Your activity: 2 p.v.

Vedolizumab: Drug information

Vedolizumab: Drug information
(For additional information see "Vedolizumab: Patient drug information")

For abbreviations, symbols, and age group definitions used in Lexicomp (show table)
Brand Names: US
  • Entyvio
Brand Names: Canada
  • Entyvio
Pharmacologic Category
  • Gastrointestinal Agent, Miscellaneous;
  • Monoclonal Antibody;
  • Monoclonal Antibody, Selective Adhesion-Molecule Inhibitor
Dosing: Adult

Note: Prior to initiating treatment, all patients should be brought up to date with all immunizations according to current immunization guidelines.

Crohn disease

Crohn disease (alternative agent) (AGA [Feuerstein 2021]):

Note: Combination with an immunomodulator is generally preferred (Al Hashash 2021).

IV: 300 mg at 0, 2, and 6 weeks and then every 8 weeks thereafter. Discontinue therapy in patients who show no evidence of therapeutic benefit by week 14.

SUBQ [Canadian product]: Maintenance: 108 mg once every 2 weeks beginning after at least 2 IV infusions; administer in place of next scheduled IV dose and then every 2 weeks thereafter.

Missed dose: Administer next dose as soon as possible and then every 2 weeks thereafter.

Ulcerative colitis

Ulcerative colitis:

IV: 300 mg at 0, 2, and 6 weeks and then every 8 weeks thereafter. Discontinue therapy in patients who show no evidence of therapeutic benefit by week 14.

SUBQ [Canadian product]: Maintenance: 108 mg once every 2 weeks beginning after at least 2 IV infusions; administer in place of next scheduled IV dose and then every 2 weeks thereafter.

Missed dose: Administer next dose as soon as possible and then every 2 weeks thereafter.

Dosing: Kidney Impairment: Adult

There are no dosage adjustments provided in the manufacturer's labeling (has not been studied).

Dosing: Hepatic Impairment: Adult

There are no dosage adjustments provided in the manufacturer's labeling (has not been studied). Discontinue use with jaundice or signs/symptoms of hepatic injury.

Dosing: Older Adult

Refer to adult dosing.

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Solution Reconstituted, Intravenous [preservative free]:

Entyvio: 300 mg (1 ea) [contains polysorbate 80]

Generic Equivalent Available: US

No

Dosage Forms: Canada

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Solution Pen-injector, Subcutaneous:

Entyvio: 108 mg/0.68 mL (0.68 mL) [contains polysorbate 80]

Solution Prefilled Syringe, Subcutaneous:

Entyvio: 108 mg/0.68 mL (0.68 mL) [contains polysorbate 80]

Solution Reconstituted, Intravenous:

Entyvio: 300 mg (1 ea) [contains mouse (murine) and/or hamster protein, polysorbate 80]

Medication Guide and/or Vaccine Information Statement (VIS)

An FDA-approved patient medication guide, which is available with the product information and as follows, must be dispensed with this medication:

Entyvio: https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/125476s038s039lbl.pdf#page=20

Administration: Adult

IV: Infuse over 30 minutes. Do not administer by IV push or bolus. Following infusion, flush with 30 mL of sterile 0.9% sodium chloride injection or LR. Observe patients during infusion (until complete) and monitor for hypersensitivity reactions; discontinue if a reaction occurs.

SUBQ [Canadian product]: Allow pen to reach room temperature (30 minutes) after removing from refrigerator; do not warm in other ways or let sit in direct sunlight. Administer by SUBQ injection into front of thighs, abdomen (avoid area 2 inches around navel), or back of the upper arm; rotate injection sites. Do not inject into bruises, moles, scars, or damaged, hard, red, or tender skin. Administer first injection under health care provider supervision and observe for signs of severe injection-site reactions or anaphylaxis. Do not reuse prefilled pens; single use only.

Use: Labeled Indications

Crohn disease: Treatment of Crohn disease in adults.

