108 mg injection, solution in a prefilled pen 
vedolizumab

Read all of this leaflet carefully before you start using this medicine. It contains information that is important to you.

– Save this information, you may need to read it again.

– If you have any further questions, ask your doctor, pharmacist, or nurse.

– This medicine has been prescribed for you only. Do not give it to others. It may harm them, even if they show symptoms similar to yours.

– If you get any side effects, talk to your doctor, pharmacist, or nurse. This also applies to any side effects not mentioned in this information. See section 4.

In this 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 ingredients information 

1. What Entyvio is and what it is used for

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Entyvio contains the active substance vedolizumab. Vedolizumab belongs to a group of biological drugs called monoclonal antibodies (MAb).

How Entyvio works

Entyvio works by blocking a protein on the surface of the white blood cells that cause inflammation in ulcerative colitis and Crohn’s disease  This reduces inflammation.

What Entyvio is used for

Entyvio is used to treat adults with signs and symptoms of:

  • ulcerative colitis with moderate to severe disease activity
  • Crohn’s disease with moderate to severe disease activity.

Ulcerative colitis

Ulcerative colitis is a disease that causes inflammation in the colon. If you have ulcerative colitis, you will first be treated with other medicines. If the treatment results are not satisfactory or if you do not tolerate these medicines, your doctor may give you Entyvio to reduce your symptoms.

Crohn’s disease

Crohn’s disease is a disease that causes inflammation in the digestive system. If you have Crohn’s disease, you will first be treated with other medicines. If the treatment results are not satisfactory or if you do not tolerate these medicines, your doctor may give you Entyvio to reduce your symptoms.

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 tuberculosis, sepsis, severe diarrhea and vomiting (gastrointestinal catarrh ), infection of the nervous system.

Warnings and cautions

Talk to your doctor, pharmacist, or nurse before 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 blurred vision, vision loss or double vision, speech difficulties, weakness in an arm or leg, an altered gait or balance difficulties, persistent numbness, decreased or lost feeling memory loss, or confusion. All of these can be symptoms of a serious and potentially fatal condition that affects the brain and is called progressive multifocal leukoencephalopathy ( PML ).
  • If you have an infection or think you have an infection – symptoms include chills, tremors, persistent cough, or high fever. Some infections can become serious and even life-threatening if left untreated.
  • if you experience signs of an allergic reaction such as wheezing, difficulty breathing, hives, itching, swelling, or dizziness. More detailed information on allergic reactions can be found in section 4.
  • if you are going to be vaccinated or have recently been vaccinated. Entyvio may affect your response to the vaccination.
  • If you have cancer, talk to your doctor about it. Your doctor will then need to decide if you can continue with Entyvio or not.
  • if you do not feel better, as it may take up to 14 weeks before vedolizumab starts working for some patients who have Crohn’s disease with severe disease activity.

Children and young people

Entyvio is not recommended for use in children and adolescents (under 18 years of age) due to a lack of data 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 take any other medicines.

  • Entyvio should not be given with other biological drugs that inhibit the immune response, 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 used to treat certain types of cancer and rheumatoid arthritis ).

Your doctor will decide if you should receive Entyvio or not.

Pregnancy, breastfeeding, and fertility

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 using this medicine.

Pregnancy

The effects of Entyvio in pregnant women are unknown. This medicine is therefore not recommended during pregnancy. You and your doctor should decide if the benefit to you outweighs the potential risk to you and the unborn baby.

If you are a woman of childbearing potential, avoid getting pregnant while using Entyvio. Use the appropriate method of contraception during treatment and for at least 4.5 months after the end of treatment.

Breast-feeding

Tell your doctor if you are breast-feeding or about to start breast-feeding. Entyvio passes into breast milk. There is not enough information on how this can affect your child. A decision must be made whether to stop breast-feeding or stop treatment with Entyvio, after taking into account the benefit of breast-feeding for your baby and the benefit of treatment for you.

Driving and using machines

This medicine has less effect on the ability to drive and use power tools or machines. A small number of patients have suffered from dizziness after receiving Entyvio. If you feel dizzy, do not drive or use any tools or machines.

Entyvio 108 mg solution for injection contains sodium

This medicine contains less than 1 mmol (23 mg) sodium per dose, ie essentially ‘sodium-free’.

3. How to use Entyvio

Always use this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.

You or the person caring for you will receive training in how Entyvio is given as an injection under the skin ( subcutaneous injection ).

