Entyvio: Used to treat Crohn’s disease and ulcerative colitis

Entyvio generic or biosimilar

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 can have biosimilars. Biosimilars are “similar” to the parent drug and are considered effective and safe.

Like generics, biosimilars are often less expensive compared to brand-name medications.

Entyvio dosage

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.

Drug forms and strengths

Entyvio comes in the following forms:

• intravenous (IV) infusion (an injection into a vein that’s given over time), which lasts about 30 minutes
• liquid solution given by subcutaneous injection (an injection under your skin), which is available as a single-dose prefilled injection pen

The IV infusion comes in a strength of 300 milligrams (mg). The solution for subcutaneous injection comes in a strength of 108 mg per 68 milliliters (108 mg/0.68 mL).

Entyvio dosing schedule

You will receive the first two doses of Entyvio as IV infusions at week 0 and week 2 of treatment. Specifically, you’ll receive one 300-mg infusion and another one 2 weeks later.

For your third dose (week 6), you might continue with infusions, or your doctor may have you to switch to subcutaneous injections. Specifically:

• If you continue with infusions, you’ll have a third 300-mg infusion 4 weeks after the previous infusion. After this, you’ll receive infusions every 8 weeks.
• If your doctor switches you to subcutaneous injections, you’ll have a 108-mg injection 4 weeks after your previous infusion and every 2 weeks after that.

After the initial period of 6 weeks, which is called induction, you’ll follow a maintenance dose schedule. During the maintenance dosing, you’ll receive Entyvio every 8 weeks or every 2 weeks.

Note: This article is based on United States prescribing information. Outside of the United States, Entyvio dosages and forms may vary.

What if I miss a dose?

If you miss an appointment to receive an Entyvio dose, call your doctor’s office or clinic right away to reschedule for as soon as possible.

If you self-inject Entyvio and you miss a dose, you should inject the dose as soon as you remember. Your next injection should be 2 weeks later.

Will I need to use this drug long term?

Yes, Entyvio is usually prescribed for long-term treatment. But if Entyvio doesn’t reduce your symptoms or improve your condition after 14 weeks, your doctor will likely have you stop using the drug.

For more information, you can refer to this Entyvio dosage article.

How Entyvio is given

You will receive your Entyvio infusions in your doctor’s office, an infusion center, or a hospital or clinic. Each infusion lasts about 30 minutes. For details, including how to prepare and what to expect, see “How to prepare for an Entyvio infusion.”

A healthcare professional or caregiver may administer your Entyvio subcutaneous injections, or you may be able to self-inject them. Your doctor or another healthcare professional can show you how to give yourself Entyvio injections. You can self-inject Entyvio into your abdomen or thigh. Caregivers can also inject it into your upper arm.

Entyvio’s website has details and instructions regarding infusions and self-injections.

Entyvio side effects

Entyvio can cause mild or serious side effects. The following list contains some key side effects that may occur while taking Entyvio. This list does not include all possible side effects.

For more information about the possible side effects of Entyvio, talk with your doctor or pharmacist. They can give you tips on how to manage any side effects that may concern or bother you.

Note: The Food and Drug Administration (FDA) tracks side effects of drugs it has approved. If you would like to notify the FDA about a side effect you’ve had with Entyvio, you can do so through MedWatch.

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
• injection site reaction, when Envtyvio is given as a subcutaneous injection
• 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, also called an infusion reaction. (See below for details.)
• Liver damage, which can cause symptoms such as:
  • yellowing of your skin or the whites of your eyes
  • fatigue
  • abdominal pain
• Infections, such as:
  • tuberculosis
  • a brain infection called progressive multifocal leukoencephalopathy
• Sepsis (a life threatening response to an infection). Symptoms can include:
  • fever and chills
  • fast pulse
  • trouble breathing
  • dizziness
  • pale skin

For more information, you can refer to this article on Entyvio’s side effects.

Allergic reaction or infusion reaction

For some people, Entyvio can cause an allergic reaction. If this happens with an Entyvio infusion, it may be called an infusion reaction.

These reactions are usually not severe but may be severe in some cases. If a severe reaction occurs, administration of Entyvio will need to be stopped. These reactions can happen after the first or later doses of Entyvio.

