What Is Entyvio? Entyvio (vedolizumab) is a monoclonal antibody used to treat Crohn’s disease and ulcerative colitis (UC), two types of inflammatory bowel disease (IBD). It helps relieve symptoms by reducing inflamed gastrointestinal
Entyvio (vedolizumab) is a monoclonal antibody used to treat Crohn’s disease and ulcerative colitis (UC), two types of inflammatory bowel disease (IBD). It helps relieve symptoms by reducing inflamed gastrointestinal parenchymal tissue.
Entyvio is given intravenously (IV, in the vein) by a healthcare provider. You will visit a healthcare facility to receive this infusion.
Generic Name: Vedolizumab
Brand Name(s): Entyvio
Drug Availability: Prescription
Administration Route: Intravenous
Therapeutic Classification: Monoclonal antibody
Available Generically: No
Controlled Substance: N/A
Active Ingredient: Vedolizumab
Dosage Form(s): Powder for solution
Entyvio is administered via intravenous (IV) infusion over 30 minutes by a trained healthcare provider in a setting equipped to monitor you for severe allergic reactions (anaphylaxis).
Since a healthcare provider administers Entyvio, it will be kept in a healthcare facility. The vials should be stored in original packaging to protect them from light and kept in the refrigerator prior to preparing for administration.
Entyvio is initially given more frequently to help get IBD under control (induce remission). Symptoms should improve during the induction period (first six weeks of treatment). Your healthcare provider may discontinue Entyvio if your symptoms do not improve by 14 weeks.
This is not a complete list of side effects and others may occur. A healthcare provider can advise you on side effects. If you experience other effects, contact your healthcare provider. You may report side effects to the FDA at fda.gov/medwatch or 1-800-FDA-1088.
The most common side effects of Entyvio are:
Call your healthcare provider right away if you have serious side effects. Call 911 if your symptoms feel life-threatening or if you think you’re having a medical emergency. Serious side effects and their symptoms can include the following:
There is a chance of developing an immune response to Entyvio, which may decrease the drug’s effectiveness in treating IBD. During clinical trials, about 4% of people developed anti-vedolizumab antibodies, and some of them had reduced or undetectable concentrations of Entyvio.
Entyvio may cause other side effects. Call your healthcare provider if you have any unusual problems while taking this medication.
If you experience a serious side effect, you or your healthcare provider may send a report to the FDA's MedWatch Adverse Event Reporting Program or by phone (800-332-1088).
Entyvio will be administered by a healthcare provider through an IV infusion for over 30 minutes. You will need to visit a medical facility to receive your infusions. The typical treatment regimen is an IV infusion of Entyvio at zero, two, and six weeks and then every eight weeks after.
In some cases, you may need to modify (change) your dose or treatment with Entyvio. Factors that may affect your treatment include pregnancy, breastfeeding, and age.
There are no adequate studies of Entyvio in pregnancy. This drug should only be used in pregnancy if the benefits to the pregnant person outweigh the risks to the fetus.
Theoretically, any adverse pregnancy effect would likely be more significant in the second and third trimesters of pregnancy. This is because monoclonal antibodies pass across the placenta in greater amounts later in pregnancy.
Small studies suggest that Entyvio is excreted in breastmilk in small quantities. Most experts believe that absorption by the nursing infant is minimal. It is likely OK to use Entyvio while breastfeeding. However, it would be best to exercise caution still until more data becomes available. Speak with your healthcare provider about the potential risks if you're receiving Entyvio and want to breastfeed your child.
Clinical trials of Entyvio only included a small number of older adults aged 65 and older. The number was too small to determine whether people in this age group respond differently to Entyvio compared to younger people. No overall differences in safety or effectiveness compared to younger adults were noted in the small group of older adults.
If you miss an infusion of Entyvio, contact your healthcare provider for guidance on rescheduling your appointment.
Since this medication is infused in a professional setting, overdose is unlikely to occur. Toxic effects are expected to be similar to adverse effects seen with usual doses, and management is supportive.
It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly. Blood tests may be needed to check for unwanted effects.
Vedolizumab may cause an infusion reaction while you are receiving it or right after the infusion ends. Check with your doctor or nurse right away if you have chest pain, a fever, chills, itching, hives, a rash, dizziness, fainting, lightheadedness, a headache, joint pain, difficulty with swallowing, trouble breathing, or swelling of the face, tongue, and throat.
This medicine may cause serious allergic reactions, including anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Call your doctor right away if you have a rash, itching, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth with this medicine.
Your body's ability to fight an infection may be reduced with this medicine. Avoid being near people who are sick and wash your hands often. Tell your doctor if you have ever had an infection that would not go away or an infection that kept coming back. Check with your doctor right away if you have a fever, chills, cough, flu-like symptoms, or unusual tiredness or weakness.
This medicine may increase your risk of getting a rare brain infection called progressive multifocal leukoencephalopathy (PML). Call your doctor right away if you have back pain, blurred vision, confusion, dizziness, drowsiness, a fever or headache, seizures, or unusual tiredness or weakness.
Check with your doctor right away if you have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, vomiting, or yellow eyes or skin. These could be symptoms of a serious liver problem.
While you are being treated with vedolizumab, do not have any immunizations (vaccines) without your doctor's approval. Your vaccinations need to be current before you receive vedolizumab.
Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.
Do not take Vedolizumab if you have a known serious or severe hypersensitivity (allergy) to Entyvio or any of its inactive components. The signs and symptoms of serious reactions include:
Some medications may interact with Entyvio when used together. Tell your healthcare team about all the medications (prescription and over-the-counter), vitamins, and herbal supplements you take and if you plan on receiving any live vaccines.
Interactions can include:
Natalizumab is another monoclonal antibody used to treat Crohn’s disease. It should not be used together with Entyvio.
Entyvio is used to treat ulcerative colitis and Crohn’s disease in adults who cannot take a tumor necrosis factor blocker due to intolerance or poor/inadequate/lost response or had an insufficient response or dependence on corticosteroids.
White blood cells normally circulate in the body as part of the immune system. In IBD, more white blood cells enter the GI tract. This leads to inflammation of the GI tract and symptoms of IBD. Entyvio works by binding to white blood cells directed to the GI tract and preventing excess white blood cells from entering the GI tract, decreasing inflammation.
The most common side effects of Entyvio are headaches, joint pain, nausea, nasopharyngitis (sore throat), upper respiratory infection, fever, and fatigue.
Before starting treatment with Entyvio, be sure that you are up to date on all immunizations according to current immunization guidelines. Entyvio may result in a less robust response to immunizations. You may continue to receive non-live vaccines and may receive live vaccines if the benefits outweigh the risks.
Look out for and report any symptoms of allergic reaction to your healthcare provider. These can include:
Infusion-related reactions can occur hours after receiving an infusion.
If you are taking corticosteroids (e.g., prednisone) along with Entyvio, work closely with your healthcare provider to see if your steroid dose can be gradually decreased over time.
Keep track of your infusion schedule and next infusion date. You’ll receive Entyvio more frequently in the beginning, and then infusions will space out to every eight weeks. You and your healthcare provider will determine whether you are benefiting from this drug after 14 weeks of treatment. If symptoms have not improved by 14 weeks, this medication should be stopped.
Verywell Health's drug information is meant for educational purposes only and is not intended to replace medical advice, diagnosis, or treatment from a healthcare provider. Consult your healthcare provider before taking any new medication(s). IBM Watson Micromedex provides some of the drug content, as indicated on the page.