Guideline Recommendations: The American Gastroenterological Association guidelines on the medical management of moderate to severe luminal and perianal fistulizing Crohn disease suggest the use of vedolizumab with or without an immunomodulator for treatment-naïve patients, or in patients with primary or secondary nonresponse to tumor necrosis factor-alpha inhibitors. In addition, vedolizumab may be used in combination with an antibiotic in patients with fistulizing disease for induction or maintenance of fistula remission (AGA [Feuerstein 2021]).

Ulcerative colitis: Treatment of ulcerative colitis in adults.

Adverse Reactions

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.

>10%:

Immunologic: Antibody development (4% to 13%; neutralizing: 2%)

Nervous system: Headache (12%)

Neuromuscular & skeletal: Arthralgia (12%)

Respiratory: Nasopharyngitis (13%)

1% to 10%:

Dermatologic: Pruritus (3%), skin rash (3%)

Gastrointestinal: Nausea (9%)

Hepatic: Increased serum alanine aminotransferase (≥3 x ULN: <2%), increased serum aspartate aminotransferase (≥3 x ULN: <2%)

Infection: Influenza (4%)

Nervous system: Fatigue (6%)

Neuromuscular & skeletal: Back pain (4%), limb pain (3%)

Respiratory: Bronchitis (4%), cough (5%), oropharyngeal pain (3%), sinusitis (3%), upper respiratory tract infection (7%)

Miscellaneous: Fever (9%), infusion related reaction (4%)

Frequency not defined: Hematologic & oncologic: Malignant neoplasm (excluding dysplasia and basal cell carcinoma)

Postmarketing:

Hepatic: Hepatitis, increased serum bilirubin, increased serum transaminases

Hypersensitivity: Anaphylaxis, bronchospasm, hypersensitivity reaction

Infection: Infection (including anal abscess, sepsis, tuberculosis, salmonella sepsis, meningitis due to Listeria monocytogenes, giardiasis, cytomegalovirus disease [colitis])

Nervous system: Progressive multifocal leukoencephalopathy (in a patient with multiple risk factors [ie, HIV, CD4 count 300 cells/mm3, prolonged prior and concurrent immunosuppression]) (Loftus 2020)

Contraindications

Serious or severe hypersensitivity to vedolizumab or any component of the formulation

Canadian labeling: Additional contraindications (not in US labeling): Patients with active severe infections or opportunistic infections.

Warnings/Precautions

Concerns related to adverse effects:

• Hypersensitivity/infusion-related reactions: Hypersensitivity and infusion-related reactions have been reported including anaphylaxis, dyspnea, bronchospasm, urticaria, flushing, rash, and increased BP and heart rate. Reactions may occur with the first or subsequent infusions; onset may vary from during the infusion or up to several hours post-infusion. If anaphylaxis or other serious infusion-related or hypersensitivity reactions occur, discontinue administration immediately and initiate appropriate treatment.

• Infections: Use may be associated with an increased risk for developing infections; most commonly reported infections included upper respiratory and nasal mucosa. Serious infections have also been reported in patients treated, including anal abscess, sepsis (some fatal), tuberculosis, salmonella sepsis, Listeria meningitis, giardiasis, and cytomegaloviral colitis. Therapy is not recommended in patients with uncontrolled, active, severe infections. If a patient develops a serious infection, consider discontinuing therapy. Use with caution in patients with a history of recurring severe infections. Screening for tuberculosis should be considered.

• Liver injury: Elevations of transaminase and/or bilirubin have been reported in patients receiving vedolizumab. Discontinue therapy in patients with jaundice or other evidence of significant liver injury such as fatigue, anorexia, right upper abdominal discomfort, or dark urine.

• Progressive multifocal leukoencephalopathy: Progressive multifocal leukoencephalopathy (PML), a rare and often fatal opportunistic infection of the CNS caused by the John Cunningham virus, has been reported with integrin receptor antagonists, including vedolizumab. The case with vedolizumab occurred in a patient with multiple risk factors for PML (ie, HIV, CD4 count 300 cells/mm3, prolonged prior and concurrent immunosuppression) (Lotus 2020). Monitor patients for any new onset or worsening of neurological signs and symptoms including 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. Symptoms may progress over days to weeks and can lead to death or severe disability in weeks to months. If PML is suspected, withhold therapy and refer to a neurologist; if confirmed, discontinue therapy permanently.

