ENTYVIO® (Non-English)

ENTYVIO ® (Vedolizumab) for Bowel Disease: Key Features and Benefits

ENTYVIO ® (vedolizumab) is a humanized monoclonal antibody that selectively targets α4β7 integrin to reduce gastrointestinal inflammation, particularly in bowel diseases such as ulcerative colitis (UC) and Crohn’s disease (CD). It is commonly used for patients with moderate to severe inflammatory bowel disease (IBD).

Selective Mechanism for Bowel Disease Patients

• Targets α4β7 integrin, limiting the immune response to the gut endothelial cells while sparing systemic immunity.
• Unlike infliximab or adalimumab, it specifically addresses gut-related inflammation without broad immunosuppression.

Effective Treatment with Vedolizumab in Clinical Trials

• Demonstrated clinical remission and response in patients with ulcerative colitis and Crohn’s disease.
• Reduced corticosteroid dependence and showed significant endoscopic improvement in long-term treatment.

Flexible Administration Options for Patients

• Available as intravenous (IV) infusion and subcutaneous (SC) injection, offering patients flexible treatment choices.
• IV infusion therapy can transition to SC injection for long-term care.

ENTYVIO ® Indications

ENTYVIO ® is indicated for patients with moderately to severely active ulcerative colitis (UC) and Crohn’s disease (CD).

Ulcerative Colitis (UC) Treatment

• Helps induce and maintain remission in patients with ulcerative colitis.
• Reduces corticosteroid use and improves endoscopic appearance of the mucosa.
• Compared to infliximab and adalimumab, vedolizumab offers a more gut-specific approach.

Crohn’s Disease (CD) Treatment

• Helps patients achieve corticosteroid-free remission.
• Reduces disease activity by targeting gut endothelial cells.
• Clinical reviews show significant benefits for long-term health.

ENTYVIO ® Ingredients

Each dose of ENTYVIO® contains:

Active Ingredient

• Vedolizumab (300 mg per IV infusion, 108 mg per SC injection)

Excipients

• IV Formulation: Histidine, Polysorbate 80, Sucrose.
• SC Formulation: Sodium Citrate, Citric Acid, Arginine Hydrochloride.

ENTYVIO ® How To Use

ENTYVIO® is administered via intravenous infusion (IV) or subcutaneous injection (SC).

Intravenous (IV) Dosage

• 300 mg infused over 30 minutes at Week 0, 2, 6, then every 8 weeks.
• If no response by Week 14, treatment should be discontinued.

Subcutaneous (SC) Dosage (UC only)

• After IV doses at Weeks 0 and 2, transition to 108 mg SC injection every 2 weeks starting at Week 6.
• Administer SC injections in thigh, abdomen, or upper arm.
• If a dose is missed, inject as soon as possible and resume every 2 weeks.

ENTYVIO ® Side Effects

ENTYVIO ® has potential side effects that patients should discuss with their healthcare provider.

Common Side Effects (≥3% Incidence)

• Nasopharyngitis, headache, nausea, joint pain, fever, fatigue, cough.
• Injection site reactions: redness, swelling, rash.

Serious Side Effects and Risks

• Infusion reactions: Hypersensitivity, anaphylaxis.
• Infections: Upper respiratory infections, sepsis.
• Progressive Multifocal Leukoencephalopathy (PML): Monitor for neurological symptoms.
• Liver Injury: Elevated liver enzymes; discontinue if severe.
• Skin Reactions: Rash, injection site irritation.

Comparison with Other Treatments

• Vedolizumab vs. Infliximab: Vedolizumab is gut-selective, while infliximab affects systemic immunity.
• Vedolizumab vs. Adalimumab: Adalimumab is a TNF inhibitor, while vedolizumab selectively targets gut endothelial cells.

ENTYVIO ® Clinical Studies and Patient Reviews

ENTYVIO® has been extensively tested in Phase 3 clinical trials for UC and CD.

Ulcerative Colitis (UC) Trials

• Clinical Remission at Week 52:
  • 42% (ENTYVIO IV every 8 weeks) vs. 16% (Placebo)
  • 46% (ENTYVIO SC every 2 weeks) vs. 14% (Placebo)
• Endoscopic Improvement:
  • 52% (IV) vs. 20% (Placebo)
  • 57% (SC) vs. 21% (Placebo)

Crohn’s Disease (CD) Trials

• Clinical Remission at Week 52:
  • 39% (ENTYVIO IV every 8 weeks) vs. 22% (Placebo)
• Corticosteroid-Free Remission:
  • 32% (ENTYVIO IV every 8 weeks) vs. 16% (Placebo)

Patient Reviews and Treatment Outcomes

• Updated clinical reviews suggest vedolizumab is effective in maintaining remission.
• Healthcare providers recommend it for patients with moderate to severe IBD.

Cost, Coverage, and Patient Support for ENTYVIO ® Treatment

Medication Cost Considerations

• The cost of ENTYVIO ® varies based on insurance coverage and region.
• Patients should consult their healthcare provider for financial assistance programs.

Supplements and Supportive Care

• Patients may require vitamin and mineral supplements to maintain overall health.
• A care team should monitor nutritional intake.

ENTYVIO ® FAQ

1. How long does it take for ENTYVIO® to work?

• Patients may see improvement within 6 weeks, but full effects can take 14 weeks.

2. Can ENTYVIO® be self-administered?

• Subcutaneous ENTYVIO® (108 mg) can be self-injected after proper training.

3. What should I do if I miss a dose?

• Take the missed SC dose as soon as possible and continue every 2 weeks thereafter.

4. Can ENTYVIO® be used during pregnancy?

• No increased risk of birth defects was found, but immune system effects on infants are unknown. Consult your doctor.

5. Can I receive vaccines while on ENTYVIO®?

• Live vaccines should be avoided; non-live vaccines are recommended.

ENTYVIO ® Manufacturer Information

• Manufacturer: Takeda Pharmaceuticals U.S.A., Inc.
• Contact: 1-877-825-3327
• FDA Adverse Event Reporting: 1-800-FDA-1088