InfoCons Consumer Protection informs you – Entyvio – Package Leaflet
Entyvio – Package Leaflet: InfoCons – Consumer Protection presents, in an accessible format, the official package leaflet of the medicine Entyvio, as authorised in the European Union and published in the Union Register of medicinal products.
Before anything else
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.
ℹ️ 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 called monoclonal antibodies (MAbs).
How Entyvio works
Entyvio works by blocking a protein on the surface of white blood cells that cause the inflammation in ulcerative colitis and Crohn’s disease. This reduces the amount of inflammation.
What Entyvio is used for
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 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’s disease 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.
⚠️ 2. What you need to know before you use 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 an active severe infection – such as TB (tuberculosis), blood poisoning, severe diarrhoea and vomiting (gastroenteritis), nervous system infection.
Warnings and precautions
Talk to your doctor, pharmacist or nurse before using Entyvio.
Tell your doctor, pharmacist or nurse immediately when you first use this medicine, during treatment, and between doses:
- 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 such as wheezing, difficulty breathing, hives, itching, swelling or dizziness. For more detailed information, see 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.
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, pharmacist 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.
Pregnancy and breast -feeding 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 t he benefit of therapy for you.
Driving and using machines
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.
Entyvio 108 mg solution for injection contains sodium
This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say 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. Tell your doctor if you have any known allergies.
💊 3. How to use Entyvio
Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
You or your caregiver will be given training on how to use Entyvio injections under the skin (subcutaneous injections).
How much Entyvio you will receive Treatment with Entyvio is the same for ulcerative colitis and Crohn’s disease.
The recommended dose is 108 mg of Entyvio administered by subcutaneous injection once every 2 weeks.
- At the start of treatment, the doctor will give initial doses of Entyvio through a drip into a vein in your arm (intravenous infusion) over about 30 minutes.
- After at least 2 intravenous infusions, you can start receiving Entyvio by a subcutaneous injection. The first subcutaneous injection is given at the time of the next scheduled intravenous infusion, and every 2 weeks thereafter.
Injecting Entyvio The subcutaneous injections can be given by yourself or a caregiver, after training on how to do it. Instructions are provided at the end of this leaflet.
If you forget to take or miss your Entyvio injection
If you forget or miss a dose, inject the next dose as soon as possible and then every 2 weeks thereafter .
If you stop using Entyvio
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 pharmacist or nurse.
❗ 4. Possible side effects
Like all medicines, this medicine can cause side effects although not everybody gets them.
Serious side effects
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, redness of skin and
- infections (may affect up to 1 in 10 people) – the signs may include: chills or shivering, high fever or rash
Other side effects
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)
- pneumonia
- infection of the large intestine due to Clostridium difficile bacteria
- fever
- chest infection
- changes in how your liver works, increase in liver enzymes (shown in blood tests)
- 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)
- injection site reactions (including pain, swelling, redness or itching)
- shingles (herpes zoster)
Uncommon side effects (may affect up to 1 in 100 people)
- redness and tenderness of hair follicle
- throat and mouth yeast infection
- vaginal infection 88 • blurred vision (loss of sharpness of eyesight)
Very rare side effects (may affect up to 1 in 10 000 people)
- 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)
- inflammation of the liver (hepatitis). Signs and symptoms of hepatitis may include abnormal liver function tests, eye or skin yellowing (jaundice), pain on the right side of your stomach area, bruising
Not known (frequency cannot be estimated from the available data)
- lung disease causing shortness of breath (interstitial lung disease)
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist 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.
- Do not use this medicine after the expiry date which is stated on the carton, an d on the label, after “EXP”. The expiry date refers to the last day of that month.
- Entyvio is for single use only.
- Store in a refrigerator (2 °C-8 °C). Keep the pre-filled pen(s) in the original carton in order to protect from light. If needed, one pre -filled pen can be left out of the refrigerator protected from light at room temperature (up to 25 ° C) for up to 7 days. Do not use if left out of the refrigerator for more than 7 days.
