Vedolizumab is a type of drug called a monoclonal antibody. It is used to treat inflammatory bowel disease (IBD), including ulcerative colitis and Crohn's disease.

Vedolizumab is a targeted therapy that was designed to be a gut-selective immunotherapy. Other immunosuppressive drugs used for IBD affect the whole body.

Vedolizumab belongs to a class of drugs called integrin receptor antagonist. Its mechanism of action, or how it works, is by binding to α₄β₇ integrin on the surface of a type of white blood cell called memory T-lymphocytes. Binding to α₄β₇ integrin blocks it from interacting with MAdCAM-1 (mucosal addressin cell adhesion molecule-1). This interaction plays a key role in causing the chronic inflammation seen in people with IBD.

Vedolizumab is a biological drug that was approved by the US Food and Drug Administration (FDA) in 2014. No biosimilars of vedolizumab have been approved by the FDA. Biosimilars are biological drugs that are highly similar and are designed to have the same effect on a person, but they are not identical to the original version of the drug.

What is vedolizumab used for?

Vedolizumab is a prescription medicine used in adults for the treatment of:

• moderately to severely active ulcerative colitis.
• moderately to severely active Crohn's disease.

It is not known if vedolizumab is safe and effective in children under 18 years of age.

Vedolizumab may cause serious side effects, including:

• Infusion-related and serious allergic reactions. These reactions can happen while you are receiving vedolizumab or several hours after treatment. You may need treatment if you have an allergic reaction. Tell your healthcare provider or get medical help right away if you get any of these symptoms during or after an infusion of vedolizumab: 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).
• Infections. Vedolizumab may increase your risk of getting a serious infection. Before receiving vedolizumab and during treatment with vedolizumab, tell your healthcare provider if you think you have an infection or have symptoms of an infection such as 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.
• Progressive Multifocal Leukoencephalopathy (PML). People with weakened immune systems can get progressive multifocal leukoencephalopathy (PML) (a rare, serious brain infection caused by a virus). Although unlikely while receiving vedolizumab, a risk of PML cannot be ruled out. PML can result in death or severe disability. There is no known treatment, prevention, or cure for PML. Tell your healthcare provider right away if you have any of the following symptoms: confusion or problems thinking, loss of balance, change in the way you walk or talk, decreased strength or weakness on one side of the body, blurred vision, or loss of vision.
• Liver Problems. Liver problems can happen in people who receive vedolizumab. Tell your healthcare provider right away if you have any of the following symptoms: tiredness, loss of appetite, pain on the right side of your stomach (abdomen), dark urine, or yellowing of the skin and eyes (jaundice).

See "What are the side effects of vedolizumab?" below for more information about side effects.

• Vedolizumab is given through a needle placed in a vein (intravenous infusion) in your arm.
• Vedolizumab is given to you over a period of about 30 minutes.
• Your healthcare provider will monitor you during and after the vedolizumab infusion for side effects to see if you have a reaction to the treatment.

The recommended dosage of vedolizumab in patients with ulcerative colitis and and Crohn's disease is 300 mg infused intravenously over approximately 30 minutes at zero, two and six weeks, then every eight weeks thereafter.

See Full Prescribing information for further information about dosing.

Do not receive vedolizumab if you have had an allergic reaction to vedolizumab or any of the ingredients in vedolizumab. See below for a complete list of ingredients in vedolizumab.

What should I tell my doctor before receiving vedolizumab?

Before receiving vedolizumab, tell your healthcare provider about all of your medical conditions, including if you:

• have an infection, think you may have an infection or have infections that keep coming back (see "Important information" above).
• have liver problems.
• have tuberculosis (TB) or have been in close contact with someone with TB.
• have recently received or are scheduled to receive a vaccine. Talk to your healthcare provider about bringing your vaccines up-to-date before starting treatment with vedolizumab.

Vedolizumab may cause serious side effects, see "Important information" above.

The most common side effects of vedolizumab include: common cold, headache, joint pain, nausea, fever, infections of the nose and throat, tiredness, cough, bronchitis, flu, back pain, rash, itching, sinus infection, throat pain, and pain in extremities.

These are not all of the possible side effects of vedolizumab.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins and herbal supplements. Especially tell your healthcare provider if you take or have recently taken Tysabri (natalizumab), a Tumor Necrosis Factor (TNF) blocker medicine, a medicine that weakens your immune system (immunosuppressant), or corticosteroid medicine.