Detail

Vedolizumab

Description

Name: Vedolizumab
Type: biotech
Groups: approved
Indication: Vedolizumab is indicated for adult patients with moderately to severely active UC or CD who have had an inadequate response with, lost response to, or were intolerant to a tumor necrosis factor (TNF) blocker or immunomodulator; or had an inadequate response with, were intolerant to, or demonstrated dependence on corticosteroids.
Accession Number: DB09033 ( DB09033)
Description: Vedolizumab is a recombinant humanized IgG1 monoclonal antibody directed against the human lymphocyte ?4?7 integrin, a key mediator of gastrointestinal inflammation. It is used in the treatment of moderate to severe active ulcerative colitis and Crohn's disease for patients who have had an inadequate response with, lost response to, or were intolerant to inhibitors of tumor necrosis factor-alpha (TNF-alpha) or other conventional therapies. By blocking its primary target, ?4?7 integrin, vedolizumab reduces inflammation in the gut. Vedolizumab is administered by IV infusion over a period of 30 minutes; after the first dose, it is given again at two and six weeks and then every 8 weeks thereafter.
Structure:
Prescription Products:
NameDosageStrengthRouteMarketing StartMarketing EndCountry
Entyviopowder for solution300 mgintravenous21-04-2015Canada
Entyvioinjection, powder, lyophilized, for solution300 mg/5mLintravenous20-05-2014US

Generic Prescription Products: Not Available
Over the Counter Products: Not Available
International Brands
  • No Brands

Brand Names
  • No Brands

Brand Mixtures
Brand NameIngredients
EntyvioVedolizumab
EntyvioVedolizumab

Categories
  • No Category

Pharmacology

Indication: Vedolizumab is indicated for adult patients with moderately to severely active UC or CD who have had an inadequate response with, lost response to, or were intolerant to a tumor necrosis factor (TNF) blocker or immunomodulator; or had an inadequate response with, were intolerant to, or demonstrated dependence on corticosteroids.
Pharmacodynamics: Not Available
Mechanism of action: Vedolizumab binds to ?4?7 integrin, a key mediator of gastrointestinal inflammation expressed on the surfaces of T and B lymphocytes. By selectively inhibiting the ?4?7 integrin, vedolizumab inhibits adhesion of lymphocytes to its natural ligand, mucosal addressin cell adhesion molecule-1 (MAdCAM-1), thereby preventing lymphocytic cells from entering the gut lamina propria and gut-associated lymphoid tissue (GALT). Specifically inhibiting this pathway alleviates GI inflammation without impairing systemic immune responses.
Absorption: The intended route of administration is intravenous, therefore there is no absorption data and bioavailability is expected to be 100%.
Volume of distribution:
    Serum apparent volume of distribution at steady-state has been found to be moderately greater than the serum volume. It is therefore expected to be confined to the systemic circulation, as expected for a high molecular weight protein.

Protein binding: Vedolizumab binds specifically to ?4?7 integrin but does not bind to, or inhibit function of, ?4?1 or ?E?7 integrins. Inhibition of the ?4?7 integrin is a shared mechanism with natalizumab, however vedolizumab binds solely to the ?4?7 but not the ?4?1 integrin, unlike natalizumab which binds to both. As a result, natalizumab modulates the systemic immune system and is associated with other side effects such as progressive multifocal leukoencephalopathy (PML).
Metabolism: Not Available
Route of elimination: Renal clearance is negligible as vedolizumab is a high molecular weight protein.
Half life: Vedolizumab has a long terminal elimination half life of 336 to 362 hr.
Clearance: Not Available
Toxicity: Long-term studies in animals have not been performed to evaluate the carcinogenic potential, mutagenicity, or possible impairments to fertility. Elevated transaminase levels with or without elevated bilirubin has occurred in patients who have received this drug. Progressive multifocal leukoencephalopathy (PML) has not been reported with use of this drug, however it has occurred in patients who have received different integrin receptor antagonists and is therefore considered a risk for this product. Use of vedolizumab may increase risk of developing infections, and one study found that nasopharyngitis occurs more frequently with vedolizumab than with placebo for CD patients (Wang et al, 2014).
Affected organisms
  • Not Available

SNP Mediated Adverse Drug Reactions
  • Not Available

Pharmacoeconomics

Manufacturers:
  • Not Available

Packagers:
  • Not Available

Dosage forms
FormRouteStrength
Injection, powder, lyophilized, for solutionintravenous300 mg/5mL
Powder for solutionintravenous300 mg

