Focus U Want

Helps block certain inflammation-causing lymphocytes from entering the gut¹

ENTYVIO (vedolizumab) specifically binds to the α4β7 integrin and blocks its interaction with MAdCAM-1, which is mainly expressed on the gut endothelial cells.¹

Review the MOA

Results U Need

Lasting relief and CS-free remission at Week 52^1‡

Rapid symptom relief as early as Week 6^1‡

Individual results may vary.

Crohn’s efficacy UC efficacy

^‡Many patients taking ENTYVIO IV achieved remission at Week 52 vs placebo, some without steroids. Some achieved remission at Week 6. Clinical remission was defined as Crohn’s CDAI score ≤150 or UC complete Mayo Score of ≤2 points and no individual subscore of >1 point. CS-free remission is the proportion of patients receiving corticosteroids at baseline and who discontinued steroids and achieved clinical remission.

Experience U Expect

More than 10 years of patient experience^§

2 options for maintenance therapy with ENTYVIO (vedolizumab): IV and Pen.^1||

Pen info IV info

^§ENTYVIO IV was FDA approved in May 2014.

^||The ENTYVIO Pen is an option after at least 2 IV infusions.¹

Support U Deserve

Over 90% unrestricted commercial coverage for ENTYVIO IV and growing coverage for the ENTYVIO Pen^¶

1-on-1 support for ENTYVIO patients through EntyvioConnect

Explore support

^§ENTYVIO IV was FDA approved in May 2014.

^||The ENTYVIO Pen is an option after at least 2 IV infusions.¹

^¶For IV, unrestricted refers to coverage that does not require biologic step-edits. For pen, covered commercial lives include unrestricted coverage and biologic step-edits. Data are derived from Managed Markets Insight & Technology as of December 2024 (IV) and January 2025 (pen).

CDAI=Crohn's Disease Activity Index; CS=corticosteroid; IV=intravenous; MAdCAM-1=mucosal addressin cell adhesion molecule-1.

GEMINI I

GEMINI I was a randomized, double-blind, placebo-controlled study of adult patients with moderately to severely active ulcerative colitis¹

The foundational study of ENTYVIO (vedolizumab) vs placebo

Patients achieved clinical response at Week 6 and clinical remission at Week 52 vs placebo.¹

See the results

VARSITY TRIAL

VARSITY, which studied ENTYVIO vs Humira^® (adalimumab), was the first head-to-head trial of biologics in moderate to severe ulcerative colitis^2,3

ENTYVIO: Superior to Humira^®*

In clinical remission at Week 52 in the overall population.^2†

VARSITY was a double‑blind, double‑dummy, active‑controlled trial that compared ENTYVIO with Humira^® (adalimumab) in adults with moderately to severely active ulcerative colitis.

*Humira^® is a registered trademark of AbbVie Inc., North Chicago, IL. For information about Humira^®, please see AbbVie.com.

^†Clinical remission was defined as a complete Mayo Score of ≤2 points and no subscore >1 point. Superiority was demonstrated in the overall population. Individual results may vary.

See the full results

Up to 7 years of consistent safety data

Clinical trials evaluated safety in more than 3300 adults (UC, Crohn's, and healthy volunteers).¹

A separate open-label study of up to 7 years demonstrated consistent results across safety parameters.^1,4,5*

*In a single-arm, open-label extension study, 2243 patients received ENTYVIO IV with a median exposure of 1072 days (range 1 to 3412 days).^4,5

See safety profile

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

ENTYVIO is contraindicated in patients who have had a known serious or severe hypersensitivity reaction to ENTYVIO or any of its excipients.

