Entyvio vedolizumab 300 mg/5mL Injection, Powder, Lyophilized, For Solution — NDC 64764-300-20 (Billing 64764-0300-20)
This is a package of Entyvio vedolizumab 300 mg/5mL Injection, Powder, Lyophilized, For Solution from Takeda Pharmaceuticals America, Inc., marketed since May 2014 and currently FDA-listed. It is this product's only package size.
NDC database record
One package, one record: these facts belong to NDC 64764-300-20 alone.
- Record
- FDA NDC Directory package listing · Human prescription drug
- Code segments
- 64764 labeler · 300 product · 20 package
- Package marketed since
- May 20, 2014
- Sample package
- No — commercial package
- Listing certified through
- Dec 31, 2027
- Barcode (UPC-A, from the NDC)
- 3 6476430020 3
- Medicaid fills, this package
- 27,426 prescriptions in the last four reported quarters
- FDA record last changed
- Jul 24, 2026
Identity & classification
Regulatory identifiers FDA, NLM and CMS codes for this package
Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification
- GSN (GCN sequence number): 072362
- GCN: 36544
- GPI-14 (Medi-Span): 52503080002120
- HICL (First Databank): 041146
- AHFS class code: 90:24.92.00
- RxCUI (RxNorm): 1538137
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 6, 2026
- RxNorm (NLM RxNav) · catalog refreshed Oct 1, 2026
- Medi-Span GPI (licensed)
- First Databank (licensed) · refreshed Oct 1, 2026
RxNorm drug class
This medicine belongs to the Integrin Receptor Antagonist class.
Where does this data come from?
- RxClass (NLM) · catalog refreshed Oct 1, 2026
Clinical
- It treats adults with moderately to severely active ulcerative colitis or Crohn's disease. It works by keeping certain immune cells out of the inflamed gut.
- You'll start with two infusions into a vein, two weeks apart, at a healthcare setting. After that, you can keep getting infusions about every eight weeks or switch to an injection...
- Common ones include cold-like symptoms, headache, joint pain, nausea, fever, and tiredness. With the under-the-skin form, you may also have injection site reactions. Most are mild,...
- Get emergency help for trouble breathing, hives, flushing, or a racing heart. Call your doctor for signs of infection, yellow skin or eyes, or new weakness, vision changes, or conf...
Patient education
Supplement & herbal interactions
Some supplements/herbs that may interact with Vedolizumab — tap one for details:
Where does this data come from?
- MedlinePlus (NLM) · refreshed Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 6, 2026
Ask a licensed pharmacist directly — free, answered by our team.
Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per mL | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | Not in the retail survey — common for institutional, discontinued, or low-volume packs. | |
| Medicaid paysCMS SDUD · 12 mo | $6,631.55 | $33,157.74 / 5 ml |
| Medicare drug plans payPart D · quarterly | No Part D plan price is available for this NDC in our data. | |
| Medicare Part B allowsASP · J3380 | $21.622 / J3380 unit | — |
Where does this data come from?
- CMS NADAC weekly file
- CMS ASP pricing files · refreshed Sep 20, 2026
- CMS Medicaid State Drug Utilization Data · through Q1 2026
- CMS Part D plan pricing files · refreshed Sep 24, 2026
- VA National Acquisition Center price file
Billing & reimbursement
Where does this data come from?
- CMS ASP NDC-HCPCS crosswalk · refreshed Sep 22, 2026
- DMEPDAC NDC-HCPCS crosswalk
- openFDA NSDE billing units · refreshed Sep 7, 2026
Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Marketing end | Status |
|---|---|---|---|---|
| 64764-0300-20 You're viewing this Main listing | 1 VIAL, SINGLE-DOSE in 1 CARTON / 5 mL in 1 VIAL, SINGLE-DOSE | 2014-05-20 | — | Active |
Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Entyvio 300 mg/5mLthis 64764-0300-20 | Takeda | 1 vial | — | — | FDA listed | — |
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA Purple Book · refreshed Oct 5, 2026
- CMS NADAC weekly file
Availability & biosimilar status
Biologics have no small-molecule generics; biosimilar competition is tracked in the FDA Purple Book.
Why the date isn’t exact: Biosimilar timing can change because patents may be challenged, settled, licensed, added or removed, and litigation can move the real date earlier or later.
🛈 What do these terms mean?
- Biologic patent
- A patent the reference product’s maker has publicly listed. A biosimilar generally can’t launch until these expire — unless they’re invalidated or resolved in a settlement.
- Reference-product exclusivity
- A flat 12 years of FDA market protection from the biologic’s first licensure (the BPCIA). No biosimilar can be licensed before it ends, regardless of patents.
- Interchangeable exclusivity
- The first interchangeable biosimilar can earn a period as the only interchangeable version (pharmacists can substitute it without the prescriber).
- Earliest biosimilar (LOE)
- The latest of all the dates above — the soonest a biosimilar can realistically reach the market. Litigation and settlements can move it earlier.
Biologics have no small-molecule “generics” — competition comes from FDA-licensed biosimilars, tracked in the FDA Purple Book.
| Code | What it grants | Expires |
|---|---|---|
| RefProduct | Reference-product exclusivity (12-year, BPCIA) — no biosimilar can be licensed before this date | May 20, 2026 |
Is there a biosimilar for ENTYVIO 300 MG VIAL?
Why do different websites show different biosimilar dates?
Can a biosimilar launch before the last patent expires?
What does “current Purple Book estimate” mean?
What does “FDA listed” mean?
What does a patent or protection date mean here?
Where does this data come from?
- FDA Purple Book · refreshed Oct 5, 2026
Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
🧪 Avoiding an ingredient? See Vedolizumab Injection inactive ingredients by manufacturer: every current product's list side by side, so you can ask your pharmacy for the version that does not list it.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
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131.7 mg / 5 mL
UNII F7LTH1E20Y
Arginine hydrochloride is an amino acid salt used as a buffer and pH adjuster in medicines. It helps maintain the correct acidity level to keep the drug stable and effective.
-
23 mg / 5 mL
UNII 4QD397987E
An amino acid used as a buffer and stabilizer in medications. It helps maintain the pH balance and protects the active drug from breaking down during storage and use.
-
21.4 mg / 5 mL
UNII 1D5Q932XM6
An amino acid salt used in medicines as a buffer and pH regulator. It helps maintain the proper acidity level in liquid formulations to keep the drug stable and effective.
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3 mg / 5 mL
UNII 6OZP39ZG8H
Polysorbate 80 is a synthetic emulsifier derived from sorbitol and oleic acid. It helps mix oil and water-based ingredients together in medications and improves how the product disperses in the body.
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500 mg / 5 mL
UNII C151H8M554
A natural sugar derived from sugar cane or sugar beets. It's used as a sweetener, filler, and binder to improve taste, add bulk, and help hold tablet or capsule ingredients together.
5 inactive ingredients listed in the exact product block matched to this NDC.