Other warnings/precautions:

• Immunizations: Patients should be brought up to date with all immunizations according to immunization guidelines before initiating therapy. Live vaccines should not be given concurrently unless the benefits outweigh the risks; there are no data on the secondary transmission of infection by live vaccines with vedolizumab. Non-live vaccines may be given concurrently.

Metabolism/Transport Effects

None known.

Drug Interactions

Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.

Abrocitinib: May enhance the immunosuppressive effect of Immunosuppressants (Therapeutic Immunosuppressant Agents). Risk X: Avoid combination

Anti-TNF Agents: May enhance the adverse/toxic effect of Vedolizumab. Risk X: Avoid combination

Baricitinib: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the immunosuppressive effect of Baricitinib. Risk X: Avoid combination

BCG Products: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the adverse/toxic effect of BCG Products. Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Therapeutic Immunosuppressant Agents) may diminish the therapeutic effect of BCG Products. Risk X: Avoid combination

Brincidofovir: Immunosuppressants (Therapeutic Immunosuppressant Agents) may diminish the therapeutic effect of Brincidofovir. Risk C: Monitor therapy

Cladribine: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the immunosuppressive effect of Cladribine. Risk X: Avoid combination

Coccidioides immitis Skin Test: Immunosuppressants (Therapeutic Immunosuppressant Agents) may diminish the diagnostic effect of Coccidioides immitis Skin Test. Management: Consider discontinuing therapeutic immunosuppressants several weeks prior to coccidioides immitis skin antigen testing to increase the likelihood of accurate diagnostic results. Risk D: Consider therapy modification

COVID-19 Vaccine (Adenovirus Vector): Immunosuppressants (Therapeutic Immunosuppressant Agents) may diminish the therapeutic effect of COVID-19 Vaccine (Adenovirus Vector). Management: Administer a 2nd dose using an mRNA COVID-19 vaccine (at least 4 weeks after the primary vaccine dose) and a bivalent booster dose (at least 2 months after the additional mRNA dose or any other boosters). Risk D: Consider therapy modification

COVID-19 Vaccine (Inactivated Virus): Immunosuppressants (Therapeutic Immunosuppressant Agents) may diminish the therapeutic effect of COVID-19 Vaccine (Inactivated Virus). Risk C: Monitor therapy

COVID-19 Vaccine (mRNA): Immunosuppressants (Therapeutic Immunosuppressant Agents) may diminish the therapeutic effect of COVID-19 Vaccine (mRNA). Management: Give a 3-dose primary series for all patients aged 6 months and older taking immunosuppressive medications or therapies. Booster doses are recommended for certain age groups. See CDC guidance for details. Risk D: Consider therapy modification

COVID-19 Vaccine (Subunit): Immunosuppressants (Therapeutic Immunosuppressant Agents) may diminish the therapeutic effect of COVID-19 Vaccine (Subunit). Risk C: Monitor therapy

COVID-19 Vaccine (Virus-like Particles): Immunosuppressants (Therapeutic Immunosuppressant Agents) may diminish the therapeutic effect of COVID-19 Vaccine (Virus-like Particles). Risk C: Monitor therapy

Dengue Tetravalent Vaccine (Live): Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the adverse/toxic effect of Dengue Tetravalent Vaccine (Live). Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Therapeutic Immunosuppressant Agents) may diminish the therapeutic effect of Dengue Tetravalent Vaccine (Live). Risk X: Avoid combination

Denosumab: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the immunosuppressive effect of Denosumab. Management: Consider the risk of serious infections versus the potential benefits of coadministration of denosumab and immunosuppressants. If combined, monitor for signs/symptoms of serious infections. Risk D: Consider therapy modification

Deucravacitinib: May enhance the immunosuppressive effect of Immunosuppressants (Therapeutic Immunosuppressant Agents). Risk X: Avoid combination

