Entyvio (vedolizumab) is a brand-name prescription medication. It’s typically used to treat moderate to severe ulcerative colitis (UC) or Crohn’s disease in people who don’t have enough improvement from other medications.
Entyvio is a biologic drug that belongs to a class of medications called integrin receptor antagonists. It comes as a solution that’s given by intravenous (IV) infusion.
Effectiveness
For information about the effectiveness of Entyvio, see the “Entyvio uses” section below.
The Food and Drug Administration (FDA) approves prescription drugs such as Entyvio to treat certain conditions.
Entyvio is FDA-approved to treat two conditions: ulcerative colitis (UC) and Crohn’s disease.
Entyvio for ulcerative colitis
Entyvio is used to improve symptoms and cause symptom remission in people with moderate to severe UC. It’s prescribed for people who don’t have enough improvement with other medications, or who can’t take other medications.
Effectiveness for treating ulcerative colitis
For UC, clinical studies have found Entyvio to be effective in causing symptom remission.
Guidelines from the American Gastroenterological Association recommend using a biologic agent such as vedolizumab (the active drug in Entyvio) for inducing and maintaining remission in adults with moderate to severe UC.
Entyvio for Crohn’s disease
Entyvio is used to improve symptoms and cause symptom remission in people with moderate to severe Crohn’s disease. It’s prescribed for people who don’t have enough improvement with other medications, or who cannot take other medications.
Effectiveness for treating Crohn’s disease
For Crohn’s disease, clinical studies have found Entyvio to be effective in bringing about symptom remission.
Guidelines from the American College of Gastroenterology recommend vedolizumab (the active drug in Entyvio) for inducing remission and healing the gut in adults with moderate to severe active Crohn’s disease.
Entyvio for children
Entyvio is not FDA-approved for use in children. However, some doctors may use Entyvio off-label for treating UC or Crohn’s disease in children.
One study found that Entyvio caused remission of symptoms in 76 percent of children with UC, and 42 percent of children with Crohn’s disease. More research is needed to know Entyvio’s safety and effectiveness in children.
Entyvio can cause mild or serious side effects. The following list contains some of the key side effects that may occur while taking Entyvio. This list does not include all possible side effects.
For more information on the possible side effects of Entyvio, or tips on how to deal with a troubling side effect, talk with your doctor or pharmacist.
More common side effects
The more common side effects of Entyvio include:
- runny nose
- sore throat
- respiratory infection such as bronchitis or sinus infection
- headache
- joint pain
- nausea
- fever
- fatigue
- cough
- flu
- back pain
- rash or itchy skin
Serious side effects
Call your doctor 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:
- Allergic reaction and infusion reaction. Some people have allergic reactions or infusion reactions when Entyvio is given. These are usually not severe, but may be severe in some cases. Administration of Entyvio will need to be stopped if a severe reaction occurs. These reactions can happen after the first dose of Entyvio or later doses. Symptoms may include:
- trouble breathing
- itchy skin
- flushing
- rash
- hives
- fast heart rate
- increased blood pressure
- Liver damage. Some people who receive Entyvio can experience liver damage. If you develop liver damage symptoms, your doctor may stop your treatment with Entyvio. Symptoms of liver damage can include:
- yellowing of your skin or the whites of your eyes
- fatigue
- stomach pain
- Cancer. During studies of Entyvio, about 0.4 percent of those who received Entyvio developed cancer compared to about 0.3 percent who received a placebo. Whether Entyvio increases the risk of cancer isn’t clear.
- Infections. People who take Entyvio have an increased risk of infection, such as the common cold or flu. More serious infections may also occur. These might include tuberculosis or an infection in the brain called progressive multifocal leukoencephalopathy (see below). If you develop a severe infection while taking Entyvio, you may need to stop taking the medication until the infection has been treated.
Side effect details
You may wonder how often certain side effects occur with this drug. Here’s some detail on certain side effects this drug may cause.
