Vedolizumab, Injection

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KEY POINTS

• This medicine is given by IV to treat Crohn’s disease or ulcerative colitis.
• You may get serious infections more easily when you are taking this medicine.
• Keep all appointments for tests to see how this medicine affects you.
• This medicine may cause a serious brain infection or other unwanted side effects. Tell your healthcare provider if you have any side effects that are serious, continue, or get worse.
• Tell all healthcare providers who treat you about all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take.

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What are other names for this medicine?

Type of medicine: integrin receptor antagonist

Generic and brand names: vedolizumab, injection; Entyvio

What is this medicine used for?

This medicine is given by IV infusion (slow drip through a needle into a large vein) to treat:

• Crohn's disease
• Ulcerative colitis

This medicine is used when you can’t be treated with other medicines or when other medicines have not worked well enough.

This medicine may be used to treat other conditions as determined by your healthcare provider.

What should my healthcare provider know before I take this medicine?

Before taking this medicine, tell your healthcare provider if you have ever had:

• An allergic reaction to any medicine
• A weakened immune system from cancer treatment, diseases such as HIV/AIDS, or from taking steroid medicines or medicines to prevent organ transplant rejection
• Liver problems
• Tuberculosis (TB) or have recently been exposed to TB

Tell your healthcare provider if you have an infection or have infections that keep coming back. Also, tell your healthcare provider if you have recently had a vaccination or are scheduled to receive any kind of vaccination. It is best to have vaccines up to date before you start treatment with this medicine.

Females of childbearing age: Tell your healthcare provider if you are pregnant or plan to become pregnant. Do not breast-feed while taking this medicine without your healthcare provider's approval.

How do I use it?

Read the Medication Guide that comes in the medicine package when you start taking this medicine and each time you have a treatment.

These infusions are given by your healthcare provider. You will be monitored closely while receiving the infusion and for a period of time afterward for side effects. Keep all appointments for the infusions.

What should I watch out for?

This medicine may cause an infusion-related reaction or an allergic reaction. This can happen while you are receiving this medicine or several hours after treatment. Tell your healthcare provider or get medical help right away if you have: wheezing, dizziness, flushing, fast or irregular heartbeat; rash, itching, swelling of your lips, tongue, throat, or face, shortness of breath.

This medicine increases the risk of progressive multifocal leukoencephalopathy (PML), a brain infection that can lead to death or severe disability. If you notice new or sudden changes in thinking, walking, talking, or seeing, or sudden weakness on one side of your body, contact your healthcare provider right away.

You may get serious infections more easily when you are taking this medicine. Stay away from people with colds, flu, or other infections. Contact your healthcare provider right away if you develop a fever or ANY other symptoms of infection. Also, do not have any vaccines without getting your healthcare provider's approval first.

You need to have exams and blood tests regularly to see how this medicine affects you. Keep all appointments.

This medicine may make you dizzy or cause vision changes. Do not drive or operate machinery unless you are fully alert and can see clearly.

If you need emergency care, surgery, lab tests, or dental work, tell the healthcare provider or dentist you are taking this medicine.

What are the possible side effects?

Along with its needed effects, your medicine may cause some unwanted side effects. Some side effects may be very serious. Some side effects may go away as your body adjusts to the medicine. Tell your healthcare provider if you have any side effects that continue or get worse.

Life-threatening (Report these to your healthcare provider right away. If you cannot reach your healthcare provider right away, get emergency medical care or call 911 for help.): Allergic reaction (hives; itching; rash; trouble breathing; tightness in your chest; swelling of your lips, tongue, and throat); sudden weakness, numbness, or tingling, especially on one side of your body; sudden or severe headache; sudden trouble with vision, speech, balance, or walking.

Serious (Report these to your healthcare provider right away.): Yellowing of your skin or eyes; dark urine; severe stomach pain, diarrhea, or vomiting; loss of appetite; fever, cough, or sore throat; breathing problems; dizziness; unusual bruising or bleeding; unusual tiredness or weakness; skin rash, itching, or skin sores; trouble urinating.

Other: Runny or stuffy nose, headache, joint pain, nausea, mild tiredness, back pain.

What products might interact with this medicine?

When you take this medicine with other medicines, it can change the way this or any of the other medicines work. Nonprescription medicines, vitamins, natural remedies, and certain foods may also interact. Using these products together might cause harmful side effects. Talk to your healthcare provider if you are taking any other medicines.

• Cancer medicines such as cisplatin, doxorubicin (Doxil), hydroxyurea (Droxia, Hydrea), vinblastine, and vincristine (Marqibo)
• Corticosteroids such as betamethasone, cortisone, dexamethasone, fludrocortisone, hydrocortisone (A-Hydrocort, Cortef), methylprednisolone (Medrol, Solu-Medrol), prednisolone (Omnipred, Orapred, Prelone), prednisone (Prednisone Intensol), and triamcinolone (Aristospan, Kenalog)
• Immunosuppressants such as azathioprine (Azasan, Imuran), cyclosporine (Gengraf, Neoral, Sandimmune), sirolimus (Rapamune), and tacrolimus (Astagraf, Prograf, Protopic)
• Medicines to treat psoriasis, rheumatoid arthritis, and other immune disorders such as abatacept (Orencia), adalimumab (Humira), anakinra (Kineret), certolizumab (Cimzia), etanercept (Enbrel), golimumab (Simponi), infliximab (Remicade), leflunomide (Arava), rituximab (Rituxan), tocilizumab (Actemra), and tofacitinib (Xeljanz)
• Methotrexate (Otrexup, Rasuvo, Rheumatrex, Trexall)
• Multiple sclerosis medicines such as fingolimod (Gilenya) and natalizumab (Tysabri)
• Vaccines

If you are not sure if your medicines might interact, ask your pharmacist or healthcare provider. Keep a list of all your medicines with you. List all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take. Be sure that you tell all healthcare providers who treat you about all the products you are taking.

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This advisory includes selected information only and may not include all side effects of this medicine or interactions with other medicines. Ask your healthcare provider or pharmacist for more information or if you have any questions.

Keep all medicines out of the reach of children.

Do not share medicines with other people.