Efgartigimod Alfa: May diminish the therapeutic effect of Fc Receptor-Binding Agents. Risk C: Monitor therapy

Filgotinib: May enhance the immunosuppressive effect of Immunosuppressants (Therapeutic Immunosuppressant Agents). Risk X: Avoid combination

Inebilizumab: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the immunosuppressive effect of Inebilizumab. Risk C: Monitor therapy

Influenza Virus Vaccines: Immunosuppressants (Therapeutic Immunosuppressant Agents) may diminish the therapeutic effect of Influenza Virus Vaccines. Management: Administer influenza vaccines at least 2 weeks prior to initiating immunosuppressants if possible. If vaccination occurs less than 2 weeks prior to or during therapy, revaccinate 2 to 3 months after therapy discontinued if immune competence restored. Risk D: Consider therapy modification

Leflunomide: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the immunosuppressive effect of Leflunomide. Management: Increase the frequency of chronic monitoring of platelet, white blood cell count, and hemoglobin or hematocrit to monthly, instead of every 6 to 8 weeks, if leflunomide is coadministered with immunosuppressive agents. Risk D: Consider therapy modification

Natalizumab: Vedolizumab may enhance the adverse/toxic effect of Natalizumab. Risk X: Avoid combination

Ocrelizumab: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the immunosuppressive effect of Ocrelizumab. Risk C: Monitor therapy

Ofatumumab: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the immunosuppressive effect of Ofatumumab. Risk C: Monitor therapy

Pidotimod: Immunosuppressants (Therapeutic Immunosuppressant Agents) may diminish the therapeutic effect of Pidotimod. Risk C: Monitor therapy

Pimecrolimus: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the immunosuppressive effect of Pimecrolimus. Risk X: Avoid combination

Pneumococcal Vaccines: Immunosuppressants (Therapeutic Immunosuppressant Agents) may diminish the therapeutic effect of Pneumococcal Vaccines. Risk C: Monitor therapy

Poliovirus Vaccine (Live/Trivalent/Oral): Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the adverse/toxic effect of Poliovirus Vaccine (Live/Trivalent/Oral). Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Therapeutic Immunosuppressant Agents) may diminish the therapeutic effect of Poliovirus Vaccine (Live/Trivalent/Oral). Risk X: Avoid combination

Polymethylmethacrylate: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the potential for allergic or hypersensitivity reactions to Polymethylmethacrylate. Management: Use caution when considering use of bovine collagen-containing implants such as the polymethylmethacrylate-based Bellafill brand implant in patients who are receiving immunosuppressants. Consider use of additional skin tests prior to administration. Risk D: Consider therapy modification

Rabies Vaccine: Immunosuppressants (Therapeutic Immunosuppressant Agents) may diminish the therapeutic effect of Rabies Vaccine. Management: Complete rabies vaccination at least 2 weeks before initiation of immunosuppressant therapy if possible. If combined, check for rabies antibody titers, and if vaccination is for post exposure prophylaxis, administer a 5th dose of the vaccine. Risk D: Consider therapy modification

Rubella- or Varicella-Containing Live Vaccines: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the adverse/toxic effect of Rubella- or Varicella-Containing Live Vaccines. Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Therapeutic Immunosuppressant Agents) may diminish the therapeutic effect of Rubella- or Varicella-Containing Live Vaccines. Risk X: Avoid combination

Ruxolitinib (Topical): Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the immunosuppressive effect of Ruxolitinib (Topical). Risk X: Avoid combination

Sipuleucel-T: Immunosuppressants (Therapeutic Immunosuppressant Agents) may diminish the therapeutic effect of Sipuleucel-T. Management: Consider reducing the dose or discontinuing the use of immunosuppressants prior to initiating sipuleucel-T therapy. Risk D: Consider therapy modification

Sphingosine 1-Phosphate (S1P) Receptor Modulator: May enhance the immunosuppressive effect of Immunosuppressants (Therapeutic Immunosuppressant Agents). Risk C: Monitor therapy

Tacrolimus (Topical): Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the immunosuppressive effect of Tacrolimus (Topical). Risk X: Avoid combination

