• Entyvio is a brand (trade) name for vedolizumab which is a biological therapy that may be used to treat ulcerative colitis or Crohn’s disease.
• Entyvio (vedolizumab) binds to a protein on the surface of T-lymphocytes called the alpha4beta7 integrin and blocks its interaction with the mucosal addressin cell adhesion molecule-1 (MAdCAM-1) which inhibits the migration of memory T-lymphocytes (a type of white blood cell) across the endothelium into inflamed gastrointestinal tract tissue. The interaction of the alpha4beta7 integrin with MAdCAM-1 has been recognized as an important contributor to the chronic inflammation that is characteristic of ulcerative colitis and Crohn's disease. Put simply, Entyvio works by preventing too many white blood cells from entering your GI tract (intestine) which helps to control inflammation and symptoms of ulcerative colitis or Crohn's disease.
• Entyvio belongs to the drug class called integrin receptor antagonists. It may also be called a selective immunosuppressant or a monoclonal antibody.

• May be used to treat adults with moderate to severe ulcerative colitis or Crohn‘s disease.
• Entyvio has no known systemic (whole-body) immunosuppressive effects but is still likely to increase a person's risk of infections.
• Targets the gut specifically instead of the entire body, unlike some other biologics.
• The maintenance dosage of Entyvio is usually 300mg given as an infusion every 2 months (8 weeks).
• No differences in side effects or responses were noted when older people over the age of 65 years were given Entyvio.

If you are between the ages of 18 and 60, take no other medication or have no other medical conditions, side effects you are more likely to experience include:

• Infections (such as a cold, the flu, sinus infections, or bronchitis), headache, pain (in the throat, joints, arms, or legs), nausea, fever, feeling tired, cough, rash, and itching are the most common side effects reported with
• Weight gain was not reported as a side effect of Entyvio in clinical trials conducted by the manufacturer. However, when gastrointestinal diseases such as Crohn’s disease or ulcerative colitis improve, patients who have previously lost weight may gain some weight as their illness improves.
• Even though Entyvio is not considered a whole-body immunosuppressant, it is still associated with an increased risk of infections, some which may be serious. Serious infections reported in patients treated with Entyvio included anal abscess, sepsis (some fatal), tuberculosis, salmonella sepsis, listeria meningitis, giardiasis, and cytomegaloviral colitis. The most commonly reported infections in clinical trials included the common cold (13%) or an upper respiratory tract infection (7%). Other infections were bronchitis (4%), influenza (4%), and sinusitis (3%). Other medications that increase the risk of infection with Entyvio include Tysabri (natalizumab) or corticosteroids (eg, prednisone or methylprednisolone).
• There is a risk of progressive multifocal leukoencephalopathy (PML) with Entyvio. PML is an opportunistic viral infection of the brain caused by the JC virus (JCV) that often leads to death or severe disability.
• Infusion and serious allergic reactions can happen during an infusion with Entyvio or for several hours after treatment. Monitor all patients during and soon after the Entyvio infusion for side effects.
• Entyvio can also cause liver problems in some people. Liver problems might lead to a loss of appetite, which in turn could lead to weight loss.
• Entyvio is expensive and costs approximately $6,700 for a supply of one 300 mg vial of powder for injection. Those with private commercial insurance may be able to get Entyvio for as little as $5 per dose. If you do not have insurance, Takeda may still be able to offer you financial assistance. Patients who receive governmental-sponsored insurance, such as Medicare, Medicaid, or TriCare are not eligible for the $5 copay program but may be able to get assistance through an independent copay foundation.
• Needs to be administered as an intravenous infusion over approximately 30 minutes by a healthcare provider. Cannot be given as a push or an IM or SC injection.
• A small percentage of people receiving Entyvio may develop antibodies to it. In the UC and CD trials, 4% (56) of patients developed antibodies to Enyvio; 9 of whom were persistently positive. Entyvio concentrations were undetectable in 6 of these 9 patients and two had reduced concentrations. None of these 9 achieved clinical remission at Weeks 6 or 52 in the controlled trials.
• Before administering Entyvio, a person's vaccination status should be all up to date.
• Discontinue Entyvio if a person is not showing any benefit after 14 weeks.
• Research has not identified an increased risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes associated with Entyvio use in pregnant women. There is also a risk to the mother and the fetus associated with uncontrolled inflammatory bowel disease. Weight up risks vs benefits. Any woman who becomes pregnant should join the pregnancy registry call 1-877-TAKEDA7 (1-877-825-3327). Data suggests that Entyvio is detectable in breast milk. The effects of this exposure on a breastfeeding infant are unknown. Weigh up benefits vs risks.
• No generic of Entyvio is currently available.

