Entyvio
Entyvio (vedolizumab) is a monoclonal antibody known as an integrin antagonist. It's used to treat ulcerative colitis (UC) and Crohn's disease (CD) in adults. Entyvio (vedolizumab) is typically given as an infusion once every 2 months (after the starting doses) by a healthcare provider. People also have the option of getting this medication as an injection under the skin once every 2 weeks if the IV infusion worked well for them. Some of the more common side effects of Entyvio (vedolizumab) include headache, mild infections, and joint pain.
What is Entyvio (vedolizumab)?
What is Entyvio (vedolizumab) used for?
Moderate-to-severe Crohn's disease (CD) in adults
Moderate-to-severe ulcerative colitis (UC) in adults
How Entyvio (vedolizumab) works
People who have ulcerative colitis (UC) or Crohn's disease (CD) have an overactive immune system that attacks the gut, which causes inflammation.
Entyvio (vedolizumab) is a monoclonal antibody, specifically known as an integrin antagonist. It works by blocking integrins, which are proteins found on immune cells. When it does, Entyvio (vedolizumab) causes the immune cells to be less active, which lowers inflammation.
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What are the side effects of Entyvio (vedolizumab)?
Common Side Effects
- Infection in nose and throat (13%)
- Headache (12%)
- Joint pain (12%)
- Nausea (9%)
- Fever (9%)
- Upper respiratory tract infection (7%)
- Fatigue (6%)
- Cough (5%)
Other Side Effects
- Bronchitis
- Flu infection
- Back pain
- Rash
- Itching
- Sinus infection
- Pain in back of the throat
- Pain in arms and legs
Serious Side Effects
- Infusion-related and allergic reactions: hives, rash, swelling of the face and eyes, trouble breathing, wheezing, trouble swallowing, vomiting, diarrhea, fast heart rate, passing out
- Serious infections: fever, difficulty breathing, diarrhea, weakness, cough, stomach pain, sweating, chills, burning when you urinate, urinating more often, sweating, chills
- Brain infection: Weakness on one side of the body, clumsiness, changes in personality, confusion
- Liver problems: swelling of your stomach, yellowing of your skin or the whites of your eyes, confusion, stomach pain, tiredness, loss of appetite, nausea
Source: DailyMed
More on Entyvio (vedolizumab) side effects
The following side effects have also been reported
Side effects that you should report to your care team as soon as possible:
- Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
- Dizziness, loss of balance or coordination, confusion or trouble speaking
- Infection—fever, chills, cough, sore throat, wounds that don't heal, pain or trouble when passing urine, general feeling of discomfort or being unwell
- Infusion reactions—chest pain, shortness of breath or trouble breathing, feeling faint or lightheaded
- Liver injury—right upper belly pain, loss of appetite, nausea, light-colored stool, dark yellow or brown urine, yellowing skin or eyes, unusual weakness or fatigue
Side effects that usually do not require medical attention (report these to your care team if they continue or are bothersome):
Pros and cons of Entyvio (vedolizumab)
Pros
Works well to treat UC and CD symptoms
Available as a prefilled syringe and pen that's given as an injection under the skin (SC) at home
Each IV infusion typically only takes 30 minutes
Cons
The IV infusion can only be given by a healthcare professional
The SC injection can be difficult for some people to administer
Can raise your risk for serious side effects, such as infusion reactions and infections
Pharmacist tips for Entyvio (vedolizumab)
Your provider will regularly check in with you to see how you're doing and if you need to continue taking this medication. But if you're not getting better after using the medication for about 3 months, your provider will stop Entyvio (vedolizumab) and talk with you about other options.
Let your provider know if you've ever had an infusion-related allergic reaction with Entyvio (vedolizumab) or other IV infusions in the past. If your past reaction was mild, your provider might give you acetaminophen (Tylenol), corticosteroids, or antihistamines right before future Entyvio (vedolizumab) infusions to prevent reactions, such as flushing, headache, and rash.
Entyvio (vedolizumab) can raise your risk of getting a severe or life-threatening infection. If you develop symptoms of an infection (e.g., fever, cough, difficulty breathing, diarrhea, weakness, sweating, chills) after starting Entyvio (vedolizumab), go to the hospital right away so they can test you for an infection. You might have to stop taking Entyvio (vedolizumab) so your body can fight the infection.
