Entyvio Vedolizumab for Injection

1. Indications and Usage
Ulcerative Colitis (UC): Treatment of adult patients with moderately to severely active UC.
Crohn’s Disease (CD): Treatment of adult patients with moderately to severely active CD.
2. Dosage and Administration
Route of Administration:
For Intravenous (IV) Infusion ONLY. Do not administer by IV push or bolus injection.
Recommended Dosage:
Standard Dose: 300 mg administered as an intravenous infusion over approximately 30 minutes.
Dosing Schedule: Administer at Weeks 0, 2, and 6 after the first dose, and then every 8 weeks thereafter.
Discontinuation of Treatment:
Therapy should be discontinued in patients who show no evidence of therapeutic benefit by Week 14.
Preparation:
Reconstitute with Sterile Water for Injection and dilute with 0.9% Sodium Chloride Injection or Lactated Ringer’s Injection.
3. Mechanism of Action
Integrin Antagonist:
Vedolizumab is a humanized IgG1 monoclonal antibody that binds to the α4β7 integrin on the surface of leukocytes.
Gut Selectivity:
By blocking the interaction between α4β7 integrin and its ligand MAdCAM-1 (expressed on gut vascular endothelium), vedolizumab inhibits the lymphocyte trafficking across the endothelium into the gastrointestinal tract.
Distinct Feature:
Unlike natalizumab, vedolizumab does not bind to α4β1 integrin and is highly selective for the gut, resulting in a lower risk of central nervous system (CNS) adverse events.
4. Safety and Warnings
Serious Infections & Immunosuppression:
Increases the risk of infections (e.g., Pneumocystis jirovecii pneumonia, systemic fungal infections). Screen for tuberculosis (TB) prior to initiation. Avoid concurrent use with other potent immunosuppressants or natalizumab.
Infusion Reactions:
Hypersensitivity reactions, including anaphylaxis, can occur. Monitor patients during infusion.
Malignancy:
Potential risk of malignancies due to immunosuppression.
Hepatotoxicity:
Cases of drug-induced liver injury have been reported. Monitor liver function tests.
Vaccinations:
Avoid administration of live vaccines (e.g., oral polio, BCG) during treatment.
5.Adverse Reactions
Most Common (Incidence ≥3% and greater than placebo):
Nasopharyngitis, headache, arthralgia, nausea, diarrhea, influenza, back pain, rash, pruritus, and upper respiratory tract infection.
6.Drug Interactions
Immunosuppressants:
Use with caution when combined with azathioprine, 6-mercaptopurine, or methotrexate.
TNF Antagonists:
Concomitant use with TNF antagonists (e.g., infliximab, adalimumab) is not recommended due to increased risk of infection.
Natalizumab:
Concomitant use is not recommended due to potential increased risk of PML and infection.
7.Pharmaceutical Information
Chemical Composition:
Active Ingredient: Vedolizumab.
Available Strength: 300 mg lyophilized powder for IV infusion in a single-dose vial.
Appearance: White to off-white, porous, low-vacuum freeze-dried cake.
Storage: Store at 2°C to 8°C (36°F to 46°F) in the original carton to protect from light.