Vedolizumab

Intravenous:
Powder for concentrate for solution for infusion: Reconstitute vial labelled as containing 300 mg with 4.8 mL of sterile water for inj to a final concentration of 60 mg/mL. Gently swirl to dissolve, do not shake or invert. Allow the vial to stand for up to 20 minutes to complete reconstitution and allow any foam to dissipate. Withdraw 5 mL from the vial, then dilute with 250 mL NaCl 0.9% solution or lactated Ringer's inj. Gently mix the infusion bag.

Hypersensitivity. Active, severe, and uncontrolled infections (e.g. TB, sepsis); opportunistic infections (e.g. progressive multifocal leucoencephalopathy [PML]).

Patients with controlled chronic severe infection, history of recurring severe infections. Hepatic impairment. Pregnancy and lactation. Avoid concomitant administration of live vaccines in immunosuppressed patients.

Significant: Hypersensitivity reactions including anaphylaxis (e.g. dyspnoea, bronchospasm), infusion-related reactions (e.g. flushing, urticaria), hepatic injury.
Gastrointestinal disorders: Nausea, constipation, dyspepsia, gastroenteritis, abdominal distension, flatulence, anal abscess, anal fissure.
General disorders and administration site conditions: Infusion site reaction, pyrexia, fatigue.
Infections and infestations: Influenza, Salmonella sepsis, Listeria meningitis.
Investigations: Liver enzymes increased.
Musculoskeletal and connective tissue disorders: Back pain, pain in extremity, arthralgia, muscular weakness, muscle spasms.
Nervous system disorders: Headache, paraesthesia.
Respiratory, thoracic and mediastinal disorders: URTI, nasal congestion, sinusitis, nasopharyngitis, cough, oropharyngeal pain, pneumonia, bronchitis.
Skin and subcutaneous tissue disorders: Rash, pruritus, eczema, erythema, acne, night sweats.
Vascular disorders: Hypertension, haemorrhoids.
Potentially Fatal: Serious infections (e.g. sepsis, PML).

This drug may cause mild dizziness, if affected, do not drive or operate machinery. Women of childbearing potential must use effective birth control methods during treatment and for at least 18 weeks after the last treatment.

Monitor LFTs and observe closely during and after each infusion for any infusion-related reactions. Perform tuberculosis screening according to local practice and pregnancy test prior to therapy. Monitor for signs and symptoms of hypersensitivity reactions, infections, hepatic injury (e.g. fatigue, anorexia, right upper abdominal discomfort, dark urine, jaundice), and PML including any new or worsening neurological status (e.g. progressive weakness or clumsiness affecting one side of the body, visual disturbance, confusion, memory difficulties, personality changes).

Increased risk of PML with natalizumab. Enhanced adverse effects with anti-tumour necrosis factor agents. May increase risk of vaccine-associated infection and decrease therapeutic effects of live vaccines.

Description:
Overview: Vedolizumab is an integrin receptor antagonist, humanised IgG₁ monoclonal antibody produced in Chinese hamster ovary cells using recombinant DNA technology.
Mechanism of Action: Vedolizumab selectively binds to α4β7 integrin, expressed in gut-homing T helper lymphocytes, inhibiting their adhesion to mucosal address in cell adhesion molecule-1 (MAdCAM-1), thus preventing migration of memory T-lymphocytes across endothelium and into the inflamed gastrointestinal parenchymal tissue.
Pharmacodynamics: In healthy subjects and in patients with ulcerative colitis or Crohn's disease, it does not increase levels of neutrophils, basophils, eosinophils, B-helper and cytotoxic T-lymphocytes, total memory helper T-lymphocytes, monocytes, or natural killer cells. The reduction of inflammation in patients with ulcerative colitis was observed for 4 or 6 weeks as assessed by histopathology. Treatment with vedolizumab has been associated with improvements in inflammatory markers such as reduction in faecal calprotectin levels in some patients with ulcerative colitis and decreased levels of C-reactive protein (CRP) in some Crohn's patients with elevated CRP levels at baseline.
Pharmacokinetics:
Absorption: Bioavailability: Approx 75% (SC). Time to peak plasma concentration: 7 days (SC).
Distribution: Crosses the placenta and enters breast milk. Volume of distribution: Approx 5 L.
Excretion: Elimination half-life: Approx 26 days.

Intravenous:
Powder for concentrate for solution for infusion: Store between 2-8°C. Protect from light. Do not freeze. Reconstituted solution Store between 2-8°C for up to 8 hours. Do not freeze. Diluted solution in NaCl 0.9% for IV infusion: Store between 20-25°C for up to 12 hours or between 2-8°C for up to 24 hours. Do not freeze. Diluted solution in lactated Ringer's inj for IV infusion: Store between 2-8°C for up to 6 hours. Do not freeze.

Subcutaneous:
Solution for inj: Store between 2-8°C. Protect from light. Do not freeze. May store below 25°C for up to 7 days. Protect from light.

GIT Regulators, Antiflatulents & Anti-Inflammatories / Immunosuppressants

L04AG05 - vedolizumab ; Belongs to the class of monoclonal antibodies. Used as immunosuppressants.

Brayfield A, Cadart C (eds). Vedolizumab. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 10/11/2025.

Entyvio 180 mg Solution for Injection in Pre-filled Pen (Takeda Pharma A/S). MHRA. https://products.mhra.gov.uk. Accessed 10/11/2025.

Entyvio 180 mg Solution for Injection in Pre-filled Syringe (Takeda Pharma A/S). MHRA. https://products.mhra.gov.uk. Accessed 10/11/2025.

Entyvio 300 mg Powder for Injection (Takeda Pharma A/S). MHRA. https://products.mhra.gov.uk. Accessed 10/11/2025.

Entyvio Injection, Powder, Lyophilized, for Solution; Entyvio Pen Injection, Solution; and Entyvio Injection, Solution (Takeda Pharmaceuticals U.S.A., Inc.). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 10/11/2025.

Joint Formulary Committee. Vedolizumab. British National Formulary [online]. London. BMJ Group and Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 10/11/2025.

Takeda New Zealand Limited. Entyvio 300 mg Powder for Injection data sheet 18 September 2025. Medsafe. http://www.medsafe.govt.nz. Accessed 10/11/2025.

Vedolizumab. UpToDate Lexidrug, AHFS DI (Adult and Pediatric) Online. American Society of Health-System Pharmacists, Inc. Waltham, MA. UpToDate, Inc. https://online.lexi.com. Accessed 10/11/2025.

Vedolizumab. UpToDate Lexidrug, Lexi-Drugs Multinational Online. Waltham, MA. UpToDate, Inc. https://online.lexi.com. Accessed 10/11/2025.