Where does this data come from?
ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.- FDA label on DailyMed · label index refreshed Oct 6, 2026
- FDA openFDA NDC Directory · synced Oct 1, 2026
Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
Why might an inactive ingredient be missing?
Can inactive ingredients matter?
Manufacturer & labeler
More NDCs from Takeda Pharmaceuticals America, Inc. labeler code 64764
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Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- Drugs@FDA
Full prescribing information FDA SPL
🎯 Indications and Usage ▾
1 INDICATIONS AND USAGE ENTYVIO is indicated in adults for the treatment of: moderately to severely active ulcerative colitis (UC). moderately to severely active Crohn's disease (CD). ENTYVIO is an integrin receptor antagonist indicated in adults for the treatment of: moderately to severely active ulcerative colitis (UC). ( 1 ) moderately to severely active Crohn's disease (CD). ( 1 )
⏱️ Dosage and Administration ▾
2 DOSAGE AND ADMINISTRATION Important Administration Information Before Initiating ENTYVIO Consider evaluating patients for tuberculosis (TB) infection. ( 2.1 , 5.2 ) Update immunizations according to current immunization guidelines. ( 2.1 , 5.5 ) Intravenous Administration : ENTYVIO should be administered intravenously by a healthcare provider.
( 2.1 ) 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. ( 2.1 ) Recommended Dosage ( 2.2 ) 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. ( 2.3 , 2.4 )
2.1Important Administration Information Before Initiating ENTYVIO Consider evaluating patients for tuberculosis (TB) infection prior to initiating treatment with ENTYVIO [see Warnings and Precautions (5.2) ]. Update immunizations according to current immunization guidelines [see Warnings and Precautions (5.5) ]. Intravenous Administration ENTYVIO should be administered by a healthcare provider prepared to manage hypersensitivity reactions including anaphylaxis, if they occur [see Warnings and Precautions (5.1) ] .
Appropriate monitoring and medical support measures should be available for immediate use. Observe patients during infusion and until the infusion is complete. Reconstitute and dilute ENTYVIO lyophilized powder prior to administration as a 30-minute intravenous infusion [see Dosage and Administration (2.3) ].
Subcutaneous Injection ENTYVIO prefilled syringe and ENTYVIO PEN are intended for subcutaneous use under the guidance and supervision of a healthcare professional. Patients may self-inject or caregivers may inject subcutaneous ENTYVIO using either the ENTYVIO prefilled syringe or ENTYVIO PEN after training in subcutaneous injection technique. Provide proper training to patients and/or caregivers on the subcutaneous injection technique of ENTYVIO.
2.2Recommended Dosage in Adults with Ulcerative Colitis and Crohn’s Disease Week 0: Administer ENTYVIO 300 mg by intravenous infusion over approximately 30 minutes [ see Dosage and Administration (2.3) ]. Week 2: Administer ENTYVIO 300 mg by intravenous infusion 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 : Administer ENTYVIO 300 mg by intravenous infusion over approximately 30 minutes and then every eight weeks thereafter. Subcutaneous Injection : Administer ENTYVIO 108 mg subcutaneously once every 2 weeks. Discontinue therapy in patients who show no 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.
2.3Preparation and Administration Instructi… [Excerpted — this section continues on DailyMed.]
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS Intravenous infusion For injection: 300 mg vedolizumab in a single-dose vial. ( 3 ) Subcutaneous injection Injection: 108 mg/0.68 mL solution in a single-dose prefilled syringe with needle safety device. ( 3 ) Injection: 108 mg/0.68 mL solution in a single-dose prefilled pen (ENTYVIO PEN).
( 3 ) Intravenous Infusion For injection: 300 mg of vedolizumab as a white to off-white lyophilized cake in a single-dose vial for reconstitution. Subcutaneous Injection Injection: 108 mg/0.68 mL vedolizumab as a clear to moderately opalescent, colorless to slightly yellow solution in a single-dose prefilled syringe with needle safety device. Injection: 108 mg/0.68 mL vedolizumab as a clear to moderately opalescent, colorless to slightly yellow solution in a single-dose prefilled pen (ENTYVIO PEN).
⛔ Contraindications ▾
4 CONTRAINDICATIONS ENTYVIO is contraindicated in patients who have had a known serious or severe hypersensitivity reaction to ENTYVIO or any of its excipients (such as dyspnea, bronchospasm, urticaria, flushing, rash and increased heart rate) [see Warnings and Precautions (5.1) ] . Patients who have had a known serious or severe hypersensitivity reaction to ENTYVIO or any of its excipients. ( 4 )
⚠️ Warnings and Cautions ▾
5 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 should not be initiated in patients with a clinically important active infection until the infection resolves or is adequately treated. If a serious infection develops, ENTYVIO should not be administered until the infection resolves.
( 5.2 ) 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. ( 5.3 )
5.1Infusion-Related Reactions and Hypersensitivity Reactions Infusion-related reactions and hypersensitivity reactions have been reported, including anaphylaxis, dyspnea, bronchospasm, urticaria, flushing, rash, and increased blood pressure and heart rate [see Adverse Reactions (6.1 , 6.2) ]. These reactions may occur with the first or subsequent infusions of ENTYVIO and may vary in their time of onset from during infusion or up to several hours post-infusion. If anaphylaxis or other serious infusion-related or hypersensitivity reactions occur, discontinue administration of ENTYVIO immediately and initiate appropriate treatment.
5.2Infections Patients treated with ENTYVIO are at increased risk for developing infections [see Adverse Reactions (6.1) ]. Serious infections reported in clinical trials include anal abscess, sepsis (some fatal), tuberculosis (TB), salmonella sepsis, Listeria meningitis, giardiasis, and cytomegaloviral colitis. Postmarketing cases of systemic bacterial, fungal, viral, and parasitic opportunistic infections have been reported.
Treatment with ENTYVIO should not be initiated in patients with a clinically important active infection until the infection resolves or is adequately treated. In patients with a chronic infection or a history of recurrent infection, consider the risks and benefits prior to prescribing ENTYVIO. During treatment with ENTYVIO, instruct patients to seek medical advice if signs or symptoms of clinically important acute or chronic infection occur.
If a serious infection develops or an infection is not responding to standard therapy, monitor the patient closely. ENTYVIO should not be administered until the infection resolves. Tuberculosis Consider evaluating patients for TB infection prior to initiating treatment with ENTYVIO.
Treatment with Entyvio should not be administered to patients with active TB infection. Initiate treatment of latent TB prior to administering ENTYVIO. Consider anti-TB therapy prior to initiation of ENTYVIO in patients with a past history of latent or active TB in whom an adequate course of treatment cannot be confirmed.
Monitor patients for signs and symptoms of active TB during and after ENTYVIO treatment.
