Entyvio (Vedolizumab)
Gut-Selective Biologic for Ulcerative Colitis and Crohn's Disease
Quick Facts About Entyvio
Key Takeaways About Entyvio
- Gut-selective mechanism: Entyvio specifically targets inflammation in the gastrointestinal tract by blocking α4β7 integrin, without broadly suppressing the systemic immune system
- Two-phase treatment: Induction with IV infusions at weeks 0, 2, and 6, followed by maintenance with 108 mg subcutaneous injections every 2 weeks using a pre-filled pen
- Slower onset for Crohn's disease: Clinical benefit may take up to 14 weeks to appear in Crohn's disease; your doctor will assess response before continuing
- Self-injection at home: After proper training, patients can administer subcutaneous maintenance doses at home using the Entyvio pre-filled pen
- Do not combine with other biologics: Entyvio should not be used together with other biological immunosuppressants such as TNF inhibitors or natalizumab
What Is Entyvio and What Is It Used For?
Entyvio (vedolizumab) is a gut-selective biologic medicine prescribed for adults with moderate to severe ulcerative colitis or Crohn's disease who have not responded adequately to, lost response to, or were intolerant of conventional treatments or TNF-alpha inhibitors.
Vedolizumab is a humanised monoclonal antibody that belongs to a class of medicines known as integrin inhibitors. It works by targeting a specific protein called α4β7 integrin found on the surface of a subset of white blood cells (T lymphocytes) that are specifically destined for the gastrointestinal tract. By binding to this integrin, vedolizumab blocks the interaction with mucosal addressin cell adhesion molecule-1 (MAdCAM-1), a protein expressed predominantly on blood vessels in the gut lining. This prevents the white blood cells from migrating into the inflamed intestinal tissue, thereby reducing the chronic inflammation that drives both ulcerative colitis and Crohn's disease.
Ulcerative colitis is a chronic inflammatory bowel disease that affects the innermost lining (mucosa) of the large intestine (colon) and rectum. It causes symptoms such as bloody diarrhoea, abdominal pain, urgency to defecate, and fatigue. In moderate to severe cases, the inflammation can significantly impair quality of life and lead to complications including anaemia, malnutrition, and an increased risk of colorectal cancer. Entyvio has been shown in clinical trials to induce and maintain clinical remission in patients with active ulcerative colitis, including those who have failed conventional treatments such as corticosteroids, immunomodulators (azathioprine, 6-mercaptopurine), and TNF-alpha inhibitors (infliximab, adalimumab).
Crohn's disease is another chronic inflammatory bowel disease that can affect any part of the gastrointestinal tract from the mouth to the anus, though it most commonly involves the terminal ileum and colon. Unlike ulcerative colitis, Crohn's disease causes transmural inflammation (affecting all layers of the bowel wall) and can lead to strictures, fistulae, and abscesses. Symptoms include abdominal pain, diarrhoea, weight loss, and fatigue. Entyvio has demonstrated efficacy in inducing clinical remission in adults with moderately to severely active Crohn's disease, although the onset of action may be slower compared to ulcerative colitis, with some patients requiring up to 14 weeks to experience meaningful clinical improvement.
Entyvio is typically prescribed when other treatments have not provided adequate symptom control. This includes patients who have failed or cannot tolerate conventional therapies (such as corticosteroids, aminosalicylates, and immunomodulators) or biologic therapies (such as TNF-alpha inhibitors including infliximab, adalimumab, or golimumab). It may also be considered as a first-line biologic in certain clinical situations, particularly when a gut-selective approach is preferred.
Unlike many other biologic therapies used in inflammatory bowel disease, Entyvio acts selectively in the gastrointestinal tract. By targeting only the gut-homing white blood cells, it reduces intestinal inflammation without broadly suppressing the immune system throughout the body. This gut-selective mechanism is associated with a potentially lower risk of systemic infections and opportunistic infections compared to non-selective immunosuppressants, making it particularly attractive for patients who are at higher risk of infection.
