Parenteral Manual

Vedolizumab (NON-FORMULARY)

Disclaimer: Official controlled document is the CHEO online copy. It is the responsibility of user to ensure that any paper copy version is the same as the online version before use.

Alternate Name(s): 
Humanized immunoglobulin G1 monoclonal antibody
Original Date: 
March 2019
Revised Date: 
December 2019
  • Treatment of moderate to severe active Ulcerative Colitis and Crohn’s Disease who have, i) inadequate response to, ii) loss of response to or, iii) unable to tolerate conventional therapy or a TNF-alpha antagonist.
Reconstitution and Stability: 



300 mg      4.8 mL      5 mL      60 mg/mL
  • Available as 300 mg lyophilized white to off white cake single use vial
  • Store vials in original carton refrigerated (2 – 8ᵒC). DO NOT FREEZE.
  • Protect from light
  • Reconstitute at room temperature
  • Gently swirl vial to reconstitute. DO NOT SHAKE OR INVERT.
  • Let reconstituted vial sit for up to 20 minutes to allow for reconstitution and for any foam to settle. May swirl and sit another 10 minutes if needed.
  • Invert vial THREE TIMES prior to withdrawing reconstituted solution.
  • Do not use if solution has uncharacteristic colour or contains particulate matter. Should be clear or opalescent, colorless to light brownish yellow.
  • Add dose to 250 mL of 0.9% sodium chloride solution (NOT smaller volume).
  • Solution may be stored up to 24 hours - up to 12 hours at room temperature and additional time refrigerated

-  Solutions Compatible: 0.9% NaCl

Incompatible:  Do not mix with other drugs or solution


(For approved routes of administration by nursing personnel, refer to Policy for the Administration of Intravenous Medications.)

IV Direct NO
IV Intermittent Infusion

YES - large volume pump only
Usual dilution: 1.2 mg/mL (300 mg in 250 mL 0.9%NaCl)
Infusion time:  30 minutes

Flush with 30 mL 0.9% NaCl post infusion

IV Continuous Infusion NO



(For neonatal dosages, refer to Neonatal IV Drug Manual.)

Pediatric (12 - 18 years) and Adult:

  • Induction dosing:

     - 300 mg IV at week 0

     - 300 mg IV 2 weeks after first treatment (Week 2)

     - 300 mg IV 6 weeks after first treatment (Week 6)

  • Maintenance dosing:

     - 300 mg IV every 8 weeks after third induction dose

Potential hazards of parenteral administration: 
  • Infusion related reactions are possible and could include, but are not limited to: anaphylaxis, hypersensitivity reactions (rash, urticaria, flushing, bronchospasm)
  • Headache, nasopharyngitis, rash, pruritus, arthralgia, nausea, constipation, fatigue, fever.
  • Potentially increased risk for development of Progressive Multifocal Leukoencephalopathy (PML). Patients are to be monitored for new or worsening neurological signs and symptoms.
  • Increased susceptibility for the development of infections, including tuberculosis (TB), cytomegalovirus (CMV) and listeriosis. TB screening should be done prior to therapy initiation.
  • Therapy is discontinued at week 14 if no clinical/therapeutic response is observed.
  • Patients should be observed for two hours after their first and second infusions, and then for one hour for all subsequent infusions secondary to the potential for these serious reactions.
  • Patients previously treated with natalizumab (Tysabri®) must wait at least 12 weeks from last dose before initiating vedolizumab.
  • Prior to therapy initiation, ensure patient has all immunizations up to date according to the public immunization guideline of their respective province of residency.


  • Conrad, M.A. et al. (2015). The Use of Vedolizumab for Treatment of Severe Pediatric Inflammatory Bowel Disease. J Gastroenterology. 148(4): S-72.
  • Entyvio Summary of Product Characteristics. Takeda Pharmaceuticals. 2014.
  • Essat, M et al. (2016). Vedolizumab for the Treatment of Adults with Moderate-to-Severe Active Ulcerative Colitis: An evidence Review Group Perspective of a NICE Single Technology Appraisal. Pharmacoeconomics. 34: 245 – 257.
  • Stallmach, A., Schmidt.C., Tewich, M. (2016). Vedolizumab for the treatment of ulcerative colitis. Expert Review of Gastroenterology & Hepatology, 10:2, 165-175.

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