Vedolizumab Injection
Vedolizumab injection (Entyvio) is a targeted biologic therapy used to treat moderately to severely active ulcerative colitis and Crohn's disease in adults.
🧬 Where this information comes from Click to expand
The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 1 clinical label set within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →
📖 Vedolizumab Injection: Patient Information Guide
A plain-language walkthrough of Vedolizumab Injection — what it treats, how it works, how it’s taken, side effects, warnings and interactions. Tap any section to expand it.
🎯What it's used for▾
Vedolizumab injection (Entyvio) is approved for adults with inflammatory bowel disease. Here are the supported uses:
- Moderately to severely active ulcerative colitis — Entyvio (intravenous or subcutaneous) is used to treat this condition in adults.
- Moderately to severely active Crohn's disease — Entyvio (intravenous or subcutaneous) is used to treat this condition in adults.
⚙️How it works▾
Vedolizumab is a monoclonal antibody (a precisely engineered immune protein) that binds to a surface protein called α4β7 integrin on certain white blood cells. By blocking this protein, it prevents those immune cells from traveling into the gut lining and triggering the chronic inflammation that drives ulcerative colitis and Crohn's disease. Because this target is found mainly in the digestive tract, the drug acts selectively in the gut rather than suppressing the entire immune system.
Studies show that vedolizumab does not significantly affect immune cell counts in the blood or the fluid around the brain and spinal cord, which distinguishes it from broader immunosuppressants.
💊How it's taken▾
Treatment begins with intravenous (IV) infusions at a clinic — at Week 0, Week 2, and Week 6 — each infused over about 30 minutes. Starting at Week 6, you may continue IV infusions every eight weeks, or switch to subcutaneous (under-the-skin) injections every two weeks using the Entyvio prefilled syringe or ENTYVIO Pen. Subcutaneous doses can be self-administered at home after you've been trained by a healthcare professional.
- If you don't show signs of improvement by Week 14, your doctor will likely stop treatment.
- If you miss a subcutaneous dose, inject as soon as you remember and then continue on your every-two-week schedule.
- There are no food restrictions — Entyvio is given by injection, not by mouth.
🤒Side effects — in detail▾
The most common side effects reported with Entyvio include:
- Nasopharyngitis (cold-like symptoms)
- Headache
- Arthralgia (joint pain)
- Nausea
- Fever
- Upper respiratory tract infection
- Fatigue
- Cough
- Back pain
- Rash or itching (pruritus)
- Injection site reactions (with subcutaneous use)
Serious reactions — including severe allergic reactions (anaphylaxis), significant infections, liver injury, and rare neurological complications — require immediate medical attention. Contact your doctor right away if you experience difficulty breathing, jaundice, signs of infection, or new neurological symptoms.
⚠️Warnings & precautions▾
- Serious infections: Entyvio increases your risk of infections, including tuberculosis, sepsis, and meningitis. Your doctor should test you for TB before you start. Tell your doctor immediately if you feel unwell or develop signs of infection.
- Infusion-related and allergic reactions: Reactions including anaphylaxis can occur during or after IV infusions. IV doses must be given in a clinical setting with monitoring and emergency support available.
- PML (progressive multifocal leukoencephalopathy): This rare but potentially fatal brain infection caused by the JC virus cannot be completely ruled out. Watch for new weakness, vision changes, confusion, or personality changes and report them immediately.
- Liver injury: Elevated liver enzymes and bilirubin have been reported. Stop taking Entyvio and seek care if you develop yellowing of the skin or eyes (jaundice).
- Vaccinations: Get all recommended vaccines up to date before starting Entyvio. Live vaccines may be used only if the benefits outweigh the risks.
🔀What it interacts with▾
Entyvio can interact with certain other medications — tell your doctor and pharmacist everything you take:
- Natalizumab products: Combining with Entyvio raises the risk of PML and other serious infections — these should not be used together.
- TNF blockers (e.g., adalimumab, infliximab): Taking these alongside Entyvio increases the risk of serious infections — avoid the combination.
- CYP450 substrate drugs: Entyvio may alter how your body processes certain other medications. Your doctor may need to check levels and adjust doses of those drugs when you start or stop Entyvio.
This is not a complete list of interactions. Always talk with your doctor or pharmacist before starting, stopping, or changing any medication.
📋Before taking it▾
- Do not use Entyvio if you have ever had a serious allergic reaction to vedolizumab or any of its ingredients.
- Tell your doctor about any active infection — treatment should not start until the infection is fully resolved.
- Get screened for tuberculosis before starting; latent TB must be treated first.
- Bring all your vaccinations up to date before your first dose.
- If you are pregnant, discuss with your doctor — available data suggest no clear increase in birth defects, but Entyvio can cross to the fetus and may affect the newborn's immune response.