Note: In general, seniors or children, people with certain medical conditions (such as liver or kidney problems, heart disease, diabetes, seizures) or people who take other medications are more at risk of developing a wider range of side effects. View complete list of side effects

• Entyvio is given as a 300 mg intravenous (IV) infusion into your vein. You will receive your infusions in your doctor’s office, local clinic, hospital, or even your home. Talk to your doctor and insurance company about which location may be the best and most affordable for you. Entyvio infusions take about 30 minutes each time, but your entire clinic visit might take a couple of hours. You can usually go back to your normal activities after the infusion.
• Before starting treatment with Entyvio, and during treatment with Entyvio, tell your health care provider if you think you have an infection or have symptoms of an infection such as a 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. Also, let them know if you have infections that keep coming back.
• You will be given 3 starting dose infusions of 30 minutes each. Initially, to start treatment, you will receive these infusions at week 0 (your 1st dose), week 2, and then at week 6. Most patients receive 300 mg per dose. After your starting doses, you'll get one 30‑minute infusion every 8 weeks to keep your disease under control.
• There have been reports of serious hypersensitivity reactions occurring with Enytvio. Symptoms of a reaction might include a rash, itching, swelling of your lips, tongue, throat, or face, shortness of breath or trouble breathing, wheezing, dizziness, feeling hot, or palpitations (racing heartbeat). If you experience these symptoms after leaving the clinic, call 911, or have someone take you to the emergency room.
• Tell your doctor If you have a history of recurring severe infections. Your doctor may also screen you for tuberculosis (TB) before starting Entyvio treatment. You may need to have your vaccines updated, as well. You should avoid live vaccines once you start treatment with Entyvio unless your doctor approves.
• See your doctor 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, sores on your body, tiredness, or pain during urination.
• Entyvio can also cause liver problems in some people. Tell your doctor right away if you experience any of the following symptoms tiredness, loss of appetite, pain on the right side of your stomach (abdomen), dark urine, and yellowing of the skin or eyes (jaundice).
• Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
• Research has not identified an increased risk of major birth defects, miscarriage, or other dangers to an unborn baby if Entyvio is given during pregnancy. However, it is generally better not to take medications during pregnancy. Tell your doctor if you inadvertently become pregnant while taking Enytvio and join the pregnancy registry (call 1-877-TAKEDA7 [1-877-825-3327]). Data also suggests that Entyvio is detectable in breast milk. The effects of this exposure on a breastfeeding infant are unknown.

• Entyvio may relieve some symptoms of ulcerative colitis (UC) within a few weeks but it may take up to six weeks for a noticeable effect to be seen. With continued treatment, Entyvio can significantly relieve symptoms, induce remission, and reduce or stop the use of corticosteroids. When people are in remission, symptoms such as stomach pain and cramping, diarrhea, and fatigue go away.
• In one trial, 46% (225 patients) had a clinical response at 6 weeks compared to 26% (149 patients) who received a placebo (inactive agent) out of 373 patients with UC who received Entyvio. Some patients achieved clinical remission at 6 weeks (17% on Entyvio vs. 5% on placebo). In studies that were carried out for one year, 42% of patients were in clinical remission at Week 52 compared to 16% of patients on a placebo.
• In two Entyvio studies that were extended to one year, 39% and 44% of patients were in remission at the end of the trial, compared to 22% and 30% of patients who received a placebo. Both studies were found to be statistically significant.
• In patients with Crohn’s disease, 15% of those receiving Entyvio in 2 studies were in remission at 6 weeks, compared to 7% and 12% on placebo. Only one study was found to be statistically significant.
• Every patient reacts differently to medication treatment and has a different level of disease severity. Not every patient will respond to Entyvio.
• If after 14 weeks you have not experienced a therapeutic benefit with Entyvio your doctor may consider discontinuing Entyvio treatment.

Medicines that interact with Entyvio may either decrease its effect, affect how long it works, increase side effects, or have less of an effect when taken with Entyvio. An interaction between two medications does not always mean that you must stop taking one of the medications; however, sometimes it does. Speak to your doctor about how drug interactions should be managed.

Common medications that may interact with Entyvio include:

• TNF blockers, such as adalimumab, etanercept, golimumab, or infliximab
• corticosteroids (such as prednisone or dexamethasone)
• herbals, such as black cohosh
• immunosuppressants such as azathioprine, cyclosporine, or tacrolimus
• interferon
• live vaccines and some other vaccines, such as BCG, cholera, measles, hepatitis b vaccines, yellow fever, or live influenza vaccines (may be administered concurrently if the benefits outweigh the risks)
• multiple sclerosis medications, such as fingolimod
• probiotics, such as lactobacillus
• tumor necrosis factor (TNF) blockers, such as natalizumab.

Note that this list is not all-inclusive and includes only common medications that may interact with Entyvio. You should refer to the prescribing information for Entyvio for a complete list of interactions.