Make sure you're up to date on all of your vaccines before starting treatment. Entyvio (vedolizumab) can weaken your immune system. It's safe to get non-live vaccines, such as the flu vaccine. But there's a chance that you might get sick from live vaccines. Live vaccines aren't recommended unless the benefit is greater than the risk. Let your provider know you're taking Entyvio (vedolizumab) before you get any vaccines.
More tips for Entyvio (vedolizumab) IV infusions:
Mark your appointments on your calendar to see your provider and get your Entyvio (vedolizumab) IV infusion. This helps you remember to get your infusions on time so you don't miss any doses. It also makes sure your treatment is monitored properly.
The typical infusion time is 30 minutes. But depending on how you tolerate the medication, it might take longer. Your provider might ask you to stay for observation to check for reactions to the medication.
Tell your provider if you have any reactions during or after your Entyvio (vedolizumab) infusions. Reactions can include changes in taste, sleepiness, trouble breathing, lower back pain, or arm or leg discomfort. Your care team can provide or recommend treatment.
More tips for how to inject Entyvio (vedolizumab) under the skin at home:
Make sure you know how to prepare and inject the medication properly. Carefully read the instructions for use for the prefilled syringe or the prefilled pen, depending on which product you have, and contact your provider or pharmacist if you have any questions.
Keep Entyvio (vedolizumab) prefilled syringes and pens in the refrigerator in the original carton and away from light. Once they're taken out of the refrigerator, they're good for 7 days.
When it's time for your dose, take out the Entyvio (vedolizumab) syringe or pen out of the refrigerator and let it reach room temperature for at least 30 minutes. Don't warm up the medication any other way (e.g., microwave, under hot water); this could damage it.
Before you inject, check that the solution is clear to a slight yellow color. Don't use the medication if it's cloudy, discolored, or contains particles. Contact your provider or pharmacist for a replacement.
Inject Entyvio (vedolizumab) under the skin into the stomach (at least 2 inches away from the belly button), front of the thigh, or back of the upper arm (only for when another person is giving you the injection). Choose a different area to inject each week to lessen skin irritation. Don't inject into moles, scars, or skin that is tender, hard, red, or damaged.
For the pen: You might hear 1 to 2 clicks throughout the injection. The clicks don't mean the injection is complete. Continue holding the pen with pressure until the window has filled with purple; this means the injection is complete.
For the syringe: Pinch your skin where you're going to inject the medication, insert the syringe at a 45-degree angle, and push the plunger all the way down until all the medicine is injected.
Throw away each used Entyvio (vedolizumab) syringe or pen by placing them in a sharps container or something made of heavy-duty plastic (e.g., empty milk carton, laundry detergent bottle). This lowers the risk of needlestick injuries. Don't throw them away in the trash. Visit the FDA's website to learn more about following your state regulations to dispose of your sharps safely.
Frequently asked questions about Entyvio (vedolizumab)
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What are the risks and warnings for Entyvio (vedolizumab)?
Entyvio (vedolizumab) can cause some serious health issues. This risk may be even higher for certain groups. If this worries you, talk to your doctor or pharmacist about other options.
Infusion-related reactions and allergic reactions
Entyvio (vedolizumab) can cause infusion-related reactions and allergic reactions, such as hives, itching, swelling of the face or tongue, flushing, difficulty breathing, high blood pressure, and fast heart rate. These reactions can happen during infusion and during the several hours after infusion. If you notice any of these symptoms after receiving your dose, get medical attention right away.
Serious infections
Risk factors: Active infection | Other medical conditions that raise your risk of infections | Taking medications that lower your immune system
Entyvio (vedolizumab) can affect your body's ability to fight off infections, which can raise your risk for serious or life-threatening bacterial, viral, or fungal infections. The risk is higher for people who have an active infection, people who have infections that keep coming back, and people with a weakened immune system. The most common infections are upper respiratory and nasal infection, but serious infections in other parts of your body, such as your blood and brain, are also possible.
If you're currently sick with an infection, you'll have to get that treated first before you can start Entyvio (vedolizumab). If you develop fever, difficulty breathing, diarrhea, weakness, cough, stomach pain, sweating, burning when you urinate, urinating more often, sweating, or chills while receiving treatment with Entyvio (vedolizumab), get medical help right away.
