Welcome to the latest installment of our Guidelines+ Monographs Series. In this edition, we will delve into the medication vedolizumab, marketed under the brand name Entyvio by Takeda Pharmaceuticals. Entyvio is an integrin receptor antagonist indicated in adults for the treatment of moderately to severely active ulcerative colitis (UC) and moderately to severely active Crohn’s disease (CD). It was initially approved in 2014.

In the following sections, we will provide a comprehensive overview of vedolizumab and analyze its positioning across various guidelines for its approved indications.

Note* – This Guidelines+ Monographs for vedolizumab (Entyvio) is current as of October 2024. Consult our clinical guidelines library and/or or medication information lookup tool to ensure you are always accessing the most current information.

Medication Overview:

  • Brand name: Entyvio
  • Generic name: vedolizumab
  • Manufacturer(s): Takeda Pharmaceuticals
  • Initial FDA approval: 2014

Indications and FDA Approval Details

Indicated ConditionIndicated Age RangeDate Approved
Ulcerative ColitisFor treatment of Ulcerative Colitis and Crohn’s DiseaseAdultsMay 2014
Crohn’s DiseaseFor treatment of Crohn’s DiseaseAdultsMay 2014
Ulcerative ColitisFor Maintenance Therapy in Moderately to Severely Active Ulcerative ColitisAdultsSeptember 2023
Crohn’s DiseaseFor Maintenance Therapy in Moderately to Severely Active Crohn’s DiseaseAdultsApril 2024

Dosage and Strengths

Important Administration Information

  • Before initiating ENTYVIO, update immunizations according to current immunization guidelines.
  • Intravenous Administration: ENTYVIO should be administered intravenously by a healthcare provider.
  • Subcutaneous Injection: ENTYVIO prefilled syringe and ENTYVIO PEN are intended for subcutaneous use. A patient may self-inject or caregiver may inject after proper training on correct subcutaneous injection technique.

Recommended Dosage

  • Week 0: 300 mg infused intravenously over approximately 30 minutes.
  • Week 2: 300 mg infused intravenously over approximately 30 minutes.
  • Week 6: Patients may remain on ENTYVIO intravenous therapy or switch to subcutaneous injection after receiving two ENTYVIO intravenous doses administered at Week 0 and Week 2.
    • Intravenous Infusion: 300 mg infused over approximately 30 minutes and then every eight weeks thereafter.
    • Subcutaneous Injection: 108 mg subcutaneously once every two weeks.
    • Discontinue ENTYVIO in patients who do not show evidence of therapeutic benefit by Week 14.
  • Patients currently receiving and responding to ENTYVIO intravenous therapy after Week 6 may also be switched to subcutaneous injection. Administer the first subcutaneous dose in place of the next scheduled intravenous infusion and every two weeks thereafter.

Preparation and Administration Instructions:

  • See full prescribing information for complete information on reconstitution, dilution, administration, and storage. 

Warnings and Precautions

  • Infusion-Related Reactions and Hypersensitivity Reactions: Discontinue ENTYVIO and initiate appropriate treatment if serious reactions occur. (5.1) • Infections: Treatment with 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.
  • Progressive Multifocal Leukoencephalopathy (PML): Although unlikely, a risk of PML cannot be ruled out. Monitor patients for any new or worsening neurological signs or symptoms.

Adverse Reactions

Most common adverse reactions (incidence ≥3% and ≥1% higher than placebo) are: nasopharyngitis, headache, arthralgia, nausea, pyrexia, upper respiratory tract infection, fatigue, cough, bronchitis, influenza, back pain, rash, pruritus, sinusitis, oropharyngeal pain, and pain in extremities.

Adverse reactions with subcutaneous ENTYVIO are similar to those reported with intravenous ENTYVIO with the exception of injection site reactions reported with subcutaneous ENTYVIO.

Now that we’ve covered the basic monograph information for vedolizumab, let’s take a closer look at how it is currently recommended in various clinical practice guidelines.

