The only gut-focused
biologic^* for Crohn’s and UC

that works right where U need it

Number 1 prescribed biologic for Crohn's and ulcerative colitis combined.

^†

^†Based on a quarterly analysis of Symphony medical and pharmacy claims with data from October 2023 through September 2024.

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

Focus
U Want

Helps block certain
inflammation-causing lymphocytes
from entering the gut¹

ENTYVIO 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:
ENTYVIO IV and
the ENTYVIO Pen^1||

Pen Info

IV Info

^§Based on Symphony claims data from June 2014 to preliminary November 2024.

^||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

^¶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

For adults with moderately to severely active ulcerative colitis (UC) or Crohn’s disease (CD).

Patients want options

Offer patients
a choice in
maintenance therapy*

*After at least 2 IV infusions, patients responding to
ENTYVIO can remain on IV or switch to the ENTYVIO Pen.¹

Learn more about the
ENTYVIO Pen

See Pen Dosing

See which pharmacies carry
the ENTYVIO Pen

Pharmacy Guide

^†

^†Based on a quarterly analysis of Symphony medical and pharmacy claims with data from October 2023 through September 2024.

‡

Focus
U Want

Helps block certain
inflammation-causing lymphocytes
from entering the gut¹

^‡ENTYVIO 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:
ENTYVIO IV and
the ENTYVIO Pen¹*

Pen Info

IV Info

^||Based on Symphony claims data from June 2014 to preliminary November 2024.

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

^¶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
For adults with moderately to severely active ulcerative colitis (UC) or Crohn’s disease (CD).

In the first head-to-head study of biologics in UC

ENTYVIO: SUPERIOR
TO HUMIRA^®(adalimumab)

in clinical remission at Week 52^1,2*^†

VARSITY Primary End Point (overall population): ENTYVIO IV 31% (n=383); 23% (n=386) with Humira^® (P=0.006; 95% CI: 3%, 15%)¹

*Clinical remission was defined as a complete Mayo Score of ≤2 points and no subscore >1 point.

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

Review the GEMINI I pivotal trial and
VARSITY trial data and analyses

See the efficacy data

See Dr. Stephen Hanauer's review of the
head-to-head trial

Get an expert perspective

^‡

Focus
U Want

Helps block certain
inflammation-causing lymphocytes
from entering the gut³

^‡ENTYVIO specifically
binds to the α4β7
integrin and blocks
its interaction with
MAdCAM-1, which is
mainly expressed on
the gut
endothelial cells³

Review the MOA

Results
U Need

GEMINI I and II Trials

Lasting relief and
CS-free remission
at Week 52^3§

Rapid symptom relief
as early as Week 6^3§

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:
ENTYVIO IV and
the ENTYVIO Pen^3¶

Pen Info

IV Info

^||Based on Symphony claims data from June 2014 to preliminary November 2024.

^¶The ENTYVIO Pen is an option after at least 2 IV infusions.³

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

^#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.

^**

^**Based on a quarterly analysis of Symphony medical and pharmacy claims with data from October 2023 through September 2024.

GEMINI I

GEMINI I was a randomized, double-blind, placebo-controlled study of
adult patients with moderately to severely active ulcerative colitis³

THE FOUNDATIONAL STUDY OF ENTYVIO (vedolizumab) VS PLACEBO

Patients achieved clinical response at Week 6 and clinical remission at Week 52 vs placebo.³

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^1,2

ENTYVIO: Superior to Humira^®*

In clinical remission at Week 52 in the overall population.^1†

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

Support for patients prescribed ENTYVIO

EntyvioConnect offers a range of programs tailored to help patients with access and affordability.

Enroll your patients

The content on this page has been written and
reviewed by Takeda.

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: Patients treated with ENTYVIO are at increased risk for developing infections. Serious infections have been reported in patients treated with ENTYVIO, including anal abscess, sepsis (some fatal), tuberculosis, salmonella sepsis, Listeria meningitis, giardiasis, and cytomegaloviral colitis. ENTYVIO is not recommended in patients with active, severe infections until the infections are controlled. Consider withholding ENTYVIO in patients who develop a severe infection while on treatment with ENTYVIO. Exercise caution in patients with a history of recurring severe infections. Consider screening for tuberculosis (TB) according to the local practice.
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.
Live and Oral Vaccines: 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

Adult Ulcerative Colitis (UC):

ENTYVIO is indicated in adults for the treatment of moderately to severely active UC.

Adult Crohn’s Disease (CD):

ENTYVIO is indicated in adults for the treatment of moderately to severely active 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.

If you are a Colorado prescriber, please see the Colorado WAC disclosure form (opens in a new tab).

If you are a Connecticut prescriber, please see the Connecticut WAC disclosure form (opens in a new tab).

©2025 Takeda Pharmaceuticals U.S.A., Inc. 500 Kendall Street, Cambridge, MA 02142. 1-877-TAKEDA-7 (1-877-825-3327). All rights reserved. Takeda and the Takeda logo are registered trademarks of Takeda Pharmaceutical Company Limited. ENTYVIO and the ENTYVIO logo are registered trademarks of Millennium Pharmaceuticals, Inc. All other trademarks are the property of their respective owners.

US-VED-1989v4.0 06/25

This site is intended for use by US healthcare professionals only.

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

Offer patients a choice in maintenance therapy*

ENTYVIO: SUPERIOR TO HUMIRA® (adalimumab)

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The only gut-focused
biologic^* for Crohn’s and UC

Offer patients
a choice in
maintenance therapy*

ENTYVIO: SUPERIOR
TO HUMIRA^®(adalimumab)