When conventional
treatments fail
Act fast
with entyvio*
*In clinical trials, patients had previously demonstrated an inadequate response to or intolerance of conventional treatments (corticosteroids or immunomodulators) and/or anti-tumor necrosis factor therapies.1
The ENTYVIO Pen for SC injection is a maintenance option after IV induction.
For adults with moderately to severely active ulcerative colitis (UC) or Crohn's disease (CD).
†Based on a quarterly analysis of Symphony medical and pharmacy claims with data from October 2022 through December 2023. Biologics include Cimzia® (certolizumab pegol; UCB, Inc.), Humira® (adalimumab; AbbVie Inc.), Skyrizi® (risankizumab-rzaa; AbbVie Inc.), Remicade® (infliximab; Janssen Biotech, Inc.), Stelara® (ustekinumab; Janssen Biotech, Inc.), Simponi® (golimumab; Janssen Biotech, Inc.), adalimumab biosimilars, and infliximab biosimilars. March 2024.
TREAT EARLY
The moment your adult patients with moderate
to severe Crohn’s or UC are not well-controlled
with conventional therapies, seek long-term
relief and remission. Patients achieved
remission at Week 52 vs placebo with the
ENTYVIO Pen or IV.1
Individual results may vary.
TREAT DIRECTLY
ENTYVIO helps address inflammation where it
occurs—in the gut.1 ENTYVIO specifically binds to
the α4β7 integrin and blocks its interaction with
MAdCAM-1, which is mainly expressed on the GI
tract endothelial cells.1-7
TREAT CONFIDENTLY
With 10 years of patient experience, 92%
unrestricted commercial coverage for ENTYVIO IV,
and growing coverage for the ENTYVIO Pen‡§‖
TREAT FLEXIBLY
With 2 options for maintenance treatment—the
ENTYVIO Pen for SC injection or IV infusions1¶
¶After at least 2 IV infusions.
‡Based on Symphony claims data from June 2014 to preliminary November 2023. February 2024.
§Unrestricted refers to coverage that does not require biologic step-edits. Data regarding current unrestricted commercial coverage for ENTYVIO as of January 2024 are derived from Managed Markets Insights & Technology (MMIT). March 2024.
‖Refers to covered commercial lives including unrestricted coverage and biologic step-edits. Data regarding current commercial coverage for the ENTYVIO Pen as of July 2024 are derived from MMIT. July 2024.
GI=gastrointestinal; IV=intravenous; MAdCAM-1=mucosal addressin cell adhesion molecule-1; SC=subcutaneous.
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
vs placebo
Patients achieved clinical response at Week 6 and clinical remission at Week 52 vs placebo.1
TRIAL
VARSITY, which studied ENTYVIO vs Humira® (adalimumab), was the first
head-to-head trial of biologics in moderate to severe ulcerative colitis8,9
ENTYVIO DEMONSTRATED SUPERIORITY
TO HUMIRA®*
In clinical remission at Week 52 in the overall population.8†
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.
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.1,10,11*
*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).10,11
Support for patients prescribed ENTYVIO
EntyvioConnect offers a range of programs tailored to help patients with access and affordability.
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
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.
- Briskin M, Winsor-Hines D, Shyjan A, et al. Human mucosal addressin cell adhesion molecule-1 is preferentially expressed in intestinal tract and associated lymphoid tissue. Am J Pathol. 1997;151(1):97-110.
- Fedyk ER, Wyant T, Yang LL, et al. Exclusive antagonism of the α4β7 integrin by vedolizumab confirms the gut-selectivity of this pathway in primates. Inflamm Bowel Dis. 2012;18(11):2107-2119.
- Soler D, Chapman T, Yang LL, et al. The binding specificity and selective antagonism of vedolizumab, an anti-α4β7 integrin therapeutic antibody in development for inflammatory bowel diseases. J Pharmacol Exp Ther. 2009;330(3):864-875.
- Wyant T, Fedyk E, Abhyankar B. An overview of the mechanism of action of the monoclonal antibody vedolizumab. J Crohns Colitis. 2016;10(12):1437-1444.
- Wyant T, Leach T, Sankoh S, et al. Vedolizumab affects antibody responses to immunisation selectively in the gastrointestinal tract: randomised controlled trial results. Gut. 2015;64(1):77-83.
- Milch C, Wyant T, Xu J, et al. Vedolizumab, a monoclonal antibody to the gut homing α4β7 integrin, does not affect cerebrospinal fluid T-lymphocyte immunophenotype. J Neuroimmunol. 2013;264:123-126.
- 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.