- If you are breastfeeding, small amounts of vedolizumab have been detected in breast milk — discuss risks and benefits with your doctor.
- Entyvio is not approved for children — safety and effectiveness have not been established in pediatric patients.
- Older adults (65+) appeared to have similar safety and effectiveness in clinical trials, though the number of older patients studied was limited.
- The effect of kidney or liver disease on how your body handles vedolizumab has not been studied — let your doctor know about any kidney or liver problems.
📡Pharmacodynamics — effects in the body▾
Vedolizumab saturates α4β7 receptors on circulating immune cells involved in gut surveillance, reducing their ability to enter and inflame gut tissue. In studies, it did not significantly raise levels of other immune cells in the blood, such as neutrophils, B-cells, or natural killer cells. Biopsies from patients with ulcerative colitis showed measurable reductions in gut inflammation after four to six weeks of treatment. The drug also does not appear to affect immune cell counts in the fluid around the brain and spinal cord.
🔬Pharmacokinetics — how your body processes it▾
After IV infusion, vedolizumab circulates in the bloodstream and is cleared through both a concentration-dependent and a steady linear pathway, with a half-life of approximately 26 days — meaning it stays in your system for several weeks after a dose. When given as a subcutaneous injection, about 75% of the drug is absorbed compared to IV dosing, with peak blood levels typically reached around 7 days after the injection. The drug is not detected in cerebrospinal fluid (the fluid around the brain and spinal cord), which is consistent with its gut-selective action. Factors such as body weight, age, kidney or liver function, and concomitant immunomodulators do not appear to meaningfully change how the body handles vedolizumab, though formal studies in patients with kidney or liver insufficiency have not been conducted.
📦How to store it▾
Refrigerate ENTYVIO unopened vials, prefilled syringes, and prefilled pens at 2°C to 8°C (36° to 46°F). refrigerator in the original package at room temperature up to 25°C (77°F) for up to 7 days (for example, when traveling). refrigerator for more than 7 days.
📄 Written from Vedolizumab Injection’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Every point is grounded in that labeling — nothing is invented. How we use AI →
Supplements & herbs that interact with Vedolizumab Injection
38 supplements and herbal products have documented interactions with Vedolizumab Injection in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.
- Major · 3
- Moderate · 35
Educational information from a licensed clinical database (Natural Medicines) — see our data sources & update cadence. Not medical advice: an interaction being documented does not mean it will happen to you; do not start or stop medications or supplements without professional guidance.
🩺 Pharmacist Counseling Corner
Quick, plain-English answers to the questions patients ask most about Vedolizumab Injection — the kind of thing our pharmacy team would talk through with you at the counter.
What exactly does Entyvio do — is it like a steroid or a chemotherapy drug? ▾
Do I have to go to a clinic every time, or can I do the injections at home? ▾
What side effects should I actually watch out for? ▾
I have an old TB exposure in my history — is that a problem? ▾
Is it safe to get vaccinated while I'm on Entyvio? ▾
I'm pregnant — is Entyvio safe to take during pregnancy? ▾
Is Vedolizumab Injection available over the counter? ▾
When was Vedolizumab Injection first available? ▾
Who makes Vedolizumab Injection? ▾
💬 Answers drafted from Vedolizumab Injection’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Grounded in that labeling — nothing is made up. How we use AI →
🧰 Keep exploring
💊 How Vedolizumab Injection comes
Vedolizumab Injection is available in 1 form. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.
Injection
How this form is used
- Entyvio (intravenous) is used to treat moderately to severely active ulcerative colitis in adults.
- Entyvio (intravenous) is used to treat moderately to severely active Crohn's disease in adults.
- Entyvio (subcutaneous, prefilled syringe or ENTYVIO Pen) is used as maintenance therapy for ulcerative colitis or Crohn's disease after completing initial intravenous doses.
- ENTYVIO Pen is a subcutaneous auto-injector option for ongoing maintenance dosing after IV induction.
- Entyvio intravenous infusion is given by a healthcare provider over approximately 30 minutes; patients must be monitored during and after the infusion.
- Entyvio subcutaneous prefilled syringe and ENTYVIO Pen are injected under the skin every two weeks; patients or caregivers can self-inject at home after proper training.
- Rotate injection sites (thigh, abdomen, or upper arm) with each ENTYVIO Pen or prefilled syringe dose; avoid areas that are bruised, scarred, or irritated.
- If a subcutaneous dose is missed, inject as soon as possible and then continue on the every-two-week schedule.
📊 Vedolizumab Injection across the U.S. market
How Vedolizumab Injection appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.
Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.
📈 How widely Vedolizumab Injection is used
A general measure of how commonly Vedolizumab Injection is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.
Think of this as a proxy for how widely Vedolizumab Injection is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.
How commonly is Vedolizumab Injection prescribed? Of the 1,596 medications we measure, Vedolizumab Injection ranks #707 by Medicaid prescriptions — more than 56% of them.
