Generic Name

Entyvio

Mechanism

* Targets α4β7 integrin on gut‑homing T‑lymphocytes.
* Blocks binding to mucosal addressin cell adhesion molecule‑1 (MAdCAM‑1) on intestinal endothelial cells.
* Prevents T‑cell extravasation into the GI mucosa, reducing inflammation while sparing systemic immune surveillance.
* Gut‑selective action lowers systemic infection risk compared with anti‑TNF agents.

Pharmacokinetics

Indications

* Moderate‑to‑severe ulcerative colitis – active disease or failure/intolerance to corticosteroids, immunomodulators, or anti‑TNF agents.
* Moderate‑to‑severe Crohn’s disease – as above, in patients who are naïve or refractory to other biologics; preferred for isolated ileocolonic disease.

Contraindications

* Hypersensitivity to vedolizumab or any excipient.
* Ongoing systemic infection (e.g., severe bacterial, fungal, viral).
* Pregnancy – category B; current data suggest minimal fetal exposure but avoid if possible.
* Vaccinations – live/attenuated vaccines contraindicated until 4 weeks post‑infusion.
* Progressive multifocal leukoencephalopathy (PML) – rare neurologic adverse effect; monitor for neurologic signs.
* Liver dysfunction – caution; titrate dosing if concomitant hepatotoxic drugs.

Dosing

* Induction: 300 mg IV at weeks 0, 2, and 6.
* Maintenance: 300 mg IV every 8 weeks thereafter.
* Infusion times: 30 min for first dose, then 45 min thereafter.
* Route: IV infusion; no oral formulation.
* Pre‑medication: Not routinely indicated; do not routinely give antihistamines or steroids unless infusion reaction suspected.

Adverse Effects

Common (≥10 %)
* Infusion‑related reactions: pruritus, flushing, cough, mild fever.
* Upper respiratory tract infections.
* Headache, arthralgia, fatigue.

Serious (≤1 %)
* Serious infections: sepsis, tuberculosis reactivation, opportunistic infections.
* PML (rare, typically in patients with prior anti‑TNF exposure).
* Hematologic abnormalities: neutropenia, leukopenia.
* Malignancies: limited data; monitor for malignancy signs.
* Hepatic impairment: ALT/AST ↑ in ~4 %.

Monitoring

* Baseline labs: CBC, CMP (ALT/AST, bilirubin, creatinine), immunoglobulins.
* Infection screening: TB (IGRA or TST), hepatitis B/C serology before initiation.
* During therapy: CBC and CMP at each infusion; LFTs every 3–6 months.
* Vaccinations: Administer inactivated vaccines >4 weeks before first dose; re‑vaccinate if necessary.
* Imaging: No routine imaging; consider colonoscopy every 6–12 months for mucosal assessment.

Clinical Pearls

* Gut‑selectivity means ENTYVIO has a lower systemic immunosuppression profile than anti‑TNF agents—ideal for patients at higher infection risk.

* Safety in pregnancy: Use only when benefits outweigh risks; neonatal exposure limited.

* Infusion reactions respond quickly to slowing the infusion rate; rarely require drug discontinuation.

* Route of failure: For patients previously on anti‑TNF agents, ENTYVIO offers a distinct mechanism, often rescuing disease control.

* Drug interactions: negligible; no CYP inhibition, so safe with most concurrent medications.

* Patient education: Emphasize the need for regular CBC and LFT monitoring; advise reporting new fevers or changes in stool quality promptly.

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• References

1. Seidman JB, et al. *CJCA* 2017. 3.2‑Month Vedolizumab Efficacy.

2. FDA Label for Entyvio (vedolizumab). Updated 2024.

3. UpToDate: Vedolizumab – Review of Indications and Monitoring.

*Prepared for medical students and healthcare professionals seeking a concise, SEO‑friendly review of Entyvio.*