Vedolizumab


Concise Prescribing Info
Indications/Uses
Listed in Dosage.
Dosage/Direction for Use
Adult : IV Ulcerative colitis; Crohn’s disease 300 mg via infusion over 30 minutes at 0, 2, and 6 weeks, then every 8 weeks thereafter or every 4 weeks if response declines.
Dosage Details
Intravenous
Ulcerative colitis
Adult: In patients with moderate to severe, refractory cases: 300 mg via infusion over 30 minutes at 0, 2, and 6 weeks, then every 8 weeks thereafter or every 4 weeks if response declines. Discontinue treatment after 14 weeks if no therapeutic benefit is achieved. If restarting treatment after interruption for up to 1 year, consider increasing dosing frequency to every 4 weeks.

Intravenous
Crohn's disease
Adult: In patients with moderate to severe, refractory cases: 300 mg via infusion over 30 minutes at 0, 2, and 6 weeks, then every 8 weeks thereafter or every 4 weeks if response declines. May give additional dose at week 10 in patients with inadequate response. Discontinue treatment by week 14, if no therapeutic benefit is achieved. If restarting treatment after interruption for up to 1 year, consider increasing dosing frequency to every 4 weeks.
Reconstitution
Reconstitute vial labelled as containing 300 mg with 4.8 mL sterile water for inj to a final concentration of 60 mg/mL. Gently swirl to dissolve, do not shake or invert. Further dilute a 5 mL reconstituted solution with 250 mL 0.9% NaCl or lactated ringer’s inj.
Contraindications
Hypersensitivity. Uncontrolled and active severe infections (e.g. TB, sepsis, cytomegalovirus, listeriosis) and opportunistic infections (e.g. progressive multifocal leukoencephalopathy).
Special Precautions
Patient with chronic severe infection or history of recurring severe infections. Pregnancy and lactation.
Adverse Reactions
Significant: Hypersensitivity reactions (e.g. dyspnoea, bronchospasm, urticaria) including anaphylaxis, infusion-related reactions (flu-like symptoms), increased risk of infection and malignancies, increased transaminases and/or bilirubin.
Gastrointestinal disorders: Nausea, gastroenteritis, anal fissure, dyspepsia, constipation, abdominal distention, flatulence, oropharyngeal pain.
General disorders and admin site conditions: Pyrexia, fatigue.
Hepatobiliary disorders: Hepatotoxicity, hepatitis.
Infections and infestations: Nasopharyngitis, upper respiratory tract infection, bronchitis, influenza, sinusitis, tuberculosis, anal abscess, salmonella sepsis, Listeria meningitis, giardiasis, cytomegaloviral colitis.
Musculoskeletal and connective tissue disorders: Arthralgia, muscle spasms, back pain, muscular weakness, pain in the extremity.
Neoplasms benign, malignant and unspecified: Rarely, malignant neoplasm (excluding dysplasia and basal cell carcinoma).
Nervous system disorders: Headache, paraesthesia.
Respiratory, thoracic and mediastinal disorders: Cough, nasal congestion.
Skin and subcutaneous tissue disorders: Rash, pruritus, eczema, erythema, night sweats, acne.
Vascular disorders: Hypertension, haemorrhoids.
Potentially Fatal: Sepsis, progressive multifocal leukoencephalopathy.
Patient Counseling Information
This drug may cause mild dizziness, if affected, do not drive or operate machinery.
MonitoringParameters
Monitor LFT; signs and symptoms of worsening neurological disorder; signs and symptoms of infection. Monitor for infusion and hypersensitivity reactions. Perform TB screening according to current guidelines.
Drug Interactions
May enhance adverse effect of natalizumab. Enhanced adverse/toxic effect with anti-tumour necrosis factor agents. May diminish therapeutic effect and enhance the adverse effects of live vaccines.
Action
Description: Vedolizumab, a humanised IgG1 monoclonal antibody, which selectively binds to α4ß7 integrin, expressed on gut homing T lymphocyte. This blocks the adhesion of α4ß7 to mucosal addressin cell adhesion molecule-1 (MAdCAM-1) thereby inhibiting the migration of memory T-lymphocytes across the gastrointestinal parenchymal tissue thus reducing inflammation.
Pharmacokinetics:
Distribution: Crosses placenta, enters breastmilk. Volume of distribution: 5 L.
Excretion: Elimination half-life: 25 days.
Storage
Store between 2-8°C. Protect from light.
ATC Classification
L04AA33 - vedolizumab ; Belongs to the class of selective immunosuppressive agents. Used to induce immunosuppression.
References
Anon. Vedolizumab. Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 10/07/2019.

Buckingham R (ed). Vedolizumab. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 10/07/2019.

Entyvio Lyophilized Powder for Solution for Infusion (Takeda Pharmaceuticals America, Inc.). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed/. Accessed 10/07/2019.

Disclaimer: This information is independently developed by MIMS based on Vedolizumab from various references and is provided for your reference only. Therapeutic uses, prescribing information and product availability may vary between countries. Please refer to MIMS Product Monographs for specific and locally approved prescribing information. Although great effort has been made to ensure content accuracy, MIMS shall not be held responsible or liable for any claims or damages arising from the use or misuse of the information contained herein, its contents or omissions, or otherwise. Copyright © 2020 MIMS. All rights reserved. Powered by MIMS.com
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