A recent Phase 4 EARNEST study reported that vedolizumab induced clinical remission in 31% of patients by Week 14, compared to only 10% in the placebo group. This significant difference underscores the promise of targeted biologic therapies in managing inflammatory bowel disease (IBD).
Building on these results, Entyvio—the branded formulation of vedolizumab—has emerged as a leading treatment for IBD. By leveraging a gut-selective mechanism, Entyvio reduces intestinal inflammation while minimizing systemic immune suppression, offering a safer and more targeted approach to long-term disease management.
In this article, we will review Entyvio’s prescribing information, including approved indications, dosage guidelines, contraindications, and key clinical considerations for healthcare providers.
Key Takeaways
- Entyvio (vedolizumab) is an FDA-approved biologic therapy for moderate to severe ulcerative colitis and Crohn’s disease in adults who have not responded to conventional treatments.
- The prescribed Entyvio therapy offers two administration routes—IV infusion for induction and Entyvio Pen (SC injection) for maintenance—providing flexibility based on patient needs and clinical response.
- Initial Entyvio dosing involves 300 mg IV infusions at Weeks 0, 2, and 6, followed by 108 mg SC injections every 2 weeks for eligible patients post-induction.
- Contraindications include a history of severe hypersensitivity to vedolizumab. Common Entyvio side effects may include headache, joint pain, and cold-like symptoms.
- Physicians must perform routine monitoring, assess treatment response by Week 14, and discontinue use if they observe no clinical improvement.
- Special populations—pregnant, lactating, or pediatric patients—require caution due to limited safety data. Entyvio is not approved for use in children.
- Careful patient selection, adherence to clinical guidelines, and regular follow-ups are essential to ensure safe and effective use of Entyvio in IBD management.
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Approved Indications and Patient Selection Criteria
Entyvio (vedolizumab) is FDA-approved for the treatment of moderate to severe active ulcerative colitis and Crohn’s disease in adults. It is reserved for patients who have had an inadequate response, intolerance, or contraindication to conventional therapies such as corticosteroids, immunomodulators, or TNF blockers.
Clinical evidence has shown that Entyvio supports remission in both ulcerative colitis and Crohn’s disease, with a lower rate of systemic complications compared to broader immunosuppressive treatments. Careful patient screening and adherence to eligibility criteria maximize therapeutic success and safety.
Eligible patients must be 18 years or older with a confirmed diagnosis. This selective prescribing ensures that Entyvio’s gut-specific mechanism is targeted toward individuals who need it most, optimizing benefits while minimizing systemic risks.
Detailed Dosing Guidelines and Administration of Patients
Proper dosing protocols are essential for achieving therapeutic goals with Entyvio. For patients prescribed Entyvio, clinicians must strictly follow approved induction and maintenance regimens, depending on the chosen administration route. This achieves optimal therapeutic results and maintains remission.
In comparing Entyvio Pen vs infusion, understanding their dosing differences is key:
- IV Infusion: Initiate with 300 mg intravenously at Weeks 0, 2, and 6. Infusions take approximately 30 minutes and require supervision to monitor for infusion-related reactions, infection, or allergic reaction.
- Subcutaneous Injection: After a successful induction phase, patients may transition to Entyvio Pen (108 mg SC) administered every two weeks. This at-home method offers convenience while maintaining clinical effectiveness.
If no clinical improvement is seen by Week 14, healthcare professionals should reassess the Entyvio therapy and consider discontinuation. Proper adherence to the Entyvio dosing regimen is crucial to maintaining remission and minimizing adverse outcomes.
Contraindications and Important Safety Information
The main contraindication provided in the safety information is a history of severe hypersensitivity reactions to vedolizumab or any of its components. Hypersensitivity or allergic reaction may present as rash, itching, wheezing, or more severe systemic symptoms.
Even common Entyvio side effects such as headache, joint pain, or cold symptoms must be monitored—especially if symptoms persist or worsen.
- Of particular concern is the rare but serious progressive multifocal leukoencephalopathy (PML)—a viral brain infection associated with certain immunosuppressive drugs.
- Any signs of confusion, weakness, or vision changes require urgent evaluation.
- In addition, clinicians must be cautious in patients with potential liver problems, as elevated liver enzymes have occasionally been reported in clinical studies.
Proper patient education and pre-treatment screening for those people prescribed Entyvio reduces the risk of adverse events, reinforcing a safe and tailored use of biologic therapy.
Monitoring Requirements and Managing Adverse Reactions
Ongoing monitoring is essential to track efficacy and detect early signs of adverse reactions. Clinicians should:
- Conduct baseline and periodic screenings for latent infections (e.g., tuberculosis)
- Monitor patients during and after infusions for hypersensitivity or infusion-related issues
- Schedule regular follow-ups, including laboratory tests, symptom evaluations, and medication tolerance assessments
In the case of adverse reactions, treatment modifications—such as adjusting infusion rates or temporary discontinuation—can help manage symptoms while preserving treatment continuity.
Special Considerations: Pregnancy, Lactation, and Pediatric Use
Entyvio does not have approval for pediatric populations because trials have not determined its safety and effectiveness in children.
During pregnancy and lactation, limited data are available. Although no definitive human studies show harm, healthcare providers should only use Entyvio if the potential benefit clearly outweighs the risk. Providers should avoid prescribing it unless absolutely necessary and should consider alternative treatments when available.
Conclusion
Entyvio is a gut-selective biologic therapy that plays a significant role in treating adults with moderate to severe ulcerative colitis or Crohn’s disease. With administration options via infusion or self-injection, it allows for personalized care based on patient needs and clinical response.
By following prescribing guidelines, screening protocols, and individualized monitoring plans, healthcare providers can maximize treatment success while ensuring patient safety. As new data emerge, Entyvio remains a cornerstone in the evolving landscape of IBD management.
FAQs
1. What conditions does Entyvio have approval to treat?
Entyvio can treat adult patients with moderate to severe active inflammatory bowel diseases, including ulcerative colitis and Crohn’s disease.
2. How is Entyvio administered?
For ulcerative colitis or Crohn disease, practitioners can give Entyvio as an intravenous infusion of 300 mg at Weeks 0, 2, and 6, or as a subcutaneous injection using the Entyvio Pen at a dose of 108 mg every two weeks after induction.
3. Are there any contraindications for using Entyvio?
Patients with a history of serious hypersensitivity to vedolizumab or its components should not use Entyvio. Healthcare professionals must exercise proper and careful Entyvio patient selection to ensure treatment safety.
References
- Takeda. (2023). Takeda Announces Results from Phase 4 Vedolizumab Study in Patients with Chronic Pouchitis Published in New England Journal of Medicine. Takeda.com. https://www.takeda.com/newsroom/newsreleases/2023/takeda-announces-results-from-phase-4-vedolizumab-study/
- ENTYVIO® HIGHLIGHTS OF PRESCRIBING INFORMATION. (n.d.). Takeda. Retrieved April 16, 2025, from https://content.takeda.com/?contenttype=PI&product=ENTY&language=ENG&country=USA&documentnumber=1