PML
Progressive multifocal leukoencephalopathy (PML) is a serious viral infection of the brain. It typically only happens in people whose immune system isn’t fully functioning.
During studies, PML did not occur in anyone who took Entyvio. However, it has occurred in people receiving medications that are similar to Entyvio, such as Tysabri (natalizumab).
While you take Entyvio, your doctor will monitor you for symptoms of PML. These symptoms may include:
- weakness on one side of your body
- vision problems
- clumsiness
- memory problems
- confusion
If you have questions or concerns about this potential side effect, talk with your doctor or pharmacist.
Hair loss
Hair loss isn’t a side effect that has occurred in studies of Entyvio. However, some people have had hair loss while taking Entyvio. It’s not clear if Entyvio is the cause of hair loss. If you have questions or concerns about this potential side effect, talk with your doctor or pharmacist.
Weight gain
Weight gain isn’t a side effect that has occurred in studies of Entyvio. However, some people who take Entyvio say that they gain weight. Gaining weight may be the result of healing in the gut, especially for those who’ve lost weight due to a flare-up of symptoms of the condition being treated. If you have questions or concerns about weight gain during your treatment, talk with your doctor or pharmacist.
The following information describes dosages that are commonly used or recommended. However, be sure to take the dosage your doctor prescribes for you. Your doctor will determine the best dosage to suit your needs.
Entyvio dosing schedule
Entyvio is administered by intravenous (IV) infusion, which means it’s slowly injected into your vein. An infusion is a controlled administration of medication into your bloodstream over a period of time.
For each treatment, a dose of 300 mg is given over a period of about 30 minutes. Treatment is started according to this schedule:
- Week 0 (first week): first dose
- Week 1: no dose
- Week 2: second dose
- Week 6: third dose
After this initial period of six weeks, which is called induction, a maintenance dosing schedule is used. During the maintenance dosing, Entyvio is given every eight weeks.
What if I miss a dose?
This medication will be given by your doctor. If you miss your appointment to receive your dose, call your doctor’s office right away to reschedule your treatment.
Will I need to use this drug long-term?
Yes, Entyvio needs to be used for long-term treatment.
VaccinationsBefore starting Entyvio, you’ll need to be up to date on recommended
vaccinations . This is because you should not receive live vaccines or oral vaccines while you’re taking Entyvio. (Live vaccines contain live but weakened forms of the germs they’re meant to protect against.) Talk with your doctor about getting any vaccines you need before you start treatment with Entyvio.
Entyvio is a biologic drug that’s available only as a brand-name medication. It doesn’t come in a biosimilar form.
A biologic drug is made from living cells, while other drugs are made from chemicals. Drugs made from chemicals can have generics, which are exact copies of the active drug in the brand-name medication. Biologics, on the other hand, can’t be copied exactly. Therefore, instead of a generic, biologics have biosimilars. Biosimilars are “similar” to the parent drug, and they’re considered to be just as effective and safe.
Like generics, biosimilars are often less expensive compared to brand-name medications.
There are many different medications used to treat ulcerative colitis (UC) and Crohn’s disease. These other drugs could be considered alternatives to Entyvio.
Entyvio is a biologic drug that’s typically used to treat UC and Crohn’s disease when other medications don’t relieve symptoms enough, or if they cause bothersome side effects. Examples of other biologic medications used to treat UC or Crohn’s disease include:
- natalizumab (Tysabri), an integrin receptor antagonist
- ustekinumab (Stelara), an interleukin IL-12 and IL-23 antagonist
- tofacitinib (Xeljanz), a Janus kinase inhibitor
- tumor necrosis factor (TNF)-alpha inhibitors such as:
- adalimumab (Humira)
- certolizumab (Cimzia)
- golimumab (Simponi)
- infliximab (Remicade)
Entyvio and Remicade (infliximab) are both brand-name biologic medications, but they’re in different drug classes. Entyvio belongs to a class of drugs called integrin receptor antagonists. Remicade belongs to a class of medications called tumor necrosis factor (TNF)-alpha inhibitors.