Prices
Unit descriptionCostUnit

Patents
CountryPatent NumberApprovedExpires (estimated)
2012151248United States2012-05-022032-05-02

Interactions

Drug Interactions
DrugInteraction
AdalimumabThe risk or severity of adverse effects can be increased when Adalimumab is combined with Vedolizumab.
BelimumabThe risk or severity of adverse effects can be increased when Vedolizumab is combined with Belimumab.
Certolizumab pegolThe risk or severity of adverse effects can be increased when Certolizumab pegol is combined with Vedolizumab.
DenosumabThe risk or severity of adverse effects can be increased when Denosumab is combined with Vedolizumab.
EtanerceptThe risk or severity of adverse effects can be increased when Etanercept is combined with Vedolizumab.
golimumabThe risk or severity of adverse effects can be increased when golimumab is combined with Vedolizumab.
InfliximabThe risk or severity of adverse effects can be increased when Infliximab is combined with Vedolizumab.
LeflunomideThe risk or severity of adverse effects can be increased when Vedolizumab is combined with Leflunomide.
LenalidomideThe risk or severity of adverse effects can be increased when Lenalidomide is combined with Vedolizumab.
NatalizumabThe risk or severity of adverse effects can be increased when Vedolizumab is combined with Natalizumab.
PimecrolimusThe risk or severity of adverse effects can be increased when Pimecrolimus is combined with Vedolizumab.
PomalidomideThe risk or severity of adverse effects can be increased when Pomalidomide is combined with Vedolizumab.
RoflumilastRoflumilast may increase the immunosuppressive activities of Vedolizumab.
Sipuleucel-TThe therapeutic efficacy of Sipuleucel-T can be decreased when used in combination with Vedolizumab.
TacrolimusThe risk or severity of adverse effects can be increased when Tacrolimus is combined with Vedolizumab.
ThalidomideThe risk or severity of adverse effects can be increased when Thalidomide is combined with Vedolizumab.
TofacitinibVedolizumab may increase the immunosuppressive activities of Tofacitinib.
TrastuzumabTrastuzumab may increase the neutropenic activities of Vedolizumab.

Food Interactions:
  • Not Available

Taxonomy

Kingdom: Organic Compounds
Super Class: Not Available
Class: Not Available
Sub Class: Not Available
Direct Parent: Not Available
Alternative Parents:
  • Not Available

substituent:
  • Not Available

References

Synthesis Reference: Not Available
General Reference: # Soler D, Chapman T, Yang LL, Wyant T, Egan R, Fedyk ER: The binding specificity and selective antagonism of vedolizumab, an anti-alpha4beta7 integrin therapeutic antibody in development for inflammatory bowel diseases. J Pharmacol Exp Ther. 2009 Sep;330(3):864-75. doi: 10.1124/jpet.109.153973. Epub 2009 Jun 9. "Pubmed":http://www.ncbi.nlm.nih.gov/pubmed/19509315 # Krupka N, Baumgart DC: Designing biologic selectivity for inflammatory bowel disease--role of vedolizumab. Drug Des Devel Ther. 2014 Dec 17;9:147-54. doi: 10.2147/DDDT.S50348. eCollection 2015. "Pubmed":http://www.ncbi.nlm.nih.gov/pubmed/25552903 # Wang MC, Zhang LY, Han W, Shao Y, Chen M, Ni R, Wang GN, Wei FX, Zhang YW, Xu XD, Zhang YC: PRISMA--efficacy and safety of vedolizumab for inflammatory bowel diseases: a systematic review and meta-analysis of randomized controlled trials. Medicine (Baltimore). 2014 Dec;93(28):e326. doi: 10.1097/MD.0000000000000326. "Pubmed":http://www.ncbi.nlm.nih.gov/pubmed/25526490 # Committee for Medicinal Products for Human Use (CHMP): Entyvio Assessment Report. European Medicines Agency. 2014 March 20: Procedure No.: EMEA/H/C/002782/0000.
External Links:
ResourceLink
RxListhttp://www.rxlist.com/entyvio-drug.htm
Drugs.comhttp://www.drugs.com/entyvio.html

ATC Codes:
  • Array

AHFS Codes:
  • 56:92

MSDS: Download
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