WARNINGS AND PRECAUTIONS

Infusion-Related and Hypersensitivity Reactions: Infusion-related reactions and hypersensitivity reactions, including anaphylaxis, dyspnea, bronchospasm, urticaria, flushing, rash, and increased blood pressure and heart rate, have been reported. These reactions may occur with the first or subsequent infusions and may vary in their time of onset from during infusion or up to several hours post-infusion. If anaphylaxis or other serious infusion-related or hypersensitivity reactions occur, discontinue administration of ENTYVIO immediately and initiate appropriate treatment.
Infections: ENTYVIO increases the risk for developing infections. Serious infections in clinical trials included anal abscess, sepsis (some fatal), tuberculosis (TB), salmonella sepsis, Listeria meningitis, giardiasis, and cytomegaloviral colitis. Postmarketing reports include systemic bacterial, fungal, viral, and parasitic opportunistic infections.
Do not start ENTYVIO in patients with a clinically important active infection until resolved or adequately treated. In patients with chronic infection or history of recurrent infection, consider risks and benefits prior to ENTYVIO. Instruct patients to seek medical advice if signs or symptoms of acute or chronic infection occur. If a serious infection develops or does not respond to therapy, monitor closely and do not administer ENTYVIO until resolved.
Tuberculosis: Consider evaluating for TB prior to ENTYVIO. Do not administer ENTYVIO to patients with active TB. Before starting ENTYVIO, treat latent TB and consider anti-TB therapy in patients with a history of TB if adequate course of treatment cannot be confirmed. Monitor for active TB during and after ENTYVIO.
Progressive Multifocal Leukoencephalopathy (PML): PML, a rare and often fatal opportunistic infection of the central nervous system (CNS), has been reported with systemic immunosuppressants, including another integrin receptor antagonist. PML typically only occurs in patients who are immunocompromised. One case of PML in an ENTYVIO-treated patient with multiple contributory factors has been reported. Although unlikely, a risk of PML cannot be ruled out. Monitor patients for any new or worsening neurological signs or symptoms that may include progressive weakness on one side of the body or clumsiness of limbs, disturbance of vision, and changes in thinking, memory, and orientation leading to confusion and personality changes. If PML is suspected, withhold dosing with ENTYVIO and refer to neurologist; if confirmed, discontinue ENTYVIO dosing permanently.
Liver Injury: There have been reports of elevations of transaminase and/or bilirubin in patients receiving ENTYVIO. ENTYVIO should be discontinued in patients with jaundice or other evidence of significant liver injury.
Immunizations: Prior to initiating treatment with ENTYVIO, all patients should be brought up to date with all immunizations according to current immunization guidelines. Patients receiving ENTYVIO may receive non-live vaccines and may receive live vaccines if the benefits outweigh the risks.

ADVERSE REACTIONS

The most common adverse reactions (incidence ≥3% and ≥1% higher than placebo) were: nasopharyngitis, headache, arthralgia, nausea, pyrexia, upper respiratory tract infection, fatigue, cough, bronchitis, influenza, back pain, rash, pruritus, sinusitis, oropharyngeal pain, pain in extremities, and injection site reactions with subcutaneous administration.

DRUG INTERACTIONS

Because of the potential for increased risk of PML and other infections, avoid the concomitant use of ENTYVIO with natalizumab products and with TNF blockers. Upon initiation or discontinuation of ENTYVIO in patients treated with CYP450 substrates, monitor drug concentrations or other therapeutic parameters, and adjust the dosage of the CYP substrate as needed.

INDICATIONS

ENTYVIO is indicated in adults for the treatment of:

moderately to severely active ulcerative colitis (UC)
moderately to severely active Crohn's disease (CD)

DOSAGE FORMS & STRENGTHS

ENTYVIO Intravenous (IV) Infusion: 300 mg vedolizumab
ENTYVIO Subcutaneous (SC) Injection: 108 mg vedolizumab

Please click for Full Prescribing Information.

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

ENTYVIO is contraindicated in patients who have had a known serious or severe hypersensitivity reaction to ENTYVIO or any of its excipients.