Uses
Entyvio and Remicade are both FDA-approved for treating UC and Crohn’s disease. Remicade is also approved for treating other conditions, including:
Drug forms
Both Entyvio and Remicade are available as solutions for intravenous (IV) infusion. They’re also administered on similar schedules. After the first three doses, these medications are typically given every eight weeks.
Side effects and risks
Entyvio and Remicade have some similar side effects, and some that differ. Below are examples of these side effects.
| Both Entyvio and Remicade | Entyvio | Remicade | |
| More common side effects | • respiratory infection • nausea • cough • bronchitis • rash or itchy skin • fatigue • headache • joint pain • fever | • runny nose • sore throat • flu • back pain | • stomach pain or upset • diarrhea • high blood pressure |
| Serious side effects | • allergic reaction and infusion reaction • serious infections such as tuberculosis • cancer • liver damage | • few unique serious side effects | • heart failure • lupus-like syndrome • nervous system conditions such as multiple sclerosis and Guillain-Barré syndrome • blood disorders such as anemia and neutropenia • Boxed warnings*: serious infections, and certain types of cancer such as lymphoma |
* Remicade has boxed warnings from the FDA. A
Effectiveness
Both Entyvio and Remicade are used to treat UC and Crohn’s disease. But Entyvio is typically only used to treat UC and Crohn’s disease in people who don’t have enough improvement with other medications such as Remicade.
The effectiveness of these medications hasn’t been directly compared in clinical studies. However, some researchers in 2014 and
Guidelines from the American Gastroenterological Association recommend using a biologic agent such as vedolizumab (the active drug in Entyvio) or infliximab (the active drug in Remicade) for inducing and maintaining remission in adults with moderate to severe UC.
Guidelines from the American College of Gastroenterology recommend both vedolizumab (the active drug in Entyvio) and infliximab (the active drug in Remicade) for treating adults with moderate to severe active Crohn’s disease.
Costs
The cost of either Entyvio or Remicade may vary depending on your treatment plan. The actual price you’ll pay for either Entyvio or Remicade depends on your insurance plan, your location, and the pharmacy you use.
Entyvio and Humira (adalimumab) are both brand-name biologic medications, but they’re in different drug classes. Entyvio belongs to a class of drugs called integrin receptor antagonists. Humira belongs to a class of medications called tumor necrosis factor (TNF)-alpha inhibitors.
Uses
Entyvio and Humira are both FDA-approved for treating ulcerative colitis (UC) and Crohn’s disease. Humira is also approved for treating other conditions, including:
- rheumatoid arthritis
- psoriasis
- psoriatic arthritis
- ankylosing spondylitis
- uveitis
- juvenile idiopathic arthritis
- hidradenitis suppurativa
Drug forms
Entyvio comes as a solution for intravenous infusion that’s given in the doctor’s office. After the first three doses, Entyvio is given once every eight weeks.
Humira comes as a subcutaneous injection. This is an injection that’s given under the skin. Humira can be self-administered. After the first four weeks, it’s used every other week.
Side effects and risks
Entyvio and Humira have some similar side effects, and some that differ. Below are examples of these side effects.
| Both Entyvio and Humira | Entyvio | Humira | |
| More common side effects | • respiratory infection • nausea • headache • back pain • rash | • runny nose • sore throat • joint pain • fever • fatigue • cough • bronchitis • flu • itchy skin | • stomach pain • high cholesterol • high blood pressure • urinary tract infections |
| Serious side effects | • allergic reaction and infusion reaction • serious infections • cancer • liver damage | • few unique serious side effects | • heart failure • lupus-like syndrome • nervous system conditions such as multiple sclerosis and Guillain-Barré syndrome • blood disorders such as leukopenia and neutropenia • Boxed warnings*: serious infections, and certain types of cancer such as lymphoma |
* Humira has a
Effectiveness
Entyvio and Humira are used to treat both UC and Crohn’s disease. However, Entyvio is typically only used for people who don’t have enough improvement using other medications, such as Humira.