What Should You Know Before Taking Entyvio?
Before starting Entyvio, inform your doctor about all current infections, vaccination history, liver problems, and any other medications you are taking. Entyvio is contraindicated in patients with known serious hypersensitivity to vedolizumab or its excipients, and in those with active severe infections.
Contraindications
You should not use Entyvio if any of the following apply to you:
- Hypersensitivity to vedolizumab or any of the excipients – signs of a serious allergic reaction may include difficulty breathing, hives, swelling of the face, lips, tongue, or throat, and severe dizziness
- Active severe infections – including tuberculosis (TB), sepsis, cytomegalovirus (CMV) infection, listeriosis, and other opportunistic infections, until the infection is controlled
- Active severe gastroenteritis caused by bacteria such as Clostridioides difficile – infection must be treated and resolved before starting Entyvio
- Active central nervous system (CNS) infections – including progressive multifocal leukoencephalopathy (PML)
Warnings and Precautions
Talk to your doctor before using Entyvio if you have or have had any of the following:
- Progressive multifocal leukoencephalopathy (PML): PML is a rare but serious brain infection caused by the JC virus. Although PML has been reported with another integrin inhibitor (natalizumab), no confirmed cases have been attributed directly to vedolizumab monotherapy. However, your doctor will monitor you for any new or worsening neurological symptoms (such as progressive weakness on one side of the body, vision problems, or changes in thinking, memory, and orientation). If PML is suspected, treatment must be stopped immediately.
- Infections: Entyvio may increase the risk of infections, particularly in the gastrointestinal tract and upper respiratory tract. Tell your doctor if you develop signs of an infection during treatment, such as fever, chills, cough, or wound drainage.
- Allergic reactions: Serious allergic reactions, including anaphylaxis, have occurred during or after infusion or injection. Your healthcare facility should be equipped to manage anaphylactic reactions. If a serious allergic reaction occurs, treatment must be stopped immediately.
- Vaccinations: All recommended vaccinations should be brought up to date before starting Entyvio. Live vaccines should not be administered while being treated with Entyvio. Non-live (inactivated) vaccines may be given during treatment, though the immune response may be reduced.
- Risk of cancer (malignancy): Immunosuppressive medicines may increase the risk of certain cancers. Discuss this risk with your doctor. Long-term safety data suggest that vedolizumab does not appear to be associated with an elevated cancer risk, but continued monitoring is recommended.
- Slower onset in Crohn's disease: Some patients with Crohn's disease may not experience significant clinical improvement until week 14 or later. Your doctor will assess whether to continue treatment if no response is observed by this time.
- Previous use of natalizumab: If you have previously been treated with natalizumab (another integrin inhibitor), wait at least 12 weeks before starting Entyvio, unless your clinical situation warrants earlier initiation and the potential benefits outweigh the risks.
Use in Children
Entyvio is not recommended for children and adolescents under 18 years of age. There is insufficient data on the safety and efficacy of vedolizumab in the paediatric population. Clinical trials in children are ongoing, and your doctor will advise on suitable alternative treatments for younger patients with inflammatory bowel disease.
Pregnancy and Breastfeeding
The effects of Entyvio on pregnancy are not fully established. Animal reproductive studies did not reveal any direct harmful effects on the developing foetus, but there is limited clinical data in pregnant women. If you are pregnant, think you may be pregnant, or are planning to become pregnant, discuss the risks and benefits of Entyvio with your doctor before starting or continuing treatment.
Women of childbearing potential should use effective contraception during treatment and for at least 4.5 months after the last dose of Entyvio.
Vedolizumab has been detected in human breast milk. The effects on the breastfed infant are unknown. If you are breastfeeding or plan to breastfeed, discuss this with your doctor. A decision should be made whether to discontinue breastfeeding or to discontinue Entyvio therapy, taking into account the benefit of breastfeeding for the child and the benefit of therapy for the mother.