5.3Progressive Multifocal Leukoencephalopathy PML, a rare and often fatal opportunistic infection of the central nervous system (CNS), has been reported with systemic immunosuppressants, including another integrin receptor antagonist. PML is caused by the John Cunningham (JC) virus and typically only occurs in patients who are immunocompromised. One case of PML in an ENTYVIO-treated patient with multiple contributory factors has been reported in the postmarketing setting (e.g., human immunodeficiency virus [HIV] infection with a CD4 count of 300 cells/mm 3 and prior and concomitant immunosuppression).
Although unlikely, a risk of PML cannot be ruled out. Monitor patients on ENTYVIO for any new onset, or worsening, of neurological signs and symptoms. Typical signs and symptoms associated with PML are diverse, progress over days to weeks, and include progressive weakness on one side of the body or clumsiness of limbs, disturbance of vision, and changes in thinking, memory, and orientation leading to confusion and personality changes.
The progression of deficits usually leads to death or severe disability over weeks or months. I… [Excerpted — this section continues on DailyMed.]
🤒 Adverse Reactions ▾
6 ADVERSE REACTIONS The following topics are also discussed in detail in the Warnings and Precautions section: Infusion-Related Reactions and Hypersensitivity Reactions [see Warnings and Precautions (5.1) ] Infections [see Warnings and Precautions (5.2) ] Progressive Multifocal Leukoencephalopathy [see Warnings and Precautions (5.3) ] Liver Injury [see Warnings and Precautions (5.4) ] 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.
( 6.1 ) Adverse reactions with subcutaneous ENTYVIO are similar to those reported with intravenous ENTYVIO with the exception of injection site reactions reported with subcutaneous ENTYVIO. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Takeda Pharmaceuticals U.S.A., Inc. at 1-877-TAKEDA-7 (1-877-825-3327) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
6.1Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The data described below reflect exposure to intravenous ENTYVIO in 3,326 patients and healthy volunteers in clinical trials, including 1,396 exposed for greater than one year, and 835 exposed for greater than two years. Intravenous Infusion The safety data described in Table 2 are derived from four controlled Phase 3 trials (UC Trials I and II and CD Trials I and III); data from adult patients receiving open-label intravenous ENTYVIO treatment at Weeks 0 and 2 (prior to entry into UC Trial II and CD Trial III) and from Weeks 6 to 52 (non-responders at Week 6 of UC Trial I and CD Trial I) are included [see Clinical Studies (14.1 , 14.2) ] .
In these trials, 1,434 patients received ENTYVIO 300 mg intravenously for up to 52 weeks, and 297 patients received placebo for up to 52 weeks. Of these, 769 patients had ulcerative colitis and 962 patients had Crohn's disease. Patients were exposed for a mean duration of 259 days (UC Trials I and II) and 247 days (CD Trials I and III).
Adverse reactions were reported in 52% of patients treated with intravenous ENTYVIO and 45% of patients treated with placebo (UC Trials I and II: 49% with ENTYVIO and 37% with placebo; CD Trials I and III: 55% with ENTYVIO and 47% with placebo). Serious adverse reactions were reported in 7% of patients treated with intravenous ENTYVIO compared to 4% of patients treated with placebo (UC Trials I and II: 8% with ENTYVIO and 7% with placebo; CD Trials I and III: 12% with ENTYVIO and 9% with placebo). The most common adverse reactions (reported by ≥3% of patients treated with intravenous ENTYVIO in the UC Trials I and II and CD Trials I and III combined group and ≥1% higher than in combined placebo group) were nasopharyngitis, headache, arthralgia, nausea, pyrexia, upper respiratory tract infection, fatigue, cough, bronchitis, influenza, back pain, rash, pruritus, sinusitis, oropharyngeal pain, and pain in extremities (Table 2) .
Table 2. Adverse Reactions in ≥3% of Intravenous ENTYVIO-Treated Adult Patients and ≥1% Higher than in Placebo (UC Trials I and II Data from patients receiving open-label intravenous ENTYVIO treatment at Weeks 0 and 2 (prior to entry into UC Trial II and CD Trial III) and from Weeks 6 to 52 (non-responders at Week 6 of UC Trial I and CD Trial I) are included. and CD Trials I and III ) Adverse Reaction ENTYVIO IV Patients who received ENTYVIO for up to 52 weeks. (N=1434) Placebo Patients who received placebo for up to 52 weeks.
(N=297) Nasopharyngitis 13% 7% Headache 12% 11% Arthralgia 12% 10% Nausea 9% 8% Pyrexia 9% 7% Upper respiratory tract infection 7% 6% Fatigue 6% 3% Cough 5% 3% Bronchitis 4% 3% Influenza 4% 2% Back… [Excerpted — this section continues on DailyMed.]
🔄 Drug Interactions ▾
7 DRUG INTERACTIONS
7.1Natalizumab Products Because of the potential for increased risk of PML and other infections, avoid the concomitant use of ENTYVIO with natalizumab products.
7.2TNF Blockers Because of the potential for increased risk of infections, avoid the concomitant use of ENTYVIO with TNF blockers.
7.3CYP450 Substrates The formation of CYP450 enzymes may be suppressed by increased levels of certain cytokines (e.g., IL-6, IL-10, TNFα, IFN) during chronic inflammation. Therefore, use of ENTYVIO may normalize the formation of CYP450 enzymes by modulating the underlying disease. Upon initiation or discontinuation of ENTYVIO in patients treated with CYP450 substrates, monitor drug concentrations or other therapeutic parameters, and adjust the dosage of the CYP substrate as needed.
See the prescribing information of specific CYP substrates.
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS
8.1Pregnancy Risk Summary Available data from the Organization of Teratology Information Specialists (OTIS)/MotherToBaby ENTYVIO Pregnancy Registry, published literature and pharmacovigilance in pregnant women have not reliably identified an ENTYVIO-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes (see Data ) . There are risks to the mother and the fetus associated with inflammatory bowel disease in pregnancy (see Clinical Considerations ) . No fetal harm was observed in animal reproduction studies with intravenous administration of vedolizumab to rabbits and monkeys at dose levels 20 times the recommended human dosage (see Data ) .
The background risk of major birth defects and miscarriage for the indicated populations is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and miscarriage is 15 to 20%, respectively.
Clinical Considerations Disease-Associated Maternal and Embryo/Fetal Risk Published data suggest that the risk of adverse pregnancy outcomes in women with inflammatory bowel disease (IBD) is associated with increased disease activity. Adverse pregnancy outcomes include preterm delivery (before 37 weeks of gestation), low birth weight (less than 2,500 g) infants, and small for gestational age at birth. Fetal/Neonatal Adverse Reactions ENTYVIO administered during pregnancy could affect immune responses in the in utero-exposed newborn and infant.
The clinical significance of low levels of ENTYVIO in utero-exposed infants is unknown. The safety of administering live or live-attenuated vaccines in exposed infants is unknown. Data Human Data The vedolizumab pregnancy exposure registry conducted by OTIS/MotherToBaby study in the United States and Canada collected prospective observational data between 2015 and 2022 to assess the risk of major birth defects in live-born infants of women with ulcerative colitis (UC) or Crohn’s disease (CD) treated with vedolizumab during pregnancy.