- Do not freeze. Do not leave in direct sunlight.
- Do not use this medicine if you notice any particles in the liquid or discolouration (should be colourless to 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.
📦 6. Contents of the pack and other information
What Entyvio contains
- The active substance is vedolizumab. Each pre -filled pen contains 108 mg of vedolizumab.
- The other ingredients are citric acid monohydrate (E 330), sodium 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”.
What Entyvio looks like and contents of the pack
- Entyvio is a colourless to yellow solution for injection provided in a glass pre -filled pen equipped with an automated needle shield to extend and lock over the needle once the device is removed from the injection site .
- Entyvio is available in cartons containing 1, 2 or 6 pre-filled pens. Not all pack sizes may be marketed.
89 Marketing Authorisation Holder Takeda Pharma A/S Delta Park 45 2665 Vallensbaek Strand Denmark
Manufacturer
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 Takeda Belgium NV Tél/Tel: +32 2 464 06 11 [email protected] Lietuva Takeda, UAB Tel: +370 521 09 070 [email protected] България Такеда България ЕООД Тел.: +359 2 958 27 36 [email protected] Luxembourg/Luxemburg Takeda Belgium NV Tél/Tel: +32 2 464 06 11 [email protected] Česká republika Takeda Pharmaceuticals Czech Republic s.r.o.
Tel: +420 234 722 722 [email protected] Magyarország Takeda Pharma Kft.
Tel.: +36 1 270 7030 [email protected] Danmark Takeda Pharma A/S Tlf.: +45 46 77 10 10 [email protected] Malta Drugsales Ltd Tel: +356 21419070 [email protected] Deutschland Takeda GmbH Tel: +49 (0)800 825 3325 [email protected] Nederland Takeda Nederland B.V.
Tel: +31 20 203 5492 [email protected] Eesti Takeda Pharma OÜ Tel: +372 6177 669 [email protected] Norge Takeda AS Tlf: +47 800 800 30 [email protected] Ελλάδα TAKEDA ΕΛΛΑΣ Α.Ε.
Τηλ: +30 210 6387800 [email protected] Österreich Takeda Pharma Ges.m.b.H.
Tel: +43 (0) 800-20 80 50 [email protected] España Takeda Farmacéutica España, S.A.
Tel: +34 917 90 42 22 [email protected] Polska Takeda Pharma Sp. z o.o.
Tel.: +48223062447 [email protected] 90 France Takeda France SAS Tél: +33 1 40 67 33 00 [email protected] Portugal Takeda Farmacêuticos Portugal, Lda.
Tel: +351 21 120 1457 [email protected] Hrvatska Takeda Pharmaceuticals Croatia d.o.o.
Tel: +385 1 377 88 96 [email protected] România Takeda Pharmaceuticals SRL Tel: +40 21 335 03 91 [email protected] Ireland Takeda Products Ireland Ltd Tel: 1800 937 970 [email protected] Slovenija Takeda Pharmaceuticals farmacevtska družba d.o.o.
Tel: +386 (0) 59 082 480 [email protected] Ísland Vistor ehf.
Sími: +354 535 7000 [email protected] Slovenská republika Takeda Pharmaceuticals Slovakia s.r.o.
Tel: +421 (2) 20 602 600 [email protected] Italia Takeda Italia S.p.A .
Tel: +39 06 502601 [email protected] Suomi/Finland Takeda Oy Puh/Tel: 0800 774 051 [email protected] Κύπρος A.POTAMITIS MEDICARE LTD Τηλ: +357 22583333 [email protected] Sverige Takeda Pharma AB Tel: 020 795 079 [email protected] Latvija Takeda Latvia SIA Tel: +371 67840082 [email protected]
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: https://www.ema.europa.eu . ———————————————————————————————————————–
🩺 Information 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.
91 Instructions for use:
Read and follow these instructions before you inject. Y our doctor, nurse or pharmacist should show you how to use the Entyvio pre -filled pen before you use it for the first time.