The effectiveness of these medications hasn’t been directly compared in clinical studies. But certain analyses from 2014 and
Costs
The cost of either Entyvio or Humira may vary depending on your treatment plan. The actual price you’ll pay for either Entyvio or Humira depends on your insurance plan, your location, and the pharmacy you use.
Entyvio doesn’t interact with alcohol. However, drinking alcohol might worsen some of the side effects of Entyvio, such as:
- nausea
- headache
- runny nose
Also, consuming excessive alcohol might increase the risk of liver damage from Entyvio.
It’s also important to note that alcohol use might worsen some symptoms of ulcerative colitis (UC) or Crohn’s disease. These symptoms include:
- nausea
- vomiting
- stomach or intestinal bleeding
- diarrhea
Entyvio can interact with several other medications.
Different interactions can cause different effects. For instance, some can interfere with how well a drug works, while others can cause increased side effects.
Entyvio and other medications
Below is a list of medications that can interact with Entyvio. This list does not contain all drugs that may interact with Entyvio.
Before taking Entyvio, be sure to tell your doctor and pharmacist about all prescription, over-the-counter, and other drugs you take. Also tell them about any vitamins, herbs, and supplements you use. Sharing this information can help you avoid potential interactions.
If you have questions about drug interactions that may affect you, ask your doctor or pharmacist.
Drugs that may interact with Entyvio include:
- Tumor necrosis factor inhibitors. Taking Entyvio with tumor necrosis factor inhibitors can increase your risk of infections. Examples of these drugs include:
- adalimumab (Humira)
- certolizumab (Cimzia)
- golimumab (Simponi)
- infliximab (Remicade)
- Natalizumab (Tysabri). Taking Entyvio with natalizumab might increase the risk of a serious brain infection called progressive multifocal leukoencephalopathy (PML).
Entyvio and live vaccines
Some vaccines contain active but weakened viruses or bacteria. These are often called live vaccines. If you take Entyvio, you should not receive live vaccines. These may increase your risk of getting the infection that the vaccine is meant to prevent. Examples of these vaccines include:
- nasal spray flu vaccine (FluMist)
- rotavirus vaccines (Rotateq, Rotarix)
- measles, mumps, rubella (MMR)
- chickenpox vaccine (Varivax)
- yellow fever vaccine (YF Vax)
Entyvio is given as an intravenous (IV) infusion. This means it needs to be given in your doctor’s office, hospital, or infusion center.
Before your appointment
Your doctor or nurse will give you specific instructions on how to prepare for the infusion, but here are some tips:
- Drink fluids. Be sure to drink plenty of fluids the day or two before your infusion appointment. For most people, this should be six to eight glasses of water or fluids daily. Try to avoid drinking too much caffeine, which can cause fluid loss.
- Tell your doctor. If you have symptoms of an infection, such as cough or fever, be sure to let your doctor know. Also tell your doctor if you’re taking antibiotics. In either case, you may need to reschedule your infusion.
- Arrive early. For your first infusion, plan to arrive 15 to 20 minutes early to complete paperwork, if needed.
- Come prepared. This includes:
- Dressing in layers. Some people feel cold while receiving their infusion.
- Bringing a snack or lunch. Although the infusions don’t last very long, you may want to eat if you’re having the infusion over your lunch break.
- Bringing your mobile device, headphones, or a book if you want to have entertainment during the infusion.
- Knowing your schedule. If you have an upcoming vacation or other times you’ll be unavailable, your appointment is a good time to finalize future infusion dates.
What to expect
- During your appointment, you’ll receive an IV. Once the IV is inserted into your vein, the infusion itself usually lasts about 30 minutes.