Brain infection (progressive multifocal leukoencephalopathy)
Risk factors: Other medical conditions that raise your risk of infections | Taking medications that lower your immune system
Entyvio (vedolizumab) can put you at risk of getting progressive multifocal leukoencephalopathy (PML). This is a brain infection caused by the John Cummingham virus (JCV). Though it's a common virus, people who get infected with JCV usually don't experience any symptoms. But in people who have a weakened immune system, JCV can cause PML, which can lead to death or severe disability. Your risk of PML is higher if you already have a weakened immune system from certain medical conditions, such as cancer and human immunodeficiency virus (HIV). Stop Entyvio (vedolizumab) and let your provider know right away if you experience early signs of PML, including weakness on one side of the body, clumsiness, changes in personality, and confusion. You might need to get further testing or brain imaging done to confirm whether you have PML.
Liver problems
Entyvio (vedolizumab) can cause serious liver problems that can lead to liver failure or death. You might need to get regular blood tests done to make sure your liver is working properly. If your lab work shows that you have liver injury, you might have to stop Entyvio (vedolizumab) to prevent it from getting worse. Get medical help right away if you experience serious signs of liver injury, including yellow skin and whites of your eyes, stomach pain, tiredness, loss of appetite, and nausea.
Entyvio (vedolizumab) dosage forms
Typical dosing for Entyvio (vedolizumab)
Starter doses (week 0 and week 2)
The typical dose is 300 mg given as an infusion through the vein (IV) over 30 minutes at week 0 and 2. IV Entyvio (vedolizumab) is typically given by a provider in an infusion clinic.
Maintenance doses (week 6 and onwards)
You have the option to receive maintenance doses as an infusion into the vein or as an injection under the skin.
As an infusion into the vein (intravenous or IV): The typical maintenance dose is 300 mg given IV over 30 minutes every 2 months.
As an injection under the skin (subcutaneous or SC): If you responded well to the medication, you can switch to an injection under the skin. The typical maintenance dose is 108 mg injected SC every 2 weeks.
How much does Entyvio (vedolizumab) cost?
What are alternatives to Entyvio (vedolizumab)?
Moderate-to-severe Crohn's disease (CD) in adults
Moderate-to-severe ulcerative colitis (UC) in adults
Moderate-to-severe Crohn's disease (CD)
Moderate-to-severe ulcerative colitis (UC)
Moderate-to-severe rheumatoid arthritis (RA)
Ankylosing spondylitis (AS)
Psoriatic arthritis (PsA)
Severe plaque psoriasis (PsO)
Moderate-to-severe plaque psoriasis (Ps) in adults and children ages 6 years and older
Psoriatic arthritis (PsA) in adults and children ages 6 years and older
Moderate-to-severe Crohn's disease (CD) in adults
Moderate-to-severe ulcerative colitis (UC) in adults
What is the latest news about Entyvio (vedolizumab)?
Entyvio (vedolizumab) images
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References
Best studies we foundFeagan, B. G., et al. (2019). Rapid response to vedolizumab therapy in biologic-naive patients with inflammatory bowel diseases. Clinical Gastroenterology and Hepatology.
Greenlee, J. E., et al. (2022). Progressive multifocal leukoencephalopathy (PML). Merck Manual Consumer Version.
Kaazan, P., et al. (2022). Weight and BMI patterns in a biologicals-treated IBD cohort. Digestive Diseases and Sciences.
Reich, J., et al. (2016). Vaccinating patients with inflammatory bowel disease. Gastroenterology & Hepatology.
Takeda Pharmaceuticals America, Inc. (2024). Entyvio- vedolizumab injection, powder, lyophilized, for solution; Entyvio Pen- vedolizumab injection, solution; Entyvio- vedolizumab injection, solution [package insert]. DailyMed.
Takeda Pharmaceuticals U.S.A., Inc. (2024). Administration information.
Takeda Pharmaceuticals U.S.A., Inc. (2024). Instructions for use: Entyvio® (en ti' vee oh) Pen (vedolizumab) injection, for subcutaneous use - Single-dose prefilled pen.
Takeda Pharmaceuticals U.S.A., Inc. (2024). U.S. FDA Approves Subcutaneous Administration of Takeda’s ENTYVIO® (vedolizumab) for Maintenance Therapy in Moderately to Severely Active Crohn’s Disease.
U.S. Department of Health and Human Services. (2022). Vaccine types.
U.S. Food and Drug Administration (2021). Safely using sharps (needles and syringes) at home, at work and on travel.
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