Entyvio Prescribing Information for Practitioners

For healthcare professionals managing patients with inflammatory bowel disease (IBD), understanding the prescribing information for biologic therapies is essential—not just for compliance, but for ensuring safe, effective, and individualized care. The U.S. Food and Drug Administration (FDA) highlights that precise labeling helps clinicians make informed dosing and monitoring decisions that directly impact patient outcomes.

One such therapy is Entyvio (vedolizumab), a gut-selective biologic used to treat moderately to severely active ulcerative colitis and Crohn’s disease in adults. Its official prescribing information provides a comprehensive roadmap for clinicians, outlining dosing schedules, infusion and injection protocols, safety warnings, and monitoring recommendations designed to maximize therapeutic success while minimizing risk.

This article offers a clear overview of Entyvio’s prescribing information, including key details on dosage, administration, contraindications, and clinical safety guidance. This will help practitioners deliver confident, evidence-based care to every patient.

Key Takeaways

• Entyvio (vedolizumab) is approved for moderately to severely active ulcerative colitis and Crohn’s disease in adults who have failed, lost response to, or are intolerant to conventional or TNF-based therapies.
• The recommended dosing includes IV induction at Weeks 0 and 2, followed by maintenance every 8 weeks, or a subcutaneous (SC) option of 108 mg every 2 weeks starting at Week 6 for continued maintenance.
• Pre-treatment screening should include infection history, immunization updates, and testing for tuberculosis (TB) and hepatitis B virus (HBV) before initiating therapy.
• Entyvio has a favorable safety profile, with most side effects being mild; however, clinicians should remain vigilant for serious risks such as anaphylaxis, interstitial lung disease (ILD), and pneumonitis.
• No cases of Progressive Multifocal Leukoencephalopathy (PML) have been reported after over 54,000 patient-years of exposure, underscoring its strong safety record compared to other integrin blockers.
• Therapy must be discontinued by Week 14 if patients show no evidence of therapeutic benefit, as defined by FDA prescribing guidelines.
• Dose intensification (every 4 weeks) may be considered for loss of response, though this remains an off-label adjustment used in clinical practice.

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Indications and Patient Selection

Entyvio (vedolizumab) is approved for adults with moderately to severely active ulcerative colitis or Crohn’s disease who have had an inadequate response, lost response, or are intolerant to conventional therapy or tumor necrosis factor (TNF) antagonists. It offers a gut-selective mechanism of action, providing targeted immune regulation while minimizing systemic effects. Many clinicians prefer it for long-term management of inflammatory bowel disease (IBD).

Ideal Candidates

• Those pursuing corticosteroid-free remission for sustained disease control.
  
• Individuals who have not responded to prior biologics but require a more targeted, gut-specific therapy.
  
• Patients prioritizing mucosal healing and long-term remission to prevent relapse and hospitalization.

Before initiating therapy, clinicians should conduct a comprehensive pre-treatment evaluation, including a detailed infection history, immunization review, and medication reconciliation. All patients should be brought up to date with vaccinations according to current guidelines. Screening for tuberculosis (TB) and hepatitis B virus (HBV) is recommended prior to treatment due to the potential for reactivation of latent infections. Patients with active infections should defer treatment until clinically resolved.

With its gut-specific activity and robust safety data, Entyvio offers strong efficacy for symptom control and remission maintenance. Patient selection should always balance disease severity, prior biologic exposure, and treatment goals, ensuring that each individual receives the most effective and safest care plan possible.

Dosing, Administration & Monitoring Guidelines

Entyvio is administered either as an intravenous (IV) infusion or a subcutaneous (SC) injection, with the route depending on the treatment phase and patient preference.

Standard Dosing Schedule

• Induction Phase: 300 mg IV infusion at Week 0 and Week 2.
  
• Maintenance Phase:
  
  • Continue IV infusions every 8 weeks starting at Week 6, or
    
  • Transition to subcutaneous (SC) injections of 108 mg every 2 weeks, beginning at Week 6, for adult patients with UC or Crohn’s disease who have completed the IV induction doses.

Key Administration and Monitoring Considerations

• Trained healthcare professionals should perform infusions in a clinical setting.
  
• Observe all patients during and after infusion for hypersensitivity reactions, including rash, pruritus, or anaphylaxis.
  
• Premedication is not routinely required but may be used for patients with mild prior infusion reactions.
  
• Laboratory monitoring should include liver function tests and hematologic parameters, especially for those on concurrent immunosuppressants.
  
• Assess response at Week 14: patients showing no meaningful improvement must have therapy discontinued, per FDA labeling.