- Once the infusion is completed, you can return to work or normal daily activities. Some people have mild side effects following an infusion, such as:
- tenderness or bruising at the IV site
- cold-like symptoms
- headache
- fatigue
- nausea
- joint pain
- rash
Allergic reaction and infusion reaction
Some people have allergic reactions or infusion reactions when Entyvio is given. These are usually not severe, but may be severe in some cases.
Administration of Entyvio will need to be stopped if a severe reaction occurs. These reactions can happen after the first dose of Entyvio or later doses.
Symptoms may include:
- trouble breathing
- itchy skin
- flushing
- rash
- hives
- fast heart rate
- increased blood pressure
If you have symptoms of an allergic or infusion reaction after receiving Entyvio, call your doctor. But if your symptoms feel life threatening, call 911 or have someone take you to the emergency room.
Symptoms of ulcerative colitis (UC) and Crohn’s disease are caused by inflammation in the gut. This inflammation is caused by the movement of certain white blood cells into the gut (intestines).
Entyvio’s mechanism of action is that it blocks some of the signals that cause these white blood cells to move into the gut. This action can decrease the inflammation and other symptoms of UC and Crohn’s disease.
No studies in humans have evaluated whether Entyvio is safe to use during pregnancy. Animal studies have not found any harmful effects, but studies in animals don’t always predict what would happen in humans.
If there are risks to the fetus, they may be greatest during the second and third trimesters. During this time, the fetus would likely be exposed to more of the drug.
If you’re taking Entyvio and are pregnant or thinking about becoming pregnant, talk with your doctor. They can tell you about the risks and benefits of continuing your Entyvio treatment or stopping it.
If you do receive Entyvio while pregnant, you can sign up for a registry that will help gather information about your experience.
Small amounts of Entyvio are present in breast milk. However, a small study did not find any harmful effects in children who are breastfed by people receiving Entyvio.
If you’re receiving Entyvio and want to breastfeed your child, talk with your doctor about the potential risks.
Here are answers to some frequently asked questions about Entyvio.
Is Entyvio a biologic?
Yes, Entyvio is a biologic drug. Biologics are made from a biological source, such as living cells.
How long does Entyvio take to work?
Treatment with Entyvio is broken into two parts. The first three starting doses are given during the induction phase, which lasts a total of six weeks. During this phase, the second dose is given two weeks after the first dose. The third dose is given four weeks after the second dose.
Although symptoms may begin to improve right away after the first infusion, it may take the full six-week period to get symptoms under control.
The maintenance phase follows the induction phase. During the maintenance phase, doses are given every eight weeks to keep symptoms under control.
Can you take Entyvio if you’ll be having surgery?
If you have a scheduled surgery, including dental surgery, you may need to delay or reschedule your Entyvio infusion.
Before taking Entyvio, talk with your doctor about any medical conditions you have. Entyvio may not be appropriate for you if you have certain medical conditions.
- For people with infections: Entyvio can worsen infections. If you have symptoms of an infection, such as a fever or cough, you may not be able to use Entyvio until the infection has cleared.
- For people with liver disease: Entyvio may worsen liver problems in those who already have liver disease. It can also cause liver damage.
- For people who’ve had an allergic reaction or infusion reaction: Some people have allergic reactions or infusion reactions when Entyvio is given. See the “Entyvio side effects” section above for information. If you have had an allergic or infusion reaction to Entyvio, your doctor will likely recommend that you avoid this medication.
Disclaimer: Medical News Today has made every effort to make certain that all information is factually correct, comprehensive, and up to date. However, this article should not be used as a substitute for the knowledge and expertise of a licensed healthcare professional. You should always consult your doctor or another healthcare professional before taking any medication. The drug information contained herein is subject to change and is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. The absence of warnings or other information for a given drug does not indicate that the drug or drug combination is safe, effective, or appropriate for all patients or all specific uses.
