Entyvio Vedolizumab for Injection

1. Indications and Usage
Ulcerative Colitis (UC):
Treatment of adult patients with moderately to severely active UC who have had an inadequate response to, or lost response to, conventional therapy or a TNFα blocker.
Crohn’s Disease (CD):
Treatment of adult patients with moderately to severely active CD who have had an inadequate response to, or lost response to, conventional therapy or a TNFα blocker.
2. Dosage and Administration
Route of Administration:
For Intravenous (IV) Infusion ONLY.
Recommended Dosage:
Standard Dose: 300 mg.
Schedule: Administered at Weeks 0, 2, and 6, and subsequently every 8 weeks thereafter.
Discontinuation: If no evidence of clinical benefit is observed by Week 14, therapy should be discontinued.
Critical Administration Instructions:
Reconstitution: Must be reconstituted with 4.8 mL of Sterile Water for Injection at room temperature. Do not shake vigorously.
Dilution: Dilute the reconstituted solution in 250 mL of 0.9% Sodium Chloride Injection or Lactated Ringer’s Injection.
Infusion Time: Administer over at least 30 minutes. Do not administer as an IV bolus or push.
Compatibility: Do not add other drugs to the infusion bag or administration set. Flush the line with 0.9% Sodium Chloride after infusion.
3. Mechanism of Action
Integrin Antagonism:
Vedolizumab is a humanized monoclonal antibody that specifically binds to the α4β7 integrin.
Targeted Inhibition:
It blocks the interaction between α4β7 integrin and MAdCAM-1 (Mucosal Addressin Cell Adhesion Molecule-1).
Therapeutic Result: This selectively inhibits the migration of memory T-lymphocytes across the endothelium into the gastrointestinal tract, reducing gut inflammation without causing broad systemic immunosuppression.
4. Safety and Warnings
Infections:
Increased risk of infections. Patients should be monitored for signs and symptoms of active infections.
Progressive Multifocal Leukoencephalopathy (PML):
PML, a rare and often fatal viral infection of the CNS caused by JC virus, has been reported.
Hypersensitivity:
Serious and life-threatening hypersensitivity reactions (e.g., anaphylaxis, angioedema) have been reported.
Malignancies:
The risk of malignancies with vedolizumab appears to be consistent with the background risk in patients with UC or CD.
5.Adverse Reactions and Clinical Research
Most Common Adverse Reactions:
Nasopharyngitis, headache, arthralgia, nausea, fever, upper respiratory tract infection, fatigue, cough, bronchitis, influenza, back pain, rash, pruritus, and pain in extremities.
Clinical Research Highlights:
In pivotal Phase 3 trials (GEMINI I and II), vedolizumab demonstrated significant improvement in clinical response and remission rates compared to placebo in both UC and CD patients.
6.Drug Interactions
Concomitant Immunosuppressives:
Concomitant use with other immunosuppressives (including thiopurines, methotrexate, or 5-ASA) does not significantly affect the pharmacokinetics of vedolizumab.
Live Vaccines:
Live vaccines should be avoided unless the potential benefit outweighs the risk.
TNF Blockers:
Concomitant use with TNF blockers increases the risk of infection and should be avoided.
7.Pharmaceutical Information
Chemical Composition:
Active Ingredient: Vedolizumab (IgG1κ subclass humanized monoclonal antibody).
Appearance: White to off-white lyophilized powder or cake.
Packaging: Single-use vial (300 mg).
Storage: Store in original carton at 2°C to 8°C. Do not freeze.