The study compared pregnant patients with UC or CD exposed to vedolizumab with pregnant patients with UC or CD treated with other biological products. The registry included 99 women (58 with UC, 41 with CD) treated with vedolizumab during pregnancy, and 76 women (27 with UC, 49 with CD) exposed to other biological products during pregnancy. The proportion of major birth defects among live-born infants in patients with UC or CD treated with vedolizumab and patients with UC or CD treated with other biological products was 7.4% (7/94) and 5.6% (4/71), respectively.
Overall, there was no evidence of increased risk for major structural birth defects (adjusted RR 1.07, 95% CI: 0.33, 3.52). The methodological limitations of the registry, including small sample size and the non-randomized design, resulted in a limited ability to estimate the risk of major birth defects and other maternal and infant outcomes. The conclusions from the pregnancy registry were consistent with the published literature and pharmacovigilance.
Animal Data A reproduction study has been performed in pregnant rabbits at single intravenous doses up to 100 mg/kg administered on gestation Day 7 (about 20 times the recommended human dosage) and has revealed no evidence of impaired fertility or harm to the fetus due to vedolizumab. A pre- and post-natal development study in monkeys showed no evidence of any adverse effect on pre- and post-natal development at intravenous doses up to 100 mg/kg (about 20 times the recommended human dosage).
8.2Lactation Risk Summary Data from a clinical lactation study show the presence of vedolizumab in human milk. The mean calculated daily infant dosage was 0.02 mg/kg/day orally ( see Data ) . Systemic exposure in a breastfed infant is expected to be low because monoclonal antibodies are l… [Excerpted — this section continues on DailyMed.]
🤰 Pregnancy ▾
8.1Pregnancy Risk Summary Available data from the Organization of Teratology Information Specialists (OTIS)/MotherToBaby ENTYVIO Pregnancy Registry, published literature and pharmacovigilance in pregnant women have not reliably identified an ENTYVIO-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes (see Data ) . There are risks to the mother and the fetus associated with inflammatory bowel disease in pregnancy (see Clinical Considerations ) . No fetal harm was observed in animal reproduction studies with intravenous administration of vedolizumab to rabbits and monkeys at dose levels 20 times the recommended human dosage (see Data ) .
The background risk of major birth defects and miscarriage for the indicated populations is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and miscarriage is 15 to 20%, respectively.
Clinical Considerations Disease-Associated Maternal and Embryo/Fetal Risk Published data suggest that the risk of adverse pregnancy outcomes in women with inflammatory bowel disease (IBD) is associated with increased disease activity. Adverse pregnancy outcomes include preterm delivery (before 37 weeks of gestation), low birth weight (less than 2,500 g) infants, and small for gestational age at birth. Fetal/Neonatal Adverse Reactions ENTYVIO administered during pregnancy could affect immune responses in the in utero-exposed newborn and infant.
The clinical significance of low levels of ENTYVIO in utero-exposed infants is unknown. The safety of administering live or live-attenuated vaccines in exposed infants is unknown. Data Human Data The vedolizumab pregnancy exposure registry conducted by OTIS/MotherToBaby study in the United States and Canada collected prospective observational data between 2015 and 2022 to assess the risk of major birth defects in live-born infants of women with ulcerative colitis (UC) or Crohn’s disease (CD) treated with vedolizumab during pregnancy.
The study compared pregnant patients with UC or CD exposed to vedolizumab with pregnant patients with UC or CD treated with other biological products. The registry included 99 women (58 with UC, 41 with CD) treated with vedolizumab during pregnancy, and 76 women (27 with UC, 49 with CD) exposed to other biological products during pregnancy. The proportion of major birth defects among live-born infants in patients with UC or CD treated with vedolizumab and patients with UC or CD treated with other biological products was 7.4% (7/94) and 5.6% (4/71), respectively.
Overall, there was no evidence of increased risk for major structural birth defects (adjusted RR 1.07, 95% CI: 0.33, 3.52). The methodological limitations of the registry, including small sample size and the non-randomized design, resulted in a limited ability to estimate the risk of major birth defects and other maternal and infant outcomes. The conclusions from the pregnancy registry were consistent with the published literature and pharmacovigilance.
Animal Data A reproduction study has been performed in pregnant rabbits at single intravenous doses up to 100 mg/kg administered on gestation Day 7 (about 20 times the recommended human dosage) and has revealed no evidence of impaired fertility or harm to the fetus due to vedolizumab. A pre- and post-natal development study in monkeys showed no evidence of any adverse effect on pre- and post-natal development at intravenous doses up to 100 mg/kg (about 20 times the recommended human dosage).
🧒 Pediatric Use ▾
8.4Pediatric Use Safety and effectiveness of ENTYVIO in pediatric patients have not been established.
🧓 Geriatric Use ▾
8.5Geriatric Use Clinical trials of ENTYVIO did not include sufficient numbers of patients aged 65 and over (72 patients with Crohn's disease or ulcerative colitis aged 65 and over were treated with ENTYVIO during controlled Phase 3 trials) to determine whether they respond differently from younger adult patients. However, no overall differences in safety or effectiveness were observed between these patients and younger adult patients, and other reported clinical experience has not identified differences in responses between the elderly and younger patients.
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY
12.1Mechanism of Action Vedolizumab is a humanized monoclonal antibody that specifically binds to the α4β7 integrin and blocks the interaction of α4β7 integrin with mucosal addressin cell adhesion molecule-1 (MAdCAM-1) and inhibits the migration of memory T-lymphocytes across the endothelium into inflamed gastrointestinal parenchymal tissue. Vedolizumab does not bind to or inhibit function of the α4β1 and αEβ7 integrins and does not antagonize the interaction of α4 integrins with vascular cell adhesion molecule-1 (VCAM-1).
The α4β7 integrin is expressed on the surface of a discrete subset of memory T-lymphocytes that preferentially migrate into the gastrointestinal tract. MAdCAM-1 is mainly expressed on gut endothelial cells and plays a critical role in the homing of T-lymphocytes to gut lymph tissue. The interaction of the α4β7 integrin with MAdCAM-1 has been implicated as an important contributor to the chronic inflammation that is a hallmark of ulcerative colitis and Crohn's disease.
12.2Pharmacodynamics In clinical trials with intravenous ENTYVIO at doses ranging from 0.2 to 10 mg/kg (which includes doses outside of the recommended dose), saturation of α4β7 receptors on subsets of circulating lymphocytes involved in gut-immune surveillance was observed. In clinical trials with intravenous ENTYVIO at doses ranging from 0.2 to 10 mg/kg and 180 to 750 mg (which include doses outside of the recommended dose) in healthy subjects and in patients with ulcerative colitis or Crohn's disease, vedolizumab did not elevate neutrophils, basophils, eosinophils, B-helper and cytotoxic T-lymphocytes, total memory helper T-lymphocytes, monocytes or natural killer cells.
