Entyvio 300 mg powder for concentrate for solution for infusion

• 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.

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

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

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.

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.

Tell your doctor or nurse immediately when you first receive 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 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.

This medicine contains 3.31 mg of polysorbate 80 in each Entyvio 300 mg vial. Polysorbates may cause allergic reactions. Tell your doctor if you have any known allergies.

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.

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
• 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:

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)
• rectal bleeding
• chest discomfort
• 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
• 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)

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 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.

• 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 (E 433). See section 2 “Entyvio contains 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.