Driving and Operating Machinery
Entyvio may have a minor effect on the ability to drive and use machines. Some patients may experience dizziness, fatigue, or headache during treatment. If you experience these symptoms, you should avoid driving or operating machinery until they have resolved.
How Does Entyvio Interact with Other Drugs?
Entyvio should not be used together with other biological immunosuppressants. Inform your doctor about all medications you are taking, including corticosteroids, aminosalicylates, and immunomodulators. Live vaccines should be avoided during treatment.
No formal drug interaction studies have been conducted with vedolizumab. However, clinical experience and pharmacological considerations provide guidance on potential interactions. Vedolizumab is not metabolised by cytochrome P450 enzymes but is instead catabolised by proteolytic degradation, which means it is less likely to interact with drugs that affect hepatic metabolism. Nevertheless, several important considerations apply.
Entyvio should not be used concomitantly with other biological immunosuppressants, as the safety and efficacy of such combinations have not been established, and there is a theoretical risk of excessive immunosuppression and increased susceptibility to infections. In clinical trials, patients who were previously treated with natalizumab or rituximab had higher rates of infections.
| Drug | Category | Effect | Recommendation |
|---|---|---|---|
| Natalizumab | Integrin inhibitor (biologic) | Increased risk of PML and additive immunosuppression; residual pharmacodynamic effects | Wait at least 12 weeks after natalizumab discontinuation before starting Entyvio |
| Rituximab | Anti-CD20 monoclonal antibody | Prolonged B-cell depletion combined with gut-selective immunosuppression; higher infection risk observed | Assess B-cell recovery and infection risk before starting Entyvio; consult specialist |
| Other biologics (TNF inhibitors) | Infliximab, adalimumab, golimumab, certolizumab | Potential additive immunosuppression; no established safety data for combination | Do not use concurrently; adequate washout period required before switching |
| Corticosteroids | Anti-inflammatory (prednisolone, budesonide) | Can be used during Entyvio induction; gradual tapering recommended | Continue during induction if clinically indicated; taper as disease control improves |
| Aminosalicylates | Mesalazine, sulfasalazine | No clinically significant pharmacokinetic interaction expected | May continue concomitant use; monitor as usual |
| Immunomodulators (azathioprine / 6-MP) | Thiopurines | Commonly used as combination therapy; may slightly affect vedolizumab pharmacokinetics | Concomitant use is acceptable; monitor for infections and cytopaenias |
| Live vaccines | MMR, varicella, oral polio, BCG, yellow fever, live influenza (nasal) | Risk of vaccine-strain infection due to immunosuppression; reduced vaccine efficacy | Do not administer live vaccines during treatment; complete vaccinations before starting Entyvio |
If you are switching from another biologic to Entyvio, your doctor will determine the appropriate washout period based on the specific drug, its half-life, and your clinical situation. Inactivated vaccines (such as influenza injection, pneumococcal, and hepatitis B) can generally be given during Entyvio treatment, although the immune response may be somewhat reduced.
What Is the Correct Dosage of Entyvio?
Treatment begins with intravenous infusions of 300 mg at weeks 0, 2, and 6 (induction phase). For maintenance, 108 mg is injected subcutaneously every 2 weeks using a pre-filled pen, starting after the last IV induction dose.
Always use Entyvio exactly as your doctor has instructed. Treatment is initiated and supervised by a specialist physician experienced in managing inflammatory bowel disease. The dosing regimen consists of two phases: an intravenous induction phase and a subcutaneous maintenance phase.
Induction Phase (Intravenous)
IV Infusion – Induction
Dose: 300 mg by intravenous infusion over approximately 30 minutes
Schedule: Week 0, Week 2, and Week 6
The infusions are given at a hospital or clinic by a healthcare professional. You will be monitored during and after each infusion for signs of allergic or infusion-related reactions. For ulcerative colitis, clinical response is typically assessed at week 6. For Crohn's disease, if no therapeutic benefit is observed by week 14, your doctor may decide to discontinue treatment.
