Entyvio, the brand name for vedolizumab, is an injection used to treat ulcerative colitis (UC) and Crohn's disease (CD) in adults. It belongs to a drug class called integrin antagonists that helps lower inflammation in the gut. Entyvio (vedolizumab) is an infusion that's given through the vein by a healthcare professional. After the first 2 doses, it's usually given every 2 months. If it works well, people can switch to injections under the skin every 2 weeks using prefilled syringes or pens. Side effects include headache, mild infections, and joint pain.
Moderate-to-severe ulcerative colitis (UC) in adults
Moderate-to-severe Crohn's disease (CD) in adults
Entyvio (vedolizumab) is a type of monoclonal antibody. More specifically, it's an integrin antagonist. It works by blocking proteins called integrins. These proteins are found on immune cells. They play a role in causing inflammation in the gut related to ulcerative colitis and Crohn's disease.
By blocking integrin proteins, Entyvio (vedolizumab) helps lower inflammation in the gut.
Source: DailyMed
Side effects that you should report to your care team as soon as possible:
Side effects that usually do not require medical attention (report these to your care team if they continue or are bothersome):
Have the option for infusions through the vein or injections under the skin after 6 weeks of treatment
Comes as prefilled syringes and pens for injections under the skin that can be given at home
IV infusions can only be given by a healthcare professional at a medical office
Can raise your risk of serious side effects, like infusion reactions and infections
Follow up with your prescriber to talk about how Entyvio (vedolizumab) is working for you. If you don't start feeling better after about 3 months, your prescriber will stop the medication. They'll talk with you about other treatments you can try.
Entyvio (vedolizumab) can raise your risk of infection. Call your care team right away if you feel sick. Watch for signs like fever, cough, trouble breathing, weakness, sweating, and chills. If you're sick, you might have to take a break from treatment so your body can fight the infection.
It's a good idea to be up to date on all of your vaccines before starting Entyvio (vedolizumab). This might help lessen your risk of certain infections during treatment.
Before getting any vaccines, tell the healthcare professional (HCP) you're taking Entyvio (vedolizumab). They can check if the vaccine is safe for you. It's safe to get non-live vaccines, like most types of flu shots. For live vaccines, your HCP will decide if it's okay for you depending on the risks and benefits.
Tips for Entyvio (vedolizumab) IV infusions
After the first couple doses, Entyvio (vedolizumab) IV infusions are given once every 2 months. Be sure to mark your infusion appointments on your calendar. This will help you remember to get your infusions on time.
Plan ahead for some time at the medical office or infusion center for your Entyvio (vedolizumab) IV infusions. The infusion itself takes about 30 minutes. But depending on how you tolerate it, it might take longer. Your care team might ask you to stay for observation to check for reactions to the medication.
Tell your care team if you have any reactions during or after your Entyvio (vedolizumab) infusions. These reactions can include itching, rash, headache, red or warm skin, or trouble breathing. Your care team can hep you feel better or suggest ways to manage these side effects.
Tips for Entyvio (vedolizumab) injections under the skin
Entyvio (vedolizumab) injections under the skin are given once every 2 weeks. Set reminders on your calendar or phone to help you remember when to inject it. If you miss a dose, inject the medication as soon as you can. Your next injection will be 2 weeks from then.
Your care team will show you how to use Entyvio (vedolizumab) for injections under the skin. They'll make sure you can do it on your own before you can inject at home. Carefully read the instructions for use for the prefilled syringe or prefilled pen. Ask your prescriber or pharmacist if you have any questions.
How to store Entyvio (vedolizumab) prefilled syringes and pens: Store the medication in the refrigerator, but don't let it freeze. Keep syringes and pens in the original carton to protect it from light. If needed, you can keep syringes and pens in their original box out of the fridge at temperatures up to 77ºF for up to 7 days. Don't use them if they've been out for more than 7 days.
Before injecting Entyvio (vedolizumab): When it's time for your dose, take a syringe or pen out of the refrigerator. Let it reach room temperature for at least 30 minutes. Don't warm up the medication any other way like with a microwave or under hot water because this could damage it. Wash your hands with soap and warm water. Clean the injection site with an alcohol pad.
Where to inject Entyvio (vedolizumab): Inject the medication under the skin into the front of the thigh or stomach area (at least 2 inches away from the belly button). If someone else is giving you the injection, you can also use the back of the upper arm. Choose a different spot each time to lessen skin irritation. Don't inject into moles, scars, or skin that's tender, hard, red, or damaged.
How to inject using the Entyvio Pen: Place the yellow end flat on your skin at a 90-degree angle, with the the viewing window facing you. Push the pen straight down to start the injection. Hold it in place for at least 10 seconds. You might hear 1 to 2 clicks, but they don't mean that the injection is done. Keep holding the pen with pressure until the window is completely purple. This is when your injection is done and you can lift the pen from the skin.
How to inject using the Entyvio syringe: Pinch your skin at the injection site. Then, insert the needle on the syringe at a 45-degree angle way the way into the pinched skin. Push the plunger all the way down until all the medication is injected. Then, let go of the plunger so the needle guard can cover the needle.