How much Entyvio you will get

The treatment with Entyvio is the same as for ulcerative colitis and Crohn’s disease.

The recommended dose is 108 mg Entyvio as a subcutaneous injection once every two weeks.

  • When starting treatment, your doctor will give you starting doses of Entyvio via a drip into a vein in your arm ( intravenous infusion ) for about 30 minutes.
  • After at least 2 intravenous infusions, you can start receiving Entyvio as a subcutaneous injection. The first subcutaneous injection is given at the time of the next scheduled intravenous infusion and every two weeks thereafter.

Injection of Entyvio

The subcutaneous injections can be given either by yourself or by a person who cares for you after training in how to do it. Instructions can be found at the end of this leaflet.

If you forget to use Entyvio

If you miss or miss a dose, inject the next dose as soon as possible and every two weeks thereafter.

If you stop using Entyvio

Do not stop using Entyvio without talking to a doctor.

If you have any further questions on the use of this product, 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 are

Tell a doctor immediately if you experience any of the following:

  • allergic reactions (may affect up to 1 in 100 people) with symptoms that may include: wheezing or difficulty breathing, hives  itchy skin, swelling, nausea, redness and
  • infection er (may occur in up to 1 in 10 users) with symptoms that include: chills or tremors, high fever, or rash.

Other side effects are

Talk to your doctor as soon as possible if you experience any of the following:

A very common side effect is (can occur in more than 1 in 10)

  • cold
  • joint pain
  • headache.

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

  • fever
  • respiratory tract infection
  • fatigue
  • cough
  • influenza
  • back pain
  • sore throat
  • sinusitis
  • itching
  • rash and redness
  • pain in arms/legs
  • muscle cramps
  • muscle weakness
  • throat infections
  • stomach flu
  • infection of the rectum
  • ulcers in the rectum
  • hard stools
  • inflated stomach
  • gas formation
  • high blood pressure
  • tingling or crawling
  • heartburn
  • hemorrhoids
  • nasal congestion
  • eczema
  • night sweats
  • acne (pimples)
  • injection site reactions (including pain, swelling, redness, or itching ).

Less common side effects are (may affect up to 1 in 100)

  • red and sore hair follicles
  • fungal infection of the mouth and throat
  • infection in the vagina
  • shingles ( herpes zoster).

Very rare side effects are (may affect up to 1 in 10 000 users)

  • pneumonia
  • blurred vision (reduced visual acuity )
  • the sudden, severe allergic reaction that may cause breathing problems, swelling, rapid heartbeat, sweating, drop in blood pressure, dizziness, loss of consciousness, and collapse ( anaphylactic reaction and anaphylactic shock ).

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 expiration date is the last day of the specified month.
  • Entyvio is for single use only.
  • Store in a refrigerator (2 ° C – 8 ° C). Keep the pre-filled pen in the outer carton. Sensitive to light. If needed, the pre-filled pen can be stored outside the refrigerator in its original carton at room temperature (up to 25 ° C) for up to 7 days. Do not use the pre-filled pen if it has been stored outside the refrigerator for more than 7 days.
  • Do not freeze. Do not leave in direct sunlight.
  • Do not use this medicine if it contains particles or if it is discolored (the solution should be discolored to yellow).
  • Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Contents of the packaging and other information

Content declaration

  • The active substance is vedolizumab. Each pre-filled pen contains 108 mg vedolizumab.
  • The other ingredients are citric acid monohydrate, sodium citrate dihydrate, L-histidine, L-histidine monohydrochloride, L-arginine hydrochloride, polysorbate 80, and water for injections.

What the medicine looks like and the contents of the pack

  • Entyvio is a colorless to yellow injection solution provided in a pre-filled pen of glass provided with a needle shield that is triggered automatically to cover the needle immediately after the pen is lifted from the injection site.
  • Entyvio is supplied in a pack containing 1 pre-filled pen and in multi-packs containing 2 (2 x 1) pre-filled pens or 6 (6 x 1) pre-filled pens. Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorisation Holder

Takeda Pharma A / S

Delta Park 45

2665 Vallensbaek Strand

Denmark

Manufacturer

Takeda Austria GmbH

St. Peter ‑ Straβe 25

A ‑ 4020 Linz

Austria

Contact the representative of the marketing authorization holder to find out more about this medicine:

Takeda Pharma AB

Tel .: 08 731 28 00

This leaflet was last modified on 11 May 2020

Muhammad Nadeem

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