Vedolizumab Application Scope

Moderately to severely active ulcerative colitis in adults
Moderately to severely active Crohn’s disease in adults
Also used in some cases of pouchitis and checkpoint inhibitor–induced colitis

Characteristics

Ingredients:
- Vedolizumab (300 mg/vial; 108 mg prefilled syringe or pen)
- Excipients (IV vial): arginine HCl, histidine, histidine HCl, polysorbate 80, sucrose
- Prefilled syringe/pen excipients: arginine HCl, citric acid monohydrate, histidine, histidine HCl, polysorbate 80, sodium citrate, water
Properties:
- Humanized IgG₁ monoclonal antibody targeting α₄β₇ integrin on gut-homing T lymphocytes; blocks their GI tissue migration
Packaging Specification:
- Intravenous: 300 mg lyophilized powder in single-dose glass vial (NDC 64764‑300‑20)
- Subcutaneous: 108 mg/0.68 mL solution in single-dose prefilled syringe or pen
Storage:
- Unopened vials, syringes, pens: refrigerate at 2–8 °C, protected from light
- Prefilled syringe/pen may be at room temp (≤25 °C) up to 7 days if still in original carton
- Reconstituted IV solution: vial refrigerated ≤8 hours; diluted infusion bag: 2–8 °C up to 24 hrs (≤12 hrs at room), or in Lactated Ringer’s: refrigerated ≤6 hrs
Expiry Date:
- As indicated on packaging (see NDC carton) (typically ~2–3 years from manufacture)
Executive Standard:
- FDA, EMA, Health Canada approved product; prescribing info per regulatory standards
Approval Number:
- FDA Biologics License Application approved May 20, 2014
Date of Revision:
- Latest prescribing info revision March 2020 (infusion guidance) and 2024 (label update)
Manufacturer:
- Takeda Pharmaceuticals (marketed under Entyvio)

Guidelines for the Use of Vedolizumab

Dosage and Administration:
- IV Infusion (adult UC, CD, pouchitis):
  - 300 mg IV over ~30 minutes at weeks 0, 2, and 6, then every 8 weeks
  - If insufficient response in Crohn’s, a 4‑week dose may be given; discontinue if no benefit by week 14 (UC) or 14 (CD)
  - For pouchitis: 0, 2, 6 weeks then q8w; discontinue if no benefit by week 14
- SC Injection (maintenance):
  - Prefilled syringe/pen: 108 mg every 2 weeks, can switch from maintenance IV
- Preparation:
  - Reconstitute 300 mg vial with 4.8 mL Sterile Water for Injection; swirl gently, allow to stand ~15–20 min; withdraw 5 mL into infusion bag with 250 mL 0.9% NaCl or LR; do not freeze
- Administration Environment:
  - IV infusions administered by healthcare professionals prepared for hypersensitivity management
Adverse Reactions:
- Common:
  - Infusion site reactions, headache, nausea, fatigue, upper respiratory tract infection
- Serious:
  - Infusion-related/hypersensitivity (anaphylaxis, dyspnea, bronchospasm, urticaria, flushing, BP/HR fluctuations)
  - Serious infections: sepsis, tuberculosis, Listeria meningitis, CMV colitis, pouchitis, etc.
  - Rare PML: one reported case in a high-risk patient; monitor neurological changes
  - Liver injury: elevated transaminases/bilirubin; monitor for signs of liver dysfunction
Contraindications: Known serious hypersensitivity to vedolizumab or any excipients
Precautions:
- Screen/update immunizations before initiation; avoid live vaccines during therapy
- Monitor for infections (tuberculosis, serious systemic infections)
- Observe for infusion reactions; have emergency treatment available
- Monitor liver function tests during treatment
- For SC: rotate injection sites; only trained individuals should administer in upper arm

Interactions

Drug Interactions:
No direct metabolic drug–drug interactions, but caution when using with other immunosuppressants (e.g., TNF blockers, rituximab, natalizumab) due to additive infection risk
Live vaccines contraindicated during treatment; risk of infection when administered concurrently

Note:

If there is a new packaging for the drug, the new packaging shall prevail. The above information is sourced from DengYue Medicine.
It is only for internal discussion among medical staff and does not serve as a basis for medication. For specific medication guidelines, please consult the attending physician.