Find your question, get your answer about ENTYVIO

• Biologics are genetically engineered medications made from living organisms and their products, such as proteins.
• ENTYVIO is a biologic that works by binding specifically to a protein that’s present on certain white blood cells that migrate into the gastrointestinal tract and can cause inflammation.

• When starting treatment, the initial doses of ENTYVIO will be given by a healthcare practitioner through a drip in 1 of the veins in your arm (intravenous infusion) over about 30 minutes.
• After at least 2 intravenous infusions, you can start receiving ENTYVIO by an injection under the skin (subcutaneously).

When you start ENTYVIO, you will get 3 doses in the first 6 weeks.

• First dose at week 0 – Intravenous
• Second dose at week 2 – Intravenous
• Third dose at week 6 – Subcutaneous

If you forget or miss an injection, the next dose should be injected as soon as possible and then every 2 weeks thereafter. If you are registered with the OnePath^® Patient Support Program, your Care Manager can help you reschedule.

The most common side effects are:

• Nasopharyngitis (inflammation in the nose and throat)
• Arthralgia (joint pain)
• Headache
• Nausea
• Fever
• Upper respiratory tract infection
• Fatigue
• Cough
• Injection site reactions

NOTE: This is not a complete list of side effects. If you have any unexpected effects while taking ENTYVIO, contact your doctor or pharmacist.

Some serious side effects can happen with ENTYVIO. Common serious side effects in people taking ENTYVIO are:

• Infusion and allergic reactions
• Infections

Tell your healthcare provider right away if you have any of these signs or symptoms at any time:

Rash, itching, swelling of your lips, tongue, throat or face, shortness of breath or trouble breathing, wheezing, dizziness, feeling hot, or palpitations (feel like your heart is racing)

• These are signs and symptoms of infusion and allergic reactions.

Fever, chills, muscle aches, cough, shortness of breath, runny nose, sore throat, red or painful skin or sores on your body, tiredness, or pain during urination

• These are symptoms of infections.

Tiredness, loss of appetite, pain on the right side of your stomach, dark urine, or yellowing of the skin and eyes (jaundice)

• These are symptoms of liver problems.

NOTE: This is not a complete list of side effects. If you have any unexpected effects while taking ENTYVIO, contact your doctor or pharmacist.

You should not be given ENTYVIO if:

• You have an active, severe infection.
• You are allergic to vedolizumab, the active ingredient in ENTYVIO, or any of the other ingredients in ENTYVIO.

• Tell all your healthcare providers that you’re taking ENTYVIO.
• You should also tell your doctor, nurse and/or pharmacist about all the medicines you take or have taken, including prescription and non-prescription medicines, vitamins, and herbal supplements.
• ENTYVIO should not be given with other biologic drugs that suppress your immune system.

There are no studies with vedolizumab in pregnant women. It is strongly recommended that women of childbearing potential use adequate contraception to prevent pregnancy and to continue its use for at least 18 weeks after the last treatment with ENTYVIO. It is not known if ENTYVIO will harm your unborn baby.

Breast-feeding Vedolizumab has been detected in human milk. The effect of vedolizumab on breast-fed infants and the effects on milk production are unknown. It is not known if ENTYVIO will harm your baby.

Before you start, tell your doctor if any of the following applies to you:

• You experience signs of an allergic reaction or other reaction to an infusion such as wheezing, difficulty breathing, hives, itching, swelling or dizziness. These could occur during or after the infusion.
• 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).
• You have new or worsening symptoms of an infection (chills, shivering or high fever), are being treated for an infection, or get many infections or have infections that keep coming back.
• You have tuberculosis (TB) or have been in close contact with someone with TB. Your physician may want to consider testing you for TB.
• You are going to receive any vaccination or have recently had a vaccination. ENTYVIO may affect the way you respond to a vaccination.
• You have liver problems.
• You are pregnant or plan to become pregnant. It is not known if ENTYVIO will harm your unborn baby. Talk to your doctor if you are pregnant or plan to become pregnant.
• You are breastfeeding or planning to breastfeed. It is not known if ENTYVIO will harm your baby. Talk to your doctor about the best way to feed your baby while taking ENTYVIO.
• You have previously taken or are taking Tysabri^® (natalizumab), or Rituxan^® (rituximab).