Specific Inclusions of Vedolizumab in Clinical Guidelines

  • Ulcerative Colitis in Adults
    • Authoring Societies: American College of Gastroenterology (AGA)
    • Publication: February 01, 2019
      • In patients with moderately to severely active UC, AGA recommends vedolizumab for induction of remission (strong recommendation, moderate quality of evidence)
      • AGA recommends continuing vedolizumab to maintain remission in patients with previously moderately to severely active UC now in remission after vedolizumab induction (strong recommendation, moderate quality of evidence)
      • In patients with ASUC who achieve remission with cyclosporine treatment, AGA suggests maintenance of remission with vedolizumab (conditional recommendation, very low quality of evidence)
      • In patients with moderately to severely active UC who have previously failed anti-TNF therapy, AGA recommends vedolizumab for induction of remission (strong recommendation, moderate quality of evidence)

  • Management of Moderate to Severe Ulcerative Colitis
    • Authoring Society: AGA
    • Publication: January 13, 2020
      • In adult outpatients with moderate to severe ulcerative colitis, the AGA recommends using infliximab, adalimumab, golimumab, vedolizumab, tofacitinib, or ustekinumab over no treatment. (Strong recommendation, moderate quality evidence).
      • In adult outpatients with moderate to severe UC who are naïve to biologic agents, the AGA suggests using infliximab or vedolizumab rather than adalimumab, for induction of remission.
      • In adult outpatients with moderate to severe UC who have previously been exposed to infliximab, particularly those with primary nonresponse, the AGA suggests using ustekinumab or tofacitinib rather than vedolizumab or adalimumab for induction of remission.
      • In adult outpatients with active moderate to severe UC, the AGA suggests using biologic monotherapy (TNF-a antagonists, vedolizumab, or ustekinumab) or tofacitinib rather than thiopurine monotherapy for induction of remission.
      • In adult outpatients with moderate to severe UC, the AGA suggests combining TNF-a antagonists, vedolizumab or ustekinumab with thiopurines or methotrexate rather than biologic monotherapy.
      • In adult outpatients with moderate to severe UC, the AGA suggests combining TNF-a antagonists, vedolizumab, or ustekinumab with thiopurines or methotrexate rather than thiopurine monotherapy.

  • Management of Crohn’s Disease in Adults
    • Authoring Society: AGA
    • Publication: March 01, 2018
      • For patients with moderately to severely active Crohn’s disease and objective evidence of active disease, anti-integrin therapy (with vedolizumab) with or without an immunomodulator is more effective than placebo and should be considered to be used for induction of symptomatic remission in patients with Crohn’s disease (strong recommendation, high level of evidence).
      • Vedolizumab should be used for maintenance of remission of vedolizumab-induced remission of Crohn’s disease (conditional recommendation, moderate level of evidence).

  • Medical Management of Moderate to Severe Luminal and Perianal Fistulizing Crohn’s Disease
    • Authoring Society: AGA
    • Publication: May 27, 2021
      • In adult outpatients with moderate to severe CD, the AGA suggests the use of vedolizumab over no treatment for the induction and maintenance of remission.
      • In adult outpatients with moderate to severe CD who are naïve to biologic drugs, the AGA recommends the use of infliximab, adalimumab, or ustekinumab over certolizumab pegol for the induction of remission and suggests the use of vedolizumab over certolizumab pegol for the induction of remission.
      • In adult outpatients with moderate to severe CD who never responded to antiTNFa (primary nonresponse), the AGA recommends the use of ustekinumab and suggests the use of vedolizumab over no treatment for the induction of remission.
      • In adult outpatients with moderate to severe CD who previously responded to infliximab (secondary nonresponse), the AGA recommends the use of adalimumab or ustekinumab and suggests the use of vedolizumab over no treatment for the induction of remission.

This concludes our Guidelines+ Monographs for vedolizumab (Entyvio). This list is current as of October 2024 and may be updated over time as new indications are approved and/or new guidelines published or updated. Sign up for alerts and stay informed on the latest published guidelines and articles.

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