ENTYVIO® (Non-English)

ENTYVIO® (vedolizumab) is a gut-selective biologic therapy used in adult patients to treat moderately to severely active ulcerative colitis (UC) and Crohn’s disease (CD). It is a humanized monoclonal antibody that targets the α4β7 integrin, blocking its interaction with MAdCAM-1, a molecule involved in the migration of T-lymphocytes into the gastrointestinal tract. By limiting this immune cell infiltration, ENTYVIO® reduces intestinal inflammation.

This product is available as:

• Intravenous infusion: 300 mg vedolizumab (lyophilized powder).
  
• Subcutaneous injection: 108 mg/0.68 mL prefilled syringe or pen.
  

It is indicated for adult patients who have not responded adequately to conventional therapy or TNF blockers. Clinical studies show significant benefits in achieving and maintaining remission in UC and CD, with a favorable safety profile and low systemic immunosuppression risk.

ENTYVIO® can be administered intravenously or subcutaneously, depending on treatment phase and patient condition.

Key Features:

• Initiation is via IV infusion; maintenance may continue with IV or switch to subcutaneous injection.
  
• Proper training is required for subcutaneous self-injection.
  

IV Protocol:

• 300 mg over 30 minutes at Weeks 0, 2, and 6, then every 8 weeks
  

Subcutaneous Protocol (UC only):

• Start Week 6: 108 mg every 2 weeks.
  

Other Administration Notes:

• Inspect solution before use.
  
• Use a different injection site each time.
  
• Discontinue if no response by Week 14.
  

ENTYVIO® is indicated for:

• Moderately to severely active ulcerative colitis
  
• Moderately to severely active Crohn’s disease
  

Contraindications:

• Known serious hypersensitivity to vedolizumab or excipients.
  

Common Side Effects:

• Nasopharyngitis (13%)
  
• Headache (12%)
  
• Arthralgia (12%)
  
• Nausea, fatigue, rash, back pain, URTI
  

Severe Risks Include:

• Infusion-related reactions
  
• Sepsis
  
• Progressive Multifocal Leukoencephalopathy (PML)
  
• Liver injury
  

ENTYVIO® contains vedolizumab, a monoclonal antibody, with the following excipients:

IV Formulation:

• 300 mg vedolizumab
  
• Arginine hydrochloride (131.7 mg)
  
• Histidine, histidine HCl
  
• Polysorbate 80 (3 mg)
  
• Sucrose (500 mg)
  

Subcutaneous Formulation (per 108 mg/0.68 mL dose):

• Arginine hydrochloride (19.51 mg)
  
• Histidine, histidine HCl
  
• Citric acid, sodium citrate
  
• Polysorbate 80 (1.48 mg)
  

ENTYVIO® is supplied in various formats depending on the route of administration:

• IV Form:
  
  • 1 single-dose vial containing 300 mg lyophilized powder for reconstitution.
    
• Subcutaneous Forms:
  
  • 108 mg/0.68 mL prefilled syringe with safety needle.
    
  • 108 mg/0.68 mL prefilled pen (ENTYVIO PEN).
    

Each package is single-use and preservative-free.

Yes, ENTYVIO® may cause adverse effects, both common and serious.

Most Common Adverse Reactions (≥3% incidence):

• Nasopharyngitis
  
• Headache
  
• Arthralgia
  
• Nausea
  
• Upper respiratory tract infection
  
• Fatigue
  

Serious Side Effects:

• Infusion-related reactions, including anaphylaxis
  
• Serious infections: sepsis, TB, abscesses
  
• Liver injury: elevated transaminases and bilirubin
  
• Progressive Multifocal Leukoencephalopathy (PML)
  

Injection site reactions (e.g., erythema, hematoma) may occur with the subcutaneous formulation.

Proper storage ensures ENTYVIO®’s stability and safety.

Unreconstituted Vials:

• Store at 2°C to 8°C (36°F to 46°F)
  
• Do not freeze
  
• Protect from light
  

Reconstituted IV Solution:

• Use immediately, or:
  
  • Store up to 8 hours refrigerated (vial)
    
  • Once diluted:
    
    • 12–24 hours at 2–8°C in NaCl
      
    • 6 hours in Lactated Ringer’s
      

Prefilled Syringes/Pens (Subcutaneous):

• Store at 2°C to 8°C
  
• Do not freeze or shake
  
• Allow to reach room temperature before use