Maintenance Phase (Subcutaneous)
Subcutaneous Injection – Maintenance
Dose: 108 mg by subcutaneous injection using the pre-filled pen
Schedule: Every 2 weeks
The first subcutaneous dose should be administered at the next scheduled visit after the last IV induction infusion (at week 6). Once your healthcare provider has trained you on the proper injection technique, you may self-inject at home. Injection sites include the thigh (front) and abdomen (avoiding the navel area). Rotate injection sites to reduce the risk of injection-site reactions.
Self-Injection Instructions
The Entyvio pre-filled pen is designed for subcutaneous self-injection. Before your first self-injection, your doctor or nurse will demonstrate the correct technique. Key steps include:
- Remove the pen from the refrigerator and allow it to reach room temperature for approximately 30 minutes before injection
- Inspect the solution through the viewing window – it should be colourless to yellow and free of visible particles
- Clean the injection site with an antiseptic wipe
- Remove the cap, place the pen flat against the skin, and press the activation button
- Hold in place for approximately 10 seconds until the injection is complete
- Dispose of the used pen in an approved sharps container – do not reuse
Missed Dose
If you miss a scheduled subcutaneous injection, administer the dose as soon as possible. Then resume your regular dosing schedule, injecting every 2 weeks from the date of the missed dose. Do not inject a double dose to make up for a missed one. If you are unsure about your next dose, contact your doctor or pharmacist for guidance.
Stopping Treatment
Do not stop using Entyvio without first speaking with your doctor. Stopping treatment without medical advice may cause your inflammatory bowel disease symptoms to return or worsen. If you and your doctor decide to discontinue Entyvio, your doctor will monitor your condition and may switch you to an alternative therapy.
What Are the Side Effects of Entyvio?
The most common side effects of Entyvio are common cold (nasopharyngitis), headache, and joint pain. Serious side effects are uncommon but include severe allergic reactions and serious infections. Most side effects are mild to moderate in severity.
Like all medicines, Entyvio can cause side effects, although not everybody gets them. In clinical trials, vedolizumab has demonstrated a favourable safety profile consistent with its gut-selective mechanism of action. The majority of reported side effects were mild to moderate in severity.
- Signs of a serious allergic reaction: difficulty breathing, wheezing, severe dizziness, swelling of the face, lips, tongue, or throat, rapid heartbeat, sweating
- Signs of a serious infection: high fever, chills, severe diarrhoea, significant wound redness or drainage, persistent cough with mucus
- New or worsening neurological symptoms: progressive weakness on one side of the body, clumsiness, vision changes, confusion, personality changes (possible PML)
- Signs of liver problems: unexplained yellowing of the skin or eyes, dark urine, unexplained right-sided abdominal pain, unusual tiredness
Very Common
May affect more than 1 in 10 people
- Common cold (nasopharyngitis)
- Joint pain (arthralgia)
- Headache
Common
May affect up to 1 in 10 people
- Pneumonia (lung infection)
- Clostridioides difficile infection
- Fever (pyrexia)
- Upper and lower respiratory tract infections
- Altered liver function / elevated liver enzymes
- Fatigue
- Cough
- Influenza (flu)
- Back pain
- Sore throat (oropharyngeal pain)
- Sinusitis
- Itching (pruritus)
- Rash and redness (erythema)
- Pain in arms or legs (extremity pain)
- Muscle cramp
- Muscle weakness
- Throat infections (pharyngitis)
- Gastroenteritis (stomach flu)
- Rectal infection
- Rectal ulcer
- Hard stool (constipation)
- Bloating (abdominal distension)
- Flatulence
- High blood pressure (hypertension)
- Tingling or prickling sensation (paraesthesia)
- Heartburn (gastroesophageal reflux disease)
- Haemorrhoids
- Nasal congestion
- Eczema
- Night sweats
- Acne
- Injection site reactions (pain, redness, itching at injection site)
- Shingles (herpes zoster)
Uncommon
May affect up to 1 in 100 people
- Red, tender hair follicles (folliculitis)
- Oral or throat fungal infection (oropharyngeal candidiasis)
- Vaginal infection (vulvovaginal candidiasis)
- Blurred vision
Rare and Very Rare
May affect fewer than 1 in 1,000 people
- Anaphylactic reaction or anaphylactic shock (severe life-threatening allergic reaction)
- Hepatitis (liver inflammation)
- Interstitial lung disease (inflammation of the lung tissue)
If you experience any side effects not listed here, or if any side effect becomes severe or persistent, contact your doctor or pharmacist. Reporting suspected side effects helps ensure ongoing monitoring of the medicine's benefit-risk balance. Long-term safety data from clinical trials and post-marketing surveillance spanning over 10 years have confirmed that vedolizumab has a consistent and well-characterised safety profile.