In general, symptoms can be mild or serious, and may include:

• trouble breathing
• itchy skin
• flushing
• rash
• hives
• fast heart rate
• increased blood pressure, which may not cause noticeable symptoms

If you’re receiving an infusion of Entyvio, tell your healthcare professional right away if you experience any of the above symptoms.

If you’re at home and you experience mild symptoms after an Entyvio injection, such as a mild rash, call your doctor right away. They may recommend treatments to help manage your symptoms. They’ll also let you know whether you should keep taking the medication.

For severe allergic reaction symptoms, such as swelling or trouble breathing, call 911 or your local emergency number right away. These symptoms require immediate medical care because they can become life threatening. If you’ve had a serious allergic reaction to Entyvio, your doctor may recommend taking a different medication instead.

How to prepare for an Entyvio infusion

You might receive Entyvio intravenous (IV) infusions in your doctor’s office, a clinic, a hospital, or an 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 for a day or two before your infusion appointment. For most people, this should be 6 to 8 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:
  • Dress in layers. Some people feel cold while receiving their infusion.
  • Bring a snack or lunch. Although the infusion does not take very long, you may want to eat if the infusion is during lunch time.
  • Bring your mobile device, headphones, or a book for entertainment during the infusion.
  • Know 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 complete, you can return to work or your usual 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

Note: Some people have allergic or infusion reactions when receiving Entyvio. If a severe reaction occurs, the healthcare professional will stop the administration of Entyvio. See “Entyvio side effects” for details.

Entyvio cost

As with all medications, the cost of Entyvio can vary. The actual price you’ll pay depends on your insurance plan, your location, and the pharmacy you use.

If you need financial support to pay for Entyvio, or if you need help understanding your insurance coverage, help is available. You can visit Entyvio’s website to see the drug manufacturer’s resources and support options.

For more information, you can refer to this Entyvio cost article. And to learn more about saving money on prescriptions, check out this article.

Entyvio vs. Remicade

Entyvio and Remicade (infliximab) are brand-name biologic drugs approved for treating UC and Crohn’s disease. Remicade is also approved for treating other conditions, including rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis.

Remicade is given as IV infusions. Entyvio is given as IV infusions at first, and you might continue receiving infusions or switch to subcutaneous injections, depending on what your doctor prescribes.

These drugs have some similar side effects and some that differ. It’s important to note that Remicade has boxed warnings about the risk of serious infections and certain types of cancer, such as lymphoma.

To learn more about how these drugs compare, talk with your doctor or a pharmacist.

Entyvio vs. Humira

Entyvio and Humira (adalimumab) are both biologic drugs that are approved to treat UC and Crohn’s disease. Humira is also approved to treat other conditions, including rheumatoid arthritis, psoriasis, and others.

Humira comes as a subcutaneous injection. Entyvio is given as IV infusions at first, and you might continue receiving infusions or switch to subcutaneous injections, depending on what your doctor prescribes.

These drugs have some similar side effects, and some that differ. It’s important to note that Humira has boxed warnings about the risk of serious infections and certain types of cancer such as lymphoma.

You can refer to this article on Entyvio vs. Humira to learn more.

Common questions about Entyvio

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 (starting) 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 up to 6 weeks for symptoms to reduce.

The maintenance (ongoing) phase follows the induction phase. During the maintenance phase, you receive doses every 8 weeks or every 2 weeks, depending on which form of Entyvio you use. This dosage should help keep your symptoms manageable.

If Entyvio doesn’t reduce your symptoms or improve your condition after 14 weeks, your doctor will likely have you stop using the drug.

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 doses.

Does Entyvio cause hair loss?

Hair loss isn’t a side effect that occurred in clinical trials of Entyvio. However, some people have had hair loss while taking Entyvio. It’s not clear if Entyvio is the cause of hair loss. Other factors, such as hormone changes, other medications, or reduced immune system activity can contribute to hair loss.

If you have questions or concerns about hair loss during Entyvio treatment, talk with your doctor or pharmacist.

Is weight gain a side effect of Entyvio?

