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 parenchymal tissue. 

Entyvio is given intravenously (IV, in the vein) by a healthcare provider. You will visit a healthcare facility to receive this infusion.

What Is Entyvio Used For?

The Food and Drug Administration (FDA) approved Entyvio to treat moderately to severely active Crohn’s disease (CD) and ulcerative colitis (UC) in adults.

How to Take Entyvio

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).

Storage

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.

What Are the Side Effects of Entyvio?

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.

Common Side Effects

The most common side effects of Entyvio are:

• Headache
• Joint pain
• Nausea
• Fever
• Infections of the nose and throat
• Tiredness
• Cough
• Bronchitis
• Flu
• Back pain
• Rash
• Itching
• Sinus infection
• Throat pain
• Pain in extremities

Severe Side Effects

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:

• Infusion-related reactions and hypersensitivity reactions: Allergic reactions related to the infusion rarely occurred in clinical trials. Symptoms included difficulty breathing, bronchospasm, itching, flushing, rash, increased blood pressure, and increased heart rate. One case of anaphylaxis occurred during clinical trials. Hypersensitivity reactions can occur during infusion or be delayed up to several hours after infusion.
• Infection: Entyvio increases a person’s risk for infection. The most common infections were upper respiratory and nose/throat infections. Severe infections have also been reported, including tuberculosis, bloodstream infections, and meningitis. 
• Progressive multifocal leukoencephalopathy (PML): PML is a rare and often fatal infection of the central nervous system that has been associated with a drug similar to Entyvio. No cases of PML were detected during clinical trials, but the possibility cannot be ruled out. PML symptoms may progress over days to weeks, including the progressive weakness on one side of the body, vision changes, changes in thinking and memory, confusion, and personality changes. 
• Liver Injury: Entyvio was associated with rare occurrences of liver injury in clinical trials. Signs and symptoms include abdominal pain, malaise, nausea, vomiting, and loss of appetite.

Long-Term Side Effects

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.

Dosage: How Much Entyvio Should I Take?

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.

Modifications

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.

Pregnancy

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.

Breastfeeding

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.

Age

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.

Missed Dose

If you miss an infusion of Entyvio, contact your healthcare provider for guidance on rescheduling your appointment.

Overdose: What Happens If I Take Too Much Entyvio?

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.

Precautions

What Are Reasons I Shouldn’t Take Entyvio?

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:

• Difficulty breathing
• Bronchospasm
• Itching
• Flushing
• Rash
• Increased heart rate

What Other Medications Interact With Entyvio?

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:

• Tysabri (natalizumab): When used together, Entyvio and natalizumab can increase the risk of PML and other infections. 
• Tumor necrosis factor (TNF) blockers: Vedolizumab and TNF blockers (e.g., infliximab, etanercept, adalimumab, certolizumab) used together result in increased immune suppression and risk of infection. 
• Live vaccines: People receiving Entyvio may receive live vaccines (e.g., MMR, varicella vaccine, intranasal influenza vaccine) if the benefit outweighs the risk. There are no data on people becoming infected from a live vaccine while on Entyvio.

What Medications Are Similar?

Natalizumab is another monoclonal antibody used to treat Crohn’s disease. It should not be used together with Entyvio.

How Can I Stay Healthy While Taking Entyvio?

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:

• Rash
• Itching
• Shortness of breath
• Wheezing
• Flushing
• Increased heart rate

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.