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تعداد آیتم قابل مشاهده باقیمانده : 3 مورد
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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.

Colitis, immune checkpoint inhibitor-induced

Colitis, immune checkpoint inhibitor-induced (off-label use):

Note: For grade 2, 3, or 4 colitis with either high-risk endoscopic features on initial endoscopy examination or with persistent symptoms despite 3 days of corticosteroid therapy, consider adding vedolizumab to the treatment regimen (Ref).

IV: 300 mg at 0, 2, and 6 weeks and then (if needed) once every 8 weeks thereafter; use in combination with a corticosteroid (Ref).

Crohn disease

Crohn disease:

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 labeling]: 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: 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.

Adverse Reactions (Significant): Considerations
Infusion-related hypersensitivity and/or cutaneous reactions

Infusion-related reactions have been reported, including symptoms resembling anaphylaxis. Symptoms include flushing, skin rash, urticaria, arthralgia, myalgias, and fever (Ref). Acute noncardiac chest pain has also been reported. Other cutaneous manifestations (eg, IgA-mediated leukocytoclastic vasculitis or Henoch-Schönlein purpura, nodular vasculitis, pyoderma gangrenosum) have been reported and may be delayed, occurring weeks to months after initiation therapy (Ref).

Mechanism:

Immediate: Vedolizumab also contains polysorbate 80, which is a known excipient that can induce immediate hypersensitivity reactions (Ref).

Delayed reactions: Unknown; dermatological-associated events may be triggered by the impact of vedolizumab on peripheral skin inflammatory cascades (Ref); other infusion-related reactions may result from development of anti-vedolizumab antibodies, which have been detected in severe reactions including noncardiac chest pain during the infusion (Ref).

Onset: Varied; most infusion-related reactions have occurred within 2 hours of the completion of the infusion but can occur within minutes of the start of the infusion (Ref). In general, cutaneous vasculitis and other cutaneous reactions typically occur within 7 to 10 days of the inducing factor but have been identified after several vedolizumab infusions were previously tolerated and can occur after weeks or months (Ref).

Risk factors:

• Some studies suggest the presence of anti-vedolizumab antibodies in patients with infusion reactions in the absence of detectable vedolizumab trough levels (Ref).

Hepatic injury

Increased serum alanine aminotransferase and increased serum aspartate aminotransferase (≥3 times the upper limit of normal) have been reported with vedolizumab (Ref). Increased serum transaminases are commonly encountered in patients with inflammatory bowel disease (Ref), while the incidence of vedolizumab-induced hepatic injury is rare (Ref). Reported cases of vedolizumab-induced hepatic injury may present as mixed or cholestatic, and liver biochemistries tend to improve upon discontinuation (Ref). Underlying liver diseases (eg, primary biliary sclerosis) must also be excluded if vedolizumab-induced hepatic injury is suspected (Ref).

Mechanism: Not clearly established; vedolizumab inhibits α4β7 integrin, selectively preventing gut specific signaling of T-lymphocytes and eosinophil migration and adhesion, which may increase peripheral eosinophilia commonly seen in allergic reactions such as immune-mediated hepatic injury (Ref).

Onset: Varied; range reported is 14 to 275 days after exposure (Ref).

Risk factors:

• Previous injury (Ref)

• Current alcohol use (Ref)

• Older age (≥55 years) (Ref)

Progressive multifocal leukoencephalopathy

Progressive multifocal leukoencephalopathy (PML) is a neurological disorder characterized by severe disability that can be fatal and is caused by John Cunningham virus (JCV) in the setting of significant immunosuppression (Ref). Natalizumab has been linked to an increased risk of PML and has a similar mechanism of action to vedolizumab, therefore prompting concerns for evaluation and monitoring of PML in patients receiving therapy. Unlike natalizumab, vedolizumab targets a different subunit of integrin expressed on gut-homing T-lymphocytes and does not impact immune surveillance within the central nervous system (Ref). Cases of vedolizumab-associated PML have yet to be identified, and the risk remains theoretical and based on data from natalizumab exposure (Ref).

Mechanism: Time related (delayed); related to the pharmacologic action (ie, monoclonal antibody targeting α4β7 integrin, a cell surface glycoprotein on B and T lymphocytes that binds to mucosal addressin cell adhesion molecule-1 on the intestinal vasculature) (Ref).

Onset: Delayed; occurs after 30 days of drug therapy (based on data from natalizumab) (Ref).