How Should You Store Entyvio?
Store Entyvio pre-filled pens in the refrigerator at 2–8°C. Keep in the outer carton to protect from light. Do not freeze. The pen may be kept at room temperature (up to 25°C) for up to 7 days if needed.
Store the pre-filled pen in its original outer carton in the refrigerator (2–8°C). Do not freeze the product, and do not use it if it has been frozen. Protect from direct sunlight and keep in the outer carton until ready for use.
If necessary, the Entyvio pre-filled pen may be removed from the refrigerator and stored at room temperature (up to 25°C) for a maximum of 7 days. If the pen has not been used within this 7-day period, it must be discarded. Do not return it to the refrigerator after it has been stored at room temperature.
Before injection, inspect the solution through the viewing window. It should be colourless to yellow in appearance. Do not use if the solution is discoloured, cloudy, or contains visible particles. Each pre-filled pen is for single use only – do not reuse or share the pen. Dispose of used pens in an approved sharps container.
Keep this medicine out of the sight and reach of children. Do not use after the expiry date stated on the label and outer carton. The expiry date refers to the last day of the stated month.
What Does Entyvio Contain?
Each Entyvio pre-filled pen contains 108 mg of vedolizumab as the active ingredient, along with pharmaceutical excipients including citric acid monohydrate, sodium citrate dihydrate, L-histidine, and polysorbate 80 in water for injections.
Active Ingredient
The active substance is vedolizumab. Each pre-filled pen delivers 108 mg of vedolizumab in 0.68 mL of solution for subcutaneous injection.
Inactive Ingredients (Excipients)
The other ingredients are:
- Citric acid monohydrate
- Sodium citrate dihydrate
- L-histidine
- L-histidine monohydrochloride
- L-arginine hydrochloride
- Polysorbate 80
- Water for injections
Sodium Content
This medicine contains less than 1 mmol (23 mg) sodium per dose, meaning it is essentially "sodium-free". This is relevant for patients on a sodium-restricted diet.
Appearance and Packaging
Entyvio solution for injection is a colourless to yellow liquid supplied in a pre-filled pen with automatic needle guard. The pen contains a pre-filled syringe with a stainless steel needle.
Available pack sizes: 1, 2, or 6 pre-filled pens. Not all pack sizes may be marketed in your country.
Manufacturer
Entyvio is manufactured by Takeda Pharmaceuticals. The marketing authorisation holder is Takeda Pharma A/S.
Frequently Asked Questions About Entyvio
Entyvio (vedolizumab) is used to treat moderate to severe ulcerative colitis and Crohn's disease in adults. It is prescribed when conventional therapies (such as corticosteroids and immunomodulators) or TNF-alpha inhibitors (such as infliximab or adalimumab) have not worked well enough, have stopped working, or cannot be tolerated. Entyvio works by selectively blocking inflammation in the gut without broadly suppressing the immune system throughout the body.
Unlike TNF inhibitors (such as infliximab or adalimumab) that suppress the immune system broadly throughout the body, Entyvio is gut-selective. It specifically targets the α4β7 integrin on white blood cells that are destined for the gastrointestinal tract, preventing them from migrating into inflamed intestinal tissue. This means Entyvio primarily reduces gut inflammation while preserving immune function elsewhere in the body, which may lead to a lower risk of systemic infections compared to non-selective immunosuppressants.
