discolouration prior to dilution. 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.
Once dissolved, gently invert vial 3 times.
Immediately withdraw 5 mL (300 mg) of reconstituted Entyvio using a syringe with a 21-25 gauge needle.
Add the 5 mL (300 mg) of reconstituted Entyvio to 250 mL of sterile sodium chloride 9 mg/mL (0.9%) solution for injection, and gently mix the infusion bag (5 mL of sodium chloride
9 mg/mL (0.9%) solution for injection 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.
Once reconstituted, the infusion solution should be used as soon as possible.
Storage Condition | ||
Refrigerator (2 °C-8 °C) | 20 °C-25 °C | |
Reconstituted solution in the vial | 8 hours | Do not hold1 |
Diluted solution in sodium chloride 9 mg/mL (0.9%) solution for injection | 24 hours2, 3 | 12 hours2 |
Up to 30 minutes are allowed for reconstitution
This time assumes the reconstituted solution is immediately diluted in the sodium chloride 9 mg/mL (0.9%) solution for injection and held in the infusion bag only. 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.
This period may include up to 12 hours at 20 °C-25 °C.
Do not freeze. Do not store any unused portion of the reconstituted solution or 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.