Risk factors:

• Duration of therapy >2 years (Ref)

• Prior or concurrent immunosuppression during therapy (Ref)

• Positive JCV antibody identified prior to or during therapy (Ref)

• History of blood cancers (Ref)

Serious infections

Although the immunosuppressive activity of vedolizumab is focused on gut specific pathways, use may be associated with an increased risk for developing infection; most reported infections included upper respiratory tract infections and nasopharyngitis (Ref). The risk of serious infections, requiring hospitalization, is like other anti-TNF agents based on recent pooled analyses (Ref) and have resolved with treatment discontinuation (Ref).

Mechanism: Related to the pharmacologic action (ie, monoclonal antibody targeting α4β7 integrin, a cell surface glycoprotein on B and T lymphocytes that binds to mucosal addressin cell adhesion molecule-1 on the intestinal vasculature) (Ref).

Risk factors:

• Prior anti-TNF use (Ref)

• Concurrent narcotic use (Ref)

• Older age (Ref)

• Concurrent corticosteroid use (Ref)

• Cirrhosis (Ref)

Adverse Reactions

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

>10%:

Immunologic: Antibody development (6%; neutralizing: 3% to 4%)

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 × ULN: <2%), increased serum aspartate aminotransferase (≥3 × ULN: <2%)

Hypersensitivity: Infusion-related reaction (4%) (table 1)

Infection: Influenza (4%)

Local: Injection-site reaction (9%; including bruising at injection site, erythema at injection site, hematoma at injection site, rash at injection site, swelling at injection site)

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%)

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

Postmarketing:

Gastrointestinal: Acute pancreatitis, cholestasis (Honap 2021)

Hematologic & oncologic: Peripheral eosinophilia (De Marco 2022)

Hepatic: Hepatic injury (De Marco 2022), hepatitis (including toxic hepatitis) (Mascarenhas Saraiva 2020), increased serum bilirubin, increased serum transaminases (including increased serum alkaline phosphatase, increased gamma-glutamyl transferase) (De Marco 2022)

Hypersensitivity: Hypersensitivity reaction (including anaphylaxis)

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

Disease-related concerns:

• Infection: 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.

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.

Dosage Forms: US

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 Reconstituted, Intravenous [preservative free]:

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

Generic Equivalent Available: US

No

Pricing: US

Solution (reconstituted) (Entyvio Intravenous)

300 mg (per each): $10,399.90

Solution Pen-injector (Entyvio Subcutaneous)

108MG/0.68ML (per 0.68 mL): $3,743.96

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.

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]

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: Allow pen to reach room temperature (30 minutes) after removing from refrigerator; do not warm in other ways or let sit in direct sunlight. Do not shake. 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. Initial use is recommended under supervision of physician; self injection may occur after proper training. Do not reuse prefilled pens; single use only.

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/2023/761133s000lbl.pdf#page=23

Use: Labeled Indications

Crohn disease: Treatment of Crohn disease in adults.

Ulcerative colitis: Treatment of ulcerative colitis in adults.

Use: Off-Label: Adult

Colitis, immune checkpoint inhibitor-induced

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

Antithymocyte Globulin (Equine): Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the adverse/toxic effect of Antithymocyte Globulin (Equine). Specifically, these effects may be unmasked if the dose of immunosuppressive therapy is reduced. Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the immunosuppressive effect of Antithymocyte Globulin (Equine). Specifically, infections may occur with greater severity and/or atypical presentations. Risk C: Monitor therapy

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

Brivudine: May enhance the adverse/toxic effect of Immunosuppressants (Therapeutic Immunosuppressant Agents). Risk X: Avoid combination

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

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

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

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

Mumps- Rubella- or Varicella-Containing Live Vaccines: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the adverse/toxic effect of Mumps- 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 Mumps- Rubella- or Varicella-Containing Live Vaccines. Risk X: Avoid combination

Nadofaragene Firadenovec: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the adverse/toxic effect of Nadofaragene Firadenovec. Specifically, the risk of disseminated adenovirus infection may be increased. Risk X: Avoid combination

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

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

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

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

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

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): Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the adverse/toxic effect of Vaccines (Live). Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Therapeutic Immunosuppressant Agents) may diminish the therapeutic effect of Vaccines (Live). 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 patients with inflammatory bowel disease planning to become pregnant (Mahadevan 2019). Treatment algorithms are available for use of biologics in 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; Julsgaard 2021; Mahadevan 2021; Mitrova 2021).