The time to response varies between patients and conditions. For ulcerative colitis, clinical response is often seen by week 6 after the initial intravenous induction doses. For Crohn's disease, the onset of action may be slower, and some patients may not experience significant clinical improvement until week 14 or later. Your doctor will assess your response at appropriate time points and decide whether to continue treatment based on your individual progress.
Yes, after completing the intravenous induction phase (infusions at weeks 0, 2, and 6) and receiving proper training from your healthcare provider, you can self-inject Entyvio at home using the pre-filled pen (108 mg subcutaneous injection every 2 weeks). Your doctor or nurse will teach you how to prepare, administer, and dispose of the injection safely. You should not attempt self-injection until you are confident in the technique. Suitable injection sites include the front of the thigh and the abdomen (avoiding the navel area).
If you miss a scheduled subcutaneous injection, administer the dose as soon as you remember. Then resume your regular every-two-week schedule from the date of the missed dose. Do not inject a double dose to compensate for the missed one. If you are unsure about when to take your next dose, or if a significant amount of time has passed since the missed dose, contact your doctor or pharmacist for personalised guidance.
The safety of Entyvio during pregnancy has not been fully established. Animal studies did not show direct harmful effects on the foetus, but there are limited data from pregnant women. If you are pregnant or planning a pregnancy, discuss the potential risks and benefits with your doctor. Women of childbearing potential are advised to use effective contraception during treatment and for at least 4.5 months after the last dose. Vedolizumab has been detected in breast milk, so breastfeeding should also be discussed with your healthcare provider.
References
This article is based on the following international medical guidelines and peer-reviewed sources. All medical claims have evidence level 1A, the highest quality of evidence based on systematic reviews of randomised controlled trials.
- Feagan BG, Rutgeerts P, Sands BE, et al. Vedolizumab as induction and maintenance therapy for ulcerative colitis. New England Journal of Medicine. 2013;369(8):699–710. doi:10.1056/NEJMoa1215734
- Sandborn WJ, Feagan BG, Rutgeerts P, et al. Vedolizumab as induction and maintenance therapy for Crohn's disease. New England Journal of Medicine. 2013;369(8):711–721. doi:10.1056/NEJMoa1215739
- European Medicines Agency (EMA). Entyvio (vedolizumab) – European Public Assessment Report (EPAR). EMA product information database. Accessed January 2026.
- U.S. Food and Drug Administration (FDA). Entyvio prescribing information. FDA drug labelling. Accessed January 2026.
- Colombel JF, Sands BE, Rutgeerts P, et al. The safety of vedolizumab for ulcerative colitis and Crohn's disease. Gut. 2017;66(5):839–851. doi:10.1136/gutjnl-2015-311079
- World Health Organization (WHO). WHO Model List of Essential Medicines – 23rd list. Geneva: WHO; 2023.
- British National Formulary (BNF). Vedolizumab. NICE BNF monograph. Accessed January 2026.
- Torres J, Bonovas S, Doherty G, et al. ECCO Guidelines on Therapeutics in Crohn's Disease: Medical Treatment. Journal of Crohn's and Colitis. 2020;14(1):4–22. doi:10.1093/ecco-jcc/jjz180
Editorial Team
This article has been written and reviewed by the iMedic Medical Editorial Team, a group of licensed specialist physicians with expertise in gastroenterology, clinical immunology, and internal medicine.
Medical Writers
Board-certified physicians specialising in gastroenterology and clinical immunology with documented academic and clinical experience in inflammatory bowel disease.
Medical Reviewers
Independent review board ensuring clinical accuracy, adherence to international guidelines (ECCO, AGA, NICE, WHO), and evidence level 1A standards.
All content follows the GRADE evidence framework and is reviewed against current international guidelines. We have no commercial funding or pharmaceutical sponsorship. For more information, see our editorial standards and medical team pages.