Your Entyvio single -dose pre-filled pen Before Use Purple Cap Viewing window After Use Yellow needle shield Viewing window (Completed Injection) 1) Place what you need for the injection on a clean, flat surface Take the pre-filled pen carton out of the refrigerator.
- If you are opening the carton for the first time, check to make sure the carton is properly sealed . Do not use the pre-filled pen(s) if any of the seals on the carton are broken or missing.
- Check the expiry date (EXP) on the carton. Do not use if the expiry date on the carton has passed.
- Remove one pre -filled pen from the carton. Keep any remaining pre -filled pens in the carton in the refrigerator.
Wait 30 minutes to let the pre -filled pen come to room temperature.
- Do not warm the pre-filled pen in any other way.
- Do not let it sit in direct sunlight.
- Do not take the pre-filled pen out of its tray until you are ready to inject.
You will also need:
- Alcohol pad
- Cotton ball or gauze
- Sharps disposal container Wait 30 minutes 92 2) Open and check the pre -filled pen Wash your hands.
Peel back the paper on the tray and lift the pre -filled pen out. Inspect the pre-filled pen for damage.
- Do not use the pre-filled pen if any part of it is damaged.
Check the expiry date on the pre -filled pen.
- Do not use if the expiry date on the pre -filled pen has passed.
Check the medicine. It should be colourless to yellow.
- Do not use the pre-filled pen if the medicine is cloudy or has particles floating in it.
You may see air bubbles in the pre-filled pen. This is normal.
- Do not shake 3) Prepare the injection site Choose an injection site on your bare skin from 1 of the following.
- Front of the thighs, or
- Stomach area (abdomen) except for the area 5 cm around the belly button (navel), or
- Back of the upper arm (only if a caregiver gives the injection).
Use a new injection site or a different area within the same injection site for each injection.
- Do not inject into moles, scars, bruises, or skin that is tender, hard, red, or damaged.
Wipe the chosen site with an alcohol pad. Let your skin dry.
- Do not touch this area again before you inject.
Pull the purple cap straight off and throw it away.
- Do not put or press thumb, fingers or hand over the yellow needle shield.
- Do not re-cap the pre -filled pen.
- Do not use a dropped pre -filled pen.
93 4) Inject Entyvio Hold the pre -filled pen so you can see the viewing window. Place the pre- filled pen at 90 degrees to the injection site.
- Be sure the yellow end is toward the injection site.
- Do not push down until you are ready to inject.
Push down on the pre -filled pen as far as it will go to begin the injection. Hold and count to 10 while pushing down with constant pressure.
This will allow all of the medicine to be injected.
- You may hear 2 clicks, one at the start and one near the end of the injection.
Confirm that the viewing window is filled with purple before you stop pushing.
- You will see a small amount of grey in the window. This is normal.
Lift the pre -filled pen from the injection site.
- The yellow needle shield will drop down and lock over the needle.
- If the viewing window did not fill completely, call your doctor, nurse or pharmacist. You may not have received your full dose of medicine.
You may see a small amount of blood at the injection site.
If you do, press on your skin with a cotton ball or gauze.
PUSH HOLD (Count to 10) CONFIRM 5) Throw away used material Put the used pre -filled pen in a puncture -resistant container, like a sharps container, immediately after use.
- Dispose of your sharps container according to your local regulations.
The rest of the material can be thrown away in your household rubbish.
📄 Package Leaflet – official source
This article reproduces the information in the official package leaflet, as authorised in the European Union. You can consult the original document here: Product information Entyvio (PDF, ec.europa.eu).
You can check this medicine at any time in the Union Register of medicinal products (EU number EU/1/14/923).
⚠️ Important: This article is for information purposes only and does not replace medical advice or the package leaflet inside the medicine box. Read the leaflet carefully before use. For any questions about your treatment, talk to your doctor or pharmacist. If you experience side effects, tell your doctor or pharmacist and report them through your national reporting system.