Talimogene Laherparepvec: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the adverse/toxic effect of Talimogene Laherparepvec. Specifically, the risk of infection from the live, attenuated herpes simplex virus contained in talimogene laherparepvec may be increased. Risk X: Avoid combination

Tertomotide: Immunosuppressants (Therapeutic Immunosuppressant Agents) may diminish the therapeutic effect of Tertomotide. Risk X: Avoid combination

Tofacitinib: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the immunosuppressive effect of Tofacitinib. Management: Coadministration of tofacitinib with potent immunosuppressants is not recommended. Use with non-biologic disease-modifying antirheumatic drugs (DMARDs) was permitted in psoriatic arthritis clinical trials. Risk X: Avoid combination

Travelers' Diarrhea and Cholera Vaccine: Vedolizumab may diminish the therapeutic effect of Travelers' Diarrhea and Cholera Vaccine. Management: Administer travelers' diarrhea and cholera vaccine prior to initiation of therapy with vedolizumab. Risk D: Consider therapy modification

Typhoid Vaccine: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the adverse/toxic effect of Typhoid Vaccine. Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Therapeutic Immunosuppressant Agents) may diminish the therapeutic effect of Typhoid Vaccine. Risk X: Avoid combination

Upadacitinib: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the immunosuppressive effect of Upadacitinib. Risk X: Avoid combination

Vaccines (Inactivated/Non-Replicating): Immunosuppressants (Therapeutic Immunosuppressant Agents) may diminish the therapeutic effect of Vaccines (Inactivated/Non-Replicating). Management: Give inactivated vaccines at least 2 weeks prior to initiation of immunosuppressants when possible. Patients vaccinated less than 14 days before initiating or during therapy should be revaccinated at least 2 to 3 months after therapy is complete. Risk D: Consider therapy modification

Vaccines (Live): May enhance the adverse/toxic effect of Immunosuppressants (Therapeutic Immunosuppressant Agents). Specifically, the risk of vaccine-associated infection may be increased. Vaccines (Live) may diminish the therapeutic effect of Immunosuppressants (Therapeutic Immunosuppressant Agents). Risk X: Avoid combination

Yellow Fever Vaccine: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the adverse/toxic effect of Yellow Fever Vaccine. Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Therapeutic Immunosuppressant Agents) may diminish the therapeutic effect of Yellow Fever Vaccine. Risk X: Avoid combination

Reproductive Considerations

Biologics, such as vedolizumab, may be continued in females with inflammatory bowel disease planning a pregnancy (Mahadevan 2019). Treatment algorithms are available for use of biologics in female patients with Crohn disease who are planning a pregnancy (Weizman 2019). When treatment for inflammatory bowel disease is needed, serum levels of biologic therapy should be optimized prior to conception (Mahadevan 2019).

Pregnancy Considerations

Vedolizumab crosses the placenta (Flanagan 2020; Mahadevan 2016).

Vedolizumab is a humanized monoclonal antibody (IgG1). Placental transfer of human IgG is dependent upon the IgG subclass, maternal serum concentrations, birth weight, and gestational age, generally increasing as pregnancy progresses. The lowest exposure would be expected during the period of organogenesis (Palmeira 2012; Pentsuk 2009). Vedolizumab concentrations in cord blood and newborn serum are lower than those in the maternal serum at delivery (Flanagan 2020; Mahadevan 2016). Newborn clearance of vedolizumab is variable. In a study of 17 mother-infant pairs, vedolizumab serum concentrations were available in a subset of infants at 6 to 8 weeks of age (last intrapartum dose given at a median 30 weeks). Vedolizumab was measurable in the serum of 6 infants and not detected in the serum of 4 infants. Vedolizumab remained measurable in 1 infant at 12 weeks of age (Flanagan 2020).

Information related to the use of vedolizumab in pregnancy is available (Bar-Gil Shitrit 2019; Julsgaard 2017; Mahadevan 2017; Moens 2019; Moens 2020; Sheridan 2017). Based on available data, an increased risk of adverse maternal or fetal effects has not been observed following vedolizumab exposure in pregnancy (Nielsen 2020; Terjung 2020).