Safety, Warnings, and Risk Management

Entyvio’s overall safety profile is favorable, with most side effects being mild to moderate and manageable through standard clinical care. Nonetheless, practitioners must remain vigilant for both common and serious adverse events.

Common Adverse Events

• Headache, fatigue, or joint pain (arthralgia)
  
• Mild upper respiratory infections
  
• Nausea or abdominal pain

Serious Risks

• Hypersensitivity reactions: Rare cases of anaphylaxis have occurred; discontinue immediately if such a reaction develops.
  
• Infection risk: Monitor for reactivation of latent infections, including TB and HBV.
  
• Interstitial Lung Disease (ILD) and pneumonitis: Added to the FDA’s April 2024 postmarketing safety update; evaluate any new or worsening respiratory symptoms promptly.
  
• Progressive Multifocal Leukoencephalopathy (PML): While a risk associated with certain integrin blockers, no cases of PML have been reported with vedolizumab across more than 54,000 patient-years of clinical and post-marketing exposure, underscoring its favorable safety profile.
  
• Infusion-related reactions: Pause infusion if symptoms occur; resume only after resolution under medical supervision.

Healthcare practitioners may recommend routine laboratory and physical assessments during therapy, especially if they are combining Entyvio with corticosteroids or other immunomodulators. Patient education on early symptom recognition is critical to minimizing risks. 

Takeda Pharmaceutical Company, Entyvio’s manufacturer, continues to maintain robust pharmacovigilance systems to ensure long-term safety through transparent data collection and reporting.

Switching, Response Assessment & Dose Adjustment

Switching between biologic therapies has become increasingly common in IBD management. For patients transitioning to vedolizumab, most clinical experts now support shortened or overlapping switches from previous biologics, instead of extended washout periods, as current evidence shows this approach does not increase the risk of serious infections.

Response Assessment

• Evaluate outcomes at Weeks 6–14 to determine induction success.
  
• Continue maintenance therapy if there is clinical improvement.
  
• Assess both symptom relief and objective biomarkers (e.g., C-reactive protein [CRP], fecal calprotectin).

Dose Adjustment Considerations

• The every 8 weeks (Q8W) regimen remains the FDA-approved maintenance schedule.
  
• In patients experiencing a loss of response, clinicians may consider shortening the interval to every 4 weeks (Q4W). However, this remains an off-label practice supported by real-world data.
  
• Adjust or discontinue therapy for adverse events or lack of efficacy.

Collaboration between gastroenterologists, pharmacists, nurses, and patients helps optimize therapy through consistent monitoring, adherence tracking, and early intervention for potential relapses.

Conclusion

For clinicians managing ulcerative colitis and Crohn’s disease, familiarity with Entyvio’s prescribing information is essential to ensure both safety and effectiveness. Its gut-selective mechanism, favorable long-term safety profile, and multiple administration options make vedolizumab a trusted therapy for patients seeking sustained remission without extensive systemic immune suppression.

By following current FDA-approved dosing schedules, performing routine monitoring, and maintaining open patient communication, healthcare providers can maximize the clinical benefits of Entyvio while minimizing risk. The result is more personalized, safer, and more effective management of chronic inflammatory bowel disease.

FAQs

1. What is the recommended dosage for Entyvio?

Healthcare practitioners administer Entyvio as a 300 mg IV infusion at Weeks 0 and 2 for induction, followed by every 8 weeks for maintenance, or as 108 mg SC injections every 2 weeks starting at Week 6.

2. What should clinicians monitor during Entyvio treatment?

Regular liver function tests, blood counts, and infection surveillance are critical. During infusions, doctors should observe patients for hypersensitivity or infusion reactions.

3. When should a patient discontinue Entyvio?

Per FDA guidance, patients who show no evidence of therapeutic benefit must discontinue it by Week 14. Moreover, patients should immediately discontinue it in cases of severe infection, anaphylaxis, or serious pulmonary complications.

References

21 CFR 201.56 — Requirements on Content and Format of Labeling for Human Prescription Drug and Biological Products. Electronic Code of Federal Regulations. https://www.ecfr.gov/current/title-21/chapter-I/subchapter-C/part-201/subpart-B/section-201.56

FDA Issues Final Guidance on Patient Labeling for Drugs and Biologics. DLA Piper. July 2022. https://www.dlapiper.com/en/insights/publications/2022/07/fda-issues-final-guidance-on-patient-labeling-for-drugs-and-biologics

Colombel JF, Sands BE, Rutgeerts P, et al. The safety of vedolizumab for ulcerative colitis and Crohn’s disease. Gut. 2016;66(5):839-851. doi:10.1136/gutjnl-2015-311079