A reduction in gastrointestinal inflammation was observed in rectal biopsy specimens from Phase 2 ulcerative colitis patients exposed to ENTYVIO for four or six weeks compared to placebo control as assessed by histopathology. In a study of 14 healthy subjects, ENTYVIO did not affect the CD4+ lymphocyte cell counts, CD8+ lymphocyte cell counts, or the CD4+:CD8+ ratios in the CSF [see Clinical Pharmacology (12.3) ] .
12.3Pharmacokinetics Similar pharmacokinetics were observed in ulcerative colitis and Crohn's disease patients administered 300 mg ENTYVIO as a 30-minute intravenous infusion on Weeks 0, 2, and 6, and then every eight weeks up to Week 52 (Table 3) . Table 3. Mean ± SD Vedolizumab Concentrations in Patients Data from patients in UC Trials I and II and CD Trials I and III with pharmacokinetic data available; data from patients with anti-vedolizumab antibody were excluded. with Ulcerative Colitis and Crohn's Disease Patient Population Weeks 0, 2, and 6 ENTYVIO 300 mg Intravenously After Week 6 to 52 ENTYVIO 300 mg Intravenously Every 8 Weeks Trough Serum Concentration at Week 6 (mcg/mL) Trough Serum Concentration at Week 46 Steady-state trough serum concentration.
(mcg/mL) Ulcerative Colitis 26.3 ± 12.9 (N=210) 11.2 ± 7.2 (N=77) Crohn's Disease 27.4 ± 19.2 (N=198) 13.0 ± 9.1 (N=72) In ulcerative colitis and Crohn’s disease patients, administered 300 mg ENTYVIO as a 30-minute intravenous infusion on Weeks 0 and 2, followed by 108 mg ENTYVIO as a subcutaneous injection every 2 weeks starting from Week 6, the mean steady state serum trough concentrations were 35.8 mcg/mL (SD ± 15.2) and 31.4 mcg/mL (SD ± 14.7), respectively. The bioavailability of vedolizumab following a 108 mg single-dose subcutaneous injection relative to a 300 mg single-dose intravenous infusion in healthy subjects was approximately 75%.
Following a 108 mg single-dose subcutaneous injection in healthy subjects, the median T max was 7 days with a range of 3 to 14 days and the mean C max was 15.4 mcg/mL (SD ± 3.2). Vedolizumab clearance depends on both linear and nonlinear pathways; the nonlinear clearance decreases with increasing concentrations. Population pharmacokinetic analyses indicated that the linear clearance was approximately
0.16L/day, the serum half-life was app… [Excerpted — this section continues on DailyMed.]
🧬 Mechanism of Action ▾
12.1Mechanism of Action Vedolizumab is a humanized monoclonal antibody that specifically binds to the α4β7 integrin and blocks the interaction of α4β7 integrin with mucosal addressin cell adhesion molecule-1 (MAdCAM-1) and inhibits the migration of memory T-lymphocytes across the endothelium into inflamed gastrointestinal parenchymal tissue. Vedolizumab does not bind to or inhibit function of the α4β1 and αEβ7 integrins and does not antagonize the interaction of α4 integrins with vascular cell adhesion molecule-1 (VCAM-1).
The α4β7 integrin is expressed on the surface of a discrete subset of memory T-lymphocytes that preferentially migrate into the gastrointestinal tract. MAdCAM-1 is mainly expressed on gut endothelial cells and plays a critical role in the homing of T-lymphocytes to gut lymph tissue. The interaction of the α4β7 integrin with MAdCAM-1 has been implicated as an important contributor to the chronic inflammation that is a hallmark of ulcerative colitis and Crohn's disease.
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING How Supplied Intravenous Infusion ENTYVIO (vedolizumab) for injection for intravenous infusion is supplied in sterile single-dose glass vials, containing 300 mg of vedolizumab as a white to off-white lyophilized cake. ENTYVIO: 300 mg single-dose vial in individual carton: NDC 64764-300-20 Subcutaneous Injection ENTYVIO (vedolizumab) injection for subcutaneous use is available in a prefilled syringe or a prefilled pen as a clear to moderately opalescent and colorless to slightly yellow solution.
The single-dose, disposable ENTYVIO prefilled syringe and single-dose, disposable ENTYVIO prefilled pen (ENTYVIO PEN) are comprised of a 1 mL long glass syringe with a fixed 27 gauge thin wall, ½ inch needle. The syringe has a rubber needle cover encased in a plastic shell and rubber stopper. Not made with natural rubber latex.
ENTYVIO: 108 mg/0.68 single-dose prefilled syringe in an individual carton: NDC 64764-107-11 ENTYVIO PEN : 108 mg/0.68 single-dose prefilled pen in an individual carton: NDC 64764-108-21 Storage and Handling Refrigerate ENTYVIO unopened vials, prefilled syringes, and prefilled pens at 2°C to 8°C (36° to 46°F). If needed, the ENTYVIO prefilled syringe or ENTYVIO PEN can be left out of the refrigerator in the original package at room temperature up to 25°C (77°F) for up to 7 days (for example, when traveling). Do not use ENTYVIO prefilled syringe or ENTYVIO PEN if left out of the refrigerator for more than 7 days.
Do not freeze ENTYVIO vial, prefilled syringe, or prefilled pen. Do not use ENTYVIO vial, prefilled syringe, or prefilled pen if it has been frozen. Do not shake the ENTYVIO prefilled syringe or ENTYVIO PEN.
Retain in original package to protect from light until the time of use.
📦 Storage and Handling ▾
Storage and Handling Refrigerate ENTYVIO unopened vials, prefilled syringes, and prefilled pens at 2°C to 8°C (36° to 46°F). If needed, the ENTYVIO prefilled syringe or ENTYVIO PEN can be left out of the refrigerator in the original package at room temperature up to 25°C (77°F) for up to 7 days (for example, when traveling). Do not use ENTYVIO prefilled syringe or ENTYVIO PEN if left out of the refrigerator for more than 7 days.
Do not freeze ENTYVIO vial, prefilled syringe, or prefilled pen. Do not use ENTYVIO vial, prefilled syringe, or prefilled pen if it has been frozen. Do not shake the ENTYVIO prefilled syringe or ENTYVIO PEN.
Retain in original package to protect from light until the time of use.
📋 Description ▾
11 DESCRIPTION Vedolizumab, an integrin receptor antagonist, is a humanized IgG 1 monoclonal antibody produced in Chinese hamster ovary cells that binds to the human α4β7 integrin. ENTYVIO has an approximate molecular weight of 147 kilodaltons. Intravenous ENTYVIO ENTYVIO (vedolizumab) for injection is supplied as a sterile, white to off-white, preservative-free, lyophilized cake for intravenous infusion.