Due to pregnancy-induced physiologic changes, some pharmacokinetic properties of vedolizumab may be altered. Maternal serum levels may decrease as pregnancy progresses due increased clearance; however, this may not be clinically significant (Flanagan 2020).

The safety of administering live vaccines to infants exposed to vedolizumab in utero is not known. Vaccination with live vaccines (eg, rotavirus vaccine) should be avoided for the first 6 months of life if exposure to a biologic agent occurs during the third trimester of pregnancy (eg, >27 weeks' gestation) (Mahadevan 2019).

Inflammatory bowel disease is associated with adverse pregnancy outcomes including an increased risk of miscarriage, premature delivery, delivery of a low birth weight infant, and poor maternal weight gain. Management of maternal disease should be optimized prior to pregnancy. Treatment decreases disease flares, disease activity, and the incidence of adverse pregnancy outcomes (Mahadevan 2019).

When treatment for inflammatory bowel disease is needed in pregnant women, appropriate biologic therapy can be continued without interruption. Serum levels should be evaluated prior to conception and optimized to avoid subtherapeutic concentrations or high levels which may increase placental transfer. Dosing can be adjusted so delivery occurs at the lowest serum concentration. For vedolizumab, the final injection can be given 6 to 10 weeks prior to the estimated date of delivery (4 to 5 weeks before delivery if every-4-week dosing), then continued 48 hours' postpartum (Mahadevan 2019).

Data collection to monitor pregnancy and infant outcomes following exposure to vedolizumab is ongoing. Health care providers are encouraged to enroll women exposed to vedolizumab during pregnancy in a pregnancy exposure registry. Information about the registry can be obtained by calling 1-877-825-3327.

Breastfeeding Considerations

Vedolizumab is present in breast milk.

In 2 studies, with a total of 10 lactating women, breast milk was sampled prior to and up to 14 days following a maternal dose. Vedolizumab was present at each time point evaluated. The highest concentrations occurred 3 to 7 days after the dose and were ≤1% of the maternal serum concentration. Breastfed infants were followed for up to 10 months and reached their developmental milestones (Julsgaard 2018; Lahat 2018); GI infections were not observed (Lahat 2018) and inactivated vaccines were administered without complication (Julsgaard 2018). A third study of 11 women also observed peak breast milk concentrations of vedolizumab to occur on days 3 to 4 following the maternal dose then decrease exponentially. Vedolizumab could be detected in breast milk in low levels up to 57 days after the infusion (Sun 2020).

It is expected that any vedolizumab ingested via breast milk would be degraded in the infant GI tract and have minimal impact to the breastfed infant (Julsgaard 2018; Lahat 2018; Sun 2020). According to the manufacturer, the decision to breastfeed during therapy should consider the risk of infant exposure, the benefits of breastfeeding to the infant, and benefits of treatment to the mother; however, available guidelines note maternal use of vedolizumab is considered compatible with breastfeeding (Mahadevan 2019).

Monitoring Parameters

Observe patients during infusion (until complete) and monitor for hypersensitivity reactions; LFTs; tuberculosis screening according to local practice; signs/symptoms of infection; any new onset or worsening of neurological signs and symptoms

Mechanism of Action

Vedolizumab is a humanized monoclonal antibody that binds to the alpha4beta7 integrin and blocks the interaction of alpha4beta7 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. The interaction of the alpha4beta7 integrin with MAdCAM-1 has been implicated as an important contributor to the chronic inflammation that is a hallmark of ulcerative colitis and Crohn disease.

Pharmacokinetics

Bioavailability: SUBQ [Canadian product]: ~75%.

Distribution: Vd: 5 L.

Half-life elimination: IV: 25 days (serum, at 300 mg dosage); SUBQ [Canadian product]: 23 days.

Time to peak: SUBQ [Canadian product]: 7 days (range: 3 to 14 days).