Vedolizumab is a humanized monoclonal antibody (IgG1). Human IgG crosses the placenta. Fetal exposure is dependent upon the IgG subclass, maternal serum concentrations, placental integrity, newborn birth weight, and gestational age, generally increasing as pregnancy progresses. The lowest exposure would be expected during the period of organogenesis and the highest during the third trimester (Clements 2020; Palmeira 2012; Pentsuk 2009). Vedolizumab concentrations in cord blood and newborn serum are generally lower than those in the maternal serum at delivery (Flanagan 2020; Julsgaard 2021; Mahadevan 2021). 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). In a study of 43 mother-infant pairs, there were no infants exposed to vedolizumab in utero that had detectable serum concentrations at 6 months of age (Julsgaard 2021).

Data related to the use of vedolizumab in pregnancy are available (Bar-Gil Shitrit 2019; Chambers 2021; Ghalandari 2022; Julsgaard 2017; Mahadevan 2017; Mitrova 2022; Moens 2019; Moens 2020; Sheridan 2017; Wils 2021).

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 patients, 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 patients 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).

Vedolizumab was not detectable in the serum of 4 infants exposed in-utero and via breast milk. Vedolizumab was present in cord blood at birth, but not detectable in their serum at 3 months of age and until sampling stopped at 12 months of age. Vedolizumab breast milk concentrations were not evaluated in this study (Julsgaard 2021).

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; signs/symptoms of progressive multifocal leukoencephalopathy, including new onset or worsening of neurological signs and symptoms (eg, 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); 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 (Adult Data Unless Noted)

Distribution: Vd: ~5 L.

Bioavailability: SUBQ: ~75%.

Half-life elimination: ~24 days.

Time to peak: SUBQ: 7 days (range: 3 to 14 days).

Brand Names: International
International Brand Names by Country
For country code abbreviations (show table)

  • (AE) United Arab Emirates: Entyvio;
  • (AR) Argentina: Entyvio;
  • (AT) Austria: Entyvio;
  • (AU) Australia: Entyvio;
  • (BE) Belgium: Entyvio;
  • (BG) Bulgaria: Entyvio;
  • (BR) Brazil: Entyvio;
  • (CH) Switzerland: Entyvio;
  • (CN) China: Entyvio;
  • (CO) Colombia: Entyvio;
  • (CZ) Czech Republic: Entyvio;
  • (DE) Germany: Entyvio;
  • (EC) Ecuador: Entyvio;
  • (EE) Estonia: Entyvio;
  • (EG) Egypt: Entyvio;
  • (ES) Spain: Entyvio;
  • (FI) Finland: Entyvio;
  • (FR) France: Entyvio;
  • (GB) United Kingdom: Entyvio;
  • (GR) Greece: Entyvio;
  • (HK) Hong Kong: Entyvio;
  • (HR) Croatia: Entyvio;
  • (HU) Hungary: Entyvio;
  • (ID) Indonesia: Entyvio;
  • (IE) Ireland: Entyvio;
  • (IT) Italy: Entyvio;
  • (JP) Japan: Entyvio;
  • (KE) Kenya: Entyvio;
  • (KR) Korea, Republic of: Kynteles;
  • (KW) Kuwait: Entyvio;
  • (LB) Lebanon: Entyvio;
  • (LT) Lithuania: Entyvio;
  • (LU) Luxembourg: Entyvio;
  • (LV) Latvia: Entyvio;
  • (MX) Mexico: Entyvio;
  • (MY) Malaysia: Entyvio;
  • (NL) Netherlands: Entyvio;
  • (NO) Norway: Entyvio;
  • (NZ) New Zealand: Entyvio;
  • (PE) Peru: Entyvio;
  • (PH) Philippines: Entyvio;
  • (PL) Poland: Entyvio;
  • (PT) Portugal: Entyvio;
  • (QA) Qatar: Entyvio;
  • (RO) Romania: Entyvio;
  • (RU) Russian Federation: Entyvio;
  • (SA) Saudi Arabia: Entyvio;
  • (SE) Sweden: Entyvio;
  • (SG) Singapore: Entyvio;
  • (SI) Slovenia: Entyvio;
  • (SK) Slovakia: Entyvio;
  • (TH) Thailand: Entyvio;
  • (TR) Turkey: Entyvio;
  • (TW) Taiwan: Entyvio;
  • (UA) Ukraine: Entivio;
  • (ZA) South Africa: Entyvio
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Topic 95501 Version 192.0

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