After reconstitution with 4.8 mL Sterile Water for Injection, USP, 0.9% Sodium Chloride Injection, USP, or Lactated Ringer's Injection, USP, the resulting concentration is 60 mg/mL with a deliverable volume of 5 mL (300 mg) and the resulting pH is approximately 6.3. Each single-dose vial contains 300 mg vedolizumab, arginine hydrochloride (131.7 mg), histidine (23 mg), histidine monohydrochloride (21.4 mg), polysorbate 80 (3 mg), and sucrose (500 mg). Subcutaneous ENTYVIO ENTYVIO (vedolizumab) injection is supplied as a sterile, clear to moderately opalescent, colorless to slightly yellow, preservative-free solution for subcutaneous administration.
Each single-dose prefilled syringe or single-dose prefilled pen (ENTYVIO PEN) contains 108 mg vedolizumab, arginine hydrochloride (17.77 mg), citric acid monohydrate (0.18 mg), histidine (3.86 mg), histidine monohydrochloride (1.86 mg), polysorbate 80 (1.35 mg), sodium citrate dihydrate (4.71 mg) and Sterile Water for Injection, USP, at a pH of 6.5.
💬 Information for Patients ▾
17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Medication Guide and Instructions for Use). Infusion-Related and Hypersensitivity Reactions Instruct patients to report immediately if they experience symptoms consistent with a hypersensitivity reaction during or following an infusion of ENTYVIO [see Warnings and Precautions (5.1) ] . Infections Inform patients that they may be more likely to develop infections when taking ENTYVIO.
Instruct patients to tell their healthcare provider if they develop any symptoms of an infection [see Warnings and Precautions (5.2) ] . Progressive Multifocal Leukoencephalopathy Inform patients that progressive multifocal leukoencephalopathy (PML) has occurred in patients who received some integrin receptor antagonist and systemic immunosuppressant products. Instruct patients to report if they experience any new onset or worsening of neurological signs and symptoms immediately, as these could be indicative of PML [see Warnings and Precautions (5.3) ].
Liver Injury Inform patients that elevated transaminase levels with or without elevated bilirubin has occurred in patients who received ENTYVIO. Instruct patients to report promptly any symptoms that may indicate liver injury, including fatigue, anorexia, right upper abdominal discomfort, dark urine or jaundice [see Warnings and Precautions (5.4) ] . Subcutaneous Dosing Technique Provide guidance to patients and caregivers on proper subcutaneous administration technique, and how to use the ENTYVIO single-dose prefilled syringe, or ENTYVIO single-dose prefilled pen correctly [see Instructions for Use] .
💬 Medication Guide ▾
MEDICATION GUIDE ENTYVIO ® (en ti' vee oh) (vedolizumab) for injection, for intravenous use ENTYVIO ® (en ti' vee oh) (vedolizumab) injection, for subcutaneous use ENTYVIO ® (en ti' vee oh) PEN (vedolizumab) injection, for subcutaneous use This Medication Guide has been approved by the U.S. Food and Drug Administration VMB245 R12 Revised: 2/2026 What is the most important information I should know about ENTYVIO? ENTYVIO may cause serious side effects, including: Infusion-related and serious allergic reactions.
These reactions can happen while you are receiving ENTYVIO or several hours after treatment. You may need treatment if you have an allergic reaction. Tell your healthcare provider or get medical help right away if you get any of these symptoms during or after an infusion of ENTYVIO: rash, itching, swelling of your lips, tongue, throat or face, shortness of breath or trouble breathing, wheezing, dizziness, feeling hot, or palpitations (feel like your heart is racing).
Infections. ENTYVIO may increase your risk of getting a serious infection. Before receiving ENTYVIO and during treatment with ENTYVIO, tell your healthcare provider if you think you have an infection or have symptoms of an infection such as fever, chills, muscle aches, cough, shortness of breath, runny nose, sore throat, red or painful skin or sores on your body, tiredness, or pain during urination.
If your healthcare provider feels that you are at risk for tuberculosis (TB), you may be treated with medicine for TB before you begin treatment with ENTYVIO. Progressive Multifocal Leukoencephalopathy (PML). People with weakened immune systems can get progressive multifocal leukoencephalopathy (PML) (a rare, serious brain infection caused by a virus).
Although unlikely while receiving ENTYVIO, a risk of PML cannot be ruled out. PML can result in death or severe disability. There is no known treatment, prevention, or cure for PML.
Tell your healthcare provider right away if you have any of the following symptoms: confusion or problems thinking, loss of balance, change in the way you walk or talk, decreased strength or weakness on one side of the body, blurred vision, or loss of vision. Liver Problems. Liver problems can happen in people who receive ENTYVIO.
Tell your healthcare provider right away if you have any of the following symptoms: tiredness, loss of appetite, pain on the right side of your stomach (abdomen), dark urine, or yellowing of the skin and eyes (jaundice). See " What are the possible side effects of ENTYVIO? " for more information about side effects. What is ENTYVIO?
ENTYVIO is a prescription medicine used in adults for the treatment of: moderately to severely active ulcerative colitis (UC). moderately to severely active Crohn's disease (CD). It is not known if ENTYVIO is safe and effective in children under 18 years of age. Who should not receive ENTYVIO?
Do not receive ENTYVIO if you have had an allergic reaction to ENTYVIO or any of the ingredients in ENTYVIO. See the end of this Medication Guide for a complete list of ingredients in ENTYVIO. Before receiving ENTYVIO, tell your healthcare provider about all of your medical conditions, including if you: have an infection, think you may have an infection or have infections that keep coming back (see " What is the most important information I should know about ENTYVIO? ") . have liver problems. have TB or have been in close contact with someone with TB. have recently received or are scheduled to receive a vaccine.
Talk to your healthcare provider about bringing your vaccines up-to-date before starting treatment with ENTYVIO. are pregnant or plan to become pregnant. It is not known if ENTYVIO will harm your unborn baby. Tell your healthcare provider right away if you become pregnant while receiving ENTYVIO. are breastfeeding or plan to breastfeed.
ENTYVIO can pass into your breast milk. Talk to your healthcare provider about the best way to feed your baby if you take ENTYVIO. Tell your healthcare… [Excerpted — this section continues on DailyMed.]
🧬 Pharmacokinetics ▾
12.3Pharmacokinetics Similar pharmacokinetics were observed in ulcerative colitis and Crohn's disease patients administered 300 mg ENTYVIO as a 30-minute intravenous infusion on Weeks 0, 2, and 6, and then every eight weeks up to Week 52 (Table 3) . Table 3. Mean ± SD Vedolizumab Concentrations in Patients Data from patients in UC Trials I and II and CD Trials I and III with pharmacokinetic data available; data from patients with anti-vedolizumab antibody were excluded. with Ulcerative Colitis and Crohn's Disease Patient Population Weeks 0, 2, and 6 ENTYVIO 300 mg Intravenously After Week 6 to 52 ENTYVIO 300 mg Intravenously Every 8 Weeks Trough Serum Concentration at Week 6 (mcg/mL) Trough Serum Concentration at Week 46 Steady-state trough serum concentration.