WARNINGS AND PRECAUTIONS

Infusion-Related and Hypersensitivity Reactions: Infusion-related reactions and hypersensitivity reactions, including anaphylaxis, dyspnea, bronchospasm, urticaria, flushing, rash, and increased blood pressure and heart rate, have been reported. These reactions may occur with the first or subsequent infusions and may vary in their time of onset from during infusion or up to several hours post-infusion. If anaphylaxis or other serious infusion-related or hypersensitivity reactions occur, discontinue administration of ENTYVIO immediately and initiate appropriate treatment.
Infections: ENTYVIO increases the risk for developing infections. Serious infections in clinical trials included anal abscess, sepsis (some fatal), tuberculosis (TB), salmonella sepsis, Listeria meningitis, giardiasis, and cytomegaloviral colitis. Postmarketing reports include systemic bacterial, fungal, viral, and parasitic opportunistic infections.
Do not start ENTYVIO in patients with a clinically important active infection until resolved or adequately treated. In patients with chronic infection or history of recurrent infection, consider risks and benefits prior to ENTYVIO. Instruct patients to seek medical advice if signs or symptoms of acute or chronic infection occur. If a serious infection develops or does not respond to therapy, monitor closely and do not administer ENTYVIO until resolved.
Tuberculosis: Consider evaluating for TB prior to ENTYVIO. Do not administer ENTYVIO to patients with active TB. Before starting ENTYVIO, treat latent TB and consider anti-TB therapy in patients with a history of TB if adequate course of treatment cannot be confirmed. Monitor for active TB during and after ENTYVIO.
Progressive Multifocal Leukoencephalopathy (PML): PML, a rare and often fatal opportunistic infection of the central nervous system (CNS), has been reported with systemic immunosuppressants, including another integrin receptor antagonist. PML typically only occurs in patients who are immunocompromised. One case of PML in an ENTYVIO-treated patient with multiple contributory factors has been reported. Although unlikely, a risk of PML cannot be ruled out. Monitor patients for any new or worsening neurological signs or symptoms that may include progressive weakness on one side of the body or clumsiness of limbs, disturbance of vision, and changes in thinking, memory, and orientation leading to confusion and personality changes. If PML is suspected, withhold dosing with ENTYVIO and refer to neurologist; if confirmed, discontinue ENTYVIO dosing permanently.
Liver Injury: There have been reports of elevations of transaminase and/or bilirubin in patients receiving ENTYVIO. ENTYVIO should be discontinued in patients with jaundice or other evidence of significant liver injury.
Immunizations: Prior to initiating treatment with ENTYVIO, all patients should be brought up to date with all immunizations according to current immunization guidelines. Patients receiving ENTYVIO may receive non-live vaccines and may receive live vaccines if the benefits outweigh the risks.

ADVERSE REACTIONS

DRUG INTERACTIONS

INDICATIONS

ENTYVIO is indicated in adults for the treatment of:

moderately to severely active ulcerative colitis (UC)
moderately to severely active Crohn's disease (CD)

DOSAGE FORMS & STRENGTHS

ENTYVIO Intravenous (IV) Infusion: 300 mg vedolizumab
ENTYVIO Subcutaneous (SC) Injection: 108 mg vedolizumab

Please click for Full Prescribing Information.

References:

ENTYVIO (vedolizumab) prescribing information. Takeda Pharmaceuticals.
Sands BE, Peyrin-Biroulet L, Loftus EV Jr, et al. Vedolizumab versus adalimumab for moderate-to-severe ulcerative colitis. N Engl J Med. 2019;381(13):1215-1226.
Macaluso FS, Maida M, Grova M, et al. Head-to-head comparison of biological drugs for inflammatory bowel disease: from randomized controlled trials to real-world experience. Therap Adv Gastroenterol. 2021;14:1-11.
Loftus EV Jr, Feagan BG, Panaccione R, et al; for the GEMINI LTS study team. Long-term safety of vedolizumab for inflammatory bowel disease. Aliment Pharmacol Ther. 2020;52(8):1353-1365.
Data on File. Takeda Pharmaceuticals.

Discover the only gut-focused biologic* for Crohn’s and UC

that works right where U need it

Focus U Want

Results U Need

Experience U Expect

Support U Deserve

GEMINI I

GEMINI I was a randomized, double-blind, placebo-controlled study of adult patients with moderately to severely active ulcerative colitis¹

The foundational study of ENTYVIO (vedolizumab) vs placebo

VARSITY TRIAL

VARSITY, which studied ENTYVIO vs Humira^® (adalimumab), was the first head-to-head trial of biologics in moderate to severe ulcerative colitis^2,3

ENTYVIO: Superior to Humira^®*

Up to 7 years of consistent safety data

You are about to leave this website and enter a website operated by an independent third party

You are about to leave this website.

Are you a US healthcare professional?

Discover the only gut-focused biologic* for Crohn’s and UC

that works right where U need it

Focus U Want

Results U Need

Experience U Expect

Support U Deserve

GEMINI I

GEMINI I was a randomized, double-blind, placebo-controlled study of adult patients with moderately to severely active ulcerative colitis1

The foundational study of ENTYVIO (vedolizumab) vs placebo

VARSITY TRIAL

VARSITY, which studied ENTYVIO vs Humira® (adalimumab), was the first head-to-head trial of biologics in moderate to severe ulcerative colitis2,3

ENTYVIO: Superior to Humira®*

Up to 7 years of consistent safety data

You are about to leave this website and enter a website operated by an independent third party

You are about to leave this website.

Are you a US healthcare professional?

GEMINI I was a randomized, double-blind, placebo-controlled study of adult patients with moderately to severely active ulcerative colitis¹

VARSITY, which studied ENTYVIO vs Humira^® (adalimumab), was the first head-to-head trial of biologics in moderate to severe ulcerative colitis^2,3

ENTYVIO: Superior to Humira^®*