Vedolizumab

Vedolizumab Uses, Dosage, Side Effects, Food Interaction and all others data.

Vedolizumab is a recombinant humanized IgG1 monoclonal antibody directed against the human lymphocyte α4β7 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, α4β7 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.

Non-clinical studies have shown that the pharmacodynamic effects of vedolizumab are reversible upon removal of the antibody: pharmacologic activity of cells inhibited by vedolizumab could be partially restored within 24 hours after removal, with near complete restoration within 4 days. There are no known drug interactions as vedolizumab is a humanized antibody and does not modulate production of cytokines, which is known to affect drug metabolism.

Trade Name Vedolizumab
Availability Prescription only
Generic Vedolizumab
Vedolizumab Other Names Vedolizumab
Related Drugs Entyvio, Humira, Stelara, Tysabri, Zeposia, Colazal, dexamethasone, hydrocortisone, budesonide, azathioprine
Weight 300mg,
Type Intravenous Powder For Injection, Intravenous
Formula C6528H10072N1732O2042S42
Weight 146837.0 Da
Protein binding

Vedolizumab binds specifically to α4β7 integrin but does not bind to, or inhibit function of, α4β1 or αEβ7 integrins. Inhibition of the α4β7 integrin is a shared mechanism with natalizumab, however vedolizumab binds solely to the α4β7 but not the α4β1 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).

Groups Approved
Therapeutic Class
Manufacturer
Available Country United States
Last Updated: September 19, 2023 at 7:00 am
Vedolizumab
Vedolizumab

Uses

Vedolizumab is an integrin blocker and anti-inflammatory agent used to manage ulcerative colitis and Crohn's disease in adults with inadequate clinical response to immunomodulators.

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.

Vedolizumab is also used to associated treatment for these conditions: Severe Crohn's Disease, Severe Ulcerative Colitis, Moderate Crohn's disease, Moderate Ulcerative colitis

How Vedolizumab works

Vedolizumab binds to α4β7 integrin, a key mediator of gastrointestinal inflammation expressed on the surfaces of T and B lymphocytes. By selectively inhibiting the α4β7 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.

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).

Food Interaction

No interactions found.

Vedolizumab Disease Interaction

Major: infections, PML, liver diseaseModerate: vaccination

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.

Elimination Route

The intended route of administration is intravenous, therefore there is no absorption data and bioavailability is expected to be 100%.

Half Life

Vedolizumab has a long terminal elimination half life of 336 to 362 hr.

Clearance

Vedolizumab has a low clearance of 0.180 to 0.266 ml/hr/kg.

Elimination Route

Renal clearance is negligible as vedolizumab is a high molecular weight protein.

Innovators Monograph

You find simplified version here Vedolizumab

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