Alternate Name(s):
ENTYVIO
Classification:
Humanized immunoglobulin G1 monoclonal antibody
Original Date:
March 2019
Revised Date:
December 2019
Indications:
- 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:
| VIAL SIZE |
STERILE WATER for INJECTION REQUIRED |
TOTAL VOLUME | FINAL CONCENTRATION |
| 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
Compatibility:
- Solutions Compatible: 0.9% NaCl
- Incompatible: Do not mix with other drugs or solution
Administration:
(For approved routes of administration by nursing personnel, refer to Policy for the Administration of Intravenous Medications.)
| SC | NO |
| IM | NO |
| IV Direct | NO |
| IV Intermittent Infusion |
YES - large volume pump only Flush with 30 mL 0.9% NaCl post infusion |
| IV Continuous Infusion | NO |
Dosage:
(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.
Notes:
- 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.
References:
- 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.