Vedolizumab Injection

What is this medication?

VEDOLIZUMAB (ve doe LIZ you mab) treats inflammatory bowel diseases. It works by decreasing inflammation in the digestive tract.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

COMMON BRAND NAME(S): Entyvio

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

• Immune system problems
• Infection, such a tuberculosis (TB) or other bacterial, fungal, or viral infections
• Liver disease
• Recent or upcoming vaccine
• An unusual or allergic reaction to vedolizumab, other medications, foods, dyes, or preservatives
• Pregnant or trying to get pregnant
• Breast-feeding

How should I use this medication?

This medication is injected into a vein. It is given by your care team in a hospital or clinic setting.

A special MedGuide will be given to you by the pharmacist with each prescription and refill. Be sure to read this information carefully each time.

Talk to your care team about the use of this medication in children. It is not approved for use in children.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

It is important not to miss your dose. Call your care team if you are unable to keep an appointment.

What may interact with this medication?

• Steroid medications, such as prednisone or cortisone
• TNF-alpha inhibitors, such as natalizumab, adalimumab, and infliximab
• Vaccines

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Visit your care team for regular checks on your progress. Tell your care team if your symptoms do not start to get better or if they get worse.

Stay away from people who are sick. Call your care team for advice if you get a fever, chills or sore throat, or other symptoms of a cold or flu. Do not treat yourself.

In some patients, this medication may cause a serious brain infection that may cause death. If you have any problems seeing, thinking, speaking, walking, or standing, tell your care team right away. If you cannot reach your care team, get urgent medical care.

What side effects may I notice from receiving this medication?

Side effects that you should report to your care team as soon as possible:

• Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
• Dizziness, loss of balance or coordination, confusion or trouble speaking
• Infection—fever, chills, cough, or sore throat
• Infusion reactions—chest pain, shortness of breath or trouble breathing, feeling faint or lightheaded
• Liver injury—right upper belly pain, loss of appetite, nausea, light-colored stool, dark yellow or brown urine, yellowing skin or eyes, unusual weakness or fatigue

Side effects that usually do not require medical attention (report to your care team if they continue or are bothersome):

• Headache
• Fatigue
• Joint pain
• Nausea

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medication?

This medication is given in a hospital or clinic and will not be stored at home.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.