Utilization by Vedolizumab Injection product
Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.
vedolizumab 300 MG Injection Most dispensed
Summed across the 1 of 2 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1538137
0.68 ML vedolizumab 159 MG/ML Auto-Injector
Summed across the 1 of 2 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 2667339
Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.
Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Vedolizumab Injection, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 2 of 4 listed Vedolizumab Injection NDCs with Medicaid activity.
🔍 Compare Vedolizumab Injection products
A representative set of FDA-listed product records for Vedolizumab Injection — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)
| Strength | Route | Manufacturer / Labeler | Category ⓘ | Details |
|---|---|---|---|---|
| 💊Injection | ||||
| 300 mg/5 mL | — | Patheon Italia S.p.A. | DRUG FOR FURTHER PROCESSING | View NDC → |
| 300 mg | — | Takeda Pharmaceutical Company Limited | DRUG FOR FURTHER PROCESSING | View NDC → |
| 108 mg/0.68 mL | Subcutaneous | Takeda Pharmaceuticals America, Inc. × 4 listings | BLA | View NDC → |
| 300 mg/5 mL | Intravenous | Takeda Pharmaceuticals America, Inc. × 3 listings | BLA | View NDC → |
Showing 9 of 9 products — FDA National Drug Code Directory. See every product, package size and price: browse all 9 Vedolizumab Injection NDCs →
📈 What people report — real-world data (FDA FAERS)
After a medicine reaches the market, patients, doctors and drugmakers can send the FDA reports of problems they think may be linked to it. Here’s what’s been reported for Vedolizumab Injection — a signal of what to watch for, not proof the drug caused it.
Source: openFDA, from the FDA Adverse Event Reporting System (FAERS). These are voluntary reports — they don’t prove the drug caused the effect, and counts reflect how often something was reported, not how often it actually happens. Reports also often name the very problem the medicine is taken for — a common reason to file one is that the drug didn’t help — so for a pain reliever you may see “pain” high on the list; that points to why the report was filed, not to the drug causing the symptom. This counts every report that lists Vedolizumab Injection in any role, so the total runs higher than the FDA’s official dashboard, which counts only cases where the drug is the suspect. For the authoritative figures, see the FDA FAERS Public Dashboard. Always talk to your pharmacist or doctor.
🏛️ The road to your pharmacy
How Vedolizumab Injection went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.
Source: Drugs@FDA.
🚨 Recall history
A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.
Source: openFDA drug enforcement (recall) reports.
RxNorm Concept Web — From Ingredient to Every Form and Strength
This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.
RxCUI 1538097 3 dose forms · 3 strengths
-
Dose form (SCDF) Auto-Injector RxCUI 2667338In current FDA listingsClinical drug / strength (SCD) 0.68 ML vedolizumab 159 MG/MLRxCUI 2667339 -
Dose form (SCDF) Injection RxCUI 1656996In current FDA listingsClinical drug / strength (SCD) 300 MGRxCUI 1538137 -
Dose form (SCDF) Prefilled Syringe RxCUI 2667331No current FDA listingClinical drug / strength (SCD) 0.68 ML vedolizumab 159 MG/MLRxCUI 2667332
Look up RxCUI 1538097 in the RxCUI Atlas →
RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.
📦 Supply & shortage status
Whether Vedolizumab Injection is in short supply in the U.S. right now, plus any shortage history the FDA has on record. A shortage usually reflects a manufacturing or demand issue — not a safety problem with the drug.
Source: openFDA, from the FDA Drug Shortages database.
🏷️ Sold under these brand names
🏭 Manufacturers & labelers
RxNorm drug class
Vedolizumab Injection belongs to the Integrin Receptor Antagonist class.
Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.
🔬 Where this comes from
Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.
How we combine label and product data
HelloPharmacist combines public FDA and NLM records; we don’t author the underlying clinical facts. We identified 1 FDA-filed SPL label set within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. The representative label is the starting point for the displayed reference monograph; the 12 largest stored in-scope SPL records, which may include that representative, are compared section by section, and the longest available version of each section is retained. Forms, routes, brands, labelers, product-listed strengths, and product-record counts are aggregated separately from ingredient-matched FDA NDC Directory records; package records listed above are associated with the linked SPL; and the normalized concept hierarchy comes from NLM RxNorm.
Where a section is identified as AI-written, its plain-language text is generated from bounded label evidence. New draft drug pages remain in the admin review queue before first publication. Takeda Pharmaceuticals America, Inc. is the representative DailyMed label linked for verification and dates; it is not the sole source used for the page.
This is general education, not medical advice — always consult your doctor or pharmacist about your medications and any medical condition. For the exact wording of the linked representative label, view that label on DailyMed; some displayed composite sections may come from other in-scope SPL labels. Learn how we use AI and our data sources & update cadence.