Pricing: US

Solution (reconstituted) (Entyvio Intravenous)

300 mg (per each): $9,255.88

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Brand Names: International
  • Entyvio (AT, AU, BE, CZ, DE, DK, EE, FR, GB, GR, HK, HR, IE, IL, IS, LB, LT, LU, MT, NL, NO, PH, PL, RO, SE, SI, SK, TW);
  • Kynteles (KR)


For country code abbreviations (show table)
  1. Al Hashash J, Regueiro M. Overview of medical management of high-risk, adult patients with moderate to severe Crohn disease. Post TW, ed. UpToDate. Waltham, MA: UpToDate Inc. https://www.uptodate.com. Accessed August 16, 2021.
  2. Bar-Gil Shitrit A, Ben Yaʼacov A, Livovsky DM, et al. Exposure to vedolizumab in IBD pregnant women appears of low risk for mother and neonate: a first prospective comparison study [published online March 5, 2019]. Am J Gastroenterol. doi: 10.14309/ajg.0000000000000186. [PubMed 30920987]
  3. Entyvio (vedolizumab) [prescribing information]. Lexington, MA: Takeda Pharmaceuticals USA Inc; June 2022.
  4. Entyvio (vedolizumab) [product monograph]. Toronto, Ontario, Canada: Takeda Canada Inc; July 2022.
  5. Feuerstein JD, Ho EY, Shmidt E, et al; American Gastroenterological Association Institute Clinical Guidelines Committee. AGA clinical practice guidelines on the medical management of moderate to severe luminal and perianal fistulizing Crohn's disease. Gastroenterology. 2021;160(7):2496-2508. doi:10.1053/j.gastro.2021.04.022 [PubMed 34051983]
  6. Feuerstein JD, Nguyen GC, Kupfer SS, Falck-Ytter Y, Singh S; American Gastroenterological Association Institute Clinical Guidelines Committee. American Gastroenterological Association Institute guideline on therapeutic drug monitoring in inflammatory bowel disease. Gastroenterology. 2017;153(3):827-834. doi: 10.1053/j.gastro.2017.07.032. [PubMed 28780013]
  7. Flanagan E, Gibson PR, Wright EK, et al; PICCOLO Study Group. Infliximab, adalimumab and vedolizumab concentrations across pregnancy and vedolizumab concentrations in infants following intrauterine exposure. Aliment Pharmacol Ther. 2020;52(10):1551-1562. doi:10.1111/apt.16102 [PubMed 32981127]
  8. Julsgaard M, Kjeldsen J, Baumgart DC. Vedolizumab safety in pregnancy and newborn outcomes. Gut. 2017;66(10):1866-1867. doi: 10.1136/gutjnl-2016-313444. [PubMed 28073891]
  9. Julsgaard M, Kjeldsen J, Bibby BM, Brock B, Baumgart DC. Vedolizumab concentrations in the breast milk of nursing mothers with inflammatory bowel disease. Gastroenterology. 2018;154(3):752-754.e1. doi: 10.1053/j.gastro.2017.08.067. [PubMed 28988916]
  10. Lahat A, Shitrit AB, Naftali T, et al. Vedolizumab levels in breast milk of nursing mothers with inflammatory bowel disease. J Crohns Colitis. 2018;12(1):120-123. doi: 10.1093/ecco-jcc/jjx120. [PubMed 28961712]
  11. Lichtenstein GR, Loftus EV, Isaacs KL, Regueiro MD, Gerson LB, Sands BE. ACG clinical guideline: management of Crohn's disease in adults. Am J Gastroenterol. 2018;113(4):481-517. [PubMed 29610508]
  12. Loftus EV Jr, Feagan BG, Panaccione R, et al. Long-term safety of vedolizumab for inflammatory bowel disease. Aliment Pharmacol Ther. 2020;52(8):1353-1365. doi:10.1111/apt.16060 [PubMed 32876349]
  13. Mahadevan U, Martin C, Kane SV, et al. Do infant serum levels of biologic agents at birth correlate with risk of adverse outcomes? Results from the PIANO registry. Abstract 437 Gastroenterology. 2016;150(4):S91-S92. https://www.gastrojournal.org/article/S0016-5085(16)30422-X/pdf.
