Registered Kenya · PPB

ENTYVIO

VEDOLIZUMAB

H2022/CTD7332/14424 300MG NEW/INNOVATOR INN generic

What it does

Vedolizumab is a medication that helps manage certain inflammatory bowel diseases.

Commonly used for: ulcerative colitis, Crohn's disease

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Plain-language summary for general understanding - not medical advice. Always follow your pharmacist/doctor.

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Registration & product details

Registration no.
H2022/CTD7332/14424
Registration date
-
Expiry date
-
Status
Registered
Active ingredient
VEDOLIZUMAB
Dosage form
300MG
Strength
-
Pack size
PRIMARY CONTAINER CLOSURE SYSTEM CONSISTS OF A SINGLE-USE 20 ML, UNTREATED, FLINT (CLEAR) CLEAR TYPE I GLASS TUBING VIAL WITH A 20 MM B2-TR AND FLUROTEC® COATED, SINGLE-VENT RUBBER STOPPER AND AN ALUMINUM SEAL WITH A PLASTIC FLIP-OFF CAP.
Therapeutic class
NEW/INNOVATOR
Manufacturer / MAH
Phillips Therapeutics
Applicant / LTR
TAKEDA PHARMA A/S
Country of origin
FOREIGN
Manufacturer location
Embakasi South, Nairobi, Kenya

Source: Pharmacy and Poisons Board · fetched 2026-01-28 20:18:59 · updated 2026-08-03 04:19:21

Disclaimer: This information is sourced from Pharmacy and Poisons Board (Kenya). Always consult a qualified healthcare professional before using any medication.

About this medicine

Vedolizumab is a medication that helps manage certain inflammatory bowel diseases.

What it treats

  • ulcerative colitis
  • Crohn's disease

How it works

It works by blocking specific proteins that cause inflammation in the gut.

Who it's for

This medicine is for adults with moderate to severe inflammatory bowel diseases who have not responded well to other treatments.

AI-assisted summary grounded in BNF data - general information only, not medical advice. Always confirm with your pharmacist or doctor.

Clinical monograph: Vedolizumab

BNF-referenced

Vedolizumab is a monoclonal antibody that specifically targets the α4β7 integrin, which is expressed on gut-homing T lymphocytes. By binding to this integrin, vedolizumab inhibits the migration of these lymphocytes to the gastrointestinal tract, thereby reducing inflammation associated with inflammatory bowel diseases such as ulcerative colitis and Crohn's disease. It is primarily used as an immunosuppressive therapy in patients who have not responded adequately to conventional therapies.

Indications

  • Ulcerative colitis
  • Crohn's disease

Dosage

Children: Refer to BNF for Children for specific paediatric dosing information.

Adults: Initially, 300 mg by intravenous infusion at weeks 0, 2, and 6, followed by maintenance therapy of 108 mg subcutaneously every 2 weeks.

Mechanism of action

Vedolizumab binds to the α4β7 integrin on T lymphocytes, blocking their interaction with mucosal addressin cell adhesion molecule-1 (MAdCAM-1) expressed on the endothelium of the gut. This prevents the migration of these immune cells to the intestinal tissue, thereby mitigating inflammation and the pathological processes in conditions like ulcerative colitis and Crohn's disease.

Pharmacodynamics

Vedolizumab's pharmacodynamics involve modulation of immune responses in the gut. By inhibiting lymphocyte trafficking, it decreases local inflammation and promotes mucosal healing in the intestinal lining, which is crucial for patients suffering from chronic inflammatory bowel diseases. Its effect is localized to the gastrointestinal tract, allowing for a favorable safety profile compared to systemic immunosuppressants.

Pharmacokinetics

Vedolizumab exhibits a biphasic elimination profile after intravenous administration with a distribution phase followed by a slower elimination phase. The half-life of vedolizumab is approximately 18 days. It is primarily cleared by the reticuloendothelial system and does not undergo significant hepatic metabolism. The pharmacokinetics may vary based on individual patient factors and concurrent medications.

Contra-indications

  • Active tuberculosis
  • Severe infusion-related reactions

Adverse effects

  • Arthralgia
  • Constipation
  • Cough
  • Fatigue
  • Fever
  • Gastrointestinal discomfort
  • Infusion-related reactions
  • Hypersensitivity reactions

Precautions

  • Monitor for signs of infection before, during, and after treatment
  • Consider pretreatment with antihistamines or hydrocortisone for patients with a history of infusion reactions
  • Patients should be brought up to date with immunisation schedule prior to treatment

Pregnancy

Manufacturer advises use only if potential benefit outweighs risk.

Breast-feeding

Use with caution; present in breast milk.

Storage

Store in a refrigerator (2 to 8 degrees Celsius). Do not freeze.

Formulations

  • Intravenous infusion: 300 mg in 10 mL solution for infusion
  • Subcutaneous injection: 108 mg in 1 mL solution
BNF 85 (British National Formulary) p.67 PubChem / pathway

AI-synthesized from BNF references - general information only, not a substitute for professional medical advice or the current BNF. Verify doses with a pharmacist.