Weight gain was not reported as a side effect in Entyvio’s clinical trials. However, if Entyvio helps reduce symptoms of your condition, this could result in weight gain. Gaining weight may be due to healing in the gut, especially if you’ve lost weight due to your symptoms flaring up in the past.

If you have questions or concerns about weight changes during your treatment, talk with your doctor.

How Entyvio works

Entyvio contains the active ingredient vedolizumab, which belongs to a drug class called integrin receptor antagonists.

Entyvio is approved to treat Crohn’s disease and ulcerative colitis. To learn about Entyvio’s mechanism of action (how it works) for these conditions, see this article.

Entyvio uses

The Food and Drug Administration (FDA) approves prescription drugs such as Entyvio to treat certain conditions. Entyvio is approved to treat ulcerative colitis (UC) and Crohn’s disease.

Entyvio for ulcerative colitis

Entyvio is used to reduce symptoms and cause symptom remission in people with moderate to severe UC.

With UC, you might have periods of mild symptoms or no symptoms at all. This is called remission. However, symptoms can come back and become severe. This is called a flare-up. The goal of Entyvio treatment is to reach and maintain remission.

To learn more about this condition, you can refer to our inflammatory bowel disease hub.

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 such as vedolizumab (the active ingredient in Entyvio) to bring about and maintain remission in adults with moderate to severe UC.

Entyvio for Crohn’s disease

Entyvio is used to reduce symptoms and cause symptom remission in people with moderate to severe Crohn’s disease.

With Crohn’s disease, you may have periods of mild or no symptoms, which is called remission. But symptoms can flare up, meaning they come back and can become severe. The goal of Entyvio treatment is to reach and maintain remission.

To learn more about this condition, you can refer to our inflammatory bowel disease hub.

Effectiveness for treating Crohn’s disease

Clinical studies have found Entyvio effective in bringing about symptom remission for Crohn’s disease.

Guidelines from the American College of Gastroenterology recommend vedolizumab (the active ingredient in Entyvio) for causing 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 prescribe it off-label for treating UC or Crohn’s disease in children. More research is needed to determine Entyvio’s safety and effectiveness in children.

Alternatives to Entyvio

There are many different medications used to treat ulcerative colitis (UC) and Crohn’s disease. These other drugs could be considered alternatives to Entyvio. Examples of other drugs used to treat UC or Crohn’s disease include:

• natalizumab (Tysabri)
• ustekinumab (Stelara)
• tofacitinib (Xeljanz)
• tumor necrosis factor (TNF)-alpha inhibitors such as:
  • adalimumab (Humira)
  • certolizumab (Cimzia)
  • golimumab (Simponi, Simponi Aria)
  • infliximab (Remicade)

Entyvio and alcohol

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 or Crohn’s disease. These symptoms include:

• nausea
• vomiting
• stomach or intestinal bleeding
• diarrhea

Entyvio interactions

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.

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.

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:

• 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, Simponi Aira)
  • infliximab (Remicade)
• Natalizumab (Tysabri): Taking Entyvio with natalizumab might increase the risk of a serious brain infection called progressive multifocal leukoencephalopathy (PML).
• CYP450 substrates: If you take a type of drug called a CYP450 substrate, your doctor might change your dosage of this drug when you start or stop Entyvio treatment. Examples include:
  • statins, such as atorvastatin (Lipitor) and pravastatin (Pravachol)
  • selective serotonin reuptake inhibitors (SSRIs), such as sertraline (Zoloft) and citalopram (Celexa)
  • theophylline
  • phenytoin (Phenytek, Dilantin)
  • warfarin (Jantoven)
  • amitriptyline

If you have questions about drug interactions that may affect you, ask your doctor or pharmacist.

Entyvio and live or oral vaccines

Before 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 protect against. These vaccines may increase your risk of getting the infection 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)

Talk with your doctor about getting any necessary vaccines before starting treatment with Entyvio.

For more information, you can refer to this Entyvio interactions article.

Entyvio and pregnancy and breastfeeding

If you can become pregnant or are breastfeeding, it’s important to consider whether Entyvio is a safe choice for you.

You can refer to this article for more information. If you have additional questions, talk with your doctor.