  14. Mahadevan U, Robinson C, Bernasko N, et al. Inflammatory bowel disease in pregnancy clinical care pathway: a report from the American Gastroenterological Association IBD Parenthood Project Working Group. Am J Obstet Gynecol. 2019;220(4):308-323. doi: 10.1016/j.ajog.2019.02.027. [PubMed 30948039]
  15. Mahadevan U, Vermeire S, Lasch K, et al. Vedolizumab exposure in pregnancy: outcomes from clinical studies in inflammatory bowel disease. Aliment Pharmacol Ther. 2017;45(7):941-950. doi: 10.1111/apt.13960. [PubMed 28169436]
  16. Moens A, van Hoeve K, Humblet E, et al; Belgian IBD Research and Development group (BIRD). Outcome of pregnancies in female patients with inflammatory bowel diseases treated with vedolizumab. J Crohns Colitis. 2019;13(1):12-18. doi: 10.1093/ecco-jcc/jjy142. [PubMed 30281093]
  17. Moens A, van der Woude CJ, Julsgaard M, et al. Pregnancy outcomes in inflammatory bowel disease patients treated with vedolizumab, anti-TNF or conventional therapy: results of the European CONCEIVE study. Aliment Pharmacol Ther. 2020;51(1):129-138. doi:10.1111/apt.15539 [PubMed 31692017]
  18. Nielsen OH, Gubatan JM, Juhl CB, Streett SE, Maxwell C. Biologics for inflammatory bowel disease and their safety in pregnancy: a systematic review and meta-analysis. Clin Gastroenterol Hepatol. 2020:S1542-3565(20)31281-7. doi:10.1016/j.cgh.2020.09.021 [PubMed 32931960]
  19. Palmeira P, Quinello C, Silveira-Lessa AL, Zago CA, Carneiro-Sampaio M. IgG placental transfer in healthy and pathological pregnancies. Clin Dev Immunol. 2012;2012:985646. [PubMed 22235228]
  20. Pentsuk N, van der Laan JW. An interspecies comparison of placental antibody transfer: new insights into developmental toxicity testing of monoclonal antibodies. Birth Defects Res B Dev Reprod Toxicol. 2009;86(4):328-344. [PubMed 19626656]
  21. Puchner A, Gröchenig HP, Sautner J, et al. Immunosuppressives and biologics during pregnancy and lactation : A consensus report issued by the Austrian Societies of Gastroenterology and Hepatology and Rheumatology and Rehabilitation. Wien Klin Wochenschr. 2019;131(1-2):29-44. doi: 10.1007/s00508-019-1448-y. [PubMed 30643992]
  22. Rubin DT, Ananthakrishnan AN, Siegel CA, Sauer BG, Long MD. ACG clinical guideline: ulcerative colitis in adults. Am J Gastroenterol. 2019;114(3):384-413. [PubMed 30840605]
  23. Sheridan J, Cullen G, Doherty G. Letter: vedolizumab in pregnancy. J Crohns Colitis. 2017;11(8):1025-1026. doi:10.1093/ecco-jcc/jjw214. [PubMed 27993997]
  24. Sun W, Fennimore B, Beaulieu DB, et al. Vedolizumab levels in breast milk: results from a prospective, postmarketing, milk-only lactation study in nursing mothers with inflammatory bowel disease. J Crohns Colitis. 2020;14:S442. doi:10.1093/ecco-jcc/jjz203.638
  25. Terjung B, Schmelz R, Ehehalt R, et al. Safety of vedolizumab in the treatment of pregnant women with inflammatory bowel disease: a targeted literature review. Therap Adv Gastroenterol. 2020;13:1756284820952592. doi:10.1177/1756284820952592 [PubMed 33149762]
  26. Weizman AV, Nguyen GC, Seow CH, et al. Appropriateness of biologics in the management of crohn's disease using RAND/UCLA appropriateness methodology. Inflamm Bowel Dis. 2019;25(2):328-335. doi: 10.1093/ibd/izy333. [PubMed 30346529]
Topic 95501 Version 162.0