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Therapeutic Vedolizumab antibody from the original Entyvio® commercial drug.
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ProductBatch | Antigen | Molecular Class | Drug Brand | Product Concentration | CoA | Quantity per vial | Storage Temperature | Expiry Date | Price from | |
|---|---|---|---|---|---|---|---|---|---|---|
alpha 4 beta 7 integrin |
Monoclonal Antibody |
Entyvio® |
158,8 mg/mL |
– |
4 mg |
-80°C |
06/2024 |
325,00 € |
||
alpha 4 beta 7 integrin |
Monoclonal Antibody |
Entyvio® |
158,8 mg/mL |
– |
4 mg |
-80°C |
12/2021 |
292,50 € |
| Drug name | Entyvio® | |||
| INN | Vedolizumab | |||
| API type | Vedolizumab is a humanised IgG1 monoclonal antibody produced in Chinese hamster ovary (CHO) cells by recombinant DNA technology. | |||
| Pharmacotherapeutic group | Immunosuppressants, selective immunosuppressants | |||
| ATC code | L04AA33 | |||
| Target of antibody | α4β7 integrin | |||
| General function | Vedolizumab is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a tumour necrosis factor-alpha (TNFα) antagonist. Entyvio is also indicated for the treatment of adult patients with moderately to severely active Crohn’s disease who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a tumour necrosis factor-alpha (TNFα) antagonist | |||
| Short description | ||||
| Pharmacodynamic properties (Mechanism of action; Source EMA document) | Vedolizumab is a gut-selective immunosuppressive biologic. It is a humanised monoclonal antibody that binds specifically to the α4β7 integrin, which is preferentially expressed on gut homing T helper lymphocytes. By binding to α4β7 on certain lymphocytes, vedolizumab inhibits adhesion of these cells to mucosal addressin cell adhesion molecule-1 (MAdCAM-1), but not to vascular cell adhesion molecule-1 (VCAM-1). MAdCAM-1 is mainly expressed on gut endothelial cells and plays a critical role in the homing of T lymphocytes to tissues within the gastrointestinal tract. Vedolizumab does not bind to, nor inhibit function of, the α4β1 and αEβ7 integrins. | |||
| Pharmacodynamic properties (Pharmacodynamic effects; Source EMA document) | The single and multiple dose pharmacokinetics of vedolizumab have been studied in healthy subjects and in patients with moderate to severely active ulcerative colitis or Crohn’s disease | |||
| Original license holder | ||||
| Marketing authorisation numbers | EU/1/14/923/002 | |||
| Marketing authorisation holder | Takeda Pharma A/S Delta Park 45 2665 Vallensbaek Strand Denmark | |||
| Name of the manufacturer of the biological active substance | AbbVie Bioresearch Center 100 Research Drive Worcester, MA 01605-4314 USA; Abbvie Biotechnology, Ltd Road #2 Km 59.2 PO Box 2191 Barceloneta Puerto Rico 00617; Lonza Biologics, Inc. 101 International Drive Portsmouth NH 03801 USA | |||
| Name and address of the manufacturer(s) responsible for batch release | Delpharm Novara S.r.l. Via Crosa, 86 28065 Cerano (NO) Italy; Takeda Austria GmbH St. Peter-Straße 25 4020 Linz Austria | |||
| Max shelf life | 24 months | |||
| Storage conditions | 2 °C-8 °C | |||
| List of excipients | Citric acid monohydrate - Sodium citrate dihydrate - L-histidine - L-histidine monohydrochloride - L-arginine hydrochloride - Polysorbate 80 - Water for injections |
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