After injecting Entyvio (vedolizumab): Throw away each used syringe or pen by placing them in a sharps container. You can also use a heavy-duty plastic container like an empty milk carton or laundry detergent bottle. Don't throw them away in the trash. This helps keep you and others safe from getting needle sticks.
The area where you injected Entyvio (vedolizumab) might get red, itchy, swollen, or bruised. This usually goes away on their own in 1 or 2 days. In the meantime, you can use cold compresses to help relieve these reactions. But if they get worse or don't go away, tell your care team.
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.
Entyvio (vedolizumab) can cause infusion-related reactions and allergic reactions. Signs include itching, rash, red or warm skin, high blood pressure, and a fast heart rate. You might also have trouble breathing and swelling in the face, lips, or tongue. Other signs of anaphylaxis are also possible. These reactions can happen during the infusion through the vein or even a few hours later.
Stop taking Entyvio (vedolizumab) and get medical help right away if you have an infusion reaction or allergic reaction.
Risk factors: Active infection | Medical conditions that raise your risk of infections | Take medications that weaken your immune system
Entyvio (vedolizumab) can affect your body's ability to fight infections. This means you could get sick more easily from bacterial, viral, or fungal infections. In studies, the most common infections during treatment were upper respiratory infections and sinus infections. But serious infections like tuberculosis (TB) and meningitis can also happen.
Before starting Entyvio (vedolizumab), tell your prescriber if you're feeling sick. You'll need to wait until you get better before starting the medication. If you get sick often, your prescriber will weigh the risks and benefits of treatment for you. They might also test you for TB first.
Call your care team or get medical help right away if you get sick while taking Entyvio (vedolizumab). Watch for signs like fever, trouble breathing, cough, weakness, sweating, and chills. Your care team can check what's going on and decide if you should keep taking this medication.
Risk factors: Medical conditions that raise your risk of infection | Take medications that weaken your immune system
Entyvio (vedolizumab) can weaken your immune system and raise the risk of infections. In particular, it can put you at risk of a serious brain infection caused by the John Cummingham virus (JCV). This infection is called progressive multifocal leukoencephalopathy (PML). It can lead to death or severe disability in people with a weakened immune system, like those taking Entyvio (vedolizumab).
Stop Entyvio (vedolizumab) and get medical help right away if you notice early signs of PML. These include weakness on one side of your body, clumsiness, and confusion. Also pay attention to any changes in vision, personality, memory, or thinking skills. You might need tests or a brain scan to check for PML. Getting help quickly is very important because PML symptoms can get worse over days to weeks.
Some people taking Entyvio (vedolizumab) have had higher liver enzyme levels on their blood tests. This can be a sign of liver problems. If the levels get too high, there's a risk of serious liver damage.
Get medical help right away if you have signs of liver damage. Watch for stomach pain, loss of appetite, nausea, tiredness, and yellow skin and whites of your eyes. You might need to stop taking Entyvio (vedolizumab) if you have liver damage.
Starter doses
Week 0 (the first day of treatment): The typical dose is 300 mg given as an infusion through the vein (IV) once. It's given by a trained healthcare professional at an infusion center.
Week 2: The typical dose is 300 mg given as an IV infusion once. It's given by a healthcare professional at an infusion center.
Maintenance doses
Week 6 and onwards: You can receive your maintenance doses as an infusion into the vein at a medical office. You can also choose to switch to injections under the skin. This depends on how your IV infusions went.
As an infusion into the vein: The typical maintenance dose is 300 mg given IV once every 2 months.
As an injection under the skin: The typical maintenance dose is 108 mg injected under the skin once every 2 weeks.
Moderate-to-severe ulcerative colitis (UC) in adults
Moderate-to-severe Crohn's disease (CD) in adults
Moderate-to-severe plaque psoriasis (Ps) - adults and children 6 years and older
Psoriatic arthritis (PsA) - adults and children 6 years and older
Moderate-to-severe Crohn's disease (CD)
Moderate-to-severe ulcerative colitis (UC)
Moderate-to-severe plaque psoriasis
Active psoriatic arthritis
Moderate-to-severe ulcerative colitis (UC)
Moderate-to-severe Crohn's disease (CD)
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Kaazan, P., et al. (2022). Weight and BMI patterns in a biologicals-treated IBD cohort. Digestive Diseases and Sciences.
National Institute of Neurological Disorders and Stroke. (2024). Progressive multifocal leukoencephalopathy.
Reich, J., et al. (2016). Vaccinating patients with inflammatory bowel disease. Gastroenterology & Hepatology.
Takeda Pharmaceuticals U.S.A., Inc. (2023). Instructions for use: Entyvio® (en ti' vee oh) Pen (vedolizumab) injection, for subcutaneous use - Single-dose prefilled pen.
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). U.S. FDA approves subcutaneous administration of Takeda’s ENTYVIO® (vedolizumab) for maintenance therapy in moderately to severely active Crohn’s disease.
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