Vedolizumab

Generic name: Vedolizumab
Brand names: Entyvio
Dosage form: intravenous (infusion) injection
Drug class: Selective immunosuppressants

Usage of Vedolizumab

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.

Vedolizumab side effects

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.

Before taking Vedolizumab

Tell your doctor if you are pregnant or plan to become pregnant. It is not known if vedolizumab will harm your unborn baby. Tell your healthcare provider right away if you become pregnant while receiving vedolizumab.

There is a pregnancy registry for women who use vedolizumab during pregnancy. The purpose of this registry is to collect information about the health of you and your baby. Talk with your healthcare provider about how you can take part in this registry or you may contact the registry at 1-877-825-3327 to enroll.

Tell your doctor if you are breastfeeding or plan to breastfeed. Vedolizumab passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby if you take vedolizumab.

Relate drugs

How to use Vedolizumab

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.

Warnings

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.

What other drugs will affect Vedolizumab

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.

Disclaimer

Every effort has been made to ensure that the information provided by Drugslib.com is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Drugslib.com information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Drugslib.com does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Drugslib.com's drug information does not endorse drugs, diagnose patients or recommend therapy. Drugslib.com's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners.

The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Drugslib.com does not assume any responsibility for any aspect of healthcare administered with the aid of information Drugslib.com provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.