(mcg/mL) Ulcerative Colitis 26.3 ± 12.9 (N=210) 11.2 ± 7.2 (N=77) Crohn's Disease 27.4 ± 19.2 (N=198) 13.0 ± 9.1 (N=72) In ulcerative colitis and Crohn’s disease patients, administered 300 mg ENTYVIO as a 30-minute intravenous infusion on Weeks 0 and 2, followed by 108 mg ENTYVIO as a subcutaneous injection every 2 weeks starting from Week 6, the mean steady state serum trough concentrations were 35.8 mcg/mL (SD ± 15.2) and 31.4 mcg/mL (SD ± 14.7), respectively. The bioavailability of vedolizumab following a 108 mg single-dose subcutaneous injection relative to a 300 mg single-dose intravenous infusion in healthy subjects was approximately 75%.
Following a 108 mg single-dose subcutaneous injection in healthy subjects, the median T max was 7 days with a range of 3 to 14 days and the mean C max was 15.4 mcg/mL (SD ± 3.2). Vedolizumab clearance depends on both linear and nonlinear pathways; the nonlinear clearance decreases with increasing concentrations. Population pharmacokinetic analyses indicated that the linear clearance was approximately
0.16L/day, the serum half-life was approximately 26 days, and the distribution volume was approximately 5 L. Vedolizumab was not detected in the cerebrospinal fluid (CSF) of 14 healthy subjects at five weeks after a single intravenous administration of 450 mg ENTYVIO (1.5 times the recommended dosage). Specific Populations Population pharmacokinetic analysis showed that the severity of disease state, body weight, prior treatment with TNF blocker therapy, age (18 to 78 years), serum albumin, coadministered immunomodulators (including azathioprine, 6-mercaptopurine, methotrexate), and coadministered aminosalicylates did not have a clinically meaningful effect on the pharmacokinetics of ENTYVIO.
Pharmacokinetics of vedolizumab in patients with renal or hepatic insufficiency have not been studied.
🧬 Pharmacodynamics ▾
12.2Pharmacodynamics In clinical trials with intravenous ENTYVIO at doses ranging from 0.2 to 10 mg/kg (which includes doses outside of the recommended dose), saturation of α4β7 receptors on subsets of circulating lymphocytes involved in gut-immune surveillance was observed. In clinical trials with intravenous ENTYVIO at doses ranging from 0.2 to 10 mg/kg and 180 to 750 mg (which include doses outside of the recommended dose) in healthy subjects and in patients with ulcerative colitis or Crohn's disease, vedolizumab did not elevate neutrophils, basophils, eosinophils, B-helper and cytotoxic T-lymphocytes, total memory helper T-lymphocytes, monocytes or natural killer cells.
A reduction in gastrointestinal inflammation was observed in rectal biopsy specimens from Phase 2 ulcerative colitis patients exposed to ENTYVIO for four or six weeks compared to placebo control as assessed by histopathology. In a study of 14 healthy subjects, ENTYVIO did not affect the CD4+ lymphocyte cell counts, CD8+ lymphocyte cell counts, or the CD4+:CD8+ ratios in the CSF [see Clinical Pharmacology (12.3) ] .
🔬 Clinical Studies ▾
14 CLINICAL STUDIES
14.1Clinical Studies in Ulcerative Colitis Intravenous Administration The safety and efficacy of intravenous ENTYVIO were evaluated in two randomized, double-blind, placebo-controlled trials (UC Trials I and II) in adult patients with moderately to severely active ulcerative colitis (UC) defined as Mayo score of 6 to 12 with endoscopy subscore of two or three. The Mayo score ranges from 0 to 12 and has four subscales that are each scored from zero (normal) to three (most severe): stool frequency, rectal bleeding, findings on endoscopy, and physician global assessment.
An endoscopy subscore of two is defined by marked erythema, lack of vascular pattern, friability, and erosions; an endoscopy subscore of three is defined by spontaneous bleeding and ulceration. Enrolled patients in the U.S. had over the previous five-year period an inadequate response or intolerance to immunomodulator therapy (i.e., azathioprine or 6-mercaptopurine) and/or an inadequate response, loss of response, or intolerance to a TNF blocker. Outside the U.S., prior treatment with corticosteroids was sufficient for entry if over the previous five-year period the patients were corticosteroid dependent (i.e., unable to successfully taper corticosteroids without a return of the symptoms of UC) or had an inadequate response or intolerance to corticosteroids.
Patients that had received natalizumab ever in the past, and patients that had received a TNF blocker in the past 60 days were excluded from enrollment. Concomitant use of natalizumab or a TNF blocker was not allowed. UC Trial I - Intravenous In UC Trial I, 374 patients were randomized in a double-blind fashion (3:2) to receive ENTYVIO 300 mg or placebo by intravenous infusion at Week 0 and Week 2.
Efficacy assessments were at Week 6. Concomitant stable dosages of aminosalicylates, corticosteroids (prednisone dosage ≤30 mg/day or equivalent), and immunomodulators (azathioprine or 6-mercaptopurine) were permitted through Week 6. At baseline, patients received corticosteroids (54%), immunomodulators (azathioprine or 6-mercaptopurine) (30%), and/or aminosalicylates (74%).
Thirty-nine percent of patients had an inadequate response, loss of response, or intolerance to a TNF blocker therapy. Eighteen percent of patients had an inadequate response, inability to taper or intolerance to prior corticosteroid treatment only (i.e., had not received prior immunomodulators or TNF blockers). The median baseline Mayo score was 9 in the ENTYVIO group and 8 in the placebo group.
In UC Trial I, a greater percentage of patients treated with intravenous ENTYVIO compared to patients treated with placebo achieved clinical response at Week 6 (defined in Table 4 ). A greater percentage of patients treated with intravenous ENTYVIO compared to patients treated with placebo also achieved clinical remission at Week 6 (defined in Table 4 ). In addition, a greater percentage of patients treated with ENTYVIO had improvement of endoscopic appearance of the mucosa at Week 6 (defined in Table 4 ).
Table 4. Proportion of Patients Meeting Efficacy Endpoints at Week 6 (UC Trial I) Endpoint Placebo N=149 ENTYVIO IV N=225 p-value Treatment Difference and 95% CI Clinical Response Clinical response: reduction in complete Mayo score of ≥3 points and ≥30% from baseline with an accompanying decrease in rectal bleeding subscore of ≥1 point or absolute rectal bleeding subscore of ≤1 point. at Week 6 26% 47% <0.001 22% (12%, 32%) Clinical Remission Clinical remission: complete Mayo score of ≤2 points and no individual subscore >1 point. at Week 6 5% 17% 0.001 12% (5%, 18%) Improvement of Endoscopic Appearance of the Mucosa Improvement of endoscopic appearance of the mucosa: Mayo endoscopy subscore of 0 (normal or inactive disease) or 1 (erythema, decreased vascular pattern, mild friability). at Week 6 25% 41% 0.001 16% (6%, 26%) UC Trial II - Intravenous In order to be randomized to treatment in UC Trial II, patients had to have receiv… [Excerpted — this section continues on DailyMed.]
🧪 Nonclinical Toxicology ▾
13 NONCLINICAL TOXICOLOGY
13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Long-term studies in animals have not been performed to evaluate the carcinogenic potential of vedolizumab. Studies to evaluate the possible impairment of fertility or mutagenic potential of vedolizumab have not been performed.
📄 Carcinogenesis, Mutagenesis, Impairment of Fertility ▾
13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Long-term studies in animals have not been performed to evaluate the carcinogenic potential of vedolizumab. Studies to evaluate the possible impairment of fertility or mutagenic potential of vedolizumab have not been performed.
📖 Instructions for Use ▾
INSTRUCTIONS FOR USE ENTYVIO ® (en ti' vee oh) PEN (vedolizumab) injection, for subcutaneous use Single-dose prefilled pen This Instructions for Use contains information on how to inject ENTYVIO. Your ENTYVIO single-dose prefilled pen Important information you need to know before injecting ENTYVIO: Read and follow this Instructions for Use before you inject ENTYVIO. Your healthcare provider should show you how to use the ENTYVIO PEN before you use it for the first time.
ENTYVIO PEN is for subcutaneous injection only (inject directly into fatty layer under the skin). Do not shake the prefilled pen. Do not remove the purple cap from the prefilled pen until you are ready to inject.
Do not put or press your thumb, fingers, or hand over the yellow needle shield. The yellow needle shield is visible when the purple cap is removed. Do not use the prefilled pen if it is dropped or damaged.
Storing ENTYVIO Store your prefilled pen in the refrigerator between 36°F to 46°F (2°C to 8°C). Your prefilled pen can be left in its box at room temperature up to 77°F (25°C) for up to 7 days (for example, when traveling). Do not use the prefilled pen if it is left out of the refrigerator for more than 7 days.
Do not freeze the prefilled pen. Do not leave the prefilled pen in direct sunlight. Throw away the prefilled pen in a FDA-cleared sharps disposal container if it has been left out of the refrigerator for more than 7 days, frozen, or left in direct sunlight.
See Step 14 for instructions on how to throw away (dispose of) the prefilled pen. Always keep ENTYVIO PENs, the sharps disposal container, and all medicines out of the reach of children. U.S.
License No. 1898 Getting Your Supplies Ready Step 1. Remove the ENTYVIO PEN box from the refrigerator Take 1 prefilled pen box from the refrigerator and check the expiration date on the box (see Figure A ).
Do not use the prefilled pen if any of the seals on the box are broken. Do not use the prefilled pen if the expiration date on the box has passed. Figure A Step 2.
Wait 30 minutes Wait 30 minutes and let the prefilled pen come to room temperature (see Figure B ). Do not warm the prefilled pen any other way. Do not let the prefilled pen sit in direct sunlight.
Do not take the prefilled pen out of its tray until you are ready to inject. Figure B Step 3. Gather supplies Find a clean, flat surface like a table.
Gather supplies that are not in the prefilled pen box (see Figure C ). Alcohol pad Cotton ball or gauze Sharps disposal container (see Step 14 "Throw away (dispose of) the prefilled pen") Figure C Preparing to Inject ENTYVIO Step 4. Wash hands Wash your hands with soap and clean water (see Figure D ).
Figure D Step 5. Remove the prefilled pen from the tray Peel off the paper on the tray and lift the prefilled pen straight out (see Figure E ). Do not shake the prefilled pen.
Do not remove the purple cap from the prefilled pen until Step 9 . Figure E Step 6. Inspect the prefilled pen Check the expiration date (EXP) printed on the prefilled pen and the medicine in the prefilled pen viewing window (see Figure F ).
The medicine should be colorless to pale yellow. It is normal to see air bubbles. Inspect the prefilled pen for any damage.
Do not use the prefilled pen if the expiration date on the prefilled pen has passed. Do not use the prefilled pen if the medicine is cloudy or has particles floating in it. Do not use the prefilled pen if any part of it is damaged.
Step 7. Choose injection site Choose an injection site on your bare skin from one of the following (see Figure G ): - front of the thighs - stomach area (avoid the area 2 inches around the belly button) For caregivers only: back of the upper arms may also be used. Do not inject into the same spot you used for your last injection.
Do not inject into moles, scars, bruises, or skin that is tender, hard, red, or damaged. Figure G Step 8. Clean the injection site Clean the injection site with an alcohol pad (see Figure H ).
Let your skin dry. Do… [Excerpted — this section continues on DailyMed.]
📄 Recent Major Changes ▾
Dosage and Administration Important Administration Information ( 2.1 ) 2/2026 Warnings and Precautions Infections ( 5.2 ) 2/2026
📄 Package Label / Principal Display Panel ▾
PRINCIPAL DISPLAY PANEL - 300 mg Vial Label NDC 64764-300-20 Rx only Entyvio vedolizumab for injection 300 mg per vial* For Intravenous Use Only Must be reconstituted and diluted prior to use Single-Dose Vial - Discard Unused Portion Principal Display Panel - 300 mg Vial Label
PRINCIPAL DISPLAY PANEL - 300 mg Vial Carton NDC 64764-300-20 Rx only Entyvio vedolizumab for injection 300 mg per vial* ATTENTION: Each patient is required to receive the enclosed Medication Guide. For Intravenous Use Only Must be reconstituted and diluted prior to use Single-Dose Vial - Discard Unused Portion Takeda Principal Display Panel - 300 mg Vial Carton
PRINCIPAL DISPLAY PANEL - 108 mg/0.68 mL Pen Tray Carton NDC 64764-108-21 Rx only ENTYVIO ® PEN (vedolizumab) injection 108 mg/0.68 mL For Subcutaneous Use Only 1 Single-Dose Prefilled Pen ATTENTION PHARMACIST: Each patient is required to receive the enclosed Medication Guide. PRINCIPAL DISPLAY PANEL - 108 mg/0.68 mL Pen Tray Carton
PRINCIPAL DISPLAY PANEL - 108 mg/0.68 mL Syringe Tray Carton NDC 64764-107-11 Rx only ENTYVIO ® (vedolizumab) injection 108 mg/0.68 mL For Subcutaneous Use Only 1 Single-Dose Prefilled Syringe ATTENTION PHARMACIST: Each patient is required to receive the enclosed Medication Guide. PRINCIPAL DISPLAY PANEL - 108 mg